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articles nature publishing group

Intervention and Prevention

Effect of Diet and Exercise, Alone or


Combined, on Weight and Body Composition
in Overweight-to-Obese Postmenopausal
Women
Karen E. Foster-Schubert1,2, Catherine M. Alfano3, Catherine R. Duggan1, Liren Xiao1,
Kristin L. Campbell4, Angela Kong1, Carolyn E. Bain1, Ching-Yun Wang1,2, George L. Blackburn5
and Anne McTiernan1,2

Lifestyle interventions for weight loss are the cornerstone of obesity therapy, yet their optimal design is debated.
This is particularly true for postmenopausal women; a population with a high prevalence of obesity yet toward whom
fewer studies are targeted. We conducted a year-long, 4-arm randomized trial among 439 overweight-to-obese
postmenopausal sedentary women to determine the effects of a calorie-reduced, low-fat diet (D), a moderate-
intensity, facility-based aerobic exercise program (E), or the combination of both interventions (D+E), vs. a no-lifestyle-
change control (C) on change in body weight and composition. The group-based dietary intervention had a weight-
reduction goal of ≥10%, and the exercise intervention consisted of a gradual escalation to 45-min aerobic exercise
5 day/week. Participants were predominantly non-Hispanic whites (85%) with a mean age of 58.0 ± 5.0 years, a
mean BMI of 30.9 ± 4.0 kg/m2 and an average of 47.8 ± 4.4% body fat. Baseline and 12-month weight and adiposity
measures were obtained by staff blinded to participants’ intervention assignment. Three hundred and ninety nine
women completed the trial (91% retention). Using an intention-to-treat analysis, average weight loss at 12 months
was −8.5% for the D group (P < 0.0001 vs. C), −2.4% for the E group (P = 0.03 vs. C), and −10.8% for the D+E group
(P < 0.0001 vs. C), whereas the C group experienced a nonsignificant −0.8% decrease. BMI, waist circumference, and
% body fat were also similarly reduced. Among postmenopausal women, lifestyle-change involving diet, exercise, or
both combined over 1 year improves body weight and adiposity, with the greatest change arising from the combined
intervention.

Obesity (2012) 20, 1628–1638. doi:10.1038/oby.2011.76

Introduction nonrandomized interventions have demonstrated improve-


The prevalence of obesity has reached epidemic levels over the ments in biomarkers relating to diabetes, cardiovascular dis-
past few decades, and concurrent with this rise are increases ease, and cancer risk (3,5). Smaller-scale randomized studies of
in numerous obesity-associated diseases including heart dis- lifestyle change to induce weight loss have shown improvements
ease, certain types of cancer, and diabetes (1). The cornerstone in hypertension and metabolic syndrome (6–8). The Diabetes
of therapeutic interventions to treat or prevent these diseases Prevention Program (DPP) randomized over 3,000 individuals
is weight loss via lifestyle modification, including hypocaloric at high risk for developing diabetes to an intensive, individual-
diet and/or increased physical activity along with behavioral focused combined diet-and-exercise lifestyle intervention vs.
techniques to support these changes (2). Typical weight loss pharmaceutical therapies or placebo and demonstrated sig-
resulting from lifestyle change is between 5 and 10% of base- nificant reductions in diabetes incidence. Particularly, those in
line weight, so such approaches rarely bring an obese indi- the lifestyle intervention arm experienced the greatest (58%)
vidual to a normal body weight (3). However, losing even this decrease in disease incidence over 3 years, providing strong
modest amount of weight brings health benefits (4). Multiple evidence for the efficacy of the lifestyle program (9).

1
Fred Hutchinson Cancer Research Center, Seattle, Washington, USA; 2University of Washington School of Medicine, Seattle, Washington, USA; 3Office of Cancer
Survivorship, National Cancer Institute, Bethesda, Maryland, USA; 4University of British Columbia, Vancouver, British Columbia, Canada; 5Harvard Medical School,
Boston, Massachusetts, USA. Correspondence: Anne McTiernan (amctiern@fhcrc.org)
Received 1 September 2010; accepted 3 March 2011; advance online publication 14 April 2011. doi:10.1038/oby.2011.76

1628 VOLUME 20 NUMBER 8 | august 2012 | www.obesityjournal.org


articles
Intervention and Prevention

Given the health impacts of the obesity epidemic and the postmenopausal hormone therapy within the prior 3 months; history
research suggesting that weight loss can ameliorate these prob- of breast cancer or other serious medical condition(s); alcohol intake
in excess of 2 drinks/day or current smoker; contraindication to par-
lems, there have been numerous calls for optimal obesity treat-
ticipating in the diet or exercise intervention for any reason, including
ment strategies. The NIH Obesity Education Initiative Expert an abnormal exercise tolerance test, current or planned participation
Panel suggested a caloric deficit of 500–1,000 kcal/day using an in another structured weight loss program, use of weight loss medica-
individualized dietary strategy, along with 45 min of moder- tions, or additional factors that might interfere with measurement of
ate-intensity physical activity 5 days/week (5). The Institute of outcomes or with the success of the intervention (e.g., inability to attend
facility-based sessions).
Medicine recommended at least 1 h/day of moderately intense
Women were recruited through targeted mass mailing campaigns and
physical activity coupled with a caloric deficit whereas the media publicity or community outreach (Figure 1). Invitation letters
US Department of Agriculture similarly suggests individu- were sent to 126,802 age-eligible women and 5,621 responded; in addi-
als engage in close to 1 h of moderate-to-vigorous intensity tion we received 2,048 media and community outreach-prompted calls.
exercise on most days of the week, without exceeding caloric 929 women were telephone screen-eligible, a total of 703 women attended
the information session, 684 women were screened in clinic, and 439
intake requirements (3,10). The US Center for Disease Control
were randomized into the study (~80% from mass mailings, 20% from
instead suggests at least 30 min/day of moderate-intensity media and community outreach).
exercise most days of the week while maintaining sensible por-
tion sizes (11). The recommendations from these agencies are Study design and randomization
all based on expert opinion supported by the available data. The study design for the NEW trial is shown in Figure 1. Following
baseline data collection, eligible women were randomized into one of
Although numerous studies have examined the effect of life-
four study arms: (i) dietary weight loss (D, N = 118); (ii) moderate-
style interventions on body weight, few have focused on post- to-vigorous intensity aerobic exercise (E, N = 117); (iii) both interven-
menopausal women, a group experiencing particularly high tions combined (D+E, N = 117); or (iv) no-lifestyle-change control (C,
rates of overweight and obesity using a tested intervention such N = 87). The random assignment was generated by a computerized
as that undertaken by the DPP, a program known to reduce program, stratified according to BMI (<30 kg/m2 or ≥30 kg/m2) and
participants’ self-reported race/ethnicity (non-Hispanic white, black,
disease risk in other populations, and measured effects over a
or other). In addition, to achieve a proportionally smaller number of
12-month period (12). Hence, questions still remain regarding women assigned to the control group, a permuted blocks randomiza-
the best approach for weight loss from lifestyle change for this tion with blocks of four was used, wherein the control assignment was
group in particular, and randomized, controlled studies are randomly eliminated from each block with a probability of ~1 in 4.
the best way to demonstrate effectiveness of interventions that
could influence public health recommendations. Lifestyle-change interventions
The NEW dietary weight-loss intervention comprised our modifica-
We conducted a year-long, group-based lifestyle intervention tion of the dietary component of the DPP (9) and the Look Action
to examine the independent and combined effects of physical for Health in Diabetes (AHEAD) (13) lifestyle intervention programs,
activity and dietary weight loss on body weight as well as body with the following goals: total daily energy intake of 1,200–2,000 kcal/
composition among 439 sedentary, overweight/obese post- day based on baseline weight, <30% daily energy intake from fat, and a
menopausal women. We hypothesized that the women rand- 10% reduction in body weight by 6 months with maintenance thereaf-
ter to 12 months. Content of the dietary counseling sessions was modi-
omized to the intervention groups would experience greater fied to better fit our study population (less focus on diabetes or diabetes
weight loss and improvements in body composition param- risk), and the frequency and type of sessions (individual vs. group) also
eters than those randomized to the control group (who main- varied from DPP and Look AHEAD. Women met individually with a
tained their usual lifestyle), and furthermore that weight loss study dietitian for personalized goal-setting on at least two occasions,
and changes in body composition would vary among the inter- followed by weekly meetings in groups of ~5–10 women, through the
first 6 months. Thereafter (months 7–12), dietitians had contact with
vention groups based on the separate and combined impacts of participants twice a month, including one face-to-face contact (indi-
diet and exercise on overall energy balance. vidual or group session) and one additional contact via phone or email.
Participants were permitted additional in-person sessions, phone, or
Methods and Procedures email contacts beyond the 32 expected, if they or the dietician felt these
The Nutrition and Exercise in Women (NEW) study, conducted from would help to achieve intervention goals. This combination of individ-
2005 to 2009, was a 12-month randomized, controlled trial using a ual and group-based approaches was used to maximize the benefits of
4-arm design to compare the effect of three lifestyle-change interven- targeted, personalized recommendations along with the social support
tions (moderate-to-vigorous intensity aerobic exercise, dietary weight and greater cost-effectiveness of a group setting. Women were asked to
loss, or both interventions combined) vs. control (no lifestyle change) on record all food eaten daily for at least 6 months, or until they reached
body weight and composition. All study procedures were reviewed and their individual weight loss goal (10%). Food journals were collected by
approved by the Fred Hutchinson Cancer Research Center (FHCRC) the dietitian and returned with feedback. Journaling, weekly weigh-ins,
institutional review board in Seattle, WA, and all participants provided and session attendance were tracked to promote adherence to the diet
signed informed consent. intervention.
Based on our previous exercise research in a similar population, the
Participant recruitment, inclusion, and exclusion criteria goal of the NEW exercise intervention was ≥45 min of moderate-to-vigor-
The target population for the NEW study included postmenopau- ous intensity exercise, 5 days/week (225 min/week) for 12 months (14,15).
sal women from the greater Seattle, WA area, aged 50–75 years, who Participants attended at least three sessions/week at our study facility
were overweight or obese (BMI ≥25 kg/m2, or ≥23 kg/m2 for Asian- where they were supervised by an exercise physiologist, and exercised for
American women), and exercising <100 min/week at moderate inten- their remaining sessions at home. The exercise training program began
sity or greater. Specific exclusion criteria included: diagnosed diabetes, with a 15 min session at 60–70% maximal heart rate (determined by
fasting blood glucose ≥126 mg/dl, or use of diabetes medications; use of baseline exercise treadmill testing) and progressed to the target 70–85%

obesity | VOLUME 20 NUMBER 8 | august 2012 1629


articles
Intervention and Prevention

Women sent mass mailings Women calling in response to


126,802 media and community outreach
2,048
Returned interest survey
5,621

Eligible after phone interview (N = 929)

Attended information session (N = 703)

Screened in clinic (N = 684)


Not randomized (N = 245)
Anthropometry = 506 eligible
Did not meet eligibility criteria = 191
Maximal treadmill test = 443 eligible Declined participation = 54
DXA = 439 eligible

Randomized (N = 439)

Control (delayed intervention) Calorie-reduced diet Aerobic exercise Aerobic exercise + calorie-
(N = 87) (N = 118) (N = 117) reduced diet (N = 117)

Did not receive intervention Did not receive intervention Did not receive intervention Did not receive intervention
as allocated (N = 7) as allocated (N = 13) as allocated (N = 11) as allocated (N = 9)
4 = Lost to follow-up 6 = Lost to follow-up 5 = Lost to follow-up 1 = missing baseline blood
3 = Withdrew (dissatisfied with 7 = Withdrew (4 = dissatisfied with 6 = Withdrew (2 = illness/medical 5 = Lost to follow-up
randomization) randomization; 2 = work or family reasons; 2 = transportation; 1 = 4 = Withdrew (2 = work or family
demands; 1 = illness/medical work or family demands; 1 = death demands; 1 = illness/medical
reasons) unrelated to intervention) reasons; 1 = relocation)

Completed trial Completed trial Completed trial Completed trial


(N = 80) (N = 105) (N = 106) (N = 108)
Anthropometry = 80 Anthropometry = 103 Anthropometry = 106 Anthropometry = 108
DXA = 80 DXA = 104 DXA = 105 DXA = 107
VO2max = 73 VO2max = 97 VO2max = 96 VO2max = 104

Figure 1  Flow diagram of the progress through the NEW trial. DXA, dual X-ray absorptiometry; VO2max, cardiorespiratory fitness test.

maximal heart rate for 45 min by the 7th week after enrollment where it their diet or exercise habits for the duration of the trial. At the end of
was maintained for the remainder of the study. Women wore Polar heart 12 months, participants in the control group were offered four group
rate monitors (Polar Electro, Lake Success, NY) during facility exercise nutrition classes and 8 weeks of facility exercise training with individual-
sessions to assist with attaining their target heart rate. In addition, during ized guidance from an exercise physiologist, as an incentive to undergo
both facility and home sessions they recorded the mode and duration randomization.
of exercise, and peak heart rate achieved. Facility-based exercise con-
sisted of treadmill walking, stationary bicycling, and use of other aerobic Study measures and data collection
machines; while a variety of home exercises were encouraged including All study measures were obtained by trained study personnel who were
walking/hiking, aerobics, and bicycling. A small amount of resistance blinded to the participants’ randomization status.
training to strengthen joints and limit injury was recommended, though Participants completed a series of questionnaires at their baseline
not required. Activities of at least four metabolic equivalents according screening visit before randomization, including demographic informa-
to the Compendium of Physical Activities (16) such as brisk walking tion, medical history, health habits, reproductive and body weight history,
were counted toward the prescribed aerobic exercise target. Activity logs diet intake (via a validated 120-item self-administered Food Frequency
were reviewed weekly by study staff in order to monitor adherence. Par- Questionnaire (FFQ)) (17), as well as frequency, duration, and intensity
ticipants who were not meeting exercise targets were contacted by staff of physical activity over the preceding 3-month period (via an interview-
to discuss barriers and approaches to increase activity. In addition, the administered Minnesota Physical Activity Questionnaire) (18). These
dietitians and exercise physiologists met regularly with a clinical health same questionnaires were completed at the end of the 12-month study
psychologist experienced in lifestyle behavior change to discuss partici- period.
pant progress and refine behavior modification goals according to each Anthropometric measures were obtained at baseline and again at 12
participant’s needs. months, whereas participants wore a hospital gown without shoes. Weight
Women randomized to the diet + exercise group received both the and height were measured to the nearest 0.1 kg and 0.1 cm, respectively,
dietary weight loss and aerobic exercise interventions. They participated with a balance beam scale and stadiometer. Both measures were made
in separate groups for the dietary weight-loss intervention from women in duplicate and averaged. BMI was calculated as weight in kilograms
assigned to diet alone. Although the diet + exercise group could use the divided by the square of height in meters. Waist and hip circumferences
exercise facility at the same time as participants assigned to the exercise- were measured in duplicate to the nearest 0.5 cm using a fiberglass tape,
only group, they were instructed not to discuss the diet intervention. and averaged. Waist circumference was obtained at the end of normal
Women randomized to the control group were requested not to change expiration in the horizontal plane at the minimal waist, whereas the hip

1630 VOLUME 20 NUMBER 8 | august 2012 | www.obesityjournal.org


articles
Intervention and Prevention

measure was obtained at the maximum point also in the horizontal plane. body ­composition as well as additional anthropometric measures. With
Total and percentage body fat and lean mass were measured using a dual 439 women enrolled in the NEW trial, we had over 80% power to detect
X-ray absorptiometry whole-body scanner (GE Lunar, Madison, WI) a 3.16 kg difference between groups, using a Bonferroni adjustment
with participants in a supine position. for the multiple comparisons (two-sided α = 0.05/6), and assuming a
Adherence to the diet and exercise interventions was assessed via 10% drop-out rate/5% drop-in rate. We experienced 91% retention at
multiple approaches. The dietary intervention was evaluated by weight 12 months, with 399 out of the 439 women randomized returning for
loss, and monitoring frequency of session attendance (19), food journal final assessments (Figure 1). All analyses were based on the assigned
completion and submission, and self-weighing. These measures were intervention at the time of randomization regardless of adherence
reviewed weekly by study dieticians. Exercise participants tracked their (i.e., intention-to-treat), with a conservative no-change-from-baseline
activities in a daily exercise log that was reviewed on a weekly basis by imputation made for the missing values.
the exercise physiologists. All participants completed certain measures We computed the mean change in body weight, anthropometric, and
at baseline and 12 months to assess differences and change across study body composition measures from baseline to 12 months and assessed the
arms. FFQs were completed primarily to assess dietary patterns and differences between each of the intervention and control groups. As these
change in fat intake. Participants wore pedometers (Accusplit, Silicon outcome measures were normally distributed, data transformation was
Valley, CA) while awake for 7 consecutive days in order to determine not necessary. We used the generalized estimating equations modification
an average daily step count. Cardiorespiratory fitness (VO2max) was of linear regression to account for the longitudinal nature of the data and
assessed using a maximal graded treadmill test according to a modified correlation within individuals. As a secondary analysis, we compared the
branching protocol starting at 3.0 mph and 0% grade with incremental mean 12-month changes in outcomes by tertiles of adherence measures.
increases in speed or grade every 2 min (20,21). Heart rate and oxygen Additional descriptive data are presented as mean ± s.d., unless otherwise
uptake were continuously monitored with an automated metabolic cart noted. All statistical analyses were performed using SAS software version
(MedGraphics, St Paul, MN). 9.1 (SAS Institute, Cary, NC).

Statistical analyses
Our primary outcome was the comparison of change in body weight Results
by study group from baseline to 12 months. Secondary outcomes The baseline characteristics of the 439 participants randomized
included the comparison by study group of the 12-month change in to the NEW trial are shown in Table 1. Women were on average

Table 1  Baseline characteristics of NEW trial participants


All (N = 439) Control (N = 87) Diet (N = 118) Exercise (N = 117) Diet+Exercise (N = 117)
Mean (s.d.) Mean (s.d.) Mean (s.d.) Mean (s.d.) Mean (s.d.) P a
Age (years) 58.0 (5.0) 57.4 (4.4) 58.1 (6.0) 58.1 (5.0) 58.0 (4.5) 0.76
Weight (kg) 83.6 (11.8) 84.2 (12.5) 84.0 (11.8) 83.7 (12.3) 82.5 (10.8) 0.71
BMI (kg/m2) 30.9 (4.0) 30.7 (3.9) 31.1 (3.9) 30.7 (3.7) 31.0 (4.3) 0.83
Waist circumference 94.5 (10.1) 94.8 (10.2) 94.6 (10.2) 95.1 (10.1) 93.7 (9.9) 0.76
(cm)
Body fat mass (kg) 39.8 (8.1) 40.1 (8.5) 39.8 (8.1) 39.9 (8.2) 39.4 (7.9) 0.95
Body fat (%) 47.2 (4.3) 47.3 (4.4) 47.0 (4.3) 47.3 (4.1) 47.4 (4.5) 0.90
Lean mass (kg) 40.2 (5.0) 40.6 (5.3) 40.7 (5.1) 40.2 (5.3) 39.6 (4.3) 0.36
Lean mass (%) 48.5 (4.2) 48.5 (4.3) 48.7 (4.3) 48.3 (3.9) 48.3 (4.4) 0.87
VO2max (kg/ml/min) 22.9 (4.0) 23.1 (4.1) 22.7 (3.8) 22.5 (4.1) 23.5 (4.1) 0.17
Usual physical activity 32.8 (44.1) 23.8 (41.2) 33.6 (45.5) 37.7 (43.7) 33.6 (44.7) 0.16
(min/week)b
Total calories (kcal/day)c 1,934 (638) 1,988 (669) 1,884 (661) 1,986 (589) 1,890 (638) 0.46
Fat intake (percentage of 34.3 (6.9) 35.6 (6.9) 33.1 (6.3) 33.6 (6.9) 35.3 (7.3) 0.02
total kcal/day)c
N (%) N (%) N (%) N (%) N (%) Pd
Ethnicity
  Non-Hispanic white 373 (85.0) 74 (85.1) 101 (85.6) 98 (83.8) 100 (85.5) 0.15
  Non-Hispanic black 35 (8.0) 6 (6.9) 9 (7.6) 15 (12.8) 5 (4.3) 0.07
Education
  College graduate 287 (65.4) 59 (67.8) 76 (64.4) 70 (59.9) 82 (70.1) 0.26
Employment
  Part-time employed 123 (28.0) 25 (33.8) 34 (32.4) 34 (35.4) 30 (29.1) 0.62
  Full-time employed 222 (50.6) 47 (63.5) 58 (55.2) 53 (55.2) 64 (62.1) 0.42
a
ANOVA test, comparing baseline characteristics among four groups. bFrom Physical Activity Index Questionnaire. cN = 427 for total; N = 85 for control; N = 114 for diet,
exercise, and diet + exercise groups. dχ2-test or Fisher exact test, comparing baseline characteristics among four groups.

obesity | VOLUME 20 NUMBER 8 | august 2012 1631


1632
Table 2  Baseline and 12-month body weights, anthropometric measures, and body composition measures by intervention group
Control (N = 87) Diet (N = 118) Exercise (N = 117) Diet + exercise (N = 116)
articles

Baseline 12 months %Δ Baseline 12 months %Δ Baseline 12 months %Δ Baseline 12 months %Δ


Mean (s.d.) Mean (s.d.) Mean (s.d.) Mean (s.d.)
Weight (kg) 84.2 (12.5) 83.5 (12.3) –0.8 84.0 (11.8) 76.9 (13.4) –8.5 83.7 (12.3) 81.7 (12.4) –2.4 82.5 (10.8) 73.6 (11.5) –10.8
PC < 0.0001 PE < 0.0001 PD+E = 0.03 PC = 0.03 PD < 0.0001 PD+E < 0.0001 PC < 0.0001 PE < 0.0001 PD = 0.03
BMI (kg/m2) 30.7 (3.9) 30.5 (4.1) –0.7 31.0 (3.9) 28.4 (4.6) –8.6 30.7 (3.7) 29.9 (3.8) –2.4 31.0 (4.3) 27.6 (4.5) –10.8
PC < 0.0001 PE < 0.0001 PD+E = 0.02 PC = 0.017 PD < 0.0001 PD+E < 0.0001 PC < 0.0001 PE < 0.0001 PD = 0.02
Waist (cm) 94.8 (10.2) 95.7 (9.6) 1.0 94.6 (10.2) 90.2 (11.5) –4.7 95.1 (10.1) 93.1 (9.8) –2.1 93.7 (9.9) 86.7 (11.6) –7.5
Intervention and Prevention

PC < 0.0001 PE = 0.004 PD+E = 0.004 PC = 0.001 PD = 0.004 PD+E < 0.0001 PC < 0.0001 PE < 0.0001 PD = 0.004
Body fat (kg) 40.1 (8.5) 39.7 (8.7) –1.0 39.7 (8.1) 33.6 (10.0) –15.6 39.9 (8.2) 37.8 (8.7) –5.3 39.4 (7.9) 31.2 (9.5) –20.8
PC < 0.0001 PE < 0.0001 PD+E = 0.006 PC = 0.0006 PD < 0.0001 PD+E < 0.0001 PC < 0.0001 PE < 0.0001 PD = 0.006
Body fat (%) 47.3 (4.4) 47.1 (5.2) –0.3 47.0 (4.3) 42.8 (6.6) –8.9 47.3 (4.1) 45.7 (4.9) –3.3 47.4 (4.5) 41.5 (7.0) –12.4
PC < 0.0001 PE < 0.0001 PD+E = 0.005 PC = 0.0006 PD < 0.0001 PD+E < 0.0001 PC < 0.0001 PE < 0.0001 PD = 0.005
Lean mass (kg) 40.6 (5.3) 40.5 (5.0) –0.1 40.7 (5.1) 39.9 (4.8) –1.9 40.2 (5.3) 40.5 (5.1) 0.7 39.6 (4.3) 39.2 (3.9) –1.1
PC = 0.0048 PE < 0.0001 PD+E = 0.15 PC = 0.20 PD < 0.0001 PD+E = 0.003 PC = 0.15 PE = 0.003 PD = 0.15
Lean mass (%) 48.5 (4.3) 48.9 (4.8) 0.8 48.7 (4.3) 52.8 (6.5) 8.3 48.3 (3.9) 50.0 (4.8) 3.5 48.3 (4.4) 54.0 (7.0) 11.8
PC < 0.0001 PE < 0.0001 PD+E = 0.008 PC = 0.0005 PD < 0.0001 PD+E < 0.0001 PC < 0.0001 PE < 0.0001 PD = 0.008
Physical activity 23.8 (41.2) 63.8 (96.3) 168 33.6 (45.5) 57.7 (87.8) 72 37.7 (43.7) 223.0 (135) 491 33.6 (44.7) 238.0 (138) 609
(min/week)a
PC = 0.21 PE < 0.0001 PD+E < 0.0001 PC < 0.0001 PD < 0.0001 PD+E = 0.28 PC < 0.0001 PD < 0.0001 PE = 0.28
Pedometer 5,605 6,155 9.8 5,539 6,110 10.3 5,777 8,192 41.8 5,980 9,448 58.0
(steps/week)b (2,334) (2,811) (2,257) (2,865) (2,129) (3,373) (2,393) (3,316)
PC = 0.95 PE < 0.0001 PD+E < 0.0001 PC < 0.0001 PD < 0.0001 PD+E = 0.0056 PC < 0.0001 PD < 0.0001 PD+E = 0.0056
VO2max (l/min) 1.93 (0.37) 1.91 (0.33) –1.1 1.89 (0.31) 1.87 (0.31) –1.0 1.85 (0.31) 2.02 (0.34) 8.9 1.93 (0.34) 2.05 (0.41) 6.5
PC = 0.92 PE < 0.0001 PD+E < 0.0001 PC < 0.0001 PD < 0.0001 PD+E = 0.38 PC = 0.0007 PE = 0.38 PD < 0.0001
Total calories 1,988 (669) 1,768 (606) –11.0 1,884 (661) 1,637 (621) –13.0 1,986 (589) 1,801 (551) –9.3 1,890 (638) 1,617 (598) –14.0
(kcal/day)c
PC = 0.72 PE = 0.37 PD+E = 0.70 PC = 0.66 PD = 0.37 PD+E = 0.17 PC = 0.48 PE = 0.17 PD = 0.70
Fat intake 35.6 (6.9) 33.4 (6.8) –6.2 33.1 (6.3) 27.3 (7.2) –18.0 33.6 (6.9) 32.5 (7.3) –3.3 35.3 (7.3) 28.3 (7.6) –20.0
(percentage of 
PC < 0.0001 PE < 0.0001 PD+E = 0.18 PC = 0.12 PD < 0.0001 PD+E < 0.0001 PC < 0.0001 PE < 0.0001 PD = 0.18
kcal/day)c
Baseline observation carried forward for 12-month missing values, P < 0.05/6 = 0.0083 considered significant.
PC, comparing the change from baseline to 12-month follow-up between control and intervention group; PE, comparing the change from baseline to 12-month follow-up between exercise and other intervention group;
PD, comparing the change from baseline to 12-month follow-up between diet and other intervention group; PD+E, comparing the change from baseline to 12-month follow-up between diet + exercise and other intervention
group.
a
From Physical Activity Index Questionnaire. bN = 82 for control, N = 117 for diet, N = 114 for exercise, N = 115 for diet + exercise. cN = 85 for control, N = 114 for diet, exercise, and diet + exercise group.

VOLUME 20 NUMBER 8 | august 2012 | www.obesityjournal.org


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Intervention and Prevention

58.0 ± 5.0 years old, obese (BMI 30.9 ± 4.0 kg/m2) with a high the diet-alone and diet + exercise groups, women attended an
percent body fat (47.2 ± 4.3%), and had poor cardiorespiratory average of 27-diet behavior change sessions (86%). Women
fitness (VO2max 22.9 ± 4.0 kg/ml/min). Approximately 85% of randomized to exercise alone achieved on average 80% of the
participants were non-Hispanic white, 65% were college grad- target 225 min/week aerobic exercise over the 12-month trial,
uates, and about half were full-time employed. With the excep- whereas women randomized to diet + exercise achieved 85%.
tion of percent fat intake in the diet estimated by FFQ, there Both groups significantly increased their average pedometer
were no statistically significant differences in any demographic steps/day (E: 2,354 ± 2,749 steps/day, 42% increase; D+E: 3,408
or lifestyle variables between the study groups at baseline. Forty ± 3,001 steps/day, 58% increase) and VO2max (E: 0.16 ± 0.36 l/
women did not complete the study (D = 13, E = 11, D+E = 9, C min, 9% increase; D+E: 0.12 ± 0.34 l/min, 7% increase), com-
= 7), with the primary reasons for study discontinuation being: pared to baseline.
dissatisfaction with randomization, work or family demands, Body weight, anthropometric, and body composition
or injury or other medical issues unrelated to the intervention. changes were evaluated at 12 months and are presented in
At 12 months, 399 participants completed follow-up visits for Table 2. Participants in the diet-alone group lost a mean 7.2 kg
body weight and anthropometric assessments, 396 underwent (−8.5%, P < 0.0001), those in the exercise alone group lost a
a dual X-ray absorptiometry scan, and 370 participants com- mean 2.0 kg (−2.4%, P = 0.034), whereas those in the diet +
pleted a maximal treadmill test (Figure 1). exercise group lost a mean 8.9 kg (−10.8%, P < 0.0001), each
Overall, adherence to the dietary weight loss and aero- compared to a 0.7 kg decrease among controls. The weight
bic exercise interventions was excellent (Table 2). Estimated reductions for the diet-alone and diet + exercise groups both
relative fat intake (percentage of total kcal/day) decreased by were significantly greater than that experienced by the exercise
18% in the diet-alone group and by 20% in the diet + exercise alone group (both P < 0.0001), though the difference between
group. Changes in total kcal intake among D and D+E groups diet-alone and diet + exercise did not reach the adjusted level
did not change significantly compared to controls, however the of statistical significance (P = 0.02). Waist circumference
FFQ is not as robust for estimating this parameter (17). In both decreased significantly in all intervention groups compared to

Table 3  Baseline and 12-month weight, anthropometric, and body composition measures for diet group, stratified by adherence
Baseline 12 Months
N Mean STD N Mean STD % P valuea P valueb
Weight (kg) Control 87 84.2 12.5 80 83.7 12.3 –0.6 Ref.
<84.3% 41 87.3 12.7 28 81.8 12.0 –6.3 0.006 Ref.
84.3–106% 37 80.6 10.8 36 72.3 9.8 –10.4 <0.0001 <0.0001
≥106% 40 83.9 11.1 40 72.5 12.9 –13.5 <0.0001 <0.0001
(<0.0001 ) c
(<0.0001d)
BMI (kg/m ) 2
Control 87 30.7 3.9 80 30.4 4.1 –0.8 Ref.
<84.3% 41 32.4 4.1 28 30.6 4.1 –5.5 0.004 Ref.
84.3–106% 37 29.9 3.5 36 26.8 3.3 –10.3 <0.0001 <0.0001
≥106% 40 30.8 3.9 40 26.6 4.5 –13.6 <0.0001 <0.0001
(<0.0001c) (<0.0001d)
Waist (cm) Control 87 94.8 10.2 79 95.4 9.6 0.7 Ref.
<84.3% 41 96.3 10.6 28 93.9 9.8 –2.5 0.10 Ref.
84.3–106% 37 92.8 11.0 35 86.9 8.8 –6.4 <0.0001 <0.0001
≥106% 40 94.5 8.9 40 86.3 11.2 –8.7 <0.0001 <0.0001
(<0.0001c) (0.0001d)
Body fat (%) Control 87 47.3 4.4 80 47.2 5.3 –0.2 Ref.
<84.3% 41 47.7 4.8 28 45.8 4.5 –3.9 0.03 Ref.
84.3–106% 37 46.3 3.7 36 41.8 6.3 –9.8 <0.0001 <0.0001
≥106% 40 46.9 4.4 40 39.7 6.5 –15.3 <0.0001 <0.0001
(<0.0001c) (<0.0001d)
Adherence defined by percent of in-person nutrition session attendance, by tertiles.
a
Testing difference in change from baseline to 12 months in body composition measure compared to controls. bTesting difference in change from baseline to 12 months
in body composition measure compared to low adherence group, excluding controls. cTesting for a trend in change from baseline to 12 months in body composition
measures from controls through high adherence group. dTesting for a trend in change from baseline to 12 months in body composition measures from low adherence
group through high adherence group.

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the nonsignificant 0.9 cm increase among controls (D: −4.5 cm tertiles of percentage of in-person diet intervention session
P < 0.0001; E: −2.0 cm P = 0.001; D+E: −7.0 cm P < 0.0001). attendance are shown in Table 3 (D group) and Table 4 (D+E
Furthermore, the decrease in waist circumference was signifi- group). Women from the diet-alone group who participated
cantly greater for the diet + exercise participants than for either in ≥106% of sessions (included optional visits) lost the most
the diet-alone or exercise-alone participants (P = 0.004 D+E vs. weight, with an 11.4 kg (13.5%) decrease, compared to losses of
D and P < 0.0001 D+E vs. E), and women who were assigned to 8.3 kg (10.4%) among women attending 84–106% of sessions,
diet alone also experienced significantly greater decrease com- 5.5 kg (6.3%) among those attending <84%, or a 0.5 kg loss
pared to those assigned to exercise alone (P = 0.004). Similarly, (0.6%) among controls (all P trend <0.0001). Comparable find-
% body fat decreased among all intervention groups compared ings were noted for BMI, waist circumference, and % body fat
to controls, with an absolute percent change of −4.2% for diet (all P trend ≤0.0001, Table 3). Similarly to the diet-alone par-
alone, −1.6% for exercise alone, and −5.9% for diet + exercise ticipants, women from the diet + exercise group who attended
(all P < 0.0001). Paralleling the findings for waist circumfer- the most in-person sessions also lost the most weight, with a
ence, comparing these reductions among intervention groups 10.9 kg (13.4%) decrease, compared to losses of 9.4 kg (11.5%)
revealed the rank-order for the reduction was also D+E > D among women attending 84–106% of sessions, and 8.1 kg
> E (all P < 0.005). Finally, lean mass increased only among (9.6%) among those attending <84% (all P trend <0.0001).
those participating in exercise alone (+0.3 kg). Although this Equivalent changes were observed for other all outcome meas-
increase did not differ significantly from control women, it was ures (Table 4).
significantly greater compared to the reductions in lean mass Changes in outcome measures at 12 months stratified by
among women in the diet alone (−0.8 kg, P < 0.0001 E vs. D) or tertiles of reported exercise (exercise logbook min/week) are
diet + exercise (−0.4 kg, P = 0.003 E vs. D+E) groups. shown in Table 5 (E group) and Table 6 (D+E group). Women
We assessed measures of adherence for the combined diet + from the exercise-alone group who participated in ≥196 min/
exercise group separately from either intervention alone. week physical activity (highly active) lost the most weight, with
Changes in outcome measures at 12 months stratified by a 3.1 kg (3.9%) decrease, compared to losses of 2.0 kg (2.4%)

Table 4  Baseline and 12-month weight, anthropometric, and body composition measures for diet + exercise group, stratified by
adherence
Baseline 12 Months
N Mean STD N Mean STD % P valuea P valueb
Weight (kg) Control 87 84.2 12.5 80 83.7 12.3 –0.6 Ref.
<84.3% 33 84.4 10.6 25 76.3 9.5 –9.6 <0.0001 Ref.
84.3–106% 43 82.0 12.2 43 72.6 13.1 –11.5 <0.0001 <0.0001
≥106% 41 81.5 9.4 41 70.6 8.7 –13.4 <0.0001 <0.0001
(<0.0001 ) c
(0.03d)
BMI (kg/m2) Control 87 30.7 3.9 80 30.4 4.1 –0.8 Ref.
<84.3% 33 31.6 4.3 25 28.9 4.3 –8.5 <0.0001 Ref.
84.3–106% 43 30.9 4.8 43 27.3 5.2 –11.5 <0.0001 <0.0001
≥106% 41 30.7 3.8 41 26.6 3.4 –13.4 <0.0001 <0.0001
(<0.0001c) (0.02d)
Waist (cm) Control 87 94.8 10.2 79 95.4 9.6 0.7 Ref.
<84.3% 33 97.4 10.8 25 90.1 9.9 –7.5 <0.0001 Ref.
84.3–106% 43 92.4 10.3 43 85.1 11.8 –7.9 <0.0001 <0.0001
≥106% 41 92.1 7.9 41 83.4 9.1 –9.4 <0.0001 <0.0001
(<0.0001c) (0.24d)
Body fat (%) Control 87 47.3 4.4 80 47.2 5.3 –0.2 Ref.
<84.3% 33 47.7 4.6 25 44.4 6.1 –7.0 0.0003 Ref.
84.3–106% 43 47.0 4.5 43 40.4 7.4 –14.0 <0.0001 <0.0001
≥106% 41 47.6 4.4 41 39.8 6.6 –16.4 <0.0001 <0.0001
(<0.0001c) (0.0001d)
Adherence defined by percent of in-person nutrition session attendance, by tertiles.
a
Testing difference in change from baseline to 12 months in body composition measure compared to controls. bTesting difference in change from baseline to 12 months
in body composition measure compared to low adherence group, excluding controls. cTesting for a trend in change from baseline to 12 months in body composition
measures from controls through high adherence group. dTesting for a trend in change from baseline to 12 months in body composition measures from low adherence
group through high adherence group.

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Table 5  Baseline and 12-month weight, anthropometric, and body composition measures for exercise group, stratified by
adherence
Baseline 12 Months
N Mean STD N Mean STD % P valuea P valueb
Weight (kg) Control 87 84.2 12.5 80 83.7 12.3 –0.6 Ref.
<154 min/week 41 87.7 10.8 29 85.8 9.6 –2.2 0.40 Ref.
154–196 min/week 41 83.0 13.1 41 81.0 12.7 –2.4 0.09 0.11
≥196 min/week 35 79.8 11.9 35 76.7 12.2 –3.9 0.01 0.01
(0.009c) (0.12d)
BMI (kg/m2) Control 87 30.7 3.9 80 30.4 4.1 –0.8 Ref.
<154 min/week 41 31.9 3.8 29 31.8 3.8 –0.5 0.38 Ref.
154–196 min/week 41 30.5 3.6 41 29.8 3.6 –2.4 0.06 0.08
≥196 min/week 35 29.3 3.3 35 28.2 3.5 –3.9 0.007 0.009
(0.004 ) c
(0.10d)
Waist (cm) Control 87 94.8 10.2 79 95.4 9.6 0.7 Ref.
<154 min/week 41 98.2 10.3 30 98.3 8.3 0.1 0.18 Ref.
154–196 min/week 41 93.7 9.6 41 91.9 9.7 –1.9 0.03 0.06
≥196 min/week 35 92.9 9.9 35 89.4 9.9 –3.8 0.0009 0.002
(0.0005c) (0.10d)
Body fat (%) Control 87 47.3 4.4 80 47.2 5.3 –0.2 Ref.
<154 min/week 41 48.3 3.7 29 47.8 3.9 –0.9 0.23 Ref.
154–196 min/week 41 47.1 4.0 41 45.8 4.1 –2.9 0.009 0.01
≥196 min/week 35 46.3 4.6 35 43.4 5.8 –6.3 0.0001 0.0001
(<0.0001c) (0.003d)
Adherence defined by exercise logbook minutes per week, by tertiles.
a
Testing difference in change from baseline to 12 months in body composition measure compared to controls. bTesting difference in change from baseline to 12 months
in body composition measure compared to low adherence group, excluding controls. cTesting for a trend in change from baseline to 12 months in body composition
measures from controls through high adherence group. dTesting for a trend in change from baseline to 12 months in body composition measures from low adherence
group through high adherence group.

among intermediate-active women (154–196 min/week), clinically important and significant reductions in body weight
1.9 kg (2.2%) among low-active women (<154 min/week) or a and improvements in body composition among overweight-
0.5 kg loss (0.6%) among controls (P trend <0.0001 in refer- to-obese postmenopausal women. Our dietary intervention
ence to controls, P = 0.12 in reference to low-active group). was adapted primarily from the DPP for group-based delivery,
Comparable findings were noted for BMI, waist circumfer- whereas our exercise intervention was based on our previous
ence, and % body fat (P trend all <0.01 in reference to controls, successful physical activity programs (14,15). With excellent
Table 5); in addition these same trends were observed when overall follow-up (>90%) and adherence to the interventions,
adherence was assessed by change in cardiorespiratory fitness we observed an 8.5% weight loss among women participating
level or change in pedometer steps/week (data not shown). in diet alone, 2.4% weight loss among those participating in
Highly active women from the diet + exercise group lost 10.5 kg exercise alone, and 10.8% weight loss among those in the com-
(12.8%) decrease, similar to the weight loss achieved by active- bined diet + exercise interventions. Furthermore, we observed
intermediate women (10.5 kg or 12.7%), whereas low-active that the relative reductions in % body fat measured by dual
women lost 8.0 kg (9.6%; all P trend <0.0001 in reference to X-ray absorptiometry in each group differed significantly (at
controls, and P trend ≤0.01 in reference to low-active group). a Bonferroni-adjusted level of P < 0.05/6 to account for the
Equivalent changes were observed for other outcome measures multiple comparisons) with the following rank order: −12.4%
(Table 6), and also when adherence was assessed by change in (D+E) > −8.9% (D) > −3.3% (E) > −0.3 (C).
cardiorespiratory fitness level or change in pedometer steps/ Our combined diet + exercise group effectively put to the
week (data not shown). test the recommendation of the NIH Obesity Education
Initiative Expert Panel, which suggested a caloric deficit of
Discussion 500–1,000 kcal/day using an individualized dietary strategy,
We found that a year-long lifestyle-change program, incorpo- along with 45 min of moderate-intensity physical activity 5
rating either combined or separate dietary weight loss or mod- day/week. Most importantly, we tested this among postmeno-
erate-to-vigorous aerobic exercise interventions, produced pausal women, for whom well-designed studies examining the

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Table 6  Baseline and 12-month weight, anthropometric, and body composition measures for diet + exercise group, stratified by
adherence
Baseline 12 Months
N Mean STD N Mean STD % P valuea P valueb
Weight (kg) Control 87 84.2 12.5 80 83.7 12.3 –0.6 Ref.
<154 min/week 39 83.2 11.4 31 75.2 10.8 –9.6 <0.0001 Ref.
154–196 min/week 36 82.8 10.2 36 72.3 10.9 –12.7 <0.0001 <0.0001
≥196 min/week 42 81.7 10.8 42 71.2 11.0 –12.8 <0.0001 <0.0001
(<0.0001 ) c
(0.01d)
BMI (kg/m2) Control 87 30.7 3.9 80 30.4 4.1 –0.8 Ref.
<154 min/week 39 30.9 4.4 31 28.2 4.6 –8.8 <0.0001 Ref.
154–196 min/week 36 31.4 4.5 36 27.4 4.7 –12.7 <0.0001 <0.0001
≥196 min/week 42 30.7 4.1 42 26.7 4.1 –12.9 <0.0001 <0.0001
(<0.0001c) (0.006d)
Waist (cm) Control 87 94.8 10.2 79 95.4 9.6 0.7 Ref.
<154 min/week 39 94.6 12.0 31 88.0 11.2 –7.0 <0.0001 Ref.
154–196 min/week 36 93.3 9.4 36 86.0 11.0 –7.7 <0.0001 <0.0001
≥196 min/week 42 93.3 8.1 42 83.5 9.8 –10.5 <0.0001 <0.0001
(<0.0001c) (0.002d)
Body fat (%) Control 87 47.3 4.4 80 47.2 5.3 –0.2 Ref.
<154 min/week 39 47.3 4.4 31 43.1 6.8 –8.9 <0.0001 Ref.
154–196 min/week 36 47.8 4.6 36 41.4 6.4 −13.4 <0.0001 <0.0001
≥196 min/week 42 47.2 4.5 42 39.4 7.4 −16.5 <0.0001 <0.0001
(<0.0001c) (0.0003d)
Adherence defined by exercise logbook minutes per week, by tertiles.
a
Testing difference in change from baseline to 12 months in body composition measure compared to controls. bTesting difference in change from baseline to 12 months
in body composition measure compared to low adherence group, excluding controls. cTesting for a trend in change from baseline to 12 months in body composition
measures from controls through high adherence group. dTesting for a trend in change from baseline to 12 months in body composition measures from low adherence
group through high adherence group.

longer-term benefits of lifestyle change are needed (12). When studies vary widely with respect to type of diet and exercise
we examined the percentage of participants from our trial who interventions, the inclusion of a control group, their duration,
achieved various clinically relevant weight loss targets (<5%, size, and measures of potential greater metabolic relevance such
5–<10%, and ≥10%), the majority (60%) of women in the diet as body fat and lean mass (25–30). The MONET study also tar-
+ exercise intervention achieved ≥10%, whereas only 42% of geted postmenopausal women (N = 173), but only examined
those in diet alone, and 3% in exercise alone achieved that tar- diet vs. diet + resistance training over 6 months, and found
get (data not shown). Although adding 5 day/week of exercise equivalent weight loss between these groups (31). We found
requires effort, 20% more women attained the very relevant that exercise had an important effect of maintaining lean body
goal of 10% weight loss when they added exercise to diet modi- mass that did not occur with diet alone, and this effect could
fication. It is likely that the cost of exercise is offset by the cost certainly have important implications as older people are at
savings due to health benefits arising from increased physical increased risk for sarcopenia (32). Although it would be diffi-
activity (22). Furthermore, following a recent review of stud- cult to determine the relative impact of different diets and doses
ies examining exercise for weight loss the American College of exercise within a single study, it has been shown that most
of Sports Medicine has now increased its recommended dose diets are effective regardless of composition as long as partici-
of exercise to 150–250 min/week, suggesting that particularly pants are adherent (33,34). We found adherence, whether to
when exercise is combined with moderate caloric restriction the diet or exercise intervention, had a dose-dependent impact
these levels are necessary to augment weight loss (23). Similarly, on weight loss and change in body composition among our
the US Department of Health and Human Services Physical population of postmenopausal women.
Activity Guidelines Committee found that optimal exercise The degree of adherence to lifestyle change has been clearly
levels for weight loss and weight loss maintenance could be up shown to positively influence all weight and body compo-
to 60 min/day (24). sition-related outcomes. We found that greater adherence
Other research has demonstrated comparable degrees of to our exercise intervention, whether measured using a self-
weight loss to those we found with our interventions, though reported variable of minutes exercised per week (in relation

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to the goal of 225), or more objective measures such as ped- long-term follow-up of participants is now underway, and factors
ometer-recorded steps per week or cardiorespiratory fitness contributing to the successful maintenance of weight loss will be
(measured by an exercise tolerance test), was associated with examined in the future.
greater weight reduction or improvement in body composi- In conclusion, we have demonstrated a successful imple-
tion. Greater adherence to the exercise prescription in both the mentation of a group-based modification of the DPP dietary
DPP and the Look AHEAD trial also predicted greater rates of weight loss intervention, along with moderate-vigorous aerobic
achieving weight loss goals (19,35). The same relationship with physical activity, among a population at high risk for ongoing
adherence and weight loss was found when we examined in- weight gain and the negative metabolic consequences thereof.
person session attendance for our diet intervention. The level Although our diet and exercise interventions had beneficial
of adherence overall was very high (over 90% attendance for effects on weight loss and body composition when delivered
both D and D+E), but we were still able to see greater improve- in isolation, the greatest effects were found in the combined
ment in body weight and composition outcomes among intervention group, where 60% of participants achieved ≥10%
women in the highest adherence groups. Alhassan et al. found weight loss at 1 year. Our combined diet + exercise interven-
that adherence to diet was a key predictor of weight loss in tion group essentially followed the current recommendations
the “A to Z” study of different popular diets, similar findings by the NIH Obesity Education Initiative Expert Panel (5),
were also reported by Greenberg et al. for a randomized low providing the highest level of support for these recommenda-
fat vs. low carbohydrate diet, and again for the DPP and Look tions: a randomized clinical trial that examined each element
AHEAD (19,35–37). Further research is warranted to improve singly and in combination vs. a no-lifestyle-change control.
our understanding of behavioral and biological determinants Yet, despite the now overwhelming evidence for the benefits
of adherence, particularly those that could be modifiable. of lifestyle-induced weight loss, there are still major barriers
One limitation of our study was that exercise performed to implementing these programs, particularly at the primary
at home was self-reported, in comparison with that directly care level where the most benefit stands to be made (41,42).
observed at our facility. Although facility sessions allowed Providing group-based nutrition education along with exer-
for direct observation of participants’ activity, the applica- cise likely outweighs the costs of health consequences that
bility of our findings to less-intensive or costly community come from untreated obesity, assuming these changes can
programs to promote physical activity is not as clear. Still, be sustained over the long-term (43,44). We are conducting
the significant increases in VO2max observed only among ongoing follow-up of our NEW trial participants to examine
women randomized to the exercise groups (E and D+E) sup- the behavioral and physiologic predictors of long-term weight
port the internal validity of our data, and that these women did loss maintenance in a free-living environment post-trial, with
raise their physical activity level. Diet was also self-reported the goal that identification of these factors will help to guide
by women in the dietary weight loss arms, and although the the successful design and implementation of obesity treatment
FFQ is a valid measure for assessing diet, it has acknowledged programs with the greatest potential to impact public health.
limitations. The significant weight loss experienced by women
Acknowledgments
in the diet interventions (nearly 9% and 11% in D and D+E, This study was funded by National Cancer Institute (NCI) NIH grants
respectively) again supports that these women did reduce their R01 CA102504 and U54-CA116847. K.E.F. received support from NIH
caloric intake. Another potential factor which may have intro- 5KL2RR025015-03, A.K. was supported by NCI R25 CA94880. The authors
duced some additional variability to the weight loss achieved thank the study participants for their time and dedication to the study.
by the study groups is contact time with study staff. Study con- Disclosure
tact time may impact weight loss (38), and it varied to some The authors declared no conflict of interest.
degree by intervention group and was the least, by design, for
© 2011 The Obesity Society
women in the control group.
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1638 VOLUME 20 NUMBER 8 | august 2012 | www.obesityjournal.org

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