Table 1. Summary of randomized clinical trials for weight loss treatment with at least 75 participants and intervention lasting at least 4 months reporting results between 2001 and 2015, inclusive.
| Reference(s) | Trial Years | N | Baseline Characteristics (M± SD) | Racial Diversity | Length of intervention | Key aspects of intervention | Relevant findings |
|---|---|---|---|---|---|---|---|
|
Stevens et al., 2001 Lasser et al., 1995 |
1986-1998 | 1191 | Age: 43.3 ± 3.1 % Women: 34.3 BMI (kg/m2): 30.1 ± 3.3 Education (% college degree): 51.0 |
78.8% White; 17.5% Black | 36 mos. | TOHP II participants randomized to 1. Control group, 2. Weight loss group (WL). WL participants had group meetings weekly for 14 weeks then every other week for 3 mos. When bi-weekly meetings ended, participants were asked to contact the study bi-weekly and were encouraged to select 3 of 6 mini-modules (3 to 6 session enrichment courses) offered each year. | WL group lost more weight than control group. White participants lost 1.8 kg more than black participants at 6 and 18 mos. (p=.01, p=.03), but no difference was observed at 36 mos. Weight loss at 6 mos. was strongly related to attendance. Differential attendance by race was not reported. |
|
Ashley, St Jeor, Perumeuan-Chaney, et al., 2001 Ashley, St Jeor, Schrage, et al., 2001 |
NR* | 113 women | Age: 41.4 ± 4.7 % Women: 100.0 BMI (kg/m2): 30.0 ± 3.1 Education: NR |
NR | 12 mos. weight loss, 12 mos. maintenance | Participants randomized into 3 groups: 1. Dietitian-led group intervention (DLI); 2. DLI incorporating meal replacements (MR)(DLI+MR); and 3. Clinical office-based intervention with MR. DLI groups had 26 sessions of SBT: 3 mos. weekly, 3 mos. biweekly, 6 mos. monthly.MR groups advised to replace 2 of 3 main meals with MR shake or bar until 10% loss achieved. Once 10% loss achieved, replace 1 of 3 main meals unless regain occurs.In maintenance phase, all groups attended monthly seminars led by dietitian. | DLI+MR group lost significantly more weight than other two groups at 12 mos. and differences between groups persisted at 24 mos. Analysis by race not reported. |
| Perri et al., 2001 | NR | 103 | Age: 46.6 ± 8.8 % Women: 100.0 BMI (kg/m2): 35.8 ± 4.5 Education (yrs): 13.8 ± 1.8 |
NR | 5 mos. weight loss, 12 mos. maintenance | All received SBT for 5 mos. Randomized to receive no additional treatment (BT), Relapse Prevention Training (RPT) with bi-weekly sessions focused on “cognitive behavioral skills for anticipating, avoiding or coping with lapses, ” or Problem-Solving Therapy (PST) with bi-weekly sessions where participants reported on problems and, as a group, engaged in problem solving. | No significant weight change differences between RPT and BT, or RPT and PST. At month 17, PST had significantly greater total net loss. Analysis by race not reported. |
| McManus et al., 2001 | NR | 101 | Age: 44.0 ± 10.0 % Women: 90.0 BMI (kg/m2): 33.5 ± 4.0 Education: NR |
80% White 17% Black |
18 mos. | All participants received SBT with weekly meetings. Randomly assigned to:low fat diet (20% fat) or moderate fat diet (35% fat). | Moderate fat group lost 2.5 kg while low fat group gained 1.1 kg. Analysis by race not reported. |
| Yancy et al., 2004 | 2000-2001 | 120 | Age: 44.9 ± 9.5 % Women: 76.5 BMI (kg/m2): 34.3 ± 3.3 Education (% college degree): 59.5 |
76% White20% Black | 6 mos. | SBT with biweekly meetings for 3 mos. and monthly meetings for 3 mos.Participants randomly assigned to Atkins low-carbohydrate (low-carb) diet vs. standard low-fat diet. | Better weight loss in low carb group. Analysis by race not reported. |
| Jakicic et al., 2003 | 2000-2001 | 201 women | Age: 37.0 ± 5.7 % Women: 100 BMI (kg/m2): 32.6 ± 4.2 Education (% college degree): 27.0 |
81% White8% Black | 12 mos. | All received SBT. Weekly meetings for 24 weeks, biweekly meetings thereafter. Mos 7 to 12 received biweekly telephone call. Differed in exercise prescription - 4 exercise groups: 1. vigorous intensity/high duration, 2. moderate intensity/high duration, 3. moderate intensity/moderate duration, 4. vigorous intensity/moderate duration | No significant differences in weight loss. Analysis by race not reported. |
| Jeffery et al., 2003 | NR | 202 | Age: 42.2 ± 6.4 % Women: 58.0 BMI (kg/m2): 31.7 ± 2.6 Education (% college degree): 43.0 |
87% White | 18 mos. | All had SBT, meeting weekly for 1st 6 mos., bi-weekly for 2nd 6 mos., and monthly for final 6 mos. Randomly assigned to different physical activity goals: Standard Group: Energy Expenditure of 1000 kcal/week or approximately moderate walking for 30 min/day; High physical activity (HPA): Energy Expenditure of 2500 kcal/week or moderate walking for 75 min/day. | HPA group lost more weight from baseline to 18 mos. Analysis by race not reported. |
|
Samaha et al., 2003 Stern et al., 2004 |
2001-2002 | 132 | Age: 53.5 ± 9.0 % Women: 17.0 BMI (kg/m2): 42.2 ± 7.2 Education (% college degree): NR |
58% Black 38% White | 12 mos. | Intervention consisted of 2 hour sessions for 4 weeks, monthly 1-hr sessions for 5 months; Exercise not prescribed. Randomized to one of 2 diet groups: 1) Low Carb group - restrict carbs to 30 g/day or 2) less Low Fat Group - restrict fat to 30% or less of total calories, 500 calorie deficit per day | At 6 mos. weight loss greater for white participants than for black participants regardless of assignment. Low carb diet produced more weight loss overall, but not reported by race. High dropout rate overall (34%). |
| Burke et al., 2007 | 2002-2005 | 176 | Age: 44.1 ± 8.8 % Women: 86.9 BMI (kg/m2): 34.0 ± 4.1 Education (yrs.): 15.2 ± 2.5 |
71% White | 12 mos. with 6 mo follow-up | All participants received SBT for weight loss. Met weekly for 6 mos, biweekly for 3 mos, monthly for 3 mos and a follow-up assessment 6 mos after treatment ended. Participants were prescribed a standard low-fat diet or lacto-ovo-vegetarian diet. Participants were randomly assigned to either receive their preferred dietary assignment or to be randomly assigned to a diet group. | All groups lost weight. No effect of vegetarian diet or treatment preference on weight outcomes. Analysis by race not reported. |
|
Svetky et al., 2008 Hollis et al., 2008 Champagne et al., 2011 |
2003-2007 | 1685: Phase I (weight loss)1032: Phase II (maintenance) | Age: 54.8 ± 9.1 % Women: 67.3 BMI (kg/m2): 34.3 ± 4.8 Education (% ≥ college degree): 57.3 |
Phase I: 44% BlackPhase II: 37.6% Black | Phase I: 6 mos. Phase II: 30 mos. | Phase I: All participants received SBT in 20 weekly group sessions. Prescribed DASH Diet. Phase II: Randomized to maintenance therapy - 1. Self-directed control, 2. Interactive web site with encouragement to log on at least weekly, 3. Monthly 1:1 contact with interventionist |
Phase I: Men lost more weight than women, but within gender groups non-black participants lost more weight than black participants. Non-black participants attended more sessions, reported more physical activity, and kept more food records (p<.0001 for each test). Phase II: Those who had 1:1 contact with interventionist regained less weight than the other two groups. Statistically significant, but clinically modest. Results did not differ by race. |
| Foster et al., 2010 | 2003-2007 | 307 | Age: 45.6 ± 9.7 % Women: 67.5 BMI (kg/m2): 36.1 ± 3.5 Education: NR |
71% White 22% Black | 2 years | Low fat diet: energy intake limited to 1200 to 1800 kcal depending on gender; calories 55% carb, 30% fat, 15% protein; Low carb diet: followed Atkins guidelines, 1st 12 weeks carbs limited to 20 g/day of low glycemic index vegetables, gradually increased by 5 g/day after that. | Similar weight loss in both groups. Low carb diet improved HDL. Analysis by race not reported. |
| Jeffery et al., 2009 | 2005-2007 | 213 | Age: 48.8 ± 1.0 % Women: 53.1 BMI (kg/m2): 34.9 ± 0.3 Education (% > college degree): 71.3 |
67% White23% non-white | 18 mos. | Randomized to SBT or Maintenance Tailored Therapy (MTT). SBT met weekly 1st 6 mos., biweekly 2nd 6 mos., monthly final 6 mos. MTT had 6 8-week units with 4-week breaks between; each unit had a different focus | Weight loss greater for SBT in 1st 6 mos. No difference at 18 mos. Analysis by race not reported. |
| Sacks et al., 2009 | 2004-2007 | 811 | Age: 51.0 ± 9.0 % Women: 64.0 BMI (kg/m2): 33.0 ± 4.0 Education (% ≥ college degree): 68.0 |
79% White 16% Black |
24 mos. | All received SBT augmented with individual sessions. Groups met 3 of every 4 weeks for first 6 mos., 2 of every 4 weeks for remaining 2 years; individual sessions every 8 weeks. Randomly assigned to one of four dietary groups:1. a low-fat, average-protein diet (20% fat, 15% protein, and 65% carbohydrate),2. a low-fat, high-protein diet (20% fat, 25% protein, and 55% carbohydrate), 3. a high-fat, average-protein diet (40% fat, 15% protein, and 45% carbohydrate)4. a high-fat, high-protein diet (40% fat, 25% protein, and 35% carbohydrate) | No effect of diet type of weight change, craving, fullness, hunger, and diet satisfaction scores at 6 mos. and 2 years. Retention lower for black participants than white participants. Analysis by race not reported. |
|
Blumenthal et al., 2010 Epstein et al., 2012 |
2003-2008 | 144 | Age: 52.0 ± 10.0 % Women: 67.4 BMI (kg/m2): 33.1 ± 3.9 Education (% ≥ college degree): 46.0 |
60% White39% Black | 4 mos. | Randomized to 1 of 3 groups: 1. DASH Diet alone (DASH-A) participants were asked not to exercise or attempt to lose weight but to focus only on food choices, 2. DASH+ weight management (DASH-WM) participants received SBT and supervised exercise sessions, 3. Usual diet control participants were asked to not modify their behaviors. DASH-A and DASH-WM participants attended weekly small group sessions for 4 mos. | DASH-WM group lost significantly more weight than other groups (-8.7 kg vs.-0.3 kg (DASH-A) and 0.9 kg (control). Investigators did examine ethnicity in determining adherence; Overall, African-Americans were less adherent to the DASH diet compared to whites within the study. |
|
Fitzgibbon et al., 2008 Fitzgibbon et al., 2010 |
2005-2008 | 213 | Age: 46.0 ± 8.4 % Women: 100.0 BMI (kg/m2): 39.2 ± 5.7 Education (% college degree): 44.0 |
100% Black | 18 mos. (6 mos. weight loss + 12 mos. weight maintenance). | Participants randomized to control or culturally-tailored SBT intervention augmented with monthly motivational interviews (MI) via phone. SBT group met 2X per week for 12 mos. In mos. 13-15 met for a weekly exercise class + monthly MI session. No face-to-face meetings in mos. 16-18.Control group received monthly telephone call +newsletters covering health and safety topics weekly during the six month intervention and monthly during the 12 month maintenance phase | Participants in the SBT group lost 3.04 kg at 6 months, compared to a 0.22 kg weight gain in the control group. However, by 18 months, both groups gained weight, and there were no significant differences between the groups on weight change. |
| Burke et al., 2011 | 2006-2010 | 210 | Age: 46.8 ± 9.0 % Women: 84.8 BMI (kg/m2): 34.4 ± 4.6 Education (yrs.): 15.7 ± 3.0 |
79% White | 21 mos. (report limited to 6 mos. of treatment) | All participants received SBT for weight loss. Participants met weekly for 4 mos., biweekly for 12 mos., monthly for 6 mos. and had 1 maintenance-focused meeting in month 21. Mode of self-monitoring varied: 1. paper diary (PR), 2. electronic diary (PDA), 3. electronic diary with automated feedback program (PDA+FB) | No significant difference in weight loss between groups at 6 mos. More PDA+FB participants achieved at least 5% weight loss compared to PR. Analysis by race not reported. |
| Goodpaster et al., 2010 | 2007-2010 | 130 | Age: 46.8 ± 6.4 % Women: 88.6 BMI (kg/m2): 43.6 ± 5.4 Education (% college degree): NR |
37% Black | 12 mos. | Participants randomized into two groups, both receiving SBT for weight loss: 1. SBT + initial physical activity; 2. SBT + delayed physical activity (6 months). Participants had 3 group sessions and 1 telephone session for months 1-6. In months 7-12, participants had 2 group sessions, and 2 telephone contacts per month | Both groups lost a significant amount of weight by 6 months. The initial physical activity group lost significantly more weight in the first 6 months, compared to the delayed physical activity group. While AAs lost slightly less weight, overall, race had no significant impact on treatment outcomes between intervention groups. |
| Foster et al., 2012 | 2005-2007 | 123 | Age: 46.8 ± 12.4 % Women: 91.0 BMI (kg/m2): 34.0 ± 3.6 Education (% college degree): NR |
54% White 39% Black |
18 mos. | Participants randomized into two groups: 1. Almond-Enriched, low-calorie diet (AED); 2. Nut-free, low-calorie diet (NED). Both groups were prescribed a low-calorie diet (1200-1800kcal/d), and were encouraged to exercise 20-50 minutes 4 times per week. Both groups met weekly for 20 weeks, bi-weekly for another 20 weeks, and every 6 weeks for the remainder of the 18 mos. | Participants in the AED group loss significantly more weight than those in the NFD group at 6 months (-7.4 vs. -5.5 kg). There were no differences at 18 mos. Analysis by race not reported. |
| Foster-Schubert et al., 2012 | 2005-2009 | 439 | Age: 58.0 ± 5.0 % Women: 100.0 BMI (kg/m2): 30.9 ± 4.0 Education (% college degree): 65 |
85% White 8% Black |
12 mos. | Participants were randomized into 1 of 4 groups: 1. Calorie-reduced diet; 2. Aerobic Exercise; 3. Both interventions combined; 4. No-lifestyle change control. Participants received combination of individual and group contact for the duration of the study. | Compared to the control group, participants in diet (-8.5%), exercise (-2.4%), and the combined intervention group (-10.8%) achieved a significant weight loss at 12 months. Analysis by race not reported. |
| Jakicic et al., 2012 | 2008-2010 | 363 | Age: 42.2 ± 9.0 % Women: 83.0 BMI (kg/m2): 33.0 ± 3.6 Education (% college degree): 33.7 |
67% White 28% Black 5% Other | 18 mos. | Participants were randomized to two groups: 1. SBT; 2. Stepped-care weight loss intervention (STEP) (e.g. low-intensity weight loss intervention that increased if weight milestones are not achieved). All participants were prescribed a low-calorie diet, physical activity goals. The SBT group had weekly group meetings for months 1-6, bi-weekly for months 7-12, and monthly during 13-18 mos. The STEP group had several stages, beginning with a monthly group intervention and progressing to an individual session if needed. | At 18 months, percent weight change in the SBT group was -8.1% and -6.9% in the STEP. There were no between group differences in weight change. While race was considered in the analyses, outcomes by race were not reported. |
| Pinto et al., 2013 | 2008-2010 | 141 | Age: 49.7 ± 9.2 % Women: 90.0 BMI (kg/m2): 36.2 ± 5.5 Education: NR |
33% White 67% Non-White 55% Hispanic | 48 weeks (11 mos.) | Participants were randomly assigned to: 1) Behavioral weight loss (BWL); 2) Weight Watchers (WW); 3) 12 weeks of BWL, followed by 36 weeks of WW (CT). Those in the BWL group attended weekly meetings for 24 weeks, bi-weekly for 24 weeks. Those in the WW received free vouchers to attend WW meetings free for 48 weeks. | Significant weight loss was achieved by all groups by 12 weeks. Participants in the WW achieved greater weight loss (-6.0 kg) at 48 weeks, then compared to the CT group (-3.6 kg). Changes in the BWL group at 48 weeks were not significantly different from WW or CT (-5.4 kg). Analysis was not reported by race. |
| Nackers et al., 2013 | NR* | 125 women | Age: 52.0 ± 10.9 % Women: 100.0 BMI (kg/m2): 38.0 ± 3.9 Education (% ≥ college degree): 46.4 |
73.6% White 16.8% Black 6.15% Hispanic | 12 mos. | Participants were randomly assigned to: 1) Kcal goals of 1,000/day; 2) Kcal goal of 1,500/day. Both groups received SBT, and had 24 weekly meetings (months 0-6), and 6 monthly meetings from months 7-12. | For the first 6 months, participants in the 1,000 kcal/day group lost more weight (-10.03 kg vs. -6.23 kg). For months 7-12, however, the 1,000 kcal/day group experienced significant weight regain (+1.51 kg). Analysis was not reported by race. |
| Samuel-Hodge et al., 2013 | 2005-2007 | 189 | Age: 51.3 ± 10.9 % Women: 100.0 BMI (kg/m2): 37.1 ± 0.5 Education (yrs): 13.0 ± 0.2 |
53% Black 44% White 3% Other | 5 mos. | Participants randomized to two groups: 1) Special IV (SI) – 16 weekly group session with energy goal of no less than 1200 kcal/day, and 150 minutes/week of exercise; 2) Delayed IV (DI) – Wait-List Control – received 2 newsletters | Participants in the SI achieved a significant weight loss compared to the DI group (-3.1 kg vs. -0.4kg). Greater weight loss was associated with being non-AA (p=.005). |
*
NR = Not Reported