Table 1.
Key features of randomized controlled trials contributing data for the pooled data set.
| Characteristic | HELP Study | SHARE | Think Health! |
|---|---|---|---|
| Sponsor | American Heart Association National Center |
National Heart Lung, and Blood Institute (HL 69400) |
State of Pennsylvania Tobacco Settlement Funds |
| Time frame | 2000–2002 | 2002–2006 | 2005–2010 |
| Eligible race/ethnicity | Black American | Black American (not required for partners) |
Any, but emphasized Black Americans and Latinos |
| Study setting | Family medicine practice office in university health system |
Research offices in university area |
Primary care practices |
| Recruitment targets | Local residents with primary care provider in university of health system |
Local residents, particularly those who could identify partners to enroll with them |
Only current patients of the participating primary care practices |
| Recruitment method | Newspaper advertisements, referrals, other |
Newspaper advertisements, referrals, other |
Lists generated from practices and referrals |
| Eligible age range | 25 – 70 years | 35 – 70 years for Index 16 – 70 years for Partners |
18 – 70 years |
| Eligible BMI | 30 – 50 kg/m2 | 27 – 55 kg/m2 | 25 – 55 kg/m2 |
| Major clinical exclusions | pregnancy, unstable mental or physical health; weight altering medications |
pregnancy, unstable mental or physical health; weight altering medications |
pregnancy, unstable mental or physical health; weight altering medications |
| Number Black Americans enrolled |
237 in initial program; 128 in RCT |
344; 193 Index Participants and 151 Partners |
169 |
| Study-provided treatments |
After participating in program of 10 weekly group counseling sessions, randomized to: 1) 6 bi-weekly, then monthly group sessions (HELP classes) 2) Facilitated self-help program (Self- HELP) 3) Semi-annual health monitoring (Clinic visits only) |
If enrolled with partner (Family/Friend), randomized to: 1) 23 weekly, 12 bi-weekly, then 12 monthly group sessions including periodic personal counseling; partners attended group sessions 2) as in 1), but, no partners at group sessions If enrolled alone (Individual), randomized to: 3) as in 1), but were assigned partners within the group 4) as in 3), no partners assigned |
Randomized to: 1) brief counseling by primary care provider ~ every 4 months plus 12 monthly counseling sessions with an auxiliary staff member acting as a lifestyle coach, then bi-monthly sessions with the coach 2) brief counseling by primary care provider every 4 months |
| Participant materials | printed manuals; calorie counter; pedometer; educational video; incentives |
printed manuals and handouts; pedometers; resistance band; incentives |
printed manuals; audio versions of first 12 sessions; resistance band; incentives |
| Length of follow up | 3–6, or 11–21 months depending on enrollment date and involvement in Phase 2 |
24 months | 16 –24 months, depending on date of enrollment |
| % (n) with final weight measurements |
57% (134) of initial program 68% (87) of RCT |
63% (215) overall 66% of Index participants |
56% (95) of those randomized |
| % (n) with final BP measurements |
100% of those with final weight measurements; initial and RCT |
97% (208) of those with final weight measurements |
100% (95) of those with final weight measurements |
| Overall weight loss from baseline to end of follow up |
Mean (SD)* 0.8 (4.4) kg -HELP Classes −1.3 (5.5) kg -Self-HELP −1.4 (5.7) kg -Clinic visits only |
Mean (SD)‡ 2.6 (5.7) kg -Family/Friend 1.4 (5.2) kg -Individual |
Mean (SD)§ 0.9 (5.7) kg -moderate intensity 0.5 (5.0) kg -low intensity |
| % with > 5% weight loss | 25%# | 23.9% -Family/Friend 16.1% -Individual |
14% |
*
based on data for completers; treatment group difference were not statistically significant (p=.90)
#
data for completers pooled across treatment arms
‡
Based on intention-to-treat analyses within the Family/Friend and Individual strata for Index participants only, i.e., participants who enrolled as partners of other participants are not included; these estimates do not include a participant who had bariatric surgery during the study period. Treatment outcomes were not significantly different between the high and low social support conditions within strata
§
calculated for the black American participants in Think Health! The treatment group differences was not statistically significant