Obesity
Conditions
Keywords
Weight Management in adults, Reducing Health Disparities
Brief summary
Think Health! A Personal Weight Management Program, or ¡Vive Saludable! Un programa personalizado de control de peso aims to improve the treatment of obesity in adults in the general population, by conducting research with men and women recruited from primary care medical practices. The study has a particular focus on African Americans and Latino. The design is randomized trial of the effectiveness of two versions of a lifestyle weight loss program called delivered by primary care providers (PCP) and ancillary staff at 5 clinical practice sites to their own patients. The two versions of the lifestyle weight loss program are called Basic (minimal counseling provided by PCP every four months) and Basic Plus (same PCP counseling plus additional counseling by specially trained ancillary practice staff acting as Lifestyle Coaches (LC), monthly for the first 12 months and then every other month for up to 2 years).
Interventions
BEHAVIORALThink Health! program
Brief 10-15 minute counseling with Primary Care Provider for weight management, Participant binder with eating, physical activity and stress management educational materials, adapted from the Diabetes Prevention Program (DPP)(Knowler et al, 2002; DPP Research Group, 2002), physical activity resource guide, and telephonic health related messages (year 2).
BEHAVIORALBasic Plus program
15 minute counseling sessions with lifestyle coach, in addition to the Basic Think Health! program intervention.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Women and men 2. Ages 18 to 70 years 3. Body mass index \> 25 kg/m2 but \< 55 kg/m2 or who weigh \<400 pounds.
Exclusion criteria
1. Pregnancy or lactation, since contraindicated for weight loss or affecting weight status 2. Weight loss \> 10 pounds in the previous 3 months 3. Current use of weight loss medications 4. Use of medications known to result in significant weight gain (e.g., oral steroids or second generation anti-psychotics) 5. Psychiatric disorders including untreated major depression, psychosis, bulimia nervosa, and substance abuse 6. Active chemo- or radiation therapy 7. Unstable renal, hepatic, or cardiovascular disease, including malignant arrhythmias 8. Recent (past 3 months) history of myocardial infarction, stroke, or congestive heart failure 9. Participants age \< 18 will be excluded because we are only using adult practices and a different type of program would be needed for patients \< 18, and age \> 70 years will be excluded because our experience has been that a specially tailored program would be needed. As a design consideration, we wanted to decrease the heterogeneity of the program. 10. Participants with a BMI \> 55 kg/m2 will be excluded because they are likely to require more extensive medical and behavioral care than can be provided in this study. 11. More than 1 participant residing in the same household will be excluded to avoid contamination across the treatment conditions. 12. Final
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body weight, as measured at months 0, 12, 24 (or at final visit). | Up to 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Blood pressure, height, and waist measurements; surveys to assess health behavior changes; and attendance at treatment visits. | Up to 24 months |
Countries
United States
Outcome results
None listed