Think Health! A Personal Weight Management Program
Recruitment status was Active, not recruiting
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Obesity |
Behavioral: Think Health! program Behavioral: Basic Plus program |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Modeling Effective Obesity Treatment to Reduce Disparities Through Primary Care |
- Change in body weight, as measured at months 0, 12, 24 (or at final visit). [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
- Blood pressure, height, and waist measurements; surveys to assess health behavior changes; and attendance at treatment visits. [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
| Enrollment: | 261 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | May 2010 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Basic
Basic program participants receive 10-15 minute PCP weight management counseling at approximately four month intervals for up to 24 months and weight management materials.
|
Behavioral: Think 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).
|
|
Experimental: Basic Plus
Half of study participants are randomly assigned to Basic Plus program, where in addition to receiving the same intervention as the Basic program participants, the Basic Plus participants also receive counseling from a lifestyle coach at the primary care provider's office (monthly in year 1 and bimonthly in year 2).
|
Behavioral: Think 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).
Behavioral: Basic Plus program
15 minute counseling sessions with lifestyle coach, in addition to the Basic Think Health! program intervention.
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Women and men
- Ages 18 to 70 years
- Body mass index > 25 kg/m2 but < 55 kg/m2 or who weigh <400 pounds.
Exclusion Criteria:
- Pregnancy or lactation, since contraindicated for weight loss or affecting weight status
- Weight loss > 10 pounds in the previous 3 months
- Current use of weight loss medications
- Use of medications known to result in significant weight gain (e.g., oral steroids or second generation anti-psychotics)
- Psychiatric disorders including untreated major depression, psychosis, bulimia nervosa, and substance abuse
- Active chemo- or radiation therapy
- Unstable renal, hepatic, or cardiovascular disease, including malignant arrhythmias
- Recent (past 3 months) history of myocardial infarction, stroke, or congestive heart failure
- 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.
- 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.
- More than 1 participant residing in the same household will be excluded to avoid contamination across the treatment conditions.
- Final exclusion criteria will be determined in collaboration with participating primary care providers
Contacts and Locations| United States, Pennsylvania | |
| Greenhouse Internists | |
| Philadelphia, Pennsylvania, United States, 19119 | |
| PennCare- Edward S. Cooper Practice of General Internal Medicine | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Einstein Community Health Associates | |
| Philadelphia, Pennsylvania, United States, 19120 | |
| Northeast Family Medicine | |
| Philadelphia, Pennsylvania, United States, 19120 | |
| Penn Family Care at St. Leonard's Court | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | Shiriki K Kumanyika, PhD, MPH | University of Pennsylvania |
More Information
No publications provided
| Responsible Party: | Shiriki K. Kumanyika, Ph.D., M.P.H./Professor of Epidemiology, University of Pennsylvania School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00959608 History of Changes |
| Other Study ID Numbers: | 804917 |
| Study First Received: | August 13, 2009 |
| Last Updated: | August 13, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pennsylvania:
|
Weight Management in adults Reducing Health Disparities |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013