Think Health! A Personal Weight Management Program

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: Think Health! program; Behavioral: Basic Plus program

• Registration Number: NCT00959608
• Lead Sponsor: University of Pennsylvania

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Study First Submitted: 2009-08-13
• Study First Submitted QC: 2009-08-13
• Study First Posted: 2009-08-14
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-15
• Last Update Posted: 2016-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 261

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 exclusion criteria will be determined in collaboration with participating primary care providers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Basic	Think Health! program	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.
Basic Plus	Think Health! program	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).
Basic Plus	Basic Plus program	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).

Primary Outcome Measures

Name	Time	Method
Change in body weight, as measured at months 0, 12, 24 (or at final visit).	Up to 24 months

Secondary Outcome Measures

Name	Time	Method
Blood pressure, height, and waist measurements; surveys to assess health behavior changes; and attendance at treatment visits.	Up to 24 months

Trial Locations

Locations (5)

Greenhouse Internists; 🇺🇸 Philadelphia, Pennsylvania, United States

Einstein Community Health Associates; 🇺🇸 Philadelphia, Pennsylvania, United States

Northeast Family Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States

Penn Family Care at St. Leonard's Court; 🇺🇸 Philadelphia, Pennsylvania, United States

PennCare- Edward S. Cooper Practice of General Internal Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States