Clinical trial NCT00959608: Think Health! A Personal Weight Management Program
Official title: Modeling Effective Obesity Treatment to Reduce Disparities Through Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Weight Management in adults
Reducing Health Disparities
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2009-08-14
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Change in body weight, as measured at months 0, 12, 24 (or at final visit).
timeFrame: Up to 24 months
Secondary outcomes:
measure: Blood pressure, height, and waist measurements; surveys to assess health behavior changes; and attendance at treatment visits.
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Family Care at St. Leonard's Court
state: Pennsylvania
city: Philadelphia
country: United States
facility: PennCare- Edward S. Cooper Practice of General Internal Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Greenhouse Internists
state: Pennsylvania
city: Philadelphia
country: United States
facility: Einstein Community Health Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: Northeast Family Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Shiriki K Kumanyika, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kumanyika SK, Morales KH, Allison KC, Russell Localio A, Sarwer DB, Phipps E, Fassbender JE, Tsai AG, Wadden TA. Two-Year Results of Think Health! inverted exclamation markVive Saludable!: A Primary Care Weight-Management Trial. Obesity (Silver Spring). 2018 Sep;26(9):1412-1421. doi: 10.1002/oby.22258. Epub 2018 Aug 29.