Think Health! A Personal Weight Management Program

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by University of Pennsylvania.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00959608
First received: August 13, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted

August 13, 2009
August 13, 2009
June 2006
May 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
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 ]
Same as current
Not Provided
Not Provided
 
Think Health! A Personal Weight Management Program
Modeling Effective Obesity Treatment to Reduce Disparities Through Primary Care

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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Obesity
  • 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.
  • 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.
    Intervention: Behavioral: Think Health! program
  • 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).
    Interventions:
    • Behavioral: Think Health! program
    • Behavioral: Basic Plus program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
261
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00959608
804917
No
Shiriki K. Kumanyika, Ph.D., M.P.H./Professor of Epidemiology, University of Pennsylvania School of Medicine
University of Pennsylvania
Not Provided
Principal Investigator: Shiriki K Kumanyika, PhD, MPH University of Pennsylvania
University of Pennsylvania
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP