Think Health! A Personal Weight Management Program (Think Health!)

August 15, 2016 updated by: University of Pennsylvania

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

261

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn Family Care at St. Leonard's Court
      • Philadelphia, Pennsylvania, United States, 19104
        • PennCare- Edward S. Cooper Practice of General Internal Medicine
      • Philadelphia, Pennsylvania, United States, 19119
        • Greenhouse Internists
      • Philadelphia, Pennsylvania, United States, 19120
        • Einstein Community Health Associates
      • Philadelphia, Pennsylvania, United States, 19120
        • Northeast Family Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in body weight, as measured at months 0, 12, 24 (or at final visit).
Time Frame: Up to 24 months
Up to 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood pressure, height, and waist measurements; surveys to assess health behavior changes; and attendance at treatment visits.
Time Frame: Up to 24 months
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: Shiriki K Kumanyika, PhD, MPH, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

August 13, 2009

First Submitted That Met QC Criteria

August 13, 2009

First Posted (Estimate)

August 14, 2009

Study Record Updates

Last Update Posted (Estimate)

August 17, 2016

Last Update Submitted That Met QC Criteria

August 15, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 804917

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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