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
  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

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959608

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
Sponsors and Collaborators
University of Pennsylvania
Investigators
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 August 19, 2014