NCT00959608

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
261

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jun 2006

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2009

Completed
Last Updated

August 17, 2016

Status Verified

August 1, 2016

Enrollment Period

11 months

First QC Date

August 13, 2009

Last Update Submit

August 15, 2016

Conditions

Obesity

Keywords

Weight Management in adultsReducing Health Disparities

Outcome Measures

Primary Outcomes (1)

  • Change in body weight, as measured at months 0, 12, 24 (or at final visit).

    Up to 24 months

Secondary Outcomes (1)

  • Blood pressure, height, and waist measurements; surveys to assess health behavior changes; and attendance at treatment visits.

    Up to 24 months

Study Arms (2)

Basic

ACTIVE COMPARATOR

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

Basic Plus

EXPERIMENTAL

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! programBehavioral: Basic Plus program

Interventions

Think Health! programBEHAVIORAL

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).

BasicBasic Plus
Basic Plus programBEHAVIORAL

15 minute counseling sessions with lifestyle coach, in addition to the Basic Think Health! program intervention.

Basic Plus

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women and men
  • Ages 18 to 70 years
  • Body mass index \> 25 kg/m2 but \< 55 kg/m2 or who weigh \<400 pounds.

You may not qualify if:

  • Pregnancy or lactation, since contraindicated for weight loss or affecting weight status
  • Weight loss \> 10 pounds in the previous 3 months
  • Current use of weight loss medications
  • Use of medications known to result in significant weight gain (e.g., oral steroids or second generation anti-psychotics)
  • Psychiatric disorders including untreated major depression, psychosis, bulimia nervosa, and substance abuse
  • Active chemo- or radiation therapy
  • Unstable renal, hepatic, or cardiovascular disease, including malignant arrhythmias
  • Recent (past 3 months) history of myocardial infarction, stroke, or congestive heart failure
  • 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.
  • 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.
  • More than 1 participant residing in the same household will be excluded to avoid contamination across the treatment conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Penn Family Care at St. Leonard's Court

Philadelphia, Pennsylvania, 19104, United States

Location

PennCare- Edward S. Cooper Practice of General Internal Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Greenhouse Internists

Philadelphia, Pennsylvania, 19119, United States

Location

Einstein Community Health Associates

Philadelphia, Pennsylvania, 19120, United States

Location

Northeast Family Medicine

Philadelphia, Pennsylvania, 19120, United States

Location

Related Publications (1)

  • 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.

    PMID: 30160061DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Alkalies

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Officials

  • Shiriki K Kumanyika, PhD, MPH

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 13, 2009

First Posted

August 14, 2009

Study Start

June 1, 2006

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

August 17, 2016

Record last verified: 2016-08

Locations

US(5)