Study to Promote Weight Loss in Primary Care Practices

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

257 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine if primary care based, telephone-delivered weight loss interventions are effective.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Primary Care Intervention for Weight Management

NCT00271193

Healthy

COMPLETED PHASE3

Effectiveness of Primary Care Physicians in Delivering Weight Control Counseling

NCT00017706

Obesity

COMPLETED NA

Obesity Assessment and Education Through the Internet

NCT00149682

Obesity

COMPLETED PHASE2

Weight Loss in Primary Care With Targeted Education and Frequent Follow Ups

NCT05141084

Obesity

UNKNOWN EARLY_PHASE1

Improving the Management of Obesity in Primary Care Practice (The Power-UP Trial)

NCT00826774

Obesity Hypercholesterolemia Metabolic Syndrome +2 more

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Obesity is related to the rising incidence of type 2 diabetes. Cost-effective interventions leading to sustained weight loss are needed to improve the public health and reverse the alarming rise in diabetes, its cardiovascular complications and other obesity-related illnesses. The Diabetes Prevention Program is identified as a model for a successful weight loss intervention. The proposed study is a randomized controlled trial of 2 active telephone-based interventions based on the Diabetes Prevention Model that will be delivered at primary care sites.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Individual Telephone Intervention

Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices.

Group Type EXPERIMENTAL

Individual telephone intervention

Intervention Type BEHAVIORAL

Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff.

Group Telephone Intervention

Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices.

Group Type ACTIVE_COMPARATOR

Group telephone intervention

Intervention Type BEHAVIORAL

Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Individual telephone intervention

Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff.

Intervention Type BEHAVIORAL

Group telephone intervention

Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Obese
* Metabolic syndrome
* Read and write English
* Planning to stay in treatment with their PCP for the next 3 years
* On stable doses of medications for chronic diseases such as hypothyroidism for 3 years

Exclusion Criteria

* Unstable health
* Diabetes mellitus
* Severe medical comorbidities that might interfere with their ability to participate in intervention such as severe psychiatric disease or significant heart disease.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes