Study to Promote Weight Loss in Primary Care Practices

February 6, 2018 updated by: Ruth Weinstock, State University of New York - Upstate Medical University

Weight Loss in Primary Care: a Translation of the Diabetes Prevention Program

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

257

Phase

  • Not Applicable

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Individual Telephone Intervention
Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices.
Behavioral: 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.
Active Comparator: Group Telephone Intervention
Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: baseline, 1, 2, 3 years
Weight (kg)
baseline, 1, 2, 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure
Time Frame: baseline, 1, 2, 3 years
Systolic blood pressure (mm Hg) / Diastolic blood pressure (mm Hg)
baseline, 1, 2, 3 years
Fasting Lipid Panel
Time Frame: baseline, 1, 2, 3 years
LDL-cholesterol (mg/dL)
baseline, 1, 2, 3 years
Fasting Glucose Level
Time Frame: baseline, 1, 2, 3 years
Fasting glucose (mg/dL)
baseline, 1, 2, 3 years
Health Behaviors (Diet, Physical Activity)
Time Frame: baseline, 6 months, 1 and 2 years
National Cancer Institute Fat screener
baseline, 6 months, 1 and 2 years
SF-12 Physical Summary Score
Time Frame: baseline, 6 months, 1 and 2 years
The impact of physical health on overall quality of life; higher score reflects better quality of life. Range 0-100 (0 indicates the lowest level and 100 the highest level of health).
baseline, 6 months, 1 and 2 years
International Physical Activity Questionnaire
Time Frame: baseline, 6 months, 1 and 2 years
Measure of physical activity is calculated as in mets/week
baseline, 6 months, 1 and 2 years

Collaborators and Investigators

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

Sponsor

State University of New York - Upstate Medical University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Ruth S. Weinstock, MD PhD, State University of New York - Upstate Medical University
  • Principal Investigator: Paula Trief, PhD, State University of New York - Upstate Medical University

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

Helpful Links

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, 2009

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

September 5, 2008

First Submitted That Met QC Criteria

September 5, 2008

First Posted (Estimate)

September 9, 2008

Study Record Updates

Last Update Posted (Actual)

February 12, 2018

Last Update Submitted That Met QC Criteria

February 6, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R18DK078553 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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