Preventing Overweight in USAF Personnel: Minimal Contact Program

June 22, 2016 updated by: John P. Foreyt, Baylor College of Medicine
The prevalence of overweight in the United States Air Force (USAF) is about 22%. The objective of this study is to compare the effectiveness of a minimal contact behavioral therapy plus usual care group(MCBT+UC) using a controlled experimental comparison of usual care(UC). Subjects are USAF personnel who are 5lbs below their Maximum Allowable Weight (MAW) and heavier. The primary hypothesis is that: MCBT+UC will have significant weight loss as compared to UC.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to compare the relative effectiveness of two approaches to weight management, using a controlled comparison experiment. The two approaches are: Minimal Contact Behavior Therapy Plus Usual Care (MCBT+UC) which includes an orientation meeting, provision of a self-help book, use of an interactive weight management web site for 6 months, and 2 brief motivational interviewing telephone follow-ups, plus usual care;and Usual Care (UC) which includes and orientation meeting and usual care (consisting of required USAF annual physical and fitness exam, participation in any mandatory weight loss or fitness programs, and the requirement to stay below a Maximum Allowable Weight [MAW], with penalties or separation as potential contingencies for failure to remain below MAW). The primary outcome is weight loss.Additional outcomes include body mass index, percent body fat, and waist circumference.

Study Type

Interventional

Enrollment (Actual)

500

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
    • Texas
      • San Antonio, Texas, United States, 78236
        • Wilford Hall Medical Center AFB

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 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Within 5 pounds below or equal to their MAW or above MAW according to USAF Weight and height tables
  • Access to personal computer with Internet access
  • Plan to remain in the local area for one year
  • Male or female between the ages 18-55 years

Exclusion Criteria:

  • Pregnant, planning to become pregnant or becomes pregnant
  • Weight loss of more than 10 pounds in the past 3 months
  • No prescription or nonprescription weight-loss medication for at least 6 months prior to screening
  • On any medical profile. Specific exclusion includes history of myocardial infarction, stroke, or cancer in the past 5 years, diabetes, angina, and orthopedic or joint problems that would prohibit exercise.

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
Experimental: Lifestyle intervention
Behavioral lifestyle intervention versus control group. The Behavioral intervention consists of behavioral lessons delivered over the internet.
Behavioral: Lifestyle Intervention
lifestyle intervention .
Experimental: control
The intervention for the waiting list control group was usual care.
Other: control group
waiting list control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body Weight
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Body Mass Index
Time Frame: 1 year
1 year
Percent Body Fat
Time Frame: 1year
1year
Waist Circumference
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Baylor College of Medicine

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: John P Foreyt, Ph.D., Baylor College of Medicine

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

December 1, 2001

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

December 28, 2006

First Submitted That Met QC Criteria

December 28, 2006

First Posted (Estimate)

January 1, 2007

Study Record Updates

Last Update Posted (Estimate)

June 24, 2016

Last Update Submitted That Met QC Criteria

June 22, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-10880

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

See publication: Hunter CM et al Weight management using the internet: a randomized clinical trial. Am J Prev Med 2998;34:119-126

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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