Preventing Overweight in USAF Personnel: Minimal Contact Program

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
John P. Foreyt, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00417599
First received: December 28, 2006
Last updated: March 18, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention
Overweight
Obesity
Behavioral: Behavior Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Preventing Overweight in USAF Personnel: Minimal Contact Program

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Body Weight [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body Mass Index [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Percent Body Fat [ Time Frame: 1year ] [ Designated as safety issue: No ]
  • Waist Circumference [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 500
Study Start Date: December 2001
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle intervention Behavioral: Behavior Therapy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00417599

Locations
United States, Texas
Wilford Hall Medical Center AFB
San Antonio, Texas, United States, 78236
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: John P Foreyt, Ph.D. Baylor College of Medicine
  More Information

No publications provided

Responsible Party: John P. Foreyt, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00417599     History of Changes
Other Study ID Numbers: H-10880
Study First Received: December 28, 2006
Last Updated: March 18, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Prevention of overweight
Prevention of obesity
Treatment of overweight
Treatment of obesity

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 01, 2015