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Preventing Overweight in USAF Personnel: Minimal Contact Program

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ClinicalTrials.gov Identifier: NCT00417599
Recruitment Status : Completed
First Posted : January 1, 2007
Last Update Posted : June 24, 2016
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
John P. Foreyt, Baylor College of Medicine

Brief Summary:
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 or disease Intervention/treatment Phase
Overweight Obesity Behavioral: Lifestyle Intervention Other: control group Not Applicable

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  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preventing Overweight in USAF Personnel: Minimal Contact Program
Study Start Date : December 2001
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

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



Primary Outcome Measures :
  1. Body Weight [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Body Mass Index [ Time Frame: 1 year ]
  2. Percent Body Fat [ Time Frame: 1year ]
  3. Waist Circumference [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00417599


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John P. Foreyt, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00417599     History of Changes
Other Study ID Numbers: H-10880
First Posted: January 1, 2007    Key Record Dates
Last Update Posted: June 24, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

Keywords provided by John P. Foreyt, Baylor College of Medicine:
Prevention of overweight
Prevention of obesity
Treatment of overweight
Treatment of obesity

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms