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Preventing Overweight in USAF Personnel: Minimal Contact Program

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Intervention
control group
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring Prevention of overweight, Prevention of obesity, Treatment of overweight, Treatment of obesity

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Wilford Hall Medical Center AFB

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Lifestyle intervention

control

Arm Description

Behavioral lifestyle intervention versus control group. The Behavioral intervention consists of behavioral lessons delivered over the internet.

The intervention for the waiting list control group was usual care.

Outcomes

Primary Outcome Measures

Body Weight

Secondary Outcome Measures

Body Mass Index
Percent Body Fat
Waist Circumference

Full Information

First Posted
December 28, 2006
Last Updated
June 22, 2016
Sponsor
Baylor College of Medicine
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT00417599
Brief Title
Preventing Overweight in USAF Personnel: Minimal Contact Program
Official Title
Preventing Overweight in USAF Personnel: Minimal Contact Program
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
United States Department of Defense

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Prevention of overweight, Prevention of obesity, Treatment of overweight, Treatment of obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle intervention
Arm Type
Experimental
Arm Description
Behavioral lifestyle intervention versus control group. The Behavioral intervention consists of behavioral lessons delivered over the internet.
Arm Title
control
Arm Type
Experimental
Arm Description
The intervention for the waiting list control group was usual care.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Intervention
Intervention Description
lifestyle intervention .
Intervention Type
Other
Intervention Name(s)
control group
Intervention Description
waiting list control group
Primary Outcome Measure Information:
Title
Body Weight
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Body Mass Index
Time Frame
1 year
Title
Percent Body Fat
Time Frame
1year
Title
Waist Circumference
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P Foreyt, Ph.D.
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wilford Hall Medical Center AFB
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78236
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
18201641
Citation
Hunter CM, Peterson AL, Alvarez LM, Poston WC, Brundige AR, Haddock CK, Van Brunt DL, Foreyt JP. Weight management using the internet a randomized controlled trial. Am J Prev Med. 2008 Feb;34(2):119-26. doi: 10.1016/j.amepre.2007.09.026.
Results Reference
derived

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Preventing Overweight in USAF Personnel: Minimal Contact Program

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