Clinical trial NCT00417599: Preventing Overweight in USAF Personnel: Minimal Contact Program
Official title: Preventing Overweight in USAF Personnel: Minimal Contact Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Prevention of overweight
Prevention of obesity
Treatment of overweight
Treatment of obesity
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2007-01-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Body Weight
timeFrame: 1 year
Secondary outcomes:
measure: Body Mass Index
timeFrame: 1 year
measure: Percent Body Fat
timeFrame: 1year
measure: Waist Circumference
timeFrame: 1 year
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Wilford Hall Medical Center AFB
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: John P Foreyt, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.