Preventing Overweight in USAF Personnel: Minimal Contact Program

Obesity Clinical Trial

Official title:

Preventing Overweight in USAF Personnel: Minimal Contact Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00417599
• Other study ID #: H-10880
• Status: Completed
• Phase: N/A
• First received: December 28, 2006
• Last updated: June 22, 2016
• Start date: December 2001
• Est. completion date: November 2015

Study information

• Verified date: June 2016
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Lifestyle Intervention
lifestyle intervention .

Other:
• control group
waiting list control group

Locations

Country	Name	City	State
United States	Wilford Hall Medical Center AFB	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Weight		1 year	No
Secondary	Body Mass Index		1 year	No
Secondary	Percent Body Fat		1year	No
Secondary	Waist Circumference		1 year	No