NCT00417599

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 1, 2007

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

June 24, 2016

Status Verified

June 1, 2016

Enrollment Period

13.9 years

First QC Date

December 28, 2006

Last Update Submit

June 22, 2016

Conditions

Keywords

Prevention of overweightPrevention of obesityTreatment of overweightTreatment of obesity

Outcome Measures

Primary Outcomes (1)

  • Body Weight

    1 year

Secondary Outcomes (3)

  • Body Mass Index

    1 year

  • Percent Body Fat

    1year

  • Waist Circumference

    1 year

Study Arms (2)

Lifestyle intervention

EXPERIMENTAL

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

Behavioral: Lifestyle Intervention

control

EXPERIMENTAL

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

Other: control group

Interventions

lifestyle intervention .

Lifestyle intervention

waiting list control group

control

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wilford Hall Medical Center AFB

San Antonio, Texas, 78236, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

OverweightObesity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • John P Foreyt, Ph.D.

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 28, 2006

First Posted

January 1, 2007

Study Start

December 1, 2001

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

June 24, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will share

See publication: Hunter CM et al Weight management using the internet: a randomized clinical trial. Am J Prev Med 2998;34:119-126

Locations