NCT00212238

Brief Summary

The purpose of this study is to compare two Internet-based behavioral weight loss programs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Sep 2003

Typical duration for not_applicable obesity

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

September 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

March 18, 2010

Status Verified

March 1, 2010

First QC Date

September 19, 2005

Last Update Submit

March 17, 2010

Conditions

Obesity

Keywords

obesityweight lossInternetcognitive behavior therapycomputer assisted patient carehuman therapy evaluationphysical activityclinical trialnutrient intake activityoutcomes researchpersonal log /diaryreinforcerself caresocial support networkweight controlbehavioral /social science research tagclinical researchhuman subjectquestionnaire

Outcome Measures

Primary Outcomes (1)

  • weight change from 0 to 12 months

Secondary Outcomes (5)

  • patterns of weight change (0-3, 3-6, 6-12 months)

  • change in waist circumference

  • change in physical activity

  • change in dietary intake

  • change in social support

Interventions

internet behavioral weight loss programBEHAVIORAL

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 25 to 40

You may not qualify if:

  • heart attack, stroke, cancer in the last 5 years, angina, diabetes that is treated with oral agents or insulin (people with type 2 diabetes whose disease is controlled through diet and exercise alone will be considered eligible), orthopedic or joint problems that would prohibit exercise;
  • major psychiatric diagnoses and organic brain syndromes;
  • pregnant, lactating, less than 6 months post-partum, or plan to become pregnant w/in 12 mos.
  • currently taking weight loss medications or lost \> 5% of body weight during the past 6 months;
  • intend to move to another city within the 12 month study duration;
  • have another family member living in the household enrolled in the study
  • heart problems, frequent chest pains, or faintness or dizziness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

ObesityWeight LossMotor ActivityFeeding Behavior

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesBehaviorBehavior, Animal

Study Officials

  • Deborah F. Tate, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 19, 2005

First Posted

September 21, 2005

Study Start

September 1, 2003

Study Completion

October 1, 2006

Last Updated

March 18, 2010

Record last verified: 2010-03

Locations

US(1)