NCT00265954

Brief Summary

High quality behavioral weight loss programs are not widely accessible. The Internet offers one way to deliver health behavior programs to a wider audience. However, effective weight loss treatments are intensive and program delivery over the Internet may not be capable of duplicating the level of engagement typically generated during traditional in-person treatment. The goal of this study is to test the effectiveness of three weight loss interventions: Internet alone, Internet+periodic in-person support, and in-person alone. The investigators hypothesize that the in-person and internet+in-person interventions will produce better weight loss and maintenance than the internet only group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
481

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

December 14, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 15, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

August 6, 2019

Status Verified

August 1, 2019

Enrollment Period

3.7 years

First QC Date

December 14, 2005

Last Update Submit

August 2, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index or body weight change

    0, 6, 12, 18 month time points

Secondary Outcomes (1)

  • Social support, diet, exercise, adherence to treatment components

    0, 6, 12, 18 months

Study Arms (3)

1

EXPERIMENTAL

Individuals in this arm receive a 6 month behavioral weight loss intervention delivered on-line. Groups meet via a web chat weekly for 24 weeks and monthly for the following 12 months.

Behavioral: internet, in-person and internet+in-person

2

EXPERIMENTAL

In-person; Individuals in the in-person condition attend weekly group behavioral weight loss sessions for 24 weeks and then monthly sessions for the following 12 months.

Behavioral: internet, in-person and internet+in-person

3

EXPERIMENTAL

In-person+internet; Individuals in this condition receive a behavioral weight loss intervention over the internet weekly for 24 weeks and monthly for the following 12 months. Every month during the first 24 weeks and every third month during the following year they have an in-person meeting.

Behavioral: internet, in-person and internet+in-person

Interventions

All participants receive an 18 month behavioral weight loss program that meets weekly for the first 6 months and monthly for the next year.

123

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>18 years old
  • BMI\>25
  • Internet access

You may not qualify if:

  • pregnancy
  • major medical problems
  • inability to walk for exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Arkansas for the Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

University of Vermont

Burlington, Vermont, 05405, United States

Location

Related Publications (1)

  • Harvey-Berino J, Krukowski RA, Buzzell P, Ogden D, Skelly J, West DS. The accuracy of weight reported in a web-based obesity treatment program. Telemed J E Health. 2011 Nov;17(9):696-9. doi: 10.1089/tmj.2011.0032. Epub 2011 Sep 1.

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jean Harvey-Berino, PhD

    University of Vermont

    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
Interim Dean, College of Agriculture and Life Sciences

Study Record Dates

First Submitted

December 14, 2005

First Posted

December 15, 2005

Study Start

February 1, 2006

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

August 6, 2019

Record last verified: 2019-08

Locations