Clinical trial NCT00265954: Internet Assisted Obesity Treatment
Official title: A Randomized Trial of an Internet Versus In-person Behavioral Weight Loss Treatment Program.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: University of Arkansas
First posted: 2005-12-15
Enrollment: 481
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Currently 65% of the adult population is overweight or obese. Unfortunately, safe and effective treatments for obesity are costly and intensive; therefore, this level of support is unlikely to be feasible in most clinical settings. Moreover, an additional limitation to current obesity treatment approaches is the limited reach and availability of programs for persons who work, live in rural areas or do not want, or cannot afford participation in group support classes. The advent of telecommunications technology may provide a solution to this dilemma. Telecommunications technology can presumably improve access to services and improve efficiency of delivery. Moreover, research examining new technologies such as the Internet, will provide information for policy makers interested in disseminating low-cost, high reach effective obesity treatment interventions. However, the effectiveness of the Internet for inducing weight loss has not been rigorously tested. Therefore, the overall goal of this project is to determine if obesity treatment can be effectively delivered over the Internet. A secondary aim is to evaluate whether the effectiveness of Internet interventions can be improved with the addition of minimal in-person support. Specifically, this project is a randomized, controlled clinical trial designed to test the translation of a behavioral weight loss program to the Internet (I). The I intervention will be compared to both an in-person condition (IP) and an Internet condition supplemented with periodic in-person support (I+IP). Subjects will be 488 (30% minority) overweight and obese adults recruited from Vermont and Arkansas who will participate in a 6-month behavioral weight control treatment program followed by 12 months of weight maintenance. Assessments will include measures of body weight, adherence to treatment goals, social influence components and frequency of use of Internet website features.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Body Mass Index or body weight change
timeFrame: 0, 6, 12, 18 month time points
Secondary outcomes:
measure: Social support, diet, exercise, adherence to treatment components
timeFrame: 0, 6, 12, 18 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for the Medical Sciences
state: Arkansas
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: University of Vermont
name: Jean Harvey-Berino, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.