Condition(s) treated: Overweight; Obesity

Intervention: Behavioral weight loss therapy (Behavior)

Phase: Phase 3

Enrollment status: Recruiting. Expecting to enroll 488 people.

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Principal investigator(s) or official(s):
Jean Harvey-Berino, PhD, Principal Investigator, Affiliation: University of Vermont

Overall contact:
Doris Ogden, Phone: (802) 656-1960, Email: doris.ogden@uvm.edu

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. We hypothesize that the in-person and internet+in-person interventions will produce better weight loss and maintenance than the internet only group.

Official title: A Randomized Trial of an Internet Versus in-Person Behavioral Weight Loss Treatment Program.

Study design: Interventional, Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study

Primary outcome: Body Mass Index or body weight change measured at 0, 6, 12, and 18 month timepoints

Secondary outcome: Social support, diet, exercise, adherence to treatment components

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.

Minimum eligible age: 18 Years. Eligible gender(s): Both.

Criteria:

Inclusion Criteria:

- >18 years old

- BMI>25

- Internet access

Exclusion Criteria:

- pregnancy

- major medical problems

- inability to walk for exercise

Doris Ogden, Phone: (802) 656-1960, Email: doris.ogden@uvm.edu

University of Arkansas for the Medical Sciences, Little Rock, Arkansas 72205, United States; Recruiting
Delia Smith West, PhD, Phone: 501-526-6623, Email: dswest1@uams.edu

University of Vermont, Burlington, Vermont 05405, United States; Recruiting
Jean Harvey-Berino, Ph.D., Principal Investigator

Start date: February 2006
End date: March 2010
Last updated: September 26, 2006