Internet Assisted Obesity Treatment

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Trial of an Internet Versus In-person Behavioral Weight Loss Treatment Program.

Conditions
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Obesity, Overweight

Intervention / Treatment
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* Behavioral: internet, in-person and internet+in-person


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years old BMI>25 Internet access Exclusion Criteria: pregnancy major medical problems inability to walk for exercise

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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<br>* All participants receive an 18 month behavioral weight loss program that meets weekly for the first 6 months and monthly for the next year.<br>|
| Experimental: 2<br>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<br>* All participants receive an 18 month behavioral weight loss program that meets weekly for the first 6 months and monthly for the next year.<br>|
| Experimental: 3<br>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<br>* All participants receive an 18 month behavioral weight loss program that meets weekly for the first 6 months and monthly for the next year.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index or body weight change |  | 0, 6, 12, 18 month time points | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social support, diet, exercise, adherence to treatment components |  | 0, 6, 12, 18 months |