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Evaluation of a SlimFast Internet Behavioral Weight Loss Program

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internet weight loss with SlimFast and human counseling
Internet weight loss with SlimFast and computer counseling
Internet weight loss program with SlimFast
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Weight loss, Internet

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Overweight or obese Exclusion Criteria: heart disease stroke cancer diabetes orthopedic problems pregnancy

Sites / Locations

  • The Miriam Hospital

Outcomes

Primary Outcome Measures

Weight loss at 6 months

Secondary Outcome Measures

Frequency of use of the Internet website

Full Information

First Posted
September 14, 2005
Last Updated
April 23, 2013
Sponsor
The Miriam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00200304
Brief Title
Evaluation of a SlimFast Internet Behavioral Weight Loss Program
Official Title
Development and Evaluation of a SlimFast Internet Behavioral Weight Loss Program
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
January 2003 (Actual)
Study Completion Date
January 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The Miriam Hospital

4. Oversight

5. Study Description

Brief Summary
The Internet has been used effectively in behavioral weight loss programs. Most of these programs have involved a therapist who provides email counseling. The purpose of this study was to determine whether a computer-assisted weight loss program could be developed (that would use pre-programmed computer generated messages rather than human generated messages) and whether this program would be as effective as the therapist-assisted weight loss program.
Detailed Description
Specific Aims Over 50% of Americans are overweight. These individuals are at increased risk of morbidity and mortality. Weight losses of 5-10% of body weight have been shown to lower these risks. The majority of individuals who lose weight do so on their own, without the help of formal programs. Developing ways to improve weight loss in such individuals is a major public health challenge. We believe that the Internet holds tremendous promise for reaching large numbers of overweight individuals and assisting them in their weight loss efforts. Our previous research has shown that a structured behavioral weight loss program offered via the Internet, with regular feedback from a therapist, can produce average weight losses of 9 lbs. at 6 months. The purpose of this project is to compare the weight losses achieved at 6 months using 3 different types of Internet programs, all of which are used in combination with SlimFast as the dietary component.Subject PopulationTwo hundred twenty-five overweight individuals will be recruited, aged 20-65 with a BMI of 27-40 who want to lose weight using SlimFast. Participants must be willing to attend an initial orientation and weigh-in session and follow-up weigh-in sessions and agree that they will not begin a second weight loss program within the next 12 months. Interested participants will be required to have access to a computer with Internet connection from their home or their workplace.Methods/DesignParticipants will be randomly assigned to one of three conditions: 1) SlimFast + Current SlimFast Website; 2) SlimFast + Current SlimFast Website + Computer-Generated E-mail feedback; or 3) SlimFast + Current SlimFast Website + Therapist-Assisted E-mail feedback. All 3 groups will be placed on a calorie-restricted diet (1200-1500 kcal/day) that utilizes SlimFast for 2 meals per day and a healthy evening meal. They will be encouraged to increase their exercise to 1000 kcal/week based on walking. Group 1 will receive all other input from the SlimFast website. Group 2 will receive weekly computer-generated feedback based on diet, physical activity and weight loss information. Group 3 will receive weekly e-mail messages from a trained therapist that will provide feedback based on diet, physical activity and weight loss information.Data AnalysisAll participants will be weighed at baseline, 3 months, and 6 months to document the weight changes they experience. The primary analysis will compare weight change from baseline to 6 months for the 3 conditions. An intent-to-treat analysis will be used, where dropouts are considered to have regained back to baseline weight. Secondary analyses will examine baseline predictors of weight loss and the association between use of the various Internet components and outcome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Weight loss, Internet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Single
Allocation
Randomized
Enrollment
225 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Internet weight loss with SlimFast and human counseling
Intervention Type
Behavioral
Intervention Name(s)
Internet weight loss with SlimFast and computer counseling
Intervention Type
Behavioral
Intervention Name(s)
Internet weight loss program with SlimFast
Primary Outcome Measure Information:
Title
Weight loss at 6 months
Secondary Outcome Measure Information:
Title
Frequency of use of the Internet website

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Overweight or obese Exclusion Criteria: heart disease stroke cancer diabetes orthopedic problems pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rena R Wing, Ph.D.
Organizational Affiliation
The Miriam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16908795
Citation
Tate DF, Jackvony EH, Wing RR. A randomized trial comparing human e-mail counseling, computer-automated tailored counseling, and no counseling in an Internet weight loss program. Arch Intern Med. 2006 Aug 14-28;166(15):1620-5. doi: 10.1001/archinte.166.15.1620.
Results Reference
result

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Evaluation of a SlimFast Internet Behavioral Weight Loss Program

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