Evaluation of a SlimFast Internet Behavioral Weight Loss Program

NCT ID: NCT00200304

Last Updated: 2013-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-01-31
• Study Completion Date: 2003-01-31

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Internet weight loss with SlimFast and human counseling

Intervention Type: BEHAVIORAL

Internet weight loss with SlimFast and computer counseling

Intervention Type: BEHAVIORAL

Internet weight loss program with SlimFast

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Overweight or obese

Exclusion Criteria

• heart disease
• stroke
• cancer
• diabetes
• orthopedic problems
• pregnancy

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Miriam Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Rena R Wing, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The Miriam Hospital

Locations

The Miriam Hospital

Providence, Rhode Island, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 16908795 (View on PubMed)

Other Identifiers

2083-00

Identifier Type: -

Identifier Source: org_study_id