Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00200304
Status:
COMPLETED
Last Update Posted:
2013-04-24
First Post:
2005-09-14
Brief Title:
Evaluation of a SlimFast Internet Behavioral Weight Loss Program
Sponsor:
The Miriam Hospital
Organization:
The Miriam Hospital
Study Overview
Official Title:
Development and Evaluation of a SlimFast Internet Behavioral Weight Loss Program
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 componentSubject 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 workplaceMethodsDesignParticipants 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 kcalday that utilizes SlimFast for 2 meals per day and a healthy evening meal They will be encouraged to increase their exercise to 1000 kcalweek 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 informationData 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None