Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00284167
Status:
COMPLETED
Last Update Posted:
2011-07-27
First Post:
2006-01-24
Brief Title:
Efficacy of a Web-based Tailored Weight Management Program
Sponsor:
Robert Wood Johnson Foundation
Organization:
Robert Wood Johnson Foundation
Study Overview
Official Title:
Efficacy of a Web-based Tailored Weight Management Program With and Without Tailored Nutrition and Goal Setting Support
Status:
COMPLETED
Status Verified Date:
2011-07
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 primary objective of this study is to assess the benefit of using online tailored behavioral weight management materials Balance in combination with nutritional materials Balance and Nourish in conjunction with a goal setting tool Balance and Achieve or a combination of all three Balance Nourish and Achieve This objective will be evaluated by measuring weight loss rates as reported by study participants at 3 12 and 18 months post-enrollment The hypothesis is that adding additional materials will increase the effect of the intervention over just using Balance alone
Detailed Description:
This will be a randomized control web-based trial for weight management with four treatment arms Participants will be assigned to receive tailored materials from either 1 the Balance program 2 the Balance and Nourish programs 3 the Balance and Achieve programs or 4 the Balance Nourish and Achieve programs Participants will be recruited directly through their health care organization In order to participate participants must visit the website to confirm their eligibility eg valid e-mail address Those who wish to participate will provide consent on the Web and then will be presented with an online questionnaire These questions will provide baseline data for each participant and will be the basis for the tailoring of the Balance materials each participant will receive Within 24 hours of submitting the completed questionnaire participants will be informed by e-mail that their tailored Balance plan is available on the website They will receive follow-up materials by e-mail during the six-week period after they enroll Participants who have been assigned to additional programs will be sent e-mails with links to the relevant programs At 3 12 and 18 months all participants will be assessed via an online survey The assessment will include weight management parameters psychosocial outcomes and program utilization This data will be self-reported
STUDY POPULATION The study sample will be drawn from members of three integrated delivery systems Kaiser Permanente Colorado KPCO Kaiser Permanente Ohio KPOH and Group Health Cooperative GHC of Puget Sound In order to participate participants must access and enroll in the study on the Web A total of 1848 participants will be enrolled within a six-month period with approximately 450 participants in each treatment arm By 18-month follow-up we assume successful data collection from at least 65 percent of the enrollees or 1200 participants 300 in each treatment group The study is open to those who meet the inclusion and exclusion criteria
STUDY POPULATION The study sample will be drawn from members of three integrated delivery systems Kaiser Permanente Colorado KPCO Kaiser Permanente Ohio KPOH and Group Health Cooperative GHC of Puget Sound In order to participate participants must access and enroll in the study on the Web A total of 1848 participants will be enrolled within a six-month period with approximately 450 participants in each treatment arm By 18-month follow-up we assume successful data collection from at least 65 percent of the enrollees or 1200 participants 300 in each treatment group The study is open to those who meet the inclusion and exclusion criteria
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