Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054925
Status:
COMPLETED
Last Update Posted:
2012-03-07
First Post:
2003-02-13
Brief Title:
Weight Loss Maintenance WLM
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Weight Loss Maintenance WLM
Status:
COMPLETED
Status Verified Date:
2012-03
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:
WLM
Brief Summary:
To determine the effectiveness of continuous patient contact on weight loss maintenance
Detailed Description:
BACKGROUND
Overweightobesity is the second leading cause of death in the US and is growing in prevalence at an alarming rate Control of overweightobesity is increasingly recognized as a high national priority because of its contribution to cardiovascular CVD risk factors and ultimately to CVD itself The short-term success of behavioral interventions for weight loss has been repeatedly documented Unfortunately because weight re-gain is extremely common a disappointingly small proportion of individuals achieve long-term weight control Of the factors that are associated with sustained weight loss one of the most important is continued intervention with frequent contacts
DESIGN NARRATIVE
The study is a multi-center randomized controlled trial Weight Loss Maintenance Trial MAINTENANCE to determine the effects of two innovative behavioral interventions each designed to maintain frequent contacts compared to a usual care control group Overweight and obese individuals 60 women 40 African Americans who are taking medication for hypertension dyslipidemia andor type 2 diabetes will enter a 6-month weight loss program Those 800 individuals who lose at least 4 kg approximately 9 pounds will then be randomized into one of three groups a Personal Contact PC Intervention that provides monthly personal contacts with a trained interventionist primarily via telephone an Interactive Technology IT Intervention that provides frequent contacts through a state-of-the-art interactive web-based program supplemented by other communication technologies or Usual Care UC The primary outcome will be weight change from the end of the initial weight loss program to the end of the 30-month weight maintenance intervention period Other outcomes will include weight change in subgroups prevalence of CVD risk factors measures of behavior change and cost of implementation For each outcome the Personal Contact and Interactive Technology interventions will be compared to Usual Care and if different from Usual Care to each other To successfully combat the obesity epidemic clinicians and health care systems must have options that are effective and feasible and that can be provided to large numbers of individuals
Phase II intervention completed July 2007
Phase III intervention completed October 2009
Overweightobesity is the second leading cause of death in the US and is growing in prevalence at an alarming rate Control of overweightobesity is increasingly recognized as a high national priority because of its contribution to cardiovascular CVD risk factors and ultimately to CVD itself The short-term success of behavioral interventions for weight loss has been repeatedly documented Unfortunately because weight re-gain is extremely common a disappointingly small proportion of individuals achieve long-term weight control Of the factors that are associated with sustained weight loss one of the most important is continued intervention with frequent contacts
DESIGN NARRATIVE
The study is a multi-center randomized controlled trial Weight Loss Maintenance Trial MAINTENANCE to determine the effects of two innovative behavioral interventions each designed to maintain frequent contacts compared to a usual care control group Overweight and obese individuals 60 women 40 African Americans who are taking medication for hypertension dyslipidemia andor type 2 diabetes will enter a 6-month weight loss program Those 800 individuals who lose at least 4 kg approximately 9 pounds will then be randomized into one of three groups a Personal Contact PC Intervention that provides monthly personal contacts with a trained interventionist primarily via telephone an Interactive Technology IT Intervention that provides frequent contacts through a state-of-the-art interactive web-based program supplemented by other communication technologies or Usual Care UC The primary outcome will be weight change from the end of the initial weight loss program to the end of the 30-month weight maintenance intervention period Other outcomes will include weight change in subgroups prevalence of CVD risk factors measures of behavior change and cost of implementation For each outcome the Personal Contact and Interactive Technology interventions will be compared to Usual Care and if different from Usual Care to each other To successfully combat the obesity epidemic clinicians and health care systems must have options that are effective and feasible and that can be provided to large numbers of individuals
Phase II intervention completed July 2007
Phase III intervention completed October 2009
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL068734 | NIH | None | httpsreporternihgovquickSearchU01HL068734 |