Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-28 @ 12:03 AM
Study NCT ID:
NCT00896194
Status:
COMPLETED
Last Update Posted:
2015-07-07
First Post:
2009-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Self-Efficacy in Weight Loss Treatment
Sponsor:
Lora Burke
Organization:
Study Overview
Official Title:
Self-Efficacy in Weight Loss Treatment
Status:
COMPLETED
Status Verified Date:
2015-07
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:
SELF
Brief Summary:
This randomized clinical trial of weight loss treatment will examine if adding personalized, one-on-one treatment session to standard behavioral group treatment will result in greater weight loss, less weight regain after weight loss, and better adherence to the treatment protocol.
Everyone who enrolls in the study will receive information on healthy eating, how to increase their physical activity and develop healthy exercise habits and ways to change their eating so that they will lose weight. This information will be provided at evening group sessions. There will be a total of 20 group meetings over an 18-month period that will be held:
* every week during the first month of the study,
* every other week for the second month
* once a month for months 3-12
* every 6 weeks for months 13-18
Participants in the self-efficacy group will also be asked to participate in one-on-one lifestyle counseling sessions with a study interventionist throughout the study.
Everyone will be asked to complete questionnaires, two 24-hour dietary recalls over the phone, and have blood tests done every six months (at the beginning of the study, at 6, 12, and 18 months) a total of 4 times for the study.
Everyone who enrolls in the study will receive information on healthy eating, how to increase their physical activity and develop healthy exercise habits and ways to change their eating so that they will lose weight. This information will be provided at evening group sessions. There will be a total of 20 group meetings over an 18-month period that will be held:
* every week during the first month of the study,
* every other week for the second month
* once a month for months 3-12
* every 6 weeks for months 13-18
Participants in the self-efficacy group will also be asked to participate in one-on-one lifestyle counseling sessions with a study interventionist throughout the study.
Everyone will be asked to complete questionnaires, two 24-hour dietary recalls over the phone, and have blood tests done every six months (at the beginning of the study, at 6, 12, and 18 months) a total of 4 times for the study.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P01NR010949 | NIH | None | https://reporter.nih.gov/quic… | View |