Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06528067
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Mindful Motivation for Reducing Binge Eating
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Mindful Motivation for Reducing Binge Eating
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to test how acceptable and feasible a new eating intervention is in people with overweight and binge eating This intervention combines mindful eating with motivational interviewing to target binge eating The main questions this clinical trial aims to answer are
How well do participants accept the new intervention acceptability Is the intervention practical and easy to implement feasibility
In this trial researchers will compare the new eating intervention motivational interviewing for mindful eating digital meditation to an active control digital meditation to see if the intervention can help reduce binge eating
Participants will
1 Take online questionnaires at four different time points
2 Provide body composition and samples to measure glucose levels
3 Meditate for at least 10 minutes a day
4 If assigned to the Mindful Motivation group 8 weeks of brief counseling
How well do participants accept the new intervention acceptability Is the intervention practical and easy to implement feasibility
In this trial researchers will compare the new eating intervention motivational interviewing for mindful eating digital meditation to an active control digital meditation to see if the intervention can help reduce binge eating
Participants will
1 Take online questionnaires at four different time points
2 Provide body composition and samples to measure glucose levels
3 Meditate for at least 10 minutes a day
4 If assigned to the Mindful Motivation group 8 weeks of brief counseling
Detailed Description:
In this clinical trial researchers will recruit and randomize a total of 100 participants into an 8-week program Participants will be assigned to either the Mindful Motivation group which combines motivational interviewing for mindful eating with digital meditation via headspace or the Active Control group digital meditation via headspace only Measurements will be taken at baseline week 4 week 8 post-intervention and during a 6-month follow-up period The researchers will look at changes in weight waist circumference glycated hemoglobin A1C levels and continuous glucose levels for ten days study 2 only described below at baseline and 8-week follow up
Study 1 40 participants will be adults from the community 20 in the intervention group and 20 in the active control group
Study 2 60 participants will be UCSF graduate students 30 in the intervention group and 30 in the active control group
The Mindful Motivation program is adapted from several sources including motivational interviewing for binge eating motivational interviewing for weight management and mindfulness-based eating awareness training MB-EAT The program includes an initial one-on-one counseling session three booster calls during the 8-week intervention period engagement with an online mindful eating program instruction on mindful eating practices access to an online anonymous support group participation in an 8-week general mindfulness program Headspace and an optional 6-month follow-up with a counselor
Study 1 40 participants will be adults from the community 20 in the intervention group and 20 in the active control group
Study 2 60 participants will be UCSF graduate students 30 in the intervention group and 30 in the active control group
The Mindful Motivation program is adapted from several sources including motivational interviewing for binge eating motivational interviewing for weight management and mindfulness-based eating awareness training MB-EAT The program includes an initial one-on-one counseling session three booster calls during the 8-week intervention period engagement with an online mindful eating program instruction on mindful eating practices access to an online anonymous support group participation in an 8-week general mindfulness program Headspace and an optional 6-month follow-up with a counselor
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