Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-01-05 @ 9:55 PM
Study NCT ID:
NCT06528067
Status:
RECRUITING
Last Update Posted:
2025-03-30
First Post:
2024-07-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mindful Motivation for Reducing Binge Eating
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Mindful Motivation for Reducing Binge Eating
Status:
RECRUITING
Status Verified Date:
2025-03
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:
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:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|---|
| K23AT011048 | NIH | None | https://reporter.nih.gov/quic… | View |