Mindful Motivation for Reducing Binge Eating

NCT ID: NCT06528067

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2026-08-01

Brief Summary

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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

Detailed Description

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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.

Conditions

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Binge Eating Psychological Health Behavior Weight, Body

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Randomization in to one of two conditions:

1. Mindful Motivation Intervention
2. Active Control
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Mindful Motivation Group

Participants will be assigned to a eating intervention that combines general mindfulness (via headspace) with motivational interviewing for mindful eating They will be asked to attend an online counseling session along with three 10-minute booster phone calls. They will be asked to engage with a digital-based mindful eating program once per week over the course of 8 weeks. In addition, participants will have access to optional educational materials on mindful eating and an optional online private support forum after the intervention period is finished.

Group Type EXPERIMENTAL

Meditation

Intervention Type BEHAVIORAL

10 minute per day, 8 week digital meditation

Mindful Motivation

Intervention Type BEHAVIORAL

A single 50 minute counseling session focused on eating behaviors, and three 10-minute follow-up phone calls to check-in on eating goals

Active Control Condition

Participants in the meditation intervention group will be assigned to a digitally-based meditation intervention (via Headspace) and asked to use this for at least 10 minutes a day over the course of 8 weeks.

Group Type ACTIVE_COMPARATOR

Meditation

Intervention Type BEHAVIORAL

10 minute per day, 8 week digital meditation

Interventions

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Meditation

10 minute per day, 8 week digital meditation

Intervention Type BEHAVIORAL

Mindful Motivation

A single 50 minute counseling session focused on eating behaviors, and three 10-minute follow-up phone calls to check-in on eating goals

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Aged 18 years or older
* Overweight (BMI ≥ 25 kg/m2)
* High levels of binge eating as assessed by QEWP-5 that are at least sub-clinical for binge eating disorder
* At least 1 episode of binge eating each month over the past 3 months with significant distress about these episodes
* Daily access to a smartphone or computer


* Current student at UCSF
* Aged 18 years or older
* Overweight (BMI ≥ 25 kg/m2)
* High levels of binge eating as assessed by QEWP-5 that are at least sub-clinical for binge eating disorder
* At least 1 episode of binge eating each month over the past 3 months with significant distress about these episodes
* Daily access to a smartphone or computer

Exclusion Criteria

* Being an experienced meditator or having participated in a formal meditation practice in the last 3 months

Study 2


* Being an experienced meditator or having participated in a formal meditation practice in the last 3 months
* Inability to speak and read English or provide informed consent
* Significant medical or psychological concerns
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Headspace Meditation Limited

INDUSTRY

Sponsor Role collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

DexCom, Inc.

INDUSTRY

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rachel Radin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Elissa Epel, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Isabella Fornell, MA

Role: CONTACT

4158857733

Radin Rachel, PhD

Role: CONTACT

4158857733

Facility Contacts

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Rachel Radin, PhD

Role: primary

415-885-7733

Other Identifiers

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K23AT011048

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-40464

Identifier Type: -

Identifier Source: org_study_id

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