Mindful Motivation for Reducing Binge Eating

NCT06528067 | Active Not Recruiting

• 2 other identifiers: 23-40464K23AT011048
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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. 1.Take online questionnaires at four different time points
2. 2.Provide body composition and samples to measure glucose levels
3. 3.Meditate for at least 10 minutes a day
4. 4.If assigned to the Mindful Motivation group, 8 weeks of brief counseling

Conditions

Binge Eating; Psychological; Health Behavior; Weight, Body

Keywords

Health; Meditation; Eating; Mindfulness; Students

Outcome Measures

Primary Outcomes (7)

• Change in Client Satisfaction score, as determined by the total score on the Client Satisfaction Questionnaire (CSQ-8)

  The Client Satisfaction Questionnaire (CSQ-8) has a total score scale range of 8 to 32, with higher numbers indicating greater satisfaction

  Mid-intervention to post-intervention, an anticipated average of 4 weeks

• Change in Credibility/Expectancy and Satisfaction Questionnaire (CEQ) score, as determined by total score on the CEQ

  The CEQ consists of two subscales: credibility and expectancy. The CEQ contains 6 items rated on a 1-9 scale or a 0-100% scale depending upon the item. The first three and fifth items of the scale load onto the credibility factor and has a total score scale range of 4-36. The fourth and sixth item loads onto the expectancy factor and has a total score range of 2-22. The credibility score reflects how believable and convincing participants find the treatment, while the expectancy score reflects their expectations of how effective they think the treatment will be. Higher scores indicate greater credibility and higher expectations for the treatment's effectiveness.

  Mid-intervention to post-intervention, an anticipated average of 4 weeks

• Percentage of participants attending a phone call at the start of the intervention

  By calculating the percentage of participants who attended the phone call at the start of the intervention the investigator aim to determine treatment feasibility. The higher the percentage of participants who attend the more feasible the intervention is for participants. The investigators aim for 80% attendance.

  Baseline

• Percentage of participants attending a counseling session

  By calculating the percentage of participants who attended the counseling session following the phone call the investigators aim to determine treatment feasibility. The higher the percentage of participants who attend the more feasible the intervention is for participants. The investigators aim for 80% attendance.

  Baseline

• Percentage of participants attending a booster call # 1

  By calculating the percentage of participants who attended the first booster call at mid intervention the investigators aim to determine treatment feasibility. The higher the percentage of participants who attend the more feasible the intervention is for participants. The investigators aim for 80% attendance.

  Mid intervention, an anticipated average of 1 week after counseling session

• Percentage of participants attending a booster call #2

  By calculating the percentage of participants who attended the second booster call at mid intervention the investigator aim to determine treatment feasibility. The higher the percentage of participants who attend the more feasible the intervention is for participants. The investigators aim for 80% attendance.

  Mid intervention, an anticipated average of 2 week after first booster call

• Percentage of participants attending a booster call #3

  By calculating the percentage of participants who attended the third booster call at the end of the intervention the investigators aim to determine treatment feasibility. The higher the percentage of participants who attend the more feasible the intervention is for participants. The investigators aim for 80% attendance.

  End if the intervention, an anticipated average of 3 weeks after the second booster call

Secondary Outcomes (5)

• Change in the Mindful Attention Awareness Scale (MAAS) questionnaire, as determined by the average score on the MAAS

  Baseline to post-intervention, an anticipated average of 8 weeks

• Change in self-reported motivation to change behavior, as determined by total score

  Baseline to post-intervention, an anticipated average of 8 weeks

• Change in Weight Efficacy Lifestyle Scale (WEL-SF) score, as determined by total score on the WEL-SF

  Baseline to post-intervention, an anticipated average of 8 weeks

• Change in Reward Based Eating Drive Scale (RED-13) score, as determined by total score on the RED-13.

  Baseline to post-intervention, an anticipated average of 8 weeks

• Change in Questionnaire on Eating and Weight Patterns (QEWP) frequency of binge eating episodes per month

  baseline to post-intervention, an anticipated average of 8 weeks

Study Arms (2)

Mindful Motivation Group

EXPERIMENTAL

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.

Behavioral: Meditation; Behavioral: Mindful Motivation

Active Control Condition

ACTIVE COMPARATOR

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.

Behavioral: Meditation

Interventions

Meditation BEHAVIORAL

10 minute per day, 8 week digital meditation

Active Control Condition; Mindful Motivation Group

Mindful Motivation 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

Mindful Motivation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Being an experienced meditator or having participated in a formal meditation practice in the last 3 months
• Study 2
• Current student at UCSF
• Aged 18 years or older
• At least 1 episode of loss of control while eating each month over the past 3 months with distress about these episodes
• Daily access to a smartphone or computer
• Being an experienced meditator or having participated in a formal meditation practice in the last 3 months
• Frequent compensatory behaviors (\>1x/week)
• Inability to speak and read English or provide informed consent
• Significant medical or psychological concerns

Sponsors & Collaborators

• University of California, San Francisco: lead
• DexCom, Inc.: collaborator
• Headspace Meditation Limited: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94107, United States

Location

MeSH Terms

Conditions

Bulimia; Health Behavior; Body Weight

Interventions

Meditation

Condition Hierarchy (Ancestors)

Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Rachel Radin, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Elissa Epel, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization in to one of two conditions: 1. Mindful Motivation Intervention 2. Active Control

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 30, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)