Clinical trial NCT06528067: Mindful Motivation for Reducing Binge Eating
Official title: Mindful Motivation for Reducing Binge Eating
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Binge Eating
Psychological
Health Behavior
Weight, Body
Keywords: Health
Meditation
Eating
Mindfulness
Students
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Headspace Meditation Limited
name: National Center for Complementary and Integrative Health (NCCIH)
name: DexCom, Inc.
First posted: 2024-07-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Randomization in to one of two conditions:

1. Mindful Motivation Intervention
2. Active Control
Primary purpose: TREATMENT

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

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.

Eligibility criteria: Study 1

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

Exclusion Criteria:

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

Study 2

Inclusion Criteria:

* 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
* Inability to speak and read English or provide informed consent
* Significant medical or psychological concerns

Primary outcomes:
measure: Change in Client Satisfaction score, as determined by the total score on the Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Mid-intervention to post-intervention, an anticipated average of 4 weeks
measure: Change in Credibility/Expectancy and Satisfaction Questionnaire (CEQ) score, as determined by total score on the CEQ
timeFrame: Mid-intervention to post-intervention, an anticipated average of 4 weeks
measure: Percentage of participants attending a phone call at the start of the intervention
timeFrame: Baseline
measure: Percentage of participants attending a counseling session
timeFrame: Baseline
measure: Percentage of participants attending a booster call # 1
timeFrame: Mid intervention, an anticipated average of 1 week after counseling session
measure: Percentage of participants attending a booster call #2
timeFrame: Mid intervention, an anticipated average of 2 week after first booster call
measure: Percentage of participants attending a booster call #3
timeFrame: End if the intervention, an anticipated average of 3 weeks after the second booster call
Secondary outcomes:
measure: Change in the Mindful Attention Awareness Scale (MAAS) questionnaire, as determined by the average score on the MAAS
timeFrame: Baseline to post-intervention, an anticipated average of 8 weeks
measure: Change in self-reported motivation to change behavior, as determined by total score
timeFrame: Baseline to post-intervention, an anticipated average of 8 weeks
measure: Change in Weight Efficacy Lifestyle Scale (WEL-SF) score, as determined by total score on the WEL-SF
timeFrame: Baseline to post-intervention, an anticipated average of 8 weeks
measure: Change in Reward Based Eating Drive Scale (RED-13) score, as determined by total score on the RED-13.
timeFrame: Baseline to post-intervention, an anticipated average of 8 weeks
measure: Change in Questionnaire on Eating and Weight Patterns (QEWP) frequency of binge eating episodes per month
timeFrame: baseline to post-intervention, an anticipated average of 8 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Rachel Radin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Elissa Epel, PhD
role: PRINCIPAL_INVESTIGATOR
References: