Mindful Motivation for Reducing Binge Eating
NCT Number: NCT06528067
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Binge Eating|Psychological|Health Behavior|Weight, Body
Interventions: BEHAVIORAL: Meditation|BEHAVIORAL: Mindful Motivation
Sponsor: University of California, San Francisco
Collaborators: Headspace Meditation Limited|National Center for Complementary and Integrative Health (NCCIH)|DexCom, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-08-01
Locations: University of California, San Francisco, San Francisco, California, 94107, United States

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

Primary Outcome Measures: 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 Outcome Measures: Change in the Mindful Attention Awareness Scale (MAAS) questionnaire, as determined by the average score on the MAAS, The MAAS has a total average score scale range of 1 to 6, with higher numbers indicating greater dispositional mindfulness., Baseline to post-intervention, an anticipated average of 8 weeks|Change in self-reported motivation to change behavior, as determined by total score, This measure is composed of 3 questions, with each question ranging in score from 0 to 10, and total score scale range of 0 to 30, with higher numbers indicating motivation to change behavior. To see changes in motivation, 3 questions adapted from previous work (Miller and Rollnick, 2002) will be asked: "How important is it for the participant to change?" "How ready is the participant to change?" and If the participant decide to change, how confident is the participant that they will succeed?", 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, The WEL-SF has a total score scale range of 1 to 88, with higher numbers indicating greater confidence in one's ability to resist overeating across 8 different scenarios., 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., The RED-13 has a total score scale range of 13 to 65, with higher numbers indicating a greater drive to eat for reward or pleasure., 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, The first several items of the QEWP-5 assess the frequency of objectively large binge episodes (OBEs) per month. Frequency can range from 0 to 100+., baseline to post-intervention, an anticipated average of 8 weeks