Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by Rachel Radin, PhDElissa Epel, PhD
Headshot of Rachel Radin
Rachel Radin

Description

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

Details

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.

Keywords

Binge Eating, Psychological, Health Behavior, Weight, Body, Health, Meditation, Eating, Mindfulness, Students, Bulimia, Body Weight, Binge-Eating Disorder, Mindful Motivation

Eligibility

For people ages 18 years and up

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

Location

  • UCSF
    San Francisco California 94107 United States

Lead Scientists at UCSF

  • Rachel Radin, PhD
    Dr. Rachel Radin is an Assistant Professor in the Department of Psychiatry and Behavioral Sciences. She studies the links between eating behaviors, stress, and metabolic health in adults. Dr. Radin very interested in developing, optimizing, and disseminating interventions to reduce dysregulated eating behavior, including stress-related eating, and improve metabolic health.
  • Elissa Epel, PhD

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT06528067
Study Type
Interventional
Participants
Expecting 100 study participants
Last Updated