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Brief mHealth Self-Compassion Intervention on Internalized Weight Bias (ruby)

Primary Purpose

Obesity, Stigma, Social

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Self-compassion mindfulness practice
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring mindfulness, self-compassion, mhealth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  • At least 18 years of age
  • BMI at least 30 kg/m2
  • Elevated weight bias internalization levels
  • Must live within Eastern Standard Time zone
  • Must own a smartphone and be willing to receive 1-2 text messages daily, practice mindfulness for approximately 20 minutes daily, and engage with weekly intervention content

Exclusion criteria:

  • Under 18 years old
  • BMI < 30
  • No experienced or internalized weight bias reported
  • Lives in another time zone (not EST)
  • Currently attempting to lose weight or restrict diet
  • Currently enrolled in an intervention for weight, weight bias, self-compassion or mindfulness
  • Currently or recently a "regular meditator"
  • Plans for bariatric surgery during or immediately following intervention period
  • Investigator discretion for safety reasons

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention

    Wait-list control

    Arm Description

    Participants in the intervention group will receive a 4 week program delivered via text message. Week 1 will include psychoeducation delivered via brief readings and video. Weeks 2-4 will include daily guided mindfulness practice focusing on self-compassion and weight and body image concerns.

    Participants in the control group will receive no study content during the 4 week intervention period. They will receive access to intervention content (text messages, audio files) after completing end-of-treatment surveys 4 weeks after randomization.

    Outcomes

    Primary Outcome Measures

    Change in Internalized Weight Bias
    Self-report measured using the WBIS-M
    Change in Weight Self-Stigma
    Self-report measured using the WSSQ
    Change in Self-compassion
    Self-report measured using the SCS

    Secondary Outcome Measures

    Change in mindfulness
    Self-report measured using the SF-FFMQ

    Full Information

    First Posted
    December 17, 2020
    Last Updated
    December 17, 2020
    Sponsor
    Duke University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04678973
    Brief Title
    Brief mHealth Self-Compassion Intervention on Internalized Weight Bias
    Acronym
    ruby
    Official Title
    Effects of Brief, mHealth Self-Compassion Intervention on Internalized Weight Bias in Adults With Obesity: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2021 (Anticipated)
    Primary Completion Date
    May 2021 (Anticipated)
    Study Completion Date
    September 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Duke University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The proposed investigation is an experimental trial among 80 adults with obesity and internalized weight bias to determine preliminary effects of a smartphone-delivered brief self-compassion mindfulness intervention on internalized weight bias, compared to wait list control. All participants will receive a 4-week mindfulness-based intervention via smartphone. Participants will be randomly assigned to one of two treatment arms: (1) the intervention group, a self-compassion mindfulness practice tailored for weight and body concerns, or (2) a wait list control group, who will receive access to the intervention content following completion of end-of-treatment assessments. All intervention content will be delivered via text message.
    Detailed Description
    The proposed investigation is an experimental trial among 80 adults with obesity and internalized weight bias to determine preliminary effects of a smartphone-delivered brief self-compassion mindfulness intervention on internalized weight bias, compared to wait list control. All participants will receive a 4-week mindfulness-based intervention via smartphone. Participants will be randomly assigned to one of two treatment arms: (1) the intervention group, a self-compassion mindfulness practice tailored for weight and body concerns, or (2) a wait list control group, who will receive access to the intervention content following completion of end-of-treatment assessments. All intervention content will be delivered via text message using Duke REDCap with Twilio integration. The intervention group will also complete psychoeducation on internalized weight bias and self-compassion. We will measure a number of potential moderating and mediating constructs, such as depression, trauma history, etc. Intervention Components: Intervention Group: Guided Mindfulness Practice: Participants in the intervention group will receive compassion-based guided meditation audio recordings made publicly available by Kristin Neff at www.selfcompassion.org and Tara Brach at www.tarabrach.com. Many of these audio files were used in a previous investigation of self-compassion and body image (Albertson et al., 2015) and were selected due to their unique ability to target compassion and body concerns simultaneously. Daily mindfulness practice will require about 4-20 minutes per day to complete (days 2-28). Psychoeducation: Participants in the intervention group will receive psychoeducation delivered via study website over days 1-6 (see Table 2). They will receive a new lesson via text message on each of these days, each covering a different topic related to the intervention. The purpose of the psychoeducation phase is to orient users to their upcoming experience, provide education about internalized weight bias, the chronic stress system, the utility of self-compassion practice to regulate physiological and psychological targets, and guidance on establishing, maintaining, and generalizing a mindfulness practice. Engagement in psychoeducation materials will take approximately 20-30 minutes per day (days 1-6). Daily prompts: Participants will receive a text message every morning indicating their task for that day. Tasks include: review psychoeducation provided, or practice mindfulness today. Prompts will be brief and will require a minute or two to read. Assigned activity varies by day. Weekly prompts: Participants will receive a text message at the end of every week (Days 7, 14, 21, and 28) with a link to a brief adherence survey. This will measure how many days they practiced that week. The brief adherence survey will take approximately 5 minutes to complete.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Stigma, Social
    Keywords
    mindfulness, self-compassion, mhealth

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants will be randomly assigned to one of two groups: self-compassion intervention or wait-list control group.
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Participants in the intervention group will receive a 4 week program delivered via text message. Week 1 will include psychoeducation delivered via brief readings and video. Weeks 2-4 will include daily guided mindfulness practice focusing on self-compassion and weight and body image concerns.
    Arm Title
    Wait-list control
    Arm Type
    No Intervention
    Arm Description
    Participants in the control group will receive no study content during the 4 week intervention period. They will receive access to intervention content (text messages, audio files) after completing end-of-treatment surveys 4 weeks after randomization.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Self-compassion mindfulness practice
    Intervention Description
    Guided Mindfulness Practice: Participants in the intervention group will receive compassion-based guided meditation audio recordings. Recordings will target self-compassion and body concerns simultaneously. Psychoeducation: Participants in the intervention group will receive psychoeducation delivered via daily PDF over days 1-6. Psychoeducation will orient users to their upcoming experience, provide education about internalized weight bias, the chronic stress system, the utility of self-compassion practice to regulate physiological and psychological targets, and guidance on establishing, maintaining, and generalizing a mindfulness practice. Daily prompts: Participants will receive a text message every morning indicating their task for that day. Weekly prompts: Participants will receive a text message at the end of every week (Days 7, 14, 21, and 28) with a link to a brief adherence survey.
    Primary Outcome Measure Information:
    Title
    Change in Internalized Weight Bias
    Description
    Self-report measured using the WBIS-M
    Time Frame
    Baseline to End-of-treatment (4 weeks)
    Title
    Change in Weight Self-Stigma
    Description
    Self-report measured using the WSSQ
    Time Frame
    Baseline to End-of-treatment (4 weeks)
    Title
    Change in Self-compassion
    Description
    Self-report measured using the SCS
    Time Frame
    Baseline to End-of-treatment (4 weeks)
    Secondary Outcome Measure Information:
    Title
    Change in mindfulness
    Description
    Self-report measured using the SF-FFMQ
    Time Frame
    Baseline to End-of-treatment (4 weeks)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion criteria: At least 18 years of age BMI at least 30 kg/m2 Elevated weight bias internalization levels Must live within Eastern Standard Time zone Must own a smartphone and be willing to receive 1-2 text messages daily, practice mindfulness for approximately 20 minutes daily, and engage with weekly intervention content Exclusion criteria: Under 18 years old BMI < 30 No experienced or internalized weight bias reported Lives in another time zone (not EST) Currently attempting to lose weight or restrict diet Currently enrolled in an intervention for weight, weight bias, self-compassion or mindfulness Currently or recently a "regular meditator" Plans for bariatric surgery during or immediately following intervention period Investigator discretion for safety reasons
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Christina M Hopkins, MA
    Phone
    2152034945
    Email
    cmh119@duke.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Christina M Hopkins, MA
    Organizational Affiliation
    Duke University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Gary G Bennett, PhD
    Organizational Affiliation
    Duke University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Will share de-identified study materials that underlie results in a publication.
    IPD Sharing Time Frame
    Materials will be available following completion of the trial and all planned publications.
    IPD Sharing Access Criteria
    Individuals may request access to study materials for use in systematic reviews, metaanalyses, and other relevant uses. Please contact study PI (Hopkins) to request access.
    Citations:
    PubMed Identifier
    34842549
    Citation
    Hopkins CM, Miller HN, Brooks TL, Mo-Hunter L, Steinberg DM, Bennett GG. Designing Ruby: Protocol for a 2-Arm, Brief, Digital Randomized Controlled Trial for Internalized Weight Bias. JMIR Res Protoc. 2021 Nov 25;10(11):e31307. doi: 10.2196/31307.
    Results Reference
    derived

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    Brief mHealth Self-Compassion Intervention on Internalized Weight Bias

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