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

Effects of Brief, mHealth Self-Compassion Intervention on Internalized Weight Bias in Adults With Obesity: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Stigma, Social
• Intervention / Treatment: Behavioral: Self-compassion mindfulness practice

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27708
      • Reuben-Cooke Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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.	Behavioral: Self-compassion mindfulness practice; 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.
No Intervention: Wait-list control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Internalized Weight Bias	Self-report measured using the Weight Bias Internalization Scale (WBIS-M)	Baseline to End-of-treatment (4 weeks)
Change in Weight Self-Stigma	Self-report measured using the Weight Self-Stigma Questionnaire (WSSQ)	Baseline to End-of-treatment (4 weeks)
Change in Self-compassion	Self-report measured using the Self Compassion Scale (SCS)	Baseline to End-of-treatment (4 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mindfulness	Self-report measured using the Short-Form Five Facet Mindfulness Questionnaire (SF-FFMQ)	Baseline to End-of-treatment (4 weeks)

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Christina M Hopkins, MA, Duke University; Principal Investigator: Gary G Bennett, PhD, Duke University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): September 8, 2021

Study Registration Dates

• First Submitted: December 17, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (Actual): December 22, 2020

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: mindfulness; mhealth; self-compassion
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 2021-0033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No