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

• ClinicalTrials.gov Identifier: NCT04678973
• Recruitment Status: Not yet recruiting
• First Posted: December 22, 2020
• Last Update Posted: December 22, 2020
• Sponsor: Duke University
• Information provided by (Responsible Party): Duke University

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.

Condition or disease	Intervention/treatment	Phase
Obesity; Stigma, Social	Behavioral: Self-compassion mindfulness practice	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants will be randomly assigned to one of two groups: self-compassion intervention or wait-list control group.
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Brief, mHealth Self-Compassion Intervention on Internalized Weight Bias in Adults With Obesity: A Randomized Controlled Trial
• Estimated Study Start Date: January 2021
• Estimated Primary Completion Date: May 2021
• Estimated Study Completion Date: September 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Change in Internalized Weight Bias [ Time Frame: Baseline to End-of-treatment (4 weeks) ]
   Self-report measured using the WBIS-M
2. Change in Weight Self-Stigma [ Time Frame: Baseline to End-of-treatment (4 weeks) ]
   Self-report measured using the WSSQ
3. Change in Self-compassion [ Time Frame: Baseline to End-of-treatment (4 weeks) ]
   Self-report measured using the SCS

Secondary Outcome Measures :

1. Change in mindfulness [ Time Frame: Baseline to End-of-treatment (4 weeks) ]
   Self-report measured using the SF-FFMQ

Eligibility Criteria

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

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

Contacts and Locations

Contacts

Contact: Christina M Hopkins, MA; 2152034945; cmh119@duke.edu

Sponsors and Collaborators

Duke University

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT04678973
• Other Study ID Numbers: 2021-0033
• First Posted: December 22, 2020
• Last Update Posted: December 22, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Will share de-identified study materials that underlie results in a publication.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Analytic Code
• Time Frame: Materials will be available following completion of the trial and all planned publications.
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Duke University:

mindfulness; self-compassion; mhealth

Additional relevant MeSH terms:

Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight