Brief mHealth Self-Compassion Intervention on Internalized Weight Bias

NCT04678973 | Completed

• 1 other identifier: 2021-0033
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Stigma, Social

Keywords

mindfulness; self-compassion; mhealth

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Change in mindfulness

  Baseline to End-of-treatment (4 weeks)

Study Arms (2)

Intervention

EXPERIMENTAL

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

Wait-list control

NO INTERVENTION

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.

Interventions

Self-compassion mindfulness practice BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Reuben-Cooke Building

Durham, North Carolina, 27708, United States

Location

Related Publications (1)

• 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.

  PMID: 34842549 DERIVED

MeSH Terms

Conditions

Obesity; Social Stigma

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior

Study Officials

• Christina M Hopkins, MA

  Duke University

  PRINCIPAL INVESTIGATOR

• Gary G Bennett, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to one of two groups: self-compassion intervention or wait-list control group.

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 22, 2020
• Study Start: January 1, 2021
• Primary Completion: May 1, 2021
• Study Completion: September 8, 2021
• Last Updated: January 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (1)