Brief mHealth Self-Compassion Intervention on Internalized Weight Bias

Obesity Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04678973
• Other study ID #: 2021-0033
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: September 8, 2021

Study information

• Verified date: January 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 8, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Stigma, Social

Intervention

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.

Locations

Country	Name	City	State
United States	Reuben-Cooke Building	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Internalized Weight Bias	Self-report measured using the Weight Bias Internalization Scale (WBIS-M)	Baseline to End-of-treatment (4 weeks)
Primary	Change in Weight Self-Stigma	Self-report measured using the Weight Self-Stigma Questionnaire (WSSQ)	Baseline to End-of-treatment (4 weeks)
Primary	Change in Self-compassion	Self-report measured using the Self Compassion Scale (SCS)	Baseline to End-of-treatment (4 weeks)
Secondary	Change in mindfulness	Self-report measured using the Short-Form Five Facet Mindfulness Questionnaire (SF-FFMQ)	Baseline to End-of-treatment (4 weeks)