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OpenTrials
Completed

NCT Number: NCT04678973

Brief mHealth Self-Compassion Intervention on Internalized Weight Bias

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Reuben-Cooke Building

Durham, North Carolina, 27708, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Internalized Weight Bias

    Time frame: Baseline to End-of-treatment (4 weeks)

    Self-report measured using the Weight Bias Internalization Scale (WBIS-M)

  2. Change in Weight Self-Stigma

    Time frame: Baseline to End-of-treatment (4 weeks)

    Self-report measured using the Weight Self-Stigma Questionnaire (WSSQ)

  3. Change in Self-compassion

    Time frame: Baseline to End-of-treatment (4 weeks)

    Self-report measured using the Self Compassion Scale (SCS)

Secondary outcomes

  1. Change in mindfulness

    Time frame: Baseline to End-of-treatment (4 weeks)

    Self-report measured using the Short-Form Five Facet Mindfulness Questionnaire (SF-FFMQ)

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Acronym: ruby

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 22, 2020
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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