Reuben-Cooke Building
Durham, North Carolina, 27708, United States
NCT Number: NCT04678973
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Durham, North Carolina, 27708, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline to End-of-treatment (4 weeks)
Self-report measured using the Weight Bias Internalization Scale (WBIS-M)
Time frame: Baseline to End-of-treatment (4 weeks)
Self-report measured using the Weight Self-Stigma Questionnaire (WSSQ)
Time frame: Baseline to End-of-treatment (4 weeks)
Self-report measured using the Self Compassion Scale (SCS)
Time frame: Baseline to End-of-treatment (4 weeks)
Self-report measured using the Short-Form Five Facet Mindfulness Questionnaire (SF-FFMQ)
Duke University
Other
Effects of Brief, mHealth Self-Compassion Intervention on Internalized Weight Bias in Adults With Obesity: A Randomized Controlled Trial
Acronym: ruby
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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