Clinical trial NCT04678973: Brief mHealth Self-Compassion Intervention on Internalized Weight Bias
Official title: Effects of Brief, mHealth Self-Compassion Intervention on Internalized Weight Bias in Adults With Obesity: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Stigma, Social
Keywords: mindfulness
self-compassion
mhealth
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of two groups: self-compassion intervention or wait-list control group.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Internalized Weight Bias
timeFrame: Baseline to End-of-treatment (4 weeks)
measure: Change in Weight Self-Stigma
timeFrame: Baseline to End-of-treatment (4 weeks)
measure: Change in Self-compassion
timeFrame: Baseline to End-of-treatment (4 weeks)
Secondary outcomes:
measure: Change in mindfulness
timeFrame: Baseline to End-of-treatment (4 weeks)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Reuben-Cooke Building
state: North Carolina
Study officials:
affiliation: Duke University
name: Christina M Hopkins, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Gary G Bennett, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.