ObesityrubyNCT04678973
Brief mHealth Self-Compassion Intervention on Internalized Weight Bias
A study testing Self-compassion mindfulness practice in people with Obesity and Stigma, Social, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Stigma, Social
- What is being tested?
- Self-compassion mindfulness practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 8 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Currently or recently a "regular meditator"
- Plans for bariatric surgery during or immediately following intervention period
- Investigator discretion for safety reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Brief, mHealth Self-Compassion Intervention on Internalized Weight Bias in Adults With Obesity: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Obesity, Stigma, Social
- Being tested
- Self-compassion mindfulness practice
- Keywords
- mindfulness, self-compassion, mhealth
- Medical subject headings
- Obesity, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-compassion mindfulness practiceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Internalized Weight Bias
Self-report measured using the Weight Bias Internalization Scale (WBIS-M)
Measured: Baseline to End-of-treatment (4 weeks)
Change in Weight Self-Stigma
Self-report measured using the Weight Self-Stigma Questionnaire (WSSQ)
Measured: Baseline to End-of-treatment (4 weeks)
Change in Self-compassion
Self-report measured using the Self Compassion Scale (SCS)
Measured: Baseline to End-of-treatment (4 weeks)
Secondary outcomes (1)
Change in mindfulness
Self-report measured using the Short-Form Five Facet Mindfulness Questionnaire (SF-FFMQ)
Measured: Baseline to End-of-treatment (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start1 Jan 2021
- Primary completion1 May 2021
- Study completion8 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two groups: self-compassion intervention or wait-list control group.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina M Hopkins, MA, Principal investigator, Duke UniversityGary G Bennett, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678973
- Sponsor's protocol ID
- 2021-0033
- Acronym
- ruby
- Status last verified
- Jan 2024
- First submitted
- 17 Dec 2020
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will share de-identified study materials that underlie results in a publication.
Publications
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.
PubMed 34842549
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Brief, mHealth Self-Compassion Intervention on Internalized Weight Bias in Adults With Obesity: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04678973
- Acronym / sponsor ID
- ruby / 2021-0033
- Conditions
- Obesity, Stigma, Social
- Keywords
- mindfulness, self-compassion, mhealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 8 Sep 2021 (actual)
- First posted
- 22 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two groups: self-compassion intervention or wait-list control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Self-compassion mindfulness practiceParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-compassion mindfulness practiceGuided 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. | Behavioural | Intervention |
Primary outcome
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)
Change in Weight Self-Stigma
Time frame: Baseline to End-of-treatment (4 weeks)
Self-report measured using the Weight Self-Stigma Questionnaire (WSSQ)
Change in Self-compassion
Time frame: Baseline to End-of-treatment (4 weeks)
Self-report measured using the Self Compassion Scale (SCS)
1 secondary outcome
Change in mindfulness
Time frame: Baseline to End-of-treatment (4 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Derived from this study: PubMed 34842549Hopkins 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.
- Individual participant dataSharing planned: Yes. Will share de-identified study materials that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina M Hopkins, MA principal investigator
Duke University
Gary G Bennett, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-compassion mindfulness practice in people with Obesity and Stigma, Social, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Internalized Weight Bias (time frame: Baseline to End-of-treatment (4 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04678973, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.