ObesityNCT05036187
Refining Novel Culturally Tailored Behavioral Weight Loss Treatment Components for Sexual Minority Women With Obesity
A study testing Behavioral Weight Loss Intervention, Minority Stress Intervention and Negative Body Image Intervention in people with Obesity, run by The Miriam Hospital at 1 site in United States.
Trial summary
Obesity disproportionately impacts sexual minority women. Behavioral weight loss programs are the gold standard treatment for mild to moderate obesity. The investigators have developed an online behavioral weight loss program that is effective, low-cost, and highly scalable. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Behavioral Weight Loss Intervention, Minority Stress Intervention and Negative Body Image Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 28 Jun 2022
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Assigned female at birth and currently identify as female
- Self-identify a minority sexual orientation (e.g.,lesbian, bisexual)
- BMI>25kg/m2
- 18-70 years old
- Interested in losing weight
- Regular internet and e-mail access
- Fluent in English
Who cannot join
- Significant weight loss within past 6 months (>5%)
- Unable to participate in moderate physical activity
- Currently enrolled in a weight loss program
- Currently taking weight-loss medication
- Currently pregnant or trying to get pregnant
- Participated in a previous Phase of this study
- Reports a serious mental/physical health condition that would increase potential risks of treatment to the participant (e.g., active symptoms of psychosis, suicidality, mania, alcohol/substance use, or a medical condition that is serious, active, unstable, and degenerative (e.g., CHF)).
Trial locations and contacts
1 site in 1 country.
United States1 site
Weight Control and Diabetes Research Center, The Miriam Hospital
Providence, Rhode Island, 02903
About this study
Official title: Using the Multiphase Optimization Strategy to Optimize a Culturally Tailored Online Behavioral Weight Loss Intervention for Sexual Minority Women: Pilot Study
Obesity disproportionately impacts sexual minority women. Behavioral weight loss programs are the gold standard treatment for mild to moderate obesity. The investigators have developed an online behavioral weight loss program that is effective, low-cost, and highly scalable. However, existing research suggests that tailoring treatment to address 3 well-established weight loss barriers in sexual minority women will be critical for maximizing the relevance and efficacy of behavioral weight loss for this group. The goal of the first phase of this K23 is to develop 3 novel treatment components targeting sexual minority women's weight loss barriers (i.e., minority stress, low social support, and negative body image), to pilot the program in sexual minority women with overweight/obesity, and to conduct individual qualitative interviews to elicit feedback on the intervention's acceptability, cultural relevance, usability, and feasibility that will be used to refine the program. After a pre-piloting phase (consisting of initial content piloting, interviews, and intervention refinement; anticipated n=12), 8 participants will pilot the full 3-month weight loss program and will be randomized to pilot 0-3 novel tailored components (targeting minority stress, negative body image, and social support) over the 3-month period. Participants will complete quantitative and qualitative assessments of intervention acceptability and appropriateness post-treatment and the intervention will be refined.
- Conditions
- Obesity
- Being tested
- Behavioral Weight Loss Intervention, Minority Stress Intervention, Negative Body Image Intervention, Social Support Intervention
- Keywords
- Sexual minority women, LGBTQ health, Weight loss
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Weight Loss InterventionBehavioural
Rx Weight Loss: PRIDE is a fully automated online behavioral obesity treatment that is tailored for sexual minority women and involves viewing 12 online video lessons delivered each week, self-monitoring body weight, calorie intake, and physical activity levels, and receiving personalized automated weekly feedback on progress toward goals.
Minority Stress InterventionBehavioural
Also called Coping with Stress Program
The Minority Stress Intervention is designed to help sexual minority women cope with stress and stigma (e.g., due to weight, sexual orientation, gender). In this program, participants watch online video lessons that teach cognitive and behavioral strategies for coping with minority stress so that it may have less of an influence on participants' weight and well-being.
Negative Body Image InterventionBehavioural
Also called Body Image Program
The Negative Body Image Intervention is designed to help participants improve their body image. In this program, participants will watch online video lessons that provide education on queer women's body image and teach cognitive and behavioral strategies for improving your body image (regardless of your weight) to reduce its influence on your health.
Social Support InterventionBehavioural
The Social Support Intervention provides online opportunities for participants to receive more social support as they work toward their weight loss goals. Participants receive education on the importance of social support for weight management, they can earn badges for completing program milestones, and they gain access to a private online forum to get support and advice from other participants.
| Study group | Role | What they receive |
|---|---|---|
| Weight Loss Program Only | Experimental | Participants complete an online behavioral weight loss program. Receives: Behavioral: Behavioral Weight Loss Intervention |
| Weight Loss Program + Coping with Stress Program | Experimental | Participants complete (1) an online behavioral weight loss program and (2) an adjunctive intervention that teaches strategies for coping with stress \& stigma due to weight, sexual orientation, and gender \& its impact on weight loss. Receives: Behavioral: Behavioral Weight Loss Intervention; Behavioral: Minority Stress Intervention |
| Weight Loss Program + Coping with Stress Program + Body Image Program | Experimental | Participants complete (1) an online behavioral weight loss program, (2) an adjunctive intervention that teaches strategies for coping with stress \& stigma due to weight, sexual orientation, and gender \& its impact on weight loss, and (3) an adjunctive intervention for improving negative body image and reducing its impact on weight loss. Receives: Behavioral: Behavioral Weight Loss Intervention; Behavioral: Minority Stress Intervention; Behavioral: Negative Body Image Intervention |
| Weight Loss Program + Coping with Stress Program + Body Image Program + Social Support Program | Experimental | Participants complete (1) an online behavioral weight loss program, (2) an adjunctive intervention that teaches strategies for coping with stress \& stigma due to weight, sexual orientation, and gender \& its impact on weight loss, (3) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts, and (4) an adjunctive intervention for improving negative body image and reducing its impact on weight loss. Receives: Behavioral: Behavioral Weight Loss Intervention; Behavioral: Minority Stress Intervention; Behavioral: Negative Body Image Intervention; Behavioral: Social Support Intervention |
| Weight Loss Program + Body Image Program + Social Support Program | Experimental | Participants complete (1) an online behavioral weight loss program, (2) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts, and (3) an adjunctive intervention for improving negative body image and reducing its impact on weight loss. Receives: Behavioral: Behavioral Weight Loss Intervention; Behavioral: Negative Body Image Intervention; Behavioral: Social Support Intervention |
| Weight Loss Program + Coping with Stress Program + Social Support Program | Experimental | Participants complete a (1) online behavioral weight loss program, (2) an adjunctive intervention that teaches strategies for coping with stress \& stigma due to weight, sexual orientation, and gender \& its impact on weight loss, and (3) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts. Receives: Behavioral: Behavioral Weight Loss Intervention; Behavioral: Minority Stress Intervention; Behavioral: Social Support Intervention |
| Weight Loss Program + Body Image Program | Experimental | Participants complete (1) an online behavioral weight loss program and (2) an adjunctive intervention for improving negative body image and reducing its impact on weight loss. Receives: Behavioral: Behavioral Weight Loss Intervention; Behavioral: Negative Body Image Intervention |
| Weight Loss Program + Social Support Program | Experimental | Participants complete (1) an online behavioral weight loss program and (2) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts. Receives: Behavioral: Behavioral Weight Loss Intervention; Behavioral: Social Support Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Acceptability
A measure of intervention acceptability adapted from the Acceptability of Intervention (AIM) measure will assess acceptability outcomes post-treatment. Qualitative data on intervention acceptability and cultural appropriateness will also be considered.
Measured: Week 12 (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start1 Jun 2021
- Primary completion28 Jun 2022
- Study completion28 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- After a pre-piloting phase (consisting of initial content piloting, interviews, and intervention refinement; anticipated n=12), participants (anticipated n=8) will receive the online weight loss treatment and will be randomized to receive 0-3 novel intervention components (targeting minority stress, negative body image, and social support) over the 3-month period. Participants will complete quantitative and qualitative assessments of intervention acceptability and appropriateness post-treatment. Enrollment for both the pre-piloting phases (anticipated n=12) and open pilot trial phase (anticipated n=8) are reported here.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036187
- Sponsor's protocol ID
- 1550062
- Other IDs
- K23MD015092
- Status last verified
- Feb 2023
- First submitted
- 30 Aug 2021
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared as follows: * Results will be submitted to ClinicalTrials.gov within appropriate timelines. * Quantitative data will be published in peer-reviewed manuscripts that will be submitted to PubMed Central upon acceptance. * Study results will be presented to the scientific community at national conferences relevant to obesity and sexual minority health. * Aggregate quantitative data may be requested from other researchers 5 years after the completion of the primary endpoint by contacting Dr. Panza. If there are no restrictions imposed by institutional policies, local IRBs, or laws/regulations, the investigators will make de-identified data available to a requester within the context of a clear data-sharing agreement Qualitative data will not be shared other than de-identified qualitative data that is published as part of peer-reviewed manuscripts.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the Multiphase Optimization Strategy to Optimize a Culturally Tailored Online Behavioral Weight Loss Intervention for Sexual Minority Women: Pilot Study
- ClinicalTrials.gov ID
- NCT05036187
- Acronym / sponsor ID
- 1550062
- Conditions
- Obesity
- Keywords
- Sexual minority women, LGBTQ health, Weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 28 Jun 2022 (actual)
- First posted
- 5 Sep 2021 (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.
Obesity disproportionately impacts sexual minority women. Behavioral weight loss programs are the gold standard treatment for mild to moderate obesity. The investigators have developed an online behavioral weight loss program that is effective, low-cost, and highly scalable. However, existing research suggests that tailoring treatment to address 3 well-established weight loss barriers in sexual minority women will be critical for maximizing the relevance and efficacy of behavioral weight loss for this group. The goal of the first phase of this K23 is to develop 3 novel treatment components targeting sexual minority women's weight loss barriers (i.e., minority stress, low social support, and negative body image), to pilot the program in sexual minority women with overweight/obesity, and to conduct individual qualitative interviews to elicit feedback on the intervention's acceptability, cultural relevance, usability, and feasibility that will be used to refine the program. After a pre-piloting phase (consisting of initial content piloting, interviews, and intervention refinement; anticipated n=12), 8 participants will pilot the full 3-month weight loss program and will be randomized to pilot 0-3 novel tailored components (targeting minority stress, negative body image, and social support) over the 3-month period. Participants will complete quantitative and qualitative assessments of intervention acceptability and appropriateness post-treatment and the intervention will be refined.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- After a pre-piloting phase (consisting of initial content piloting, interviews, and intervention refinement; anticipated n=12), participants (anticipated n=8) will receive the online weight loss treatment and will be randomized to receive 0-3 novel intervention components (targeting minority stress, negative body image, and social support) over the 3-month period. Participants will complete quantitative and qualitative assessments of intervention acceptability and appropriateness post-treatment. Enrollment for both the pre-piloting phases (anticipated n=12) and open pilot trial phase (anticipated n=8) are reported here.
| Arm | Type | Receives |
|---|---|---|
| Weight Loss Program Only | Experimental | Behavioral: Behavioral Weight Loss InterventionParticipants complete an online behavioral weight loss program. |
| Weight Loss Program + Coping with Stress Program | Experimental | Behavioral: Behavioral Weight Loss Intervention, Behavioral: Minority Stress InterventionParticipants complete (1) an online behavioral weight loss program and (2) an adjunctive intervention that teaches strategies for coping with stress \& stigma due to weight, sexual orientation, and gender \& its impact on weight loss. |
| Weight Loss Program + Coping with Stress Program + Body Image Program | Experimental | Behavioral: Behavioral Weight Loss Intervention, Behavioral: Minority Stress Intervention, Behavioral: Negative Body Image InterventionParticipants complete (1) an online behavioral weight loss program, (2) an adjunctive intervention that teaches strategies for coping with stress \& stigma due to weight, sexual orientation, and gender \& its impact on weight loss, and (3) an adjunctive intervention for improving negative body image and reducing its impact on weight loss. |
| Weight Loss Program + Coping with Stress Program + Body Image Program + Social Support Program | Experimental | Behavioral: Behavioral Weight Loss Intervention, Behavioral: Minority Stress Intervention, Behavioral: Negative Body Image Intervention, Behavioral: Social Support InterventionParticipants complete (1) an online behavioral weight loss program, (2) an adjunctive intervention that teaches strategies for coping with stress \& stigma due to weight, sexual orientation, and gender \& its impact on weight loss, (3) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts, and (4) an adjunctive intervention for improving negative body image and reducing its impact on weight loss. |
| Weight Loss Program + Body Image Program + Social Support Program | Experimental | Behavioral: Behavioral Weight Loss Intervention, Behavioral: Negative Body Image Intervention, Behavioral: Social Support InterventionParticipants complete (1) an online behavioral weight loss program, (2) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts, and (3) an adjunctive intervention for improving negative body image and reducing its impact on weight loss. |
| Weight Loss Program + Coping with Stress Program + Social Support Program | Experimental | Behavioral: Behavioral Weight Loss Intervention, Behavioral: Minority Stress Intervention, Behavioral: Social Support InterventionParticipants complete a (1) online behavioral weight loss program, (2) an adjunctive intervention that teaches strategies for coping with stress \& stigma due to weight, sexual orientation, and gender \& its impact on weight loss, and (3) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts. |
| Weight Loss Program + Body Image Program | Experimental | Behavioral: Behavioral Weight Loss Intervention, Behavioral: Negative Body Image InterventionParticipants complete (1) an online behavioral weight loss program and (2) an adjunctive intervention for improving negative body image and reducing its impact on weight loss. |
| Weight Loss Program + Social Support Program | Experimental | Behavioral: Behavioral Weight Loss Intervention, Behavioral: Social Support InterventionParticipants complete (1) an online behavioral weight loss program and (2) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Assigned female at birth and currently identify as female
- Self-identify a minority sexual orientation (e.g.,lesbian, bisexual)
- BMI>25kg/m2
- 18-70 years old
- Interested in losing weight
Key exclusion criteria (7 listed)
- Significant weight loss within past 6 months (>5%)
- Unable to participate in moderate physical activity
- Currently enrolled in a weight loss program
- Currently taking weight-loss medication
- Currently pregnant or trying to get pregnant
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 |
|---|---|---|
| Behavioral Weight Loss InterventionRx Weight Loss: PRIDE is a fully automated online behavioral obesity treatment that is tailored for sexual minority women and involves viewing 12 online video lessons delivered each week, self-monitoring body weight, calorie intake, and physical activity levels, and receiving personalized automated weekly feedback on progress toward goals. | Behavioural | Weight Loss Program + Body Image Program, Weight Loss Program + Body Image Program + Social Support Program, Weight Loss Program + Coping with Stress Program, Weight Loss Program + Coping with Stress Program + Body Image Program, Weight Loss Program + Coping with Stress Program + Body Image Program + Social Support Program, Weight Loss Program + Coping with Stress Program + Social Support Program, Weight Loss Program + Social Support Program, Weight Loss Program Only |
| Minority Stress InterventionAlso: Coping with Stress ProgramThe Minority Stress Intervention is designed to help sexual minority women cope with stress and stigma (e.g., due to weight, sexual orientation, gender). In this program, participants watch online video lessons that teach cognitive and behavioral strategies for coping with minority stress so that it may have less of an influence on participants' weight and well-being. | Behavioural | Weight Loss Program + Coping with Stress Program, Weight Loss Program + Coping with Stress Program + Body Image Program, Weight Loss Program + Coping with Stress Program + Body Image Program + Social Support Program, Weight Loss Program + Coping with Stress Program + Social Support Program |
| Negative Body Image InterventionAlso: Body Image ProgramThe Negative Body Image Intervention is designed to help participants improve their body image. In this program, participants will watch online video lessons that provide education on queer women's body image and teach cognitive and behavioral strategies for improving your body image (regardless of your weight) to reduce its influence on your health. | Behavioural | Weight Loss Program + Body Image Program, Weight Loss Program + Body Image Program + Social Support Program, Weight Loss Program + Coping with Stress Program + Body Image Program, Weight Loss Program + Coping with Stress Program + Body Image Program + Social Support Program |
| Social Support InterventionThe Social Support Intervention provides online opportunities for participants to receive more social support as they work toward their weight loss goals. Participants receive education on the importance of social support for weight management, they can earn badges for completing program milestones, and they gain access to a private online forum to get support and advice from other participants. | Behavioural | Weight Loss Program + Body Image Program + Social Support Program, Weight Loss Program + Coping with Stress Program + Body Image Program + Social Support Program, Weight Loss Program + Coping with Stress Program + Social Support Program, Weight Loss Program + Social Support Program |
Primary outcome
Intervention Acceptability
Time frame: Week 12 (post-treatment)
A measure of intervention acceptability adapted from the Acceptability of Intervention (AIM) measure will assess acceptability outcomes post-treatment. Qualitative data on intervention acceptability and cultural appropriateness will also be considered.
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 2 Mar 2023.
- Individual participant dataSharing planned: No. Data will be shared as follows: * Results will be submitted to ClinicalTrials.gov within appropriate timelines. * Quantitative data will be published in peer-reviewed manuscripts that will be submitted to PubMed Central upon acceptance. * Study results will be presented to the scientific community at national conferences relevant to obesity and sexual minority health. * Aggregate quantitative data may be requested from other researchers 5 years after the completion of the primary endpoint by contacting Dr. Panza. If there are no restrictions imposed by institutional policies, local IRBs, or laws/regulations, the investigators will make de-identified data available to a requester within the context of a clear data-sharing agreement Qualitative data will not be shared other than de-identified qualitative data that is published as part of peer-reviewed manuscripts.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Weight Loss Intervention, Minority Stress Intervention and Negative Body Image Intervention in people with Obesity, run by The Miriam Hospital 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 7 inclusion and 7 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 2 Mar 2023. 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?
Intervention Acceptability (time frame: Week 12 (post-treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2023.