ObesityNCT05775497
Optimizing an Online Behavioral Weight Loss Intervention and Novel Culturally Tailored Components for Sexual Minority Women
A study testing Behavioral weight loss intervention (Online; Rx Weight Loss), Minority stress intervention and Social support 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 (Online; Rx Weight Loss), Minority stress intervention and Social support intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 29 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Assigned female at birth and currently identify as female
- Self-identify a minority sexual orientation (e.g.,lesbian, bisexual)
- BMI=25-50kg/m2
- 18-70 years old
- Interested in losing weight
- Regular internet and e-mail access
- No significant weight loss within past 6 months (>5%)
- Fluent in English
- Able to participate in moderate physical activity
- Not currently enrolled in a weight loss program
- Not currently taking weight-loss medication
- Not 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. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Weight Control and Diabetes Research Center
Providence, Rhode Island, 02903
Emily Panza, PhD, 401-793-9714, emily_panza@brown.edu
About this study
Official title: Optimizing an Online Behavioral Weight Loss Intervention and Novel Culturally Tailored Components for Sexual Minority Women: MOST Optimization Phase
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. In the Preparation Phase of this K23, the investigators developed 3 novel treatment components targeting sexual minority women's weight loss barriers (i.e., minority stress, low social support, and negative body image), the investigators piloted the program among sexual minority women of higher weight, and the investigators conducted individual qualitative interviews to elicit feedback on the intervention's acceptability, cultural relevance, usability, and feasibility, and this feedback was used to refine the program.
In the Optimization Phase of this K23 (the current phase), 88 women will receive 12 weeks of Rx Weight Loss and will be randomized to receive 0-3 tailored components in a full factorial design with 23 (8) distinct combinations of components. Novel components that increase mean weight loss (by ≥2%) or the proportion of women achieving clinically meaningful weight loss (by ≥10%) at 6 months will be retained in a finalized obesity treatment package that the investigators will evaluate in a future randomized controlled trial (RCT) (Evaluation Phase). The aims of this study are to:
Read more
Aim 2A (Optimization): Use a factorial experiment to determine how 3 novel components impact mean weight loss and the proportion of women achieving a 5+% weight loss at 6 months.
Aim 2B (Mediation): Clarify how tailored components impact weight loss by testing hypothesized mechanisms of action (i.e., coping with stress, perceived social support, weight and shape concerns).
This project will tailor and optimize an evidence-based online behavioral obesity treatment to enhance weight loss outcomes in sexual minority women.
- Conditions
- Obesity
- Being tested
- Behavioral weight loss intervention (Online; Rx Weight Loss), Minority stress intervention, Social support intervention, Negative body image 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 intervention (Online; Rx Weight Loss)Behavioural
Rx Weight Loss is a fully automated online behavioral obesity treatment that includes 3 core components: weekly online video lessons, submission of self-monitored weight, calorie intake, and activity data, and personalized automated feedback. Participants set goals for weight loss (e.g., 10%), daily calorie intake, and activity (e.g., 200 mins/week of moderate-to-vigorous intensity physical activity). Online lessons discuss healthy eating, physical activity, and behavioral skills (e.g., stimulus control, goal-setting, problem solving). To maintain participant engagement, lessons are interactive, use audio and video, and include experiential learning opportunities. Based on their progress, participants receive automated feedback that provides encouragement, praise for meeting goals, and constructive feedback. To enhance adherence, participants who do not view the weekly lesson or enter monitoring data receive e-mail reminders to re-engage.
Minority stress interventionBehavioural
Also called Coping with Stress Program
The Minority Stress Intervention will teach cognitive and behavioral strategies for coping with minority stress with a focus on how minority stress impacts weight loss behaviors. The treatment will primarily address stressors due to sexuality and weight but will also cover how minority stress intersects with other facets of identity. The intervention, while innovative, is adapted from evidence-based treatments using cognitive behavioral therapy (CBT) to address minority stress.Lessons will provide psychoeducation on minority stress related to sexuality, gender, and weight, how it intersects with other aspects of identity, and how it can interfere with weight loss (e.g., unhealthy eating, avoiding exercise and healthcare, reduced motivation, disengaging from the program).The treatment will be delivered in 12 8-10-min lessons/week (a duration comparable to previous treatments) viewed directly after Rx Weight Loss lessons in Wks 1-12.
Social support interventionBehavioural
Also called Social Support Program
The Social Support Intervention will provide sexual minority women with online opportunities to give and receive real-time social support for weight loss efforts. The treatment is based on Social Learning Theory and evidence-based online social support programs used in behavioral weight loss. The intervention will include one video lesson outlining the value of social support for weight loss and well-being, strategies for eliciting support, and an orientation to using the online platform (hosted within Rx Weight Loss). The platform will feature a private forum where participants can post to provide support and discuss their weight loss goals, challenges, and successes. To foster engagement, discussion topics will be automated to post 4 times/week and those who do not participate will be reminded via e-mail to engage (1x/month).
Negative body image interventionBehavioural
Also called Body Image Program
The Negative Body Image Intervention will teach CBT skills for improving negative body image and reducing its impact on weight loss behaviors. The treatment is derived from evidence-based CBT interventions targeting body image for women with obesity during behavioral weight loss and will be adapted to reflect the unique body image ideals and concerns of sexual minority women. Lessons will teach CBT strategies for coping with negative body image and reducing interference with weight loss efforts. The intervention will be delivered in 12 weekly 8-10-minute lessons, a treatment duration comparable to previous treatments and will be viewed immediately following Rx Weight Loss lessons during Weeks 1-12.
| 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 (Online; Rx Weight Loss) |
| 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 (Online; Rx Weight Loss); 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 (Online; Rx Weight Loss); 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 (Online; Rx Weight Loss); Behavioral: Minority stress intervention; Behavioral: Social support intervention; Behavioral: Negative body image 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 (Online; Rx Weight Loss); Behavioral: Social support intervention; Behavioral: Negative body image 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 (Online; Rx Weight Loss); 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 (Online; Rx Weight Loss); 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 (Online; Rx Weight Loss); Behavioral: Social support intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight
Body weight will be formally assessed by an RA at baseline, 3 months, and 6 months. Mean weight loss from baseline will be calculated.
Measured: 6 months
Proportion of Patients Achieving a Weight Loss of 5+% of Initial Weight
Mean weight loss at 6 months will be used to determine the proportion of participants who achieved clinically significant (5+%) weight loss.
Measured: 6 months
Secondary outcomes (5)
Change in Weight
Body weight will be formally assessed by an RA at baseline, 3 months, and 6 months. Mean weight loss from baseline will be calculated.
Measured: 3 months
Proportion of Patients Achieving a Weight Loss of 5+% of Initial Weight
Mean weight loss at 3 months will be used to determine the proportion of participants who achieved clinically significant (5+%) weight loss.
Measured: 3 months
Change in skills for coping with stress
Skills for coping with stress will be measured with the 28-item Brief COPE Scale. This widely used scale assesses adaptive and maladaptive strategies for coping with stress using 14 subscales on a 1 (I havent been doing this at all) to 4 (Ive been doing this a lot) scale. Higher scores represent more frequent coping skill use.
Measured: 3 and 6 months after baseline
Change in perceived social support
Perceived social support will be measured with the 16-item Social Support Behaviors Scale (SSB), which assesses emotional, instrumental, and sexuality-specific social support on a 1-5 scale. Higher scores indicate more support. The SSB shows excellent internal consistency and validity in studies of SGM adults
Measured: 3 and 6 months after baseline
Change in negative body image
Negative body image will be measured with the widely used weight and shape concern subscales of the Eating Disorder Examination Questionnaire. 8 items assess shape concerns and 5 items assess weight concerns on a 0 (not at all) to 6 (markedly) scale.
Measured: 3 and 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start1 May 2024
- Primary completion1 Sep 2025 (estimated)
- Study completion29 Dec 2025 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Participants (anticipated n=88) will receive the 12-week online weight loss treatment and will be randomized to receive 0-3 novel intervention components (targeting minority stress, negative body image, and social support). The primary outcome (weight loss) will be assessed at baseline, post-treatment (12 weeks), and follow-up (24 weeks).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
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
- NCT05775497
- Sponsor's protocol ID
- 1550062-02
- Status last verified
- Dec 2024
- First submitted
- 28 Feb 2023
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing an Online Behavioral Weight Loss Intervention and Novel Culturally Tailored Components for Sexual Minority Women: MOST Optimization Phase
- ClinicalTrials.gov ID
- NCT05775497
- Acronym / sponsor ID
- 1550062-02
- Conditions
- Obesity
- Keywords
- Sexual minority women, LGBTQ health, Weight loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 29 Dec 2025 (estimated)
- First posted
- 20 Mar 2023 (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. In the Preparation Phase of this K23, the investigators developed 3 novel treatment components targeting sexual minority women's weight loss barriers (i.e., minority stress, low social support, and negative body image), the investigators piloted the program among sexual minority women of higher weight, and the investigators conducted individual qualitative interviews to elicit feedback on the intervention's acceptability, cultural relevance, usability, and feasibility, and this feedback was used to refine the program.
In the Optimization Phase of this K23 (the current phase), 88 women will receive 12 weeks of Rx Weight Loss and will be randomized to receive 0-3 tailored components in a full factorial design with 23 (8) distinct combinations of components. Novel components that increase mean weight loss (by ≥2%) or the proportion of women achieving clinically meaningful weight loss (by ≥10%) at 6 months will be retained in a finalized obesity treatment package that the investigators will evaluate in a future randomized controlled trial (RCT) (Evaluation Phase). The aims of this study are to:
Aim 2A (Optimization): Use a factorial experiment to determine how 3 novel components impact mean weight loss and the proportion of women achieving a 5+% weight loss at 6 months.
Aim 2B (Mediation): Clarify how tailored components impact weight loss by testing hypothesized mechanisms of action (i.e., coping with stress, perceived social support, weight and shape concerns).
This project will tailor and optimize an evidence-based online behavioral obesity treatment to enhance weight loss outcomes in sexual minority women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 8
- Model description
- Participants (anticipated n=88) will receive the 12-week online weight loss treatment and will be randomized to receive 0-3 novel intervention components (targeting minority stress, negative body image, and social support). The primary outcome (weight loss) will be assessed at baseline, post-treatment (12 weeks), and follow-up (24 weeks).
| Arm | Type | Receives |
|---|---|---|
| Weight Loss Program Only | Experimental | Behavioral: Behavioral weight loss intervention (Online; Rx Weight Loss)Participants complete an online behavioral weight loss program. |
| Weight Loss Program + Coping with Stress Program | Experimental | Behavioral: Behavioral weight loss intervention (Online; Rx Weight Loss), 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 (Online; Rx Weight Loss), 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 (Online; Rx Weight Loss), Behavioral: Minority stress intervention, Behavioral: Social support 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, (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 (Online; Rx Weight Loss), Behavioral: Social support intervention, Behavioral: Negative body image 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 (Online; Rx Weight Loss), 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 (Online; Rx Weight Loss), 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 (Online; Rx Weight Loss), 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
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 intervention (Online; Rx Weight Loss)Rx Weight Loss is a fully automated online behavioral obesity treatment that includes 3 core components: weekly online video lessons, submission of self-monitored weight, calorie intake, and activity data, and personalized automated feedback. Participants set goals for weight loss (e.g., 10%), daily calorie intake, and activity (e.g., 200 mins/week of moderate-to-vigorous intensity physical activity). Online lessons discuss healthy eating, physical activity, and behavioral skills (e.g., stimulus control, goal-setting, problem solving). To maintain participant engagement, lessons are interactive, use audio and video, and include experiential learning opportunities. Based on their progress, participants receive automated feedback that provides encouragement, praise for meeting goals, and constructive feedback. To enhance adherence, participants who do not view the weekly lesson or enter monitoring data receive e-mail reminders to re-engage. | 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 will teach cognitive and behavioral strategies for coping with minority stress with a focus on how minority stress impacts weight loss behaviors. The treatment will primarily address stressors due to sexuality and weight but will also cover how minority stress intersects with other facets of identity. The intervention, while innovative, is adapted from evidence-based treatments using cognitive behavioral therapy (CBT) to address minority stress.Lessons will provide psychoeducation on minority stress related to sexuality, gender, and weight, how it intersects with other aspects of identity, and how it can interfere with weight loss (e.g., unhealthy eating, avoiding exercise and healthcare, reduced motivation, disengaging from the program).The treatment will be delivered in 12 8-10-min lessons/week (a duration comparable to previous treatments) viewed directly after Rx Weight Loss lessons in Wks 1-12. | 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 |
| Social support interventionAlso: Social Support ProgramThe Social Support Intervention will provide sexual minority women with online opportunities to give and receive real-time social support for weight loss efforts. The treatment is based on Social Learning Theory and evidence-based online social support programs used in behavioral weight loss. The intervention will include one video lesson outlining the value of social support for weight loss and well-being, strategies for eliciting support, and an orientation to using the online platform (hosted within Rx Weight Loss). The platform will feature a private forum where participants can post to provide support and discuss their weight loss goals, challenges, and successes. To foster engagement, discussion topics will be automated to post 4 times/week and those who do not participate will be reminded via e-mail to engage (1x/month). | 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 |
| Negative body image interventionAlso: Body Image ProgramThe Negative Body Image Intervention will teach CBT skills for improving negative body image and reducing its impact on weight loss behaviors. The treatment is derived from evidence-based CBT interventions targeting body image for women with obesity during behavioral weight loss and will be adapted to reflect the unique body image ideals and concerns of sexual minority women. Lessons will teach CBT strategies for coping with negative body image and reducing interference with weight loss efforts. The intervention will be delivered in 12 weekly 8-10-minute lessons, a treatment duration comparable to previous treatments and will be viewed immediately following Rx Weight Loss lessons during Weeks 1-12. | 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 |
Primary outcome
Change in Weight
Time frame: 6 months
Body weight will be formally assessed by an RA at baseline, 3 months, and 6 months. Mean weight loss from baseline will be calculated.
Proportion of Patients Achieving a Weight Loss of 5+% of Initial Weight
Time frame: 6 months
Mean weight loss at 6 months will be used to determine the proportion of participants who achieved clinically significant (5+%) weight loss.
5 secondary outcomes
Change in Weight
Time frame: 3 months
Proportion of Patients Achieving a Weight Loss of 5+% of Initial Weight
Time frame: 3 months
Change in skills for coping with stress
Time frame: 3 and 6 months after baseline
Change in perceived social support
Time frame: 3 and 6 months after baseline
Change in negative body image
Time frame: 3 and 6 months after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No. 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.
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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.
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 (Online; Rx Weight Loss), Minority stress intervention and Social support 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?
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: looking for participants now, as of the sponsor's last update on 27 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Panza, PhD (401-793-9714, emily_panza@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Weight (time frame: 6 months). The study lists 2 primary outcomes in all. 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 27 Dec 2024.