A Single-arm Pilot Feasibility Trial of Healthy Pride (NCT07690592) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Single-arm Pilot Feasibility Trial of Healthy Pride
40 participantsStarted 2026-07-15
Plain-language summary
This is a one-arm pilot trial of a 12-week digitally-delivered asynchronous lifestyle intervention designed for gay men and lesbian women. After the program, we will gather feedback on the acceptability of the program and unique barriers to weight loss experienced by this population, including weight stigma.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* BMI 27-45 kg/m2
* Gay male, and lesbian female
* Wi-Fi connectivity at home
* Has a Facebook account and is willing to log into it daily during the study
* Has a smartphone
* Able to participate in the study in English
* Interested in losing weight
* Lives in United States
Exclusion Criteria:
* Pregnant/lactating or plans to become pregnant during study period
* Reports having bipolar disorder, substance abuse, psychosis, an eating disorder, or severe depression
* Had bariatric surgery or plans to have surgery during the study
* Currently taking medication affecting weight (e.g., neuroleptics/antipsychotics, mood stabilizers, weight loss medication, or tricyclic antidepressants)
* Has lost ≥5% of weight in past 6 months
* Is participating or intends to participate in another weight loss program during the study
* Chronic pain that interferes with the ability to exercise
* Type 1 Diabetes
* Type 2 Diabetes
* Unable to make dietary changes or increase physical activity due to a medical condition(s)
* Unable to walk ¼ mile unaided without stopping
* Unable to walk ¼ without experiencing chest pain or dizziness
* Had a previous myocardial infarction/heart attack
* Has a known coronary artery disease (not including hypertension)
* Has chronic kidney disease
* Has a heart valve abnormality
* Has a heart arrhythmia
* Currently smokes or vapes nicotine
* Meets criteria for severe depression on the PHQ-8 (score of \>19)
* Participated in previous weight loss s…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.