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NCT Number: NCT07690592

A Single-arm Pilot Feasibility Trial of Healthy Pride

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.

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Key information

About this study

The purpose of the proposed work is to advance our understanding of the unique barriers to weight management experienced by sexual minority men and women with obesity to inform the development of a lifestyle intervention that is tailored to their needs. We will recruit 40 participants with obesity, 20 who identify as lesbian women and 20 who identify as gay men. Once recruited, we will send participants a digital scale to verify their weight at baseline and at 12 weeks. At baseline, we will ask participants to complete a survey to assess their needs and preferences for a digital lifestyle intervention. We will use that information to make modifications to our digital lifestyle intervention which was originally based on the Diabetes Prevention Program (DPP). They will then be enrolled in a 12-week digital lifestyle intervention to be delivered asynchronously via a private Facebook group where they can participate confidentially. During the intervention they will be asked to use a commercial calorie tracking app to track their dietary intake and exercise and meet a daily calorie goal that will produce 1-2 pound weight loss per week. They will also be asked to use the scale we provided to weigh themselves at least once per week. Each week, they will be given a weekly diet goal to help them achieve a heart healthy calorie controlled diet and a weekly exercise goal to help them gradually reach 150 minutes of moderate intensity physical activity per week and 3 days of strength training exercises targeting at least 3 muscle groups. In the Facebook group, one module of the DPP will be covered each week via 14 posts that will occur twice daily from the study dietitian account. Posts will be conversation starters designed to engage participants in the DPP content. Participants will also be encouraged to post updates in the group and to support each other via reactions and replies. After the 12-week intervention we will examine retention, engagement, acceptability of the intervention, and group cohesion. We will also collect qualitative data on participants' perspectives of strengths and weaknesses of the program and ways to improve it.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 studies under the PI
  • If UConn employee/student, has concerns about being in a Facebook group/meeting with other UConn faculty, staff, and students
  • Had major surgery in past 6 months and have not been cleared by their doctor to resume physical activity and diet changes
  • Plans to have major surgery during the study period
  • Prisoner

Treatment and study plan

Lifestyle Intervention

Behavioral

12-week digitally-delivered asynchronous lifestyle intervention

Primary outcomes

  1. Retention

    Time frame: 12 weeks

    The percent of participants who provided weight data at 12 weeks

  2. Engagement

    Time frame: 12 weeks

    Total number of engagements during the intervention (reactions, replies, poll votes, and posts)

  3. Intervention satisfaction

    Time frame: 12 weeks

    a 0-6 Likert scale rating of how satisfied they were with the weight loss program overall

Secondary outcomes

  1. Inclusivity

    Time frame: 12 weeks

    the sum of 3 likert scale items (0-6) on how welcoming the program was to gay people, how adequately tailored it was to gay people, and how included the group made them feel

Study contacts

Contact information is provided by the study sponsor or research team.

Denise Fernandes

CONTACT

[email protected]

860-515-8186

Sherry Pagoto, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Connecticut

Other

Registry information

Official study title

The Development of a Lifestyle Intervention Tailored to the Needs and Preferences of Sexual Minority Adults With Obesity

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 8, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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