Obesity & OverweightNCT07690592
A Single-arm Pilot Feasibility Trial of Healthy Pride
A study testing lifestyle intervention in people with Obesity & Overweight, run by University of Connecticut.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2026to 30 Jan 2027
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Sherry Pagoto, PhD contact
About this study
Official title: The Development of a Lifestyle Intervention Tailored to the Needs and Preferences of Sexual Minority Adults With Obesity
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.
Read the detailed description
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.
- Conditions
- Obesity & Overweight
- Being tested
- lifestyle intervention
- Keywords
- obesity, weight loss, weight management, healthy diet, exercise, LGBTQ, sexual minority, gay, lesbian
- Medical subject headings
- Obesity, Overweight, Weight Loss, Motor Activity, Homosexuality, Homosexuality, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle interventionBehavioural
12-week digitally-delivered asynchronous lifestyle intervention
| Study group | Role | What they receive |
|---|---|---|
| lifestyle intervention | Experimental | 12-week lifestyle intervention Receives: Behavioral: lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
The percent of participants who provided weight data at 12 weeks
Measured: 12 weeks
Engagement
Total number of engagements during the intervention (reactions, replies, poll votes, and posts)
Measured: 12 weeks
Intervention satisfaction
a 0-6 Likert scale rating of how satisfied they were with the weight loss program overall
Measured: 12 weeks
Secondary outcomes (1)
Inclusivity
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start15 Jul 2026 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherry Pagoto, University of Connecticut
- Investigators
- Sherry Pagoto, PhD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690592
- Sponsor's protocol ID
- H25-0328
- Other IDs
- Seed grant
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data and data dictionaries
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of a Lifestyle Intervention Tailored to the Needs and Preferences of Sexual Minority Adults With Obesity
- ClinicalTrials.gov ID
- NCT07690592
- Acronym / sponsor ID
- H25-0328
- Conditions
- Obesity & Overweight
- Keywords
- obesity, weight loss, weight management, healthy diet, exercise, LGBTQ, sexual minority, gay
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 8 Jul 2026 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lifestyle intervention | Experimental | Behavioral: lifestyle intervention12-week lifestyle intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (24 listed)
- 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
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 |
|---|---|---|
| lifestyle intervention12-week digitally-delivered asynchronous lifestyle intervention | Behavioural | lifestyle intervention |
Primary outcome
Retention
Time frame: 12 weeks
The percent of participants who provided weight data at 12 weeks
Engagement
Time frame: 12 weeks
Total number of engagements during the intervention (reactions, replies, poll votes, and posts)
Intervention satisfaction
Time frame: 12 weeks
a 0-6 Likert scale rating of how satisfied they were with the weight loss program overall
1 secondary outcome
Inclusivity
Time frame: 12 weeks
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 8 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified data and data dictionaries
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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.
Sherry Pagoto, PhD contact
Sherry Pagoto, PhD principal investigator
University of Connecticut
Questions about this trial
What is this clinical trial studying?
A study testing lifestyle intervention in people with Obesity & Overweight, run by University of Connecticut.
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 8 inclusion and 24 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: opening soon, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Denise Fernandes (860-515-8186, denise.fernandes@uconn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention (time frame: 12 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?
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 8 Jul 2026.