NCT07690592

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Jul 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Jul 2026Jan 2027

First Submitted

Initial submission to the registry

July 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

July 15, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2027

Last Updated

July 8, 2026

Status Verified

July 1, 2026

Enrollment Period

7 months

First QC Date

July 1, 2026

Last Update Submit

July 1, 2026

Conditions

Keywords

obesityweight lossweight managementhealthy dietexerciseLGBTQsexual minoritygaylesbian

Outcome Measures

Primary Outcomes (3)

  • Retention

    The percent of participants who provided weight data at 12 weeks

    12 weeks

  • Engagement

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

    12 weeks

  • Intervention satisfaction

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

    12 weeks

Secondary Outcomes (1)

  • Inclusivity

    12 weeks

Study Arms (1)

lifestyle intervention

EXPERIMENTAL

12-week lifestyle intervention

Behavioral: lifestyle intervention

Interventions

12-week digitally-delivered asynchronous lifestyle intervention

lifestyle intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityOverweightWeight LossMotor ActivityHomosexualityHomosexuality, Female

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesBehaviorSexualitySexual Behavior

Study Officials

  • Sherry Pagoto, PhD

    University of Connecticut

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherry Pagoto, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 1, 2026

First Posted

July 8, 2026

Study Start

July 15, 2026

Primary Completion (Estimated)

January 30, 2027

Study Completion (Estimated)

January 30, 2027

Last Updated

July 8, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

De-identified data and data dictionaries