A Single-arm Pilot Feasibility Trial of Healthy Pride

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое lifestyle intervention
  12-week digitally-delivered asynchronous lifestyle intervention

Первичные конечные точки

• Retention [Срок оценки: 12 weeks]
• Engagement [Срок оценки: 12 weeks]
• Intervention satisfaction [Срок оценки: 12 weeks]

Вторичные конечные точки (1)

• Inclusivity [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07690592 · H25-0328 · Seed grant

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗