Clinical Trials Directory

Trials / Completed

CompletedNCT04487782

Pragmatic Weight Loss Intervention During Menopause

Status
Completed
Phase
Study type
Observational
Enrollment
55 (actual)
Sponsor
Kara Marlatt · Academic / Other
Sex
Female
Age
45 Years – 60 Years
Healthy volunteers

Summary

The investigators are using a community-based participatory research (CBPR) model to develop a lifestyle intervention targeting weight loss that is specifically tailored to women in perimenopause.

Detailed description

This is a participatory research study which will enroll women (n of up to 56) with experience of menopause to help identify preferred strategies (modalities) for weight loss, which will combine calorie (dietary) restriction and exercise tactics. Aim 1: Explore attitudes and perceptions about weight gain during the menopause transition, and identify weight loss strategies from the patient (peer) perspective. \- The investigators will apply these learnings: 1) to understand barriers for weight management during menopause; 2) to establish strategies to guide retention; 3) to finalize the intervention structure, including feedback on the frequency and duration of the study visits; and 4) to gather feedback on menopause-specific education resources set to be provided throughout the intervention. Aim 2: Engage the Community Advisory Board (CAB) of the Louisiana Clinical and Translational Center (LA CaTS) to understand scalability and community-based implementation of an intervention tailored for women in perimenopause. \- The investigators will then utilize the Louisiana Clinical \& Translational Science Center (LA CaTS) Community Advisory Board (CAB) to help us tailor a lifestyle intervention in perimenopausal women with emphasis on scalability and community-based implementation using learnings obtained from the focus groups.

Conditions

Interventions

TypeNameDescription
OTHERFocus GroupsThe investigators are enrolling up to 56 women (total) to participate in semi-structured focus groups of 6-8 women per group conducted either in-person or virtually (online) to help us tailor a lifestyle intervention for midlife women during perimenopause.

Timeline

Start date
2020-02-20
Primary completion
2021-03-10
Completion
2021-03-10
First posted
2020-07-27
Last updated
2022-11-16

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04487782. Inclusion in this directory is not an endorsement.