Pragmatic Weight Loss Intervention During Menopause

Completed

• Conditions: Menopause; Menopause Related Conditions
• Interventions: Other: Focus Groups

• Registration Number: NCT04487782
• Lead Sponsor: Kara Marlatt

Brief 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.

Study Timeline

• Study Start: 2020-02-20
• Study First Submitted: 2020-07-22
• Study First Submitted QC: 2020-07-22
• Study First Posted: 2020-07-27
• Primary Completion: 2021-03-10
• Study Completion: 2021-03-10
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-11
• Last Update Posted: 2022-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 55

Inclusion Criteria

• Age 45 to 60 years
• Currently experiencing (or have experienced) the one of the following menopause-related traits:
• Vasomotor symptoms including hot flashes and/or night sweats
• Irregular menstrual cycle
• African-American (Black) or Caucasian (White) race
• Self-report having a desire to lose (or maintain) weight during menopause
• Willing to be recorded during the focus group for transcription purposes

Exclusion Criteria

• Are pre-menopausal
• Non-English speaking

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High SES / Caucasian Women	Focus Groups	Semi-structured focus groups of 6 to 8 women per group will be conducted. Women in these groups will be of higher socioeconomic status (SES) and will be Caucasian/White.
Low SES / Caucasian Women	Focus Groups	Semi-structured focus groups of 6 to 8 women per group will be conducted. Women in these groups will be of lower socioeconomic status (SES) and will be Caucasian/White.
Low SES / African-American Women	Focus Groups	Semi-structured focus groups of 6 to 8 women per group will be conducted. Women in these groups will be of lower socioeconomic status (SES) and will be African-American/Black.
High SES / African-American Women	Focus Groups	Semi-structured focus groups of 6 to 8 women per group will be conducted. Women in these groups will be of higher socioeconomic status (SES) and will be African-American/Black.

Primary Outcome Measures

Name	Time	Method
Barriers	1 day	Identify specific barriers that women would encounter if participating in a lifestyle intervention.
Duration	1 day	Identify how long would women prefer the intervention to last (e.g., number of months).
Motivation	1 day	Identify what motivates women (e.g., group setting, incentives, etc.).
Time Commitment	1 day	Identify how many times (e.g., days per week) that women would want to participate in a lifestyle intervention.
Diet	1 day	Identify the types of diets (e.g., keto, Mediterranean, intermittent fasting, etc.) that women have attempted before, and which diets they liked best.
Exercise	1 day	Identify the types of exercises (e.g., swimming, walking, weight training, etc.) that women like to do or would like to try.
Location	1 day	Identify where women would want to go to receive a lifestyle intervention (e.g., at Pennington, in local fitness centers, virtual/online, etc.).
Menopause Education	1 day	Identify specific education topics that women would like to receive as part of their lifestyle intervention.

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States