Pragmatic Weight Loss Intervention During Menopause

Menopause Clinical Trial

— WISE  

Official title:

Pragmatic Weight Loss Intervention During Menopause

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04487782
• Other study ID #: PBRC 2019-056
• Status: Completed
• Start date: February 20, 2020
• Est. completion date: March 10, 2021

Study information

• Verified date: November 2022
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: March 10, 2021
• Est. primary completion date: March 10, 2021
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Menopause
• Menopause Related Conditions
• Weight Loss

Intervention

Other:
• Focus Groups
The 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.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Kara Marlatt

Country where clinical trial is conducted

United States, 

Outcome

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