Pragmatic Weight Loss Intervention During Menopause

NCT04487782 | Completed

• 1 other identifier: PBRC 2019-056
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause; Menopause Related Conditions

Outcome Measures

Primary Outcomes (8)

• Duration

  Identify how long would women prefer the intervention to last (e.g., number of months).

  1 day

• Motivation

  Identify what motivates women (e.g., group setting, incentives, etc.).

  1 day

• Time Commitment

  Identify how many times (e.g., days per week) that women would want to participate in a lifestyle intervention.

  1 day

• 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

• 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

• 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

• Barriers

  Identify specific barriers that women would encounter if participating in a lifestyle intervention.

  1 day

• Menopause Education

  Identify specific education topics that women would like to receive as part of their lifestyle intervention.

  1 day

Study Arms (4)

High SES / African-American Women

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.

Other: Focus Groups

High SES / Caucasian Women

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.

Other: Focus Groups

Low SES / African-American Women

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.

Other: Focus Groups

Low SES / Caucasian Women

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.

Other: Focus Groups

Interventions

Focus Groups OTHER

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.

High SES / African-American Women; High SES / Caucasian Women; Low SES / African-American Women; Low SES / Caucasian Women

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The investigators will enroll up to 56 women who self-report having experience of menopause and a desire to lose (or maintain) weight during menopause. An equal distribution of African-American (AA) and Caucasian women stratified by socioeconomic status (SES) will be enrolled.

You may qualify if:

• 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

You may not qualify if:

• Are pre-menopausal
• Non-English speaking

Sponsors & Collaborators

• Kara Marlatt: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

• Kracht CL, Romain JS, Hardee JC, Santoro N, Redman LM, Marlatt KL. "It just seems like people are talking about menopause, but nobody has a solution": A qualitative exploration of menopause experiences and preferences for weight management among Black women. Maturitas. 2022 Mar;157:16-26. doi: 10.1016/j.maturitas.2021.11.005. Epub 2021 Nov 7.

  PMID: 35120668 DERIVED

MeSH Terms

Interventions

Focus Groups

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Kara L Marlatt, PhD, MPH

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor-Research

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 27, 2020
• Study Start: February 20, 2020
• Primary Completion: March 10, 2021
• Study Completion: March 10, 2021
• Last Updated: November 16, 2022

Record last verified: 2022-11

Locations

US (1)