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Completed

NCT Number: NCT04487782

Pragmatic Weight Loss Intervention During Menopause

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.

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Key information

Conditions

Menopause Menopause Related Conditions

Age range

45 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Duration

    Time frame: 1 day

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

  2. Motivation

    Time frame: 1 day

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

  3. Time Commitment

    Time frame: 1 day

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

  4. Diet

    Time frame: 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.

  5. Exercise

    Time frame: 1 day

    Identify the types of exercises (e.g., swimming, walking, weight training, etc.) that women like to do or would like to try.

  6. Location

    Time frame: 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.).

  7. Barriers

    Time frame: 1 day

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

  8. Menopause Education

    Time frame: 1 day

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

Sponsors and collaborators

Lead sponsor

Kara Marlatt

Other

Registry information

Acronym: WISE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 27, 2020
Registry last updated
Nov 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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