Pragmatic Weight Loss Intervention During Menopause

NCT ID: NCT04487782

Last Updated: 2022-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-20

Study Completion Date

2021-03-10

Brief Summary

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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

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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

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Menopause Menopause Related Conditions

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Focus Groups

Intervention Type 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 / 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.

Focus Groups

Intervention Type 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.

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.

Focus Groups

Intervention Type 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.

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.

Focus Groups

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kara Marlatt

OTHER

Sponsor Role lead

Responsible Party

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Kara Marlatt

Assistant Professor-Research

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kara L Marlatt, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

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Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35120668 (View on PubMed)

Other Identifiers

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PBRC 2019-056

Identifier Type: -

Identifier Source: org_study_id

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