Clinical trial NCT04487782: Pragmatic Weight Loss Intervention During Menopause
Official title: Pragmatic Weight Loss Intervention During Menopause
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menopause
Menopause Related Conditions
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2020-07-27
Enrollment: 55
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration
timeFrame: 1 day
measure: Motivation
timeFrame: 1 day
measure: Time Commitment
timeFrame: 1 day
measure: Diet
timeFrame: 1 day
measure: Exercise
timeFrame: 1 day
measure: Location
timeFrame: 1 day
measure: Barriers
timeFrame: 1 day
measure: Menopause Education
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Kara L Marlatt, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.