Pragmatic Weight Loss Intervention During Menopause
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Barriers
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 45 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Barriers
Time Frame: 1 day
Identify specific barriers that women would encounter if participating in a lifestyle intervention.
Duration
Time Frame: 1 day
Identify how long would women prefer the intervention to last (e.g., number of months).
Motivation
Time Frame: 1 day
Identify what motivates women (e.g., group setting, incentives, etc.).
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.
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.
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.
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.).
Menopause Education
Time Frame: 1 day
Identify specific education topics that women would like to receive as part of their lifestyle intervention.
Secondary Outcomes
No secondary outcomes reported
Investigators
Kara Marlatt
Assistant Professor-Research
Pennington Biomedical Research Center