Pragmatic Weight Loss Intervention During Menopause

Study Overview
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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.

Official Title
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Pragmatic Weight Loss Intervention During Menopause

Conditions
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Menopause, Menopause Related Conditions

Intervention / Treatment
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* Other: Focus Groups


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High SES / African-American Women<br>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<br>* 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.<br>|
| High SES / Caucasian Women<br>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<br>* 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.<br>|
| Low SES / African-American Women<br>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<br>* 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.<br>|
| Low SES / Caucasian Women<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |