WISE: Pragmatic Weight Loss Intervention During Menopause
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Other: 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.
|
| 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. |
Other: 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.
|
| 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. |
Other: 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.
|
| 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. |
Other: 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.
|
Outcome Measures
Primary Outcome Measures
- Duration [1 day]
Identify how long would women prefer the intervention to last (e.g., number of months).
- Motivation [1 day]
Identify what motivates women (e.g., group setting, incentives, etc.).
- Time Commitment [1 day]
Identify how many times (e.g., days per week) that women would want to participate in a lifestyle intervention.
- Diet [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 [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 [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.).
- Barriers [1 day]
Identify specific barriers that women would encounter if participating in a lifestyle intervention.
- Menopause Education [1 day]
Identify specific education topics that women would like to receive as part of their lifestyle intervention.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 45 to 60 years
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Currently experiencing (or have experienced) the one of the following menopause-related traits:
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Vasomotor symptoms including hot flashes and/or night sweats
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Irregular menstrual cycle
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African-American (Black) or Caucasian (White) race
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Self-report having a desire to lose (or maintain) weight during menopause
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Willing to be recorded during the focus group for transcription purposes
Exclusion Criteria:
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Are pre-menopausal
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Non-English speaking
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pennington Biomedical Research Center | Baton Rouge | Louisiana | United States | 70808 |
Sponsors and Collaborators
- Pennington Biomedical Research Center
Investigators
- Principal Investigator: Kara L Marlatt, PhD, MPH, Pennington Biomedical Research Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PBRC 2019-056