Ignite Creation Date:
2024-05-06 @ 2:59 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04487782
Status:
COMPLETED
Last Update Posted:
2022-11-16
First Post:
2020-07-22
Brief Title:
Pragmatic Weight Loss Intervention During Menopause
Sponsor:
Kara Marlatt
Organization:
Pennington Biomedical Research Center
Study Overview
Official Title:
Pragmatic Weight Loss Intervention During Menopause
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WISE
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None