Pragmatic Weight Loss Intervention During Menopause (WISE)

Kara Marlatt

Status: Completed

Conditions: Menopause Related Conditions; Menopause

Treatments: Other: Focus Groups

Study type: Observational

Funder types: Other

Identifiers

NCT04487782

PBRC 2019-056

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: Female

Ages: 45 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

55 participants in 4 patient groups

High SES / African-American Women

Description:

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.

Treatment:

Other: Focus Groups

High SES / Caucasian Women

Description:

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.

Treatment:

Other: Focus Groups

Low SES / African-American Women

Description:

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.

Treatment:

Other: Focus Groups

Low SES / Caucasian Women

Description:

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.

Treatment:

Other: Focus Groups