MenopauseWISENCT04487782
Pragmatic Weight Loss Intervention During Menopause
An observational study of Menopause and Menopause Related Conditions, run by Kara Marlatt at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Menopause, Menopause Related Conditions
- What is being tested?
- Focus Groups
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2020to 10 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- Adult
Study population: The investigators will enroll up to 56 women who self-report having experience of menopause and a desire to lose (or maintain) weight during menopause. An equal distribution of African-American (AA) and Caucasian women stratified by socioeconomic status (SES) will be enrolled.
Who may be able to join
- 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
Who cannot join
- Are pre-menopausal
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
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.
Read the 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.
- Conditions
- Menopause, Menopause Related Conditions
- Being tested
- Focus Groups
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus GroupsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Focus Groups | |
| 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. Receives: Other: Focus Groups | |
| 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. Receives: Other: Focus Groups | |
| 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. Receives: Other: Focus Groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration
Identify how long would women prefer the intervention to last (e.g., number of months).
Measured: 1 day
Motivation
Identify what motivates women (e.g., group setting, incentives, etc.).
Measured: 1 day
Time Commitment
Identify how many times (e.g., days per week) that women would want to participate in a lifestyle intervention.
Measured: 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.
Measured: 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.
Measured: 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.).
Measured: 1 day
Barriers
Identify specific barriers that women would encounter if participating in a lifestyle intervention.
Measured: 1 day
Menopause Education
Identify specific education topics that women would like to receive as part of their lifestyle intervention.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start20 Feb 2020
- Primary completion10 Mar 2021
- Study completion10 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kara Marlatt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kara Marlatt, Pennington Biomedical Research Center
- Investigators
- Kara L Marlatt, PhD, MPH, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487782
- Sponsor's protocol ID
- PBRC 2019-056
- Acronym
- WISE
- Status last verified
- Nov 2022
- First submitted
- 22 Jul 2020
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kracht CL, Romain JS, Hardee JC, Santoro N, Redman LM, Marlatt KL. "It just seems like people are talking about menopause, but nobody has a solution": A qualitative exploration of menopause experiences and preferences for weight management among Black women. Maturitas. 2022 Mar;157:16-26. doi: 10.1016/j.maturitas.2021.11.005. Epub 2021 Nov 7.
PubMed 35120668
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Weight Loss Intervention During Menopause
- ClinicalTrials.gov ID
- NCT04487782
- Acronym / sponsor ID
- WISE / PBRC 2019-056
- Conditions
- Menopause, Menopause Related Conditions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Kara MarlattUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 10 Mar 2021 (actual)
- Study completion
- 10 Mar 2021 (actual)
- First posted
- 27 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High SES / African-American Women | – | Other: Focus GroupsSemi-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. |
| High SES / Caucasian Women | – | Other: Focus GroupsSemi-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. |
| Low SES / African-American Women | – | Other: Focus GroupsSemi-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. |
| Low SES / Caucasian Women | – | Other: Focus GroupsSemi-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. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- The investigators will enroll up to 56 women who self-report having experience of menopause and a desire to lose (or maintain) weight during menopause. An equal distribution of African-American (AA) and Caucasian women stratified by socioeconomic status (SES) will be enrolled.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Are pre-menopausal
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus GroupsThe 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. | Other | High SES / African-American Women, High SES / Caucasian Women, Low SES / African-American Women, Low SES / Caucasian Women |
Primary outcome
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.).
Barriers
Time frame: 1 day
Identify specific barriers that women would encounter if participating in a lifestyle intervention.
Menopause Education
Time frame: 1 day
Identify specific education topics that women would like to receive as part of their lifestyle intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Derived from this study: PubMed 35120668Kracht CL, Romain JS, Hardee JC, Santoro N, Redman LM, Marlatt KL. "It just seems like people are talking about menopause, but nobody has a solution": A qualitative exploration of menopause experiences and preferences for weight management among Black women. Maturitas. 2022 Mar;157:16-26. doi: 10.1016/j.maturitas.2021.11.005. Epub 2021 Nov 7.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kara L Marlatt, PhD, MPH principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause and Menopause Related Conditions, run by Kara Marlatt at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration (time frame: 1 day). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04487782, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.