Women Exercising, Active, and Learning Together 2.0 (WEALTH 2)
Women Exercising: Active, and Learning Together for Health (WEALTH) Trial 2.0
Study Overview
Status
Intervention / Treatment
Detailed Description
In the United States, one in five adults (approximately 58 million) is estimated to be living with a mental illness. However, the rate of mental illness is higher in women (27.2%) compared to males (18.1%). High levels of stress, depression, and anxiety are the most reported mental health disorders among women. One protective factor against poor mental health outcomes is participation in physical activity. However, women have been underrepresented in health science studies, precluding us from understanding the best means of promoting physical activity and associated health benefits through intervention.
The Women Exercising, Active, and Learning Together for Health 2.0 (WEALTH 2.0) intervention seeks to understand how a dance fitness intervention may best serve women. This study aims to test the efficacy of a two-arm, group-based physical activity intervention for reducing stress and improving mental health outcomes in midlife women. The two major aims include 1) understanding the immediate- and long-term efficacy of the intervention on physiologic stress and mental health outcomes and 2) determining the associations between change in stress and change in secondary health outcomes. The investigative team will recruit 60 women between the ages of 30 and 60 years to participate in our study. Women will be randomly assigned to an in-person intervention condition or a waitlist control group. Classes will be offered twice per week for 30 minutes for a toal of 6-weeks in the Dance Studio of the Oschner Wellness Center here on the LSU Main Campus by a certified group fitness instructor. Classes will consist of dance fitness content and resistance training exercises to align with the U.S. physical activity guidelines.
The primary outcome of this intervention is physiologically assessed stress (saliva). Secondary outcomes will include perceived stress (questionnaire), depression symptomology (questionnaire), anxiety (questionnaire), body image (questionnaire), social health (questionnaire), intervention adherence (self-report logs), body composition (DEXA scans), and device-measured physical activity (7-day accelerometer protocols). All outcomes will be assessed at three time points: Week 0 (baseline), Week 6 (immediate post-intervention), and Week 10 (follow-up assessment). Achieving the goals of this project will 1) expand upon our previous successful feasibility study, 2) demonstrate the impact of a physical activity intervention and its effect on stress and mental health, 3) better understand the inter-relationships among stress, mental health, and health behaviors/outcomes in midlife women.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Louisiana
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Baton Rouge, Louisiana, United States, 70803
- Louisiana State University, School of Kinesiology, Huey P. Long Field House
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- age 30-60
- body mass index >18
- employed at Louisiana State University
- female
Exclusion Criteria:
- males
- age <18 or >60
- students at Louisiana State University
- Not employed at Louisiana State University
- body mass index <18
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Dance Fitness Group
Participants will attend 2 30-minute group-based, dance fitness classes per week for 6 weeks.
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This group-based intervention will be conducted with women only.
Women enrolled in the study and assigned to the intervention condition will complete 2 30-minute classes per week for 6 weeks.
All classes will be held on a university campus and take place during the lunch hour (12:30-1pm).
All classes will be led by a certified group fitness leader who is a member of the research team.
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No Intervention: Waitlist Control Group
Participants in the waitlist control group will receive no intervention and perform their usual routine.
These participants will be given access to dance fitness classes after all data collection has been completed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Physiologic Stress
Time Frame: From enrollment to the end of the follow-up period at week 10
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The primary outcome variable of physiologic stress will be assessed through markers in saliva.
Samples will be collected using the non-invasive commercially available Salimetrics polyester Oral Swab (SOS) technology (Salimetrics, CA, USA), which has been validated for salivary hormone, sIgA, and alpha-amylase measurements.
Immediately after waking up but before getting out of bed, participants will be asked to place one SOS under their tongue for 3 minutes before returning it to the provided vial.
Immediately after the first timed saliva collection, participants will be asked to place a second SOS pad under their tongue until full saliva saturation is obtained.
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From enrollment to the end of the follow-up period at week 10
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Depression
Time Frame: From enrollment to the end of the follow-up period at week 10
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Secondary outcomes related to depression/sadness will be assessed using the 8-item NIH Toolbox Sadness Short Form.
Exemplar items include marking the frequency in the past week for items such as "I felt worthless" or "I felt depressed".
This measure uses a five-point scale from "Never" (1) to "Always" (5).
This short form has shown both adequate internal consistency α = 0.88) and convergent validity (coefficient = 0.88; compared to the Center for Epidemiologic Studies Depression Scale.
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From enrollment to the end of the follow-up period at week 10
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Anxiety
Time Frame: From enrollment to the end of the follow-up period at week 10
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Anxiety will be assessed using the 8-item PROMIS-Anxiety Short Form questionnaire.
Exemplar items include marking the frequency in the past week for items such as "I felt uneasy" or "I felt anxious."
This measure uses a five-point scale from "Never" (1) to "Always" (5).
This measure has demonstrated adequate internal consistency in adult populations (α= 0.93).
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From enrollment to the end of the follow-up period at week 10
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Social Health
Time Frame: From enrollment to the end of the follow-up period at week 10
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Social health will be measured using the Emotional Support subscale from the NIH Toolbox Item Bank v3.0 will be used to measure social health.
Exemplar items include "I have someone I trust to talk with about my problems" and "I have someone to turn to for suggestions about how to deal with a problem."
All items are assessed using a five-point scale with anchors representing frequency in the past month from "Never" (1) to "Always" (5).
This measure has demonstrated adequate internal consistency in adult populations (α = 0.97) and construct validity.
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From enrollment to the end of the follow-up period at week 10
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Perceived Stress
Time Frame: From enrollment to the end of the follow-up period at week 10
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The secondary outcome of perceived stress will be assessed using the 10-item NIH Toolbox Perceived Stress Survey.
Exemplar items include "How often have you felt nervous and 'stressed'?" and "How often have you felt that things were going your way?".
All items are assessed using a five-point scale with anchors representing frequency in the past month from "Never" (1) to "Very often" (5).
This measure has demonstrated adequate internal consistency in adult populations (α = 0.91).
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From enrollment to the end of the follow-up period at week 10
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Body Image
Time Frame: From enrollment to the end of the follow-up period at week 10
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The Multidimensional Body-Self Relations Questionnaire will assess body image.
It explores the following constructs: self-esteem, physical fitness, health, concentration on body weight, and concerns about gaining weight.
There are 69 items on a scale from 1-5.
The higher the score, the greater the satisfaction with body constructs.
The following constructs are evaluated in this scale: appearance evaluation, appearance orientation, fitness evaluation, fitness orientation, health evaluation, health orientation, illness orientation, body area satisfaction, overweight preoccupation, and self-classified weight.
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From enrollment to the end of the follow-up period at week 10
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Device Measured Physical Activity
Time Frame: From enrollment to the end of the follow-up period at week 10
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Physical activity will be measured with an ActiGraph GT9X Link wrist worn accelerometer worn for 7 days at all times during waking hours.
A minimum of 4 days (three weekdays and one weekend day) and a wear time of 10 hours are needed to be included in subsequent analysis.
Cut points developed by Montoye et al. will be used to assign sedentary, light, and moderate-to-vigorous physical activity.
Participants will receive the accelerometer via the U.S. mail.
Written instructions, a QR code for a video demonstration, and contact details of the investigative team will be sent to ensure proper fitting and wearing of the device.
The accelerometer will be returned to the research team via prepaid mail envelopes.
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From enrollment to the end of the follow-up period at week 10
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Intervention Compliance
Time Frame: From enrollment to the end of the immediate intervention period at week 6
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Compliance with the intervention will be assessed via attendance logs.
For the in-person condition, a research assistant will be present for all classes to report who is in attendance.
For the online condition, compliance will be assessed via a self-report log of completing a dance fitness class cross-checked with tracking of participant access and use of the course via the online platform.
A continuous variable for total numbers of sessions attended will be recorded.
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From enrollment to the end of the immediate intervention period at week 6
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Collaborators and Investigators
Investigators
- Principal Investigator: Ryan M Hulteen, PhD, Louisiana State University A&M
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRBAM-24-106201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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