Clinical trial NCT06785025: Women Exercising, Active, and Learning Together 2.0
Official title: Women Exercising: Active, and Learning Together for Health (WEALTH) Trial 2.0
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stress
Depression Secondary to Other Disease
Anxiety
Physical Activity
Keywords: dance
intervention
women
group fitness
Lead sponsor: Louisiana State University and A&M College
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 60
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1 will receive access to a 6-week dance fitness intervention (2 classes per week for 30 minutes per class). Group 2 will be a waitlist control condition who will perform their usual routine, but get access to dance fitness classes after all data has been collected.
Primary purpose: PREVENTION

Brief summary: The goal of this randomized controlled clinical trial is to determine the efficacy of a 6 week dance fitness intervention has on reducing objective, physiological stress in women between the ages of 30 and 60. It will also learn about its ability to improve mental and psychological health outcomes. The main questions is aims to answer is : 1) To what extent can a 6-week dance fitness intervention improve the health of women? 2) Are intervention effects sustained 4 weeks after the intervention has ended? Researchers will compare the intervention condition to a waitlist control condition. Participants will: 1) complete baseline assessments, 2) complete a six week dance fitness program or complete their usual routine for six weeks, 3) complete immediate post-intervention assessments, and 4) complete follow-up assessments four weeks after the post-intervention assessments.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Physiologic Stress
timeFrame: From enrollment to the end of the follow-up period at week 10
Secondary outcomes:
measure: Depression
timeFrame: From enrollment to the end of the follow-up period at week 10
measure: Anxiety
timeFrame: From enrollment to the end of the follow-up period at week 10
measure: Social Health
timeFrame: From enrollment to the end of the follow-up period at week 10
measure: Perceived Stress
timeFrame: From enrollment to the end of the follow-up period at week 10
measure: Body Image
timeFrame: From enrollment to the end of the follow-up period at week 10
measure: Device Measured Physical Activity
timeFrame: From enrollment to the end of the follow-up period at week 10
Other outcomes:
measure: Intervention Compliance
timeFrame: From enrollment to the end of the immediate intervention period at week 6
Locations:
city: Baton Rouge
country: United States
facility: Louisiana State University, School of Kinesiology, Huey P. Long Field House
state: Louisiana
Study officials:
affiliation: Louisiana State University A&M
name: Ryan M Hulteen, PhD
role: PRINCIPAL_INVESTIGATOR
References: