Women Exercising, Active, and Learning Together 2.0

NCT ID: NCT06785025

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-21
• Study Completion Date: 2025-05-14

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.

Conditions

Stress; Depression Secondary to Other Disease; Anxiety; Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Dance Fitness Group

Participants will attend 2 30-minute group-based, dance fitness classes per week for 6 weeks.

Group Type: EXPERIMENTAL

Group-Based Dance Fitness Intervention

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Group-Based Dance Fitness Intervention

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Louisiana State University and A&M College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryan M Hulteen, PhD

Role: PRINCIPAL_INVESTIGATOR

Louisiana State University A&M

Locations

Louisiana State University, School of Kinesiology, Huey P. Long Field House

Baton Rouge, Louisiana, United States

Countries

United States

Other Identifiers

IRBAM-24-106201

Identifier Type: -

Identifier Source: org_study_id