NCT06785025

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 20, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

January 21, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2025

Completed
Last Updated

September 9, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

January 15, 2025

Last Update Submit

September 2, 2025

Conditions

Keywords

danceinterventionwomengroup fitness

Outcome Measures

Primary Outcomes (1)

  • Physiologic Stress

    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.

    From enrollment to the end of the follow-up period at week 10

Secondary Outcomes (6)

  • Depression

    From enrollment to the end of the follow-up period at week 10

  • Anxiety

    From enrollment to the end of the follow-up period at week 10

  • Social Health

    From enrollment to the end of the follow-up period at week 10

  • Perceived Stress

    From enrollment to the end of the follow-up period at week 10

  • Body Image

    From enrollment to the end of the follow-up period at week 10

  • +1 more secondary outcomes

Other Outcomes (1)

  • Intervention Compliance

    From enrollment to the end of the immediate intervention period at week 6

Study Arms (2)

Dance Fitness Group

EXPERIMENTAL

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

Behavioral: Group-Based Dance Fitness Intervention

Waitlist Control Group

NO INTERVENTION

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.

Interventions

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.

Dance Fitness Group

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study is only including individuals who identify as a female.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 30-60
  • body mass index \>18
  • employed at Louisiana State University
  • female

You may not qualify if:

  • males
  • age \<18 or \>60
  • students at Louisiana State University
  • Not employed at Louisiana State University
  • body mass index \<18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Baton Rouge, Louisiana, 70803, United States

Location

MeSH Terms

Conditions

Anxiety DisordersMotor Activity

Condition Hierarchy (Ancestors)

Mental DisordersBehavior

Study Officials

  • Ryan M Hulteen, PhD

    Louisiana State University A&M

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2025

First Posted

January 20, 2025

Study Start

January 21, 2025

Primary Completion

May 14, 2025

Study Completion

May 14, 2025

Last Updated

September 9, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Data sharing of study info was not approved by IRB

Locations