StressWEALTH 2NCT06785025
Women Exercising, Active, and Learning Together 2.0
A study testing Group-Based Dance Fitness Intervention in people with Stress and Depression Secondary to Other Disease, run by Louisiana State University and A&M College at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress, Depression Secondary to Other Disease, Anxiety
- What is being tested?
- Group-Based Dance Fitness Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2025to 14 May 2025
- Phase
- Interventional
- 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 30 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 30-60
- body mass index >18
- employed at Louisiana State University
- female
Who cannot join
- males
- age <18 or >60
- students at Louisiana State University
- Not employed at Louisiana State University
- body mass index <18
Trial locations and contacts
1 site in 1 country.
United States1 site
Louisiana State University, School of Kinesiology, Huey P. Long Field House
Baton Rouge, Louisiana, 70803
About this study
Official title: Women Exercising: Active, and Learning Together for Health (WEALTH) Trial 2.0
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.
Read the 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.
- Being tested
- Group-Based Dance Fitness Intervention
- Keywords
- dance, intervention, women, group fitness
- Medical subject headings
- Anxiety Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-Based Dance Fitness InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Dance Fitness Group | Experimental | Participants will attend 2 30-minute group-based, dance fitness classes per week for 6 weeks. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of the follow-up period at week 10
Secondary outcomes (6)
Depression
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.
Measured: From enrollment to the end of the follow-up period at week 10
Anxiety
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).
Measured: From enrollment to the end of the follow-up period at week 10
Social Health
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.
Measured: From enrollment to the end of the follow-up period at week 10
Perceived Stress
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).
Measured: From enrollment to the end of the follow-up period at week 10
Body Image
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.
Measured: From enrollment to the end of the follow-up period at week 10
Device Measured Physical Activity
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.
Measured: From enrollment to the end of the follow-up period at week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start21 Jan 2025
- Primary completion14 May 2025
- Study completion14 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University and A&M College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan M Hulteen, PhD, Principal investigator, Louisiana State University A&M
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785025
- Sponsor's protocol ID
- IRBAM-24-106201
- Acronym
- WEALTH 2
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing of study info was not approved by IRB
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women Exercising: Active, and Learning Together for Health (WEALTH) Trial 2.0
- ClinicalTrials.gov ID
- NCT06785025
- Acronym / sponsor ID
- WEALTH 2 / IRBAM-24-106201
- Keywords
- dance, intervention, women, group fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Louisiana State University and A&M CollegeUniversity, hospital or other
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- 14 May 2025 (actual)
- Study completion
- 14 May 2025 (actual)
- First posted
- 20 Jan 2025 (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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dance Fitness Group | Experimental | Behavioral: Group-Based Dance Fitness InterventionParticipants will attend 2 30-minute group-based, dance fitness classes per week for 6 weeks. |
| 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age 30-60
- body mass index >18
- employed at Louisiana State University
- female
Key exclusion criteria (5 listed)
- males
- age <18 or >60
- students at Louisiana State University
- Not employed at Louisiana State University
- body mass index <18
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 |
|---|---|---|
| Group-Based Dance Fitness InterventionThis 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. | Behavioural | Dance Fitness Group |
Primary outcome
Physiologic Stress
Time frame: From enrollment to the end of the follow-up period at week 10
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.
6 secondary outcomes
Depression
Time frame: From enrollment to the end of the follow-up period at week 10
Anxiety
Time frame: From enrollment to the end of the follow-up period at week 10
Social Health
Time frame: From enrollment to the end of the follow-up period at week 10
Perceived Stress
Time frame: From enrollment to the end of the follow-up period at week 10
Body Image
Time frame: From enrollment to the end of the follow-up period at week 10
Device Measured Physical Activity
Time frame: From enrollment to the end of the follow-up period at week 10
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 9 Sep 2025.
- Individual participant dataSharing planned: No. Data sharing of study info was not approved by IRB
Related trials for Stress
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
RecruitingPhase 4
Effect of a Furosemide Stress Test-Guided Strategy on Liberation From Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury
Acute Kidney Injury
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Active, not recruiting
Chicago Parent Program for Foster and Kinship Caregivers
Behavior Problem, Parenting
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
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.
Ryan M Hulteen, PhD principal investigator
Louisiana State University A&M
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-Based Dance Fitness Intervention in people with Stress and Depression Secondary to Other Disease, run by Louisiana State University and A&M College 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 4 inclusion and 5 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 9 Sep 2025. 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?
Physiologic Stress (time frame: From enrollment to the end of the follow-up period at week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2025.