Overweight, Obesity, Noncomunicable DiseasesCC-DanceNCT06903455
A Culturally Significant Cardiovascular Dance-based Intervention in Obese Women
A study testing Fit-folk cardio dance and Conventional physical exercise in people with Overweight, Obesity, Noncomunicable Diseases, run by Universidad Catolica Silva Henriquez at 1 site in Chile.
Trial summary
The objective of this study is to analyze a culturally relevant cardiovascular dance-based intervention called Fitfolk in overweight or obese Mapuche women from a rural community in Padre las Casas. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Overweight, Obesity, Noncomunicable Diseases
- What is being tested?
- Fit-folk cardio dance and Conventional physical exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChile
- Study dates
- 16 Dec 2024to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women ≥18 years old,
- Belonging to the Huichacura-Cayuqueo indigenous community.
- Sedentary, according to WHO criteria.
- Diagnosed with malnutrition due to excess (overweight/obesity).
- With controlled chronic diseases (diabetes, hypertension, dyslipidemia).
Who cannot join
- -Those with organic pathologies that make it impossible to engage in physical activity, such as stroke, myocardial infarction, neurological diseases, or uncontrolled chronic diseases, will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site
Comunidad indigena Huichacura Cayuqueo
Padre Las Casas, Araucania, 4850000
About this study
Official title: Effects of a Culturally Significant Cardiovascular Dance-based Intervention in Obese Women
The objective of this study is to analyze a culturally relevant cardiovascular dance-based intervention called Fitfolk in overweight or obese Mapuche women from a rural community in Padre las Casas. Participants will be randomly assigned to two groups: an experimental group that will receive a culturally relevant cardiovascular dance program (EG, n=11), and a control group that will receive a conventional physical exercise program (CG, n=11). Both groups will be trained at a community center in the same rural area, led by a physical education professional. The principle of training progression will be followed, and they will exercise three times per week with sessions of approximately one hour for 12 weeks. Physical health parameters, quality of life, motivation, and barriers to physical exercise will be assessed.
Read the detailed description
Design: A two-arm randomized controlled trial conducted according to the CONSORT declaration. The design considers single blinding. The protocol will be based on the Singapore Declaration, and all participants must voluntarily sign a consent form. The protocol will be submitted to the Scientific Ethics Committee of the Araucanía Sur Health Service.
Sample: The sample will consist of 22 adult women from rural areas of the Padre las Casas commune. The sample will be selected using a non-probability convenience method, with those who meet the inclusion criteria: women aged ≥18 years, sedentary according to WHO criteria, diagnosed with excess malnutrition (overweight/obesity), and with controlled chronic diseases (diabetes, hypertension, dyslipidemia). Those with organic pathologies that preclude physical activity, such as stroke, myocardial infarction, neurological diseases, or uncontrolled chronic diseases, will be excluded. Participants will be randomly assigned to two groups. An experimental group will receive a culturally relevant cardiovascular dance program (EG, n=11) and a control group will receive a conventional physical exercise program (CG, n=11). Both groups will receive exercise at locations in the same rural areas, led by a physical education professional. The principle of training progression will be followed, and they will exercise three times per week with sessions of approximately one hour for 12 weeks.
Procedures: An agreement will be established with two communities in rural areas of Padre las Casas, with an initial contact between an anthropologist and community leaders. The lead researcher will contact potential participants to inform them about the characteristics of the research and request their informed consent.
Instruments and variables: Assessments will be conducted before and after each intervention.
- Physical health: Handgrip strength with dynamometry, cardiovascular endurance with the Shuttle walking test, flexibility with the Sit and Reach test, blood pressure with a sphygmomanometer, glycosylated hemoglobin (HbA1c) with a blood test, lipid profile with a blood test, anthropometry (weight, height, weight, waist-hip ratio), physical activity with the Basic Physical Activity Questionnaire (GPAQ),
- Quality of life: with the quality of life questionnaire (SF-36).
- Motivation and Barriers to exercise: Motivation for physical exercise with the Exercise Behavior Regulation Questionnaire (BREQ-3), and barriers and physical benefits to physical exercise with the Exercise Benefits/Barriers Scale (EBBS).
In addition, sociodemographic data will be collected, and control variables will be measured before, during, and after each exercise session.
Statistical analysis: The sample size was calculated a priori using G*Power 3.1.9.7. Sixteen subjects in total were required (8 in each group) considering α=0.05, 1-β=0.8 and effect size (ES)=1.32 for aerobic capacity based on the results of a previous study. Considering the possibility of dropout, 6 subjects were added (total n=22; n=11 in each group). The description will be done as measures of central tendency and dispersion (continuous variables) and as percentages (categorical variables). The Shapiro-Wilk test will be used to verify the normality of the data. A two-way repeated measures analysis of variance (ANOVA) will be used to determine the effects of the interventions. The Bonferroni post hoc test will be applied to identify statistically significant comparisons. All analyses will be performed using SPSS v.25 (SPSS, Inc., Chicago, IL, USA) considering p<0.05
- Being tested
- Fit-folk cardio dance, Conventional physical exercise
- Keywords
- overweight, obesity, non-communicable diseases, exercise
- Medical subject headings
- Overweight, Obesity, Noncommunicable Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fit-folk cardio danceOther
"Fitfolk" is a new cardiovascular dance discipline that combines fitness exercises with music and dance from Chilean and Latin American folklore. This discipline promotes physical and emotional well-being and celebrates national folklore.
Conventional physical exerciseOther
conventional physical exercise program that uses resistance exercise and cardiorespiratory training
| Study group | Role | What they receive |
|---|---|---|
| culturally relevant cardio dance called Fitfolk | Experimental | "Fitfolk" is a new cardiovascular dance discipline that combines fitness exercises with music and dance from Chilean and Latin American folklore. This discipline promotes physical and emotional well-being and celebrates national folklore. Receives: Other: Fit-folk cardio dance |
| conventional physical exercise | Active comparator | physical exercise program that contains resistance exercise and cardiorespiratory training Receives: Other: Conventional physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in the physical condition of the participants related to the intervention, according to the ST3x1 step test
Its best measurement is maximum oxygen consumption, which will be measured using the ST3x1 step test. assessed as relative vo2max (mL/kg/min), where higher values indicate improvements in cardiorespiratory fitness.
Measured: from the start of treatment until its completion at 12 weeks
Improvements in participants' physical strength related to the intervention
Physical strength will be assessed using the 5-times sit-to-stand test and handgrip dynamometry. A decrease in the time spent sitting and standing 5 times and an increase in hand grip in kilograms will indicate an increase in physical strength.
Measured: From the start of treatment to its completion at 12 weeks
Improvement in participants' long-term glycemic control relative to the intervention, as measured by glycated hemoglobin assay
This variable will be measured by a blood test that measures the average blood glucose level over the last two or three months, the result is presented as a percentage.
Measured: from the start of treatment until its completion at 12 weeks
Secondary outcomes (4)
Improvement in participants' quality of life in relation to the intervention, according to the WHOQOL-BREF quality of life questionnaire
The Woqhol-Bref Quality of Life Scale is a self-report questionnaire that assesses quality of life in four domains: physical health, psychological health, social relationships, and environment. Each domain is scored on a transformed scale from 0 to 100, with lower scores indicating poorer quality of life and higher scores indicating better quality of life.
Measured: from the start of treatment until its completion at 12 weeks
Improvement in participants' physical activity compared to the intervention, according to the International Physical Activity Questionnaire (IPAQ).
The International Physical Activity Questionnaire (IPAQ) assesses physical activity levels using questions covering four domains: activity at work, at home, during transportation, and in leisure time. IPAQ results are expressed in MET-minutes per week (MET-min/wk), with higher values indicating higher levels of physical activity. Participants are also classified into three categories according to their physical activity level: low, moderate, and high.
Measured: from the start of treatment until its completion at 12 weeks
Improvement in participants' motivation to engage in physical activity relative to the intervention, according to the "BREQ-3" exercise behavior regulation questionnaire.
The Exercise Behavior Regulation Questionnaire (BREQ-3) is a 23-item self-report instrument designed to assess different forms of motivational regulation toward physical exercise, based on the principles of Self-Determination Theory. The questionnaire is structured into six factors: intrinsic motivation, integrated regulation, identified regulation, introjected regulation, external regulation, and amotivation.
Each item is answered on a 5-point Likert-type scale, ranging from 0 ("not at all true for me") to 4 ("very true for me"). Higher scores on the more self-determined regulation factors (such as intrinsic, integrated, and identified motivation) indicate more favorable motivation toward exercise, while high scores on external regulation or amotivation reflect less autonomous or unfavorable motivation.
Measured: from the start of treatment until its completion at 12 weeks
Improvements in perceived barriers and benefits to physical exercise among participants in relation to the intervention, according to the Exercise Benefits and Barriers Scale (EBBS).
The perception of benefits and barriers to physical activity will be assessed using the Exercise Benefits and Barriers Scale (EBBS). This instrument consists of 43 items divided into two subscales: one assessing perceived benefits (29 items) and another measuring perceived barriers (14 items). Each item is answered using a 4-point Likert-type scale, ranging from 1 ("strongly disagree") to 4 ("strongly agree").
Higher scores on the benefits subscale indicate a more positive perception of physical activity, while higher scores on the barriers subscale reflect greater perceptions of obstacles to physical activity.
Measured: from the start of treatment until its completion at 12 weekS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start16 Dec 2024
- Primary completion6 Mar 2025
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight, Obesity, Noncomunicable DiseasesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Catolica Silva Henriquez
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Arturo Prat
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903455
- Sponsor's protocol ID
- FONDEPORTE; n°2400120062
- Other IDs
- n°2400120062
- Acronym
- CC-Dance
- Status last verified
- Jun 2025
- First submitted
- 24 Mar 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Riquelme-Hernandez C, Reyes-Barria JP, Mancilla CS, Cavero-Redondo I, Vasquez-Carrasco E, Sepulveda P, Sandoval-Vasquez C, Cigarroa I. Study protocol for a randomized controlled trial of a culturally adapted cardiovascular dance intervention in Mapuche women with obesity. Front Public Health. 2026 Apr 23;14:1806558. doi: 10.3389/fpubh.2026.1806558. eCollection 2026.
PubMed 42110294
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Culturally Significant Cardiovascular Dance-based Intervention in Obese Women
- ClinicalTrials.gov ID
- NCT06903455
- Acronym / sponsor ID
- CC-Dance / FONDEPORTE; n°2400120062
- Keywords
- overweight, obesity, non-communicable diseases, exercise
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Universidad Catolica Silva HenriquezUniversity, hospital or other
- Collaborators
- Universidad Arturo Prat
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 6 Mar 2025 (actual)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 30 Mar 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 objective of this study is to analyze a culturally relevant cardiovascular dance-based intervention called Fitfolk in overweight or obese Mapuche women from a rural community in Padre las Casas. Participants will be randomly assigned to two groups: an experimental group that will receive a culturally relevant cardiovascular dance program (EG, n=11), and a control group that will receive a conventional physical exercise program (CG, n=11). Both groups will be trained at a community center in the same rural area, led by a physical education professional. The principle of training progression will be followed, and they will exercise three times per week with sessions of approximately one hour for 12 weeks. Physical health parameters, quality of life, motivation, and barriers to physical exercise will be assessed.
Detailed description
Design: A two-arm randomized controlled trial conducted according to the CONSORT declaration. The design considers single blinding. The protocol will be based on the Singapore Declaration, and all participants must voluntarily sign a consent form. The protocol will be submitted to the Scientific Ethics Committee of the Araucanía Sur Health Service.
Sample: The sample will consist of 22 adult women from rural areas of the Padre las Casas commune. The sample will be selected using a non-probability convenience method, with those who meet the inclusion criteria: women aged ≥18 years, sedentary according to WHO criteria, diagnosed with excess malnutrition (overweight/obesity), and with controlled chronic diseases (diabetes, hypertension, dyslipidemia). Those with organic pathologies that preclude physical activity, such as stroke, myocardial infarction, neurological diseases, or uncontrolled chronic diseases, will be excluded. Participants will be randomly assigned to two groups. An experimental group will receive a culturally relevant cardiovascular dance program (EG, n=11) and a control group will receive a conventional physical exercise program (CG, n=11). Both groups will receive exercise at locations in the same rural areas, led by a physical education professional. The principle of training progression will be followed, and they will exercise three times per week with sessions of approximately one hour for 12 weeks.
Procedures: An agreement will be established with two communities in rural areas of Padre las Casas, with an initial contact between an anthropologist and community leaders. The lead researcher will contact potential participants to inform them about the characteristics of the research and request their informed consent.
Instruments and variables: Assessments will be conducted before and after each intervention.
- Physical health: Handgrip strength with dynamometry, cardiovascular endurance with the Shuttle walking test, flexibility with the Sit and Reach test, blood pressure with a sphygmomanometer, glycosylated hemoglobin (HbA1c) with a blood test, lipid profile with a blood test, anthropometry (weight, height, weight, waist-hip ratio), physical activity with the Basic Physical Activity Questionnaire (GPAQ),
- Quality of life: with the quality of life questionnaire (SF-36).
- Motivation and Barriers to exercise: Motivation for physical exercise with the Exercise Behavior Regulation Questionnaire (BREQ-3), and barriers and physical benefits to physical exercise with the Exercise Benefits/Barriers Scale (EBBS).
In addition, sociodemographic data will be collected, and control variables will be measured before, during, and after each exercise session.
Statistical analysis: The sample size was calculated a priori using G*Power 3.1.9.7. Sixteen subjects in total were required (8 in each group) considering α=0.05, 1-β=0.8 and effect size (ES)=1.32 for aerobic capacity based on the results of a previous study. Considering the possibility of dropout, 6 subjects were added (total n=22; n=11 in each group). The description will be done as measures of central tendency and dispersion (continuous variables) and as percentages (categorical variables). The Shapiro-Wilk test will be used to verify the normality of the data. A two-way repeated measures analysis of variance (ANOVA) will be used to determine the effects of the interventions. The Bonferroni post hoc test will be applied to identify statistically significant comparisons. All analyses will be performed using SPSS v.25 (SPSS, Inc., Chicago, IL, USA) considering p<0.05
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| culturally relevant cardio dance called Fitfolk | Experimental | Other: Fit-folk cardio dance"Fitfolk" is a new cardiovascular dance discipline that combines fitness exercises with music and dance from Chilean and Latin American folklore. This discipline promotes physical and emotional well-being and celebrates national folklore. |
| conventional physical exercise | Active comparator | Other: Conventional physical exercisephysical exercise program that contains resistance exercise and cardiorespiratory training |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women ≥18 years old,
- Belonging to the Huichacura-Cayuqueo indigenous community.
- Sedentary, according to WHO criteria.
- Diagnosed with malnutrition due to excess (overweight/obesity).
- With controlled chronic diseases (diabetes, hypertension, dyslipidemia).
Key exclusion criteria (1 listed)
- -Those with organic pathologies that make it impossible to engage in physical activity, such as stroke, myocardial infarction, neurological diseases, or uncontrolled chronic diseases, will be excluded.
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 |
|---|---|---|
| Fit-folk cardio dance"Fitfolk" is a new cardiovascular dance discipline that combines fitness exercises with music and dance from Chilean and Latin American folklore. This discipline promotes physical and emotional well-being and celebrates national folklore. | Other | culturally relevant cardio dance called Fitfolk |
| Conventional physical exerciseconventional physical exercise program that uses resistance exercise and cardiorespiratory training | Other | conventional physical exercise |
Primary outcome
Improvement in the physical condition of the participants related to the intervention, according to the ST3x1 step test
Time frame: from the start of treatment until its completion at 12 weeks
Its best measurement is maximum oxygen consumption, which will be measured using the ST3x1 step test. assessed as relative vo2max (mL/kg/min), where higher values indicate improvements in cardiorespiratory fitness.
Improvements in participants' physical strength related to the intervention
Time frame: From the start of treatment to its completion at 12 weeks
Physical strength will be assessed using the 5-times sit-to-stand test and handgrip dynamometry. A decrease in the time spent sitting and standing 5 times and an increase in hand grip in kilograms will indicate an increase in physical strength.
Improvement in participants' long-term glycemic control relative to the intervention, as measured by glycated hemoglobin assay
Time frame: from the start of treatment until its completion at 12 weeks
This variable will be measured by a blood test that measures the average blood glucose level over the last two or three months, the result is presented as a percentage.
4 secondary outcomes
Improvement in participants' quality of life in relation to the intervention, according to the WHOQOL-BREF quality of life questionnaire
Time frame: from the start of treatment until its completion at 12 weeks
Improvement in participants' physical activity compared to the intervention, according to the International Physical Activity Questionnaire (IPAQ).
Time frame: from the start of treatment until its completion at 12 weeks
Improvement in participants' motivation to engage in physical activity relative to the intervention, according to the "BREQ-3" exercise behavior regulation questionnaire.
Time frame: from the start of treatment until its completion at 12 weeks
Improvements in perceived barriers and benefits to physical exercise among participants in relation to the intervention, according to the Exercise Benefits and Barriers Scale (EBBS).
Time frame: from the start of treatment until its completion at 12 weekS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Derived from this study: PubMed 42110294Riquelme-Hernandez C, Reyes-Barria JP, Mancilla CS, Cavero-Redondo I, Vasquez-Carrasco E, Sepulveda P, Sandoval-Vasquez C, Cigarroa I. Study protocol for a randomized controlled trial of a culturally adapted cardiovascular dance intervention in Mapuche women with obesity. Front Public Health. 2026 Apr 23;14:1806558. doi: 10.3389/fpubh.2026.1806558. eCollection 2026.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fit-folk cardio dance and Conventional physical exercise in people with Overweight, Obesity, Noncomunicable Diseases, run by Universidad Catolica Silva Henriquez at 1 site in Chile.
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 5 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 10 Jun 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 Chile. 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?
This study is still under way. Results are not available in the source record yet.
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?
Improvement in the physical condition of the participants related to the intervention, according to the ST3x1 step test (time frame: from the start of treatment until its completion at 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06903455, which also lists 1 linked publication.
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 10 Jun 2025.