A Culturally Significant Cardiovascular Dance-based Intervention in Obese Women

NCT ID: NCT06903455

Last Updated: 2025-06-10

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-16
• Study Completion Date: 2025-06-15

Brief 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. 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.

a. 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),

a. Quality of life: with the quality of life questionnaire (SF-36).

a. 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

Conditions

Overweight, Obesity, Noncomunicable Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

culturally relevant cardio dance called Fitfolk

"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.

Group Type: EXPERIMENTAL

Fit-folk cardio dance

Intervention Type: OTHER

"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

physical exercise program that contains resistance exercise and cardiorespiratory training

Group Type: ACTIVE_COMPARATOR

Conventional physical exercise

Intervention Type: OTHER

conventional physical exercise program that uses resistance exercise and cardiorespiratory training

Interventions

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.

Intervention Type: OTHER

Conventional physical exercise

conventional physical exercise program that uses resistance exercise and cardiorespiratory training

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

-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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universidad Arturo Prat

OTHER

Sponsor Role: collaborator

Universidad Catolica Silva Henriquez

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Comunidad indigena Huichacura Cayuqueo

Padre Las Casas, Región de la Araucanía, Chile

Countries

Chile

Other Identifiers

n°2400120062

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

FONDEPORTE; n°2400120062

Identifier Type: -

Identifier Source: org_study_id