Clinical trial NCT06903455: A Culturally Significant Cardiovascular Dance-based Intervention in Obese Women
Official title: Effects of a Culturally Significant Cardiovascular Dance-based Intervention in Obese Women
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Overweight, Obesity, Noncomunicable Diseases
Keywords: overweight, obesity, non-communicable diseases, exercise
Lead sponsor: Universidad Catolica Silva Henriquez
Sponsor class: OTHER
Collaborators: name: Universidad Arturo Prat
First posted: 2025-03-30
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Improvement in the physical condition of the participants related to the intervention, according to the ST3x1 step test
timeFrame: from the start of treatment until its completion at 12 weeks
measure: Improvements in participants' physical strength related to the intervention
timeFrame: From the start of treatment to its completion at 12 weeks
measure: Improvement in participants' long-term glycemic control relative to the intervention, as measured by glycated hemoglobin assay
timeFrame: from the start of treatment until its completion at 12 weeks
Secondary outcomes:
measure: Improvement in participants' quality of life in relation to the intervention, according to the WHOQOL-BREF quality of life questionnaire
timeFrame: from the start of treatment until its completion at 12 weeks
measure: Improvement in participants' physical activity compared to the intervention, according to the International Physical Activity Questionnaire (IPAQ).
timeFrame: from the start of treatment until its completion at 12 weeks
measure: Improvement in participants' motivation to engage in physical activity relative to the intervention, according to the "BREQ-3" exercise behavior regulation questionnaire.
timeFrame: from the start of treatment until its completion at 12 weeks
measure: 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).
timeFrame: from the start of treatment until its completion at 12 weekS
Other outcomes:
Locations:
city: Padre Las Casas
country: Chile
facility: Comunidad indigena Huichacura Cayuqueo
state: Región de la Araucanía
Study officials:
References: