Healthy Lifestyle Promotion Program in Communities From the Yaqui Valley

Study Overview
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Brief Summary
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The aim is to evaluate the change in indicators of lifestyle and its effect on cardiometabolic biomarkers as a response to an integrative mother-child intervention to promote healthy lifestyles and prevent food insecurity and child malnutrition in vulnerable communities in the Yaqui Valley, Sonora, Mexico. The intervention consists in a program including nutrition education and physical activity training, with a total duration of 6 months. The proposal addresses the problem in an integrative and non-conventional way, generating new multifactorial knowledge of cardiometabolic and behavioral markers, and their relationship with each other, helping to reduce family food insecurity and improving lifestyle and health, and to support vulnerable families in achieving social justice in the field of nutrition.

Detailed Description
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At present, the development and implementation of interventions in low-income families linking child malnutrition and food insecurity with cardiometabolic diseases, which are fundamental national health problems, is a priority. Educating mothers in this context is a fundamental tool for the prevention and early detection of nutritional diseases, since they are the main caregivers at home, and play a unique role as agents of change and promoters of family well-being. In addition, by training a child in healthy lifestyles, a healthy adult is being developed for the future, who in turn will raise healthy families. The aim of the study is to evaluate the change in indicators of lifestyle, such as diet and physical activity, and its effect on cardiometabolic biomarkers in response to an integrative mother-child intervention to promote healthy lifestyles and to prevent food insecurity and child malnutrition in vulnerable communities in the Yaqui Valley in Sonora, Mexico. The intervention consists in promoting healthy lifestyles for mothers and children in a 6-month program including: food-nutrition education to prevent child malnutrition and cardiometabolic diseases, promotion of planned physical activity, education for child health and cooking workshops. The proposal aims to address the problem in an integrative and non-conventional way, generating new knowledge from the multifactorial field of family, cardiometabolic and behavior, and it will be carried out in vulnerable rural communities. The culture and traditions of the region will be considered in the intervention so that families empower themselves and manage to develop and adopt healthy lifestyles within home, and thereby influencing the well-being and social justice of vulnerable communities. The proposal entails the participation of the mother-child dyad, evaluating the basal risk conditions, and the subsequent change in response to the intervention. This family intervention represents a sustainable community model that incorporates health and combats food insecurity.

Official Title
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Comprehensive Training Program to Promote Healthy Lifestyles and Prevent Food Insecurity and Child Malnutrition in Communities From the Yaqui Valley, Mexico

Conditions
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Cardiovascular Diseases, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: NUTRIGANDO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children: ages 7 to 12 years. Parents: father, mother or guardian, all adults. Residency in Yaqui Valley, Sonora, Mexico. Show interest and time availability to complete all the protocol and measurements. Exclusion Criteria: Children whose parents have not signed the informed consent. Those with cardiometabolic diseases such as diabetes, hypertension, etc. and therefore are subjected to a specific diet or therapeutic treatment. Those with any mental condition or illness, as well as any condition that includes a specific diet, exercise and/or lifestyle treatment/therapy that it would not reflect the common habits. Others: any other condition that physically affects the ability to participate in the program

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Health Promotion and Disease Prevention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutrition-Physical activity Program<br>Participants within the nutrition education and physical activity program | Behavioral: NUTRIGANDO<br>* Program consisting in nutrition education and physical activity training to promote healthy lifestyles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Weight in kg measured by a portable body composition scale | 6 months | 
| Height | Height in cm measured by a portable stadiometer | 6 months | 
| Body fat | Body fat in kg measured by a portable body composition scale | 6 months | 
| Body mass index | Body mass index (BMI) calculated from weight divided by height (in squared meters) | 6 months | 
| Waist circumference | Waist circumference in cm using a Lufkin tape | 6 months | 
| Blood pressure | Systolic and diastolic blood pressure measured with a blood pressure monitor | 6 months | 
| Physical activity | Physical activity will be measured using the International Physical Activity Questionnaire, which measures the time per week spent on vigorous, moderate, light, and sedentary physical activities. | 6 months | 
| Fasting glucose | Measured in serum using a clinical chemistry analyzer | 6 months | 
| Total cholesterol | Measured in serum using a clinical chemistry analyzer | 6 months | 
| Triglycerides | Measured in serum using a clinical chemistry analyzer | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychosocial well-being | Psychosocial well-being in children measured using the Strengths and Difficulties Questionnaire (SDQ) for parents, which asks about positive and negative attributes across next characteristics: Total difficulties (scale from 0 to 40, highest is the worse); Emotional symptoms (scale from 0 to 10, highest is the worse); Conduct problems (scale from 0 to 10, highest is the worse); Hyperactivity/Inattention (scale from 0 to 10, highest is the worse); Peer Relationship Problems (scale from 0 to 10, highest is the worse); and Prosocial Behavior (scale from 0 to 10, lower is the worse). | Baseline | 
| Family interaction | Measured through The McMaster Family Assessment Device (FAD), which is a 60-item questionnaire that measures an individual's perceptions of his/her family. The score is calculated by adding the responses (1-4) for each scale and dividing by the number of items in each scale (6-12). Higher scores indicate worse levels of family functioning. | Baseline | 
| Traditional Mexican Diet Score | Foods within the Traditional Mexican Diet by the score proposed by Valerino-Perea et al. (2021), which consists of a score from a minimum of 0 to a maximum of 21, in which 21 is the best score for the Traditional Mexican Diet | 6 months | 
| Food intake | Food intake measured by duplicated 24 hour recalls | 6 months | 
| Lifestyle | Measured by the Fantastic questionnaire that includes the dimensions: F = Family and friends (2 items); A = Activity and Associativity (3 items); N = Nutrition (3 items); T = Tobacco (2 items); A = Alcohol and other substances (6 items); S = Sleep and stress (3 items); T = Type of personality (3 items); I = Introspection (3 items); and C = Control of health (3 items). The score ranges from 0 to 50, with the highest score being the best (a healthy lifestyle). | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy lifestyle intervention, Cardiovascular Disease Prevention, Mother-Child intervention