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Completed

NCT Number: NCT05945862

Healthy Lifestyle Promotion Program in Communities From the Yaqui Valley

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.

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Key information

Age range

7 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Tecnologico de Sonora

Ciudad Obregón, Sonora, 85000, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NUTRIGANDO

Behavioral

Program consisting in nutrition education and physical activity training to promote healthy lifestyles

Primary outcomes

  1. Weight

    Time frame: 6 months

    Weight in kg measured by a portable body composition scale

  2. Height

    Time frame: 6 months

    Height in cm measured by a portable stadiometer

  3. Body fat

    Time frame: 6 months

    Body fat in kg measured by a portable body composition scale

  4. Body mass index

    Time frame: 6 months

    Body mass index (BMI) calculated from weight divided by height (in squared meters)

  5. Waist circumference

    Time frame: 6 months

    Waist circumference in cm using a Lufkin tape

  6. Blood pressure

    Time frame: 6 months

    Systolic and diastolic blood pressure measured with a blood pressure monitor

  7. Physical activity

    Time frame: 6 months

    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.

  8. Fasting glucose

    Time frame: 6 months

    Measured in serum using a clinical chemistry analyzer

  9. Total cholesterol

    Time frame: 6 months

    Measured in serum using a clinical chemistry analyzer

  10. Triglycerides

    Time frame: 6 months

    Measured in serum using a clinical chemistry analyzer

Secondary outcomes

  1. Psychosocial well-being

    Time frame: Baseline

    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).

  2. Family interaction

    Time frame: Baseline

    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.

  3. Traditional Mexican Diet Score

    Time frame: 6 months

    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

  4. Food intake

    Time frame: 6 months

    Food intake measured by duplicated 24 hour recalls

  5. Lifestyle

    Time frame: 6 months

    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).

Sponsors and collaborators

Lead sponsor

Instituto Tecnologico de Sonora

Other

Collaborators

  • National Council of Science and Technology, Mexico

Registry information

Official study title

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

Acronym: NUTRIGANDO

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 14, 2023
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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