- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05945862
Healthy Lifestyle Promotion Program in Communities From the Yaqui Valley (NUTRIGANDO)
March 18, 2026 updated by: ANA MARIA RENTERIA MEXIA, Instituto Tecnologico de Sonora
Comprehensive Training Program to Promote Healthy Lifestyles and Prevent Food Insecurity and Child Malnutrition in Communities From the Yaqui Valley, Mexico
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sonora
-
Ciudad Obregón, Sonora, Mexico, 85000
- Instituto Tecnologico de Sonora
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Nutrition-Physical activity Program
Participants within the nutrition education and physical activity program
|
Program consisting in nutrition education and physical activity training to promote healthy lifestyles
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight
Time Frame: 6 months
|
Weight in kg measured by a portable body composition scale
|
6 months
|
|
Height
Time Frame: 6 months
|
Height in cm measured by a portable stadiometer
|
6 months
|
|
Body fat
Time Frame: 6 months
|
Body fat in kg measured by a portable body composition scale
|
6 months
|
|
Body mass index
Time Frame: 6 months
|
Body mass index (BMI) calculated from weight divided by height (in squared meters)
|
6 months
|
|
Waist circumference
Time Frame: 6 months
|
Waist circumference in cm using a Lufkin tape
|
6 months
|
|
Blood pressure
Time Frame: 6 months
|
Systolic and diastolic blood pressure measured with a blood pressure monitor
|
6 months
|
|
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.
|
6 months
|
|
Fasting glucose
Time Frame: 6 months
|
Measured in serum using a clinical chemistry analyzer
|
6 months
|
|
Total cholesterol
Time Frame: 6 months
|
Measured in serum using a clinical chemistry analyzer
|
6 months
|
|
Triglycerides
Time Frame: 6 months
|
Measured in serum using a clinical chemistry analyzer
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Baseline
|
|
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.
|
Baseline
|
|
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
|
6 months
|
|
Food intake
Time Frame: 6 months
|
Food intake measured by duplicated 24 hour recalls
|
6 months
|
|
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).
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ana Renteria Mexia, PhD, Instituto Tecnologico de Sonora
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Barquera S, White M. Treating Obesity Seriously in Mexico: Realizing, Much Too Late, Action Must Be Immediate. Obesity (Silver Spring). 2018 Oct;26(10):1530-1531. doi: 10.1002/oby.22296. No abstract available.
- Tonnies T, Rathmann W, Hoyer A, Brinks R, Kuss O. Quantifying the underestimation of projected global diabetes prevalence by the International Diabetes Federation (IDF) Diabetes Atlas. BMJ Open Diabetes Res Care. 2021 Aug;9(1):e002122. doi: 10.1136/bmjdrc-2021-002122. No abstract available.
- Valerino-Perea S, Armstrong MEG, Papadaki A. Development of an index to assess adherence to the traditional Mexican diet using a modified Delphi method. Public Health Nutr. 2021 Oct;24(14):4387-4396. doi: 10.1017/S1368980020004565. Epub 2020 Nov 13.
- Swinburn BA, Kraak VI, Allender S, Atkins VJ, Baker PI, Bogard JR, Brinsden H, Calvillo A, De Schutter O, Devarajan R, Ezzati M, Friel S, Goenka S, Hammond RA, Hastings G, Hawkes C, Herrero M, Hovmand PS, Howden M, Jaacks LM, Kapetanaki AB, Kasman M, Kuhnlein HV, Kumanyika SK, Larijani B, Lobstein T, Long MW, Matsudo VKR, Mills SDH, Morgan G, Morshed A, Nece PM, Pan A, Patterson DW, Sacks G, Shekar M, Simmons GL, Smit W, Tootee A, Vandevijvere S, Waterlander WE, Wolfenden L, Dietz WH. The Global Syndemic of Obesity, Undernutrition, and Climate Change: The Lancet Commission report. Lancet. 2019 Feb 23;393(10173):791-846. doi: 10.1016/S0140-6736(18)32822-8. Epub 2019 Jan 27. No abstract available.
- Hernandez-Cordero S, Cuevas-Nasu L, Moran-Ruan MC, Mendez-Gomez Humaran I, Avila-Arcos MA, Rivera-Dommarco JA. Overweight and obesity in Mexican children and adolescents during the last 25 years. Nutr Diabetes. 2017 Mar 13;7(3):e247. doi: 10.1038/nutd.2016.52.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 17, 2023
Primary Completion (Actual)
December 31, 2025
Study Completion (Actual)
December 31, 2025
Study Registration Dates
First Submitted
June 21, 2023
First Submitted That Met QC Criteria
July 6, 2023
First Posted (Actual)
July 14, 2023
Study Record Updates
Last Update Posted (Actual)
March 23, 2026
Last Update Submitted That Met QC Criteria
March 18, 2026
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LNPAS_002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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