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Cardiovascular DiseasesNUTRIGANDONCT05945862

Healthy Lifestyle Promotion Program in Communities From the Yaqui Valley

A study testing NUTRIGANDO in people with Cardiovascular Diseases and Diabetes Mellitus, Type 2, run by Instituto Tecnologico de Sonora at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 7 to 60 yearsHealthy volunteers can take part
What is being tested?
NUTRIGANDO
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteMexico
Study dates
17 Jul 2023to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Instituto Tecnologico de Sonora

    Ciudad Obregón, Sonora, 85000

Other trials in Mexico

About this study

Official title: 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.

Read the 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.

Being tested
NUTRIGANDO
Keywords
Healthy lifestyle intervention, Cardiovascular Disease Prevention, Mother-Child intervention
Medical subject headings
Cardiovascular Diseases, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NUTRIGANDOBehavioural

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

Study groups in NCT05945862
Study groupRoleWhat they receive
Nutrition-Physical activity ProgramExperimentalParticipants within the nutrition education and physical activity program
Receives: Behavioral: NUTRIGANDO

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight

    Weight in kg measured by a portable body composition scale

    Measured: 6 months

  2. Height

    Height in cm measured by a portable stadiometer

    Measured: 6 months

  3. Body fat

    Body fat in kg measured by a portable body composition scale

    Measured: 6 months

  4. Body mass index

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

    Measured: 6 months

  5. Waist circumference

    Waist circumference in cm using a Lufkin tape

    Measured: 6 months

  6. Blood pressure

    Systolic and diastolic blood pressure measured with a blood pressure monitor

    Measured: 6 months

  7. 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.

    Measured: 6 months

  8. Fasting glucose

    Measured in serum using a clinical chemistry analyzer

    Measured: 6 months

  9. Total cholesterol

    Measured in serum using a clinical chemistry analyzer

    Measured: 6 months

  10. Triglycerides

    Measured in serum using a clinical chemistry analyzer

    Measured: 6 months

Secondary outcomes (5)

  1. 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).

    Measured: Baseline

  2. 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.

    Measured: Baseline

  3. 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

    Measured: 6 months

  4. Food intake

    Food intake measured by duplicated 24 hour recalls

    Measured: 6 months

  5. 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).

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2023
  2. Study start17 Jul 2023
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Health Promotion and Disease Prevention
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05945862
Sponsor's protocol ID
LNPAS_002
Acronym
NUTRIGANDO
Status last verified
Jul 2023
First submitted
21 Jun 2023
Last updated
23 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28287630

  • 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.

    PubMed 30277025

  • 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.

    PubMed 34400463

  • 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.

    PubMed 30700377

  • 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.

    PubMed 33183382

  • Escarcega-Galaz AA, Enriquez-Rabago E, Garcia-Moreno M, Leyva-Encinas S, Robles-Aguilar C, Arias-Gastelum M, Ulloa-Mercado G, Gortares-Moroyoqui P, Maldonado-Ulloa G, Hernandez-Chavez JF, Renteria-Mexia A. Comprehensive Intervention to Promote Healthy Lifestyles and Prevent Cardiometabolic Diseases in Low-Income School Children From Mexico: Protocol for the ESCOLARISANO Randomized Controlled Trial. JMIR Res Protoc. 2026 May 6;15:e82721. doi: 10.2196/82721.

    PubMed 42090578

Questions about this trial

What is this clinical trial studying?

A study testing NUTRIGANDO in people with Cardiovascular Diseases and Diabetes Mellitus, Type 2, run by Instituto Tecnologico de Sonora at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight (time frame: 6 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05945862, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.

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