Healthy Lifestyle Promotion Program in Communities From the Yaqui Valley

NCT05945862 | Completed

• 1 other identifier: LNPAS_002
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cardiovascular Diseases; Diabetes Mellitus, Type 2

Keywords

Healthy lifestyle intervention; Cardiovascular Disease Prevention; Mother-Child intervention

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (5)

• Psychosocial well-being

  Baseline

• Family interaction

  Baseline

• Traditional Mexican Diet Score

  6 months

• Food intake

  6 months

• Lifestyle

  6 months

Study Arms (1)

Nutrition-Physical activity Program

EXPERIMENTAL

Participants within the nutrition education and physical activity program

Behavioral: NUTRIGANDO

Interventions

NUTRIGANDO BEHAVIORAL

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

Nutrition-Physical activity Program

Eligibility Criteria

• Age: 7 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Council of Science and Technology, Mexico: collaborator
• Instituto Tecnologico de Sonora: lead

Study Sites (1)

Instituto Tecnologico de Sonora

Ciudad Obregón, Sonora, 85000, Mexico

Location

Related Publications (5)

• 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.

  PMID: 28287630 BACKGROUND

• 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.

  PMID: 30277025 BACKGROUND

• 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.

  PMID: 34400463 BACKGROUND

• 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.

  PMID: 30700377 BACKGROUND

• 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.

  PMID: 33183382 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ana Renteria Mexia, PhD

  Instituto Tecnologico de Sonora

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Health Promotion and Disease Prevention

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: July 14, 2023
• Study Start: July 17, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 23, 2026

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)