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Healthy Lifestyle Promotion Program in Communities From the Yaqui Valley (NUTRIGANDO)

Primary Purpose

Cardiovascular Diseases, Diabetes Mellitus, Type 2

Status
Not yet recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
NUTRIGANDO
Sponsored by
Instituto Tecnologico de Sonora
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases focused on measuring Healthy lifestyle intervention, Cardiovascular Disease Prevention, Mother-Child intervention

Eligibility Criteria

7 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Instituto Tecnologico de Sonora

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nutrition-Physical activity Program

Arm Description

Participants within the nutrition education and physical activity program

Outcomes

Primary Outcome Measures

Weight
Weight in kg measured by a portable body composition scale
Height
Height in cm measured by a portable stadiometer
Body fat
Body fat in kg measured by a portable body composition scale
Body mass index
Body mass index (BMI) calculated from weight divided by height (in squared meters)
Waist circumference
Waist circumference in cm using a Lufkin tape
Blood pressure
Systolic and diastolic blood pressure measured with a blood pressure monitor
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.
Fasting glucose
Measured in serum using a clinical chemistry analyzer
Total cholesterol
Measured in serum using a clinical chemistry analyzer
Triglycerides
Measured in serum using a clinical chemistry analyzer

Secondary Outcome Measures

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).
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.
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
Food intake
Food intake measured by duplicated 24 hour recalls
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).

Full Information

First Posted
June 21, 2023
Last Updated
July 6, 2023
Sponsor
Instituto Tecnologico de Sonora
Collaborators
National Council of Science and Technology, Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT05945862
Brief Title
Healthy Lifestyle Promotion Program in Communities From the Yaqui Valley
Acronym
NUTRIGANDO
Official Title
Comprehensive Training Program to Promote Healthy Lifestyles and Prevent Food Insecurity and Child Malnutrition in Communities From the Yaqui Valley, Mexico
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 17, 2023 (Anticipated)
Primary Completion Date
August 11, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Tecnologico de Sonora
Collaborators
National Council of Science and Technology, Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Diabetes Mellitus, Type 2
Keywords
Healthy lifestyle intervention, Cardiovascular Disease Prevention, Mother-Child intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Health Promotion and Disease Prevention
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nutrition-Physical activity Program
Arm Type
Experimental
Arm Description
Participants within the nutrition education and physical activity program
Intervention Type
Behavioral
Intervention Name(s)
NUTRIGANDO
Intervention Description
Program consisting in nutrition education and physical activity training to promote healthy lifestyles
Primary Outcome Measure Information:
Title
Weight
Description
Weight in kg measured by a portable body composition scale
Time Frame
6 months
Title
Height
Description
Height in cm measured by a portable stadiometer
Time Frame
6 months
Title
Body fat
Description
Body fat in kg measured by a portable body composition scale
Time Frame
6 months
Title
Body mass index
Description
Body mass index (BMI) calculated from weight divided by height (in squared meters)
Time Frame
6 months
Title
Waist circumference
Description
Waist circumference in cm using a Lufkin tape
Time Frame
6 months
Title
Blood pressure
Description
Systolic and diastolic blood pressure measured with a blood pressure monitor
Time Frame
6 months
Title
Physical activity
Description
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.
Time Frame
6 months
Title
Fasting glucose
Description
Measured in serum using a clinical chemistry analyzer
Time Frame
6 months
Title
Total cholesterol
Description
Measured in serum using a clinical chemistry analyzer
Time Frame
6 months
Title
Triglycerides
Description
Measured in serum using a clinical chemistry analyzer
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Psychosocial well-being
Description
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).
Time Frame
Baseline
Title
Family interaction
Description
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.
Time Frame
Baseline
Title
Traditional Mexican Diet Score
Description
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
Time Frame
6 months
Title
Food intake
Description
Food intake measured by duplicated 24 hour recalls
Time Frame
6 months
Title
Lifestyle
Description
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).
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ana Renteria Mexia, PhD
Phone
+526444109000
Ext
1693
Email
ana.renteria@itson.edu.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Renteria Mexia, PhD
Organizational Affiliation
Instituto Tecnologico de Sonora
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Tecnologico de Sonora
City
Cd. Obregon
State/Province
Sonora
ZIP/Postal Code
85000
Country
Mexico
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Renteria Mexia, PhD
Phone
+526444109000
Ext
1693
Email
ana.renteria@itson.edu.mx
First Name & Middle Initial & Last Name & Degree
Ana A Escarcega Galaz, Dr
First Name & Middle Initial & Last Name & Degree
Gabriela Ulloa Mercado, Dr
First Name & Middle Initial & Last Name & Degree
Pablo Gortares Moroyoqui, PhD
First Name & Middle Initial & Last Name & Degree
Lourdes M Diaz Tenorio, Dr
First Name & Middle Initial & Last Name & Degree
Julian Esparza Romero, PhD
First Name & Middle Initial & Last Name & Degree
Ivan J Toledo Dominguez, Dr
First Name & Middle Initial & Last Name & Degree
Hebert D Quintero Portillo, MSc
First Name & Middle Initial & Last Name & Degree
Fernando Rivera Acuña, Dr
First Name & Middle Initial & Last Name & Degree
Juan F Hernandez Chavez
First Name & Middle Initial & Last Name & Degree
Mayra Arias Gastelum, Dr
First Name & Middle Initial & Last Name & Degree
Cecilia I Bojorquez Diaz, Dr
First Name & Middle Initial & Last Name & Degree
Araceli Serna Gutierrez, Dr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28287630
Citation
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. Erratum In: Nutr Diabetes. 2017 Jun 5;7(6):e280.
Results Reference
background
PubMed Identifier
30277025
Citation
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.
Results Reference
background
PubMed Identifier
34400463
Citation
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.
Results Reference
background
PubMed Identifier
30700377
Citation
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. Erratum In: Lancet. 2019 Feb 23;393(10173):746.
Results Reference
background
PubMed Identifier
33183382
Citation
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.
Results Reference
background

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Healthy Lifestyle Promotion Program in Communities From the Yaqui Valley

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