Healthy Lifestyle Promotion Program in Communities From the Yaqui Valley

Diabetes Mellitus, Type 2 Clinical Trial

— NUTRIGANDO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05945862
• Other study ID #: LNPAS_002
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 17, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: Instituto Tecnologico de Sonora
• Contact: Ana Renteria Mexia, PhD
• Phone: +526444109000
• Email: ana.renteria[@]itson.edu.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 31, 2023
• Est. primary completion date: August 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• NUTRIGANDO
Program consisting in nutrition education and physical activity training to promote healthy lifestyles

Locations

Country	Name	City	State
Mexico	Instituto Tecnologico de Sonora	Cd. Obregon	Sonora

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Tecnologico de Sonora	National Council of Science and Technology, Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	Weight in kg measured by a portable body composition scale	6 months
Primary	Height	Height in cm measured by a portable stadiometer	6 months
Primary	Body fat	Body fat in kg measured by a portable body composition scale	6 months
Primary	Body mass index	Body mass index (BMI) calculated from weight divided by height (in squared meters)	6 months
Primary	Waist circumference	Waist circumference in cm using a Lufkin tape	6 months
Primary	Blood pressure	Systolic and diastolic blood pressure measured with a blood pressure monitor	6 months
Primary	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
Primary	Fasting glucose	Measured in serum using a clinical chemistry analyzer	6 months
Primary	Total cholesterol	Measured in serum using a clinical chemistry analyzer	6 months
Primary	Triglycerides	Measured in serum using a clinical chemistry analyzer	6 months
Secondary	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).	Baseline
Secondary	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.	Baseline
Secondary	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	6 months
Secondary	Food intake	Food intake measured by duplicated 24 hour recalls	6 months
Secondary	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).	6 months