Clinical trial NCT05945862: Healthy Lifestyle Promotion Program in Communities From the Yaqui Valley
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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Diabetes Mellitus, Type 2
Keywords: Healthy lifestyle intervention
Cardiovascular Disease Prevention
Mother-Child intervention
Lead sponsor: Instituto Tecnologico de Sonora
Sponsor class: OTHER
Collaborators: name: National Council of Science and Technology, Mexico
First posted: 2023-07-14
Enrollment: 50
Sex: ALL
Minimum age (years): 7
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Health Promotion and Disease Prevention
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Weight
timeFrame: 6 months
measure: Height
timeFrame: 6 months
measure: Body fat
timeFrame: 6 months
measure: Body mass index
timeFrame: 6 months
measure: Waist circumference
timeFrame: 6 months
measure: Blood pressure
timeFrame: 6 months
measure: Physical activity
timeFrame: 6 months
measure: Fasting glucose
timeFrame: 6 months
measure: Total cholesterol
timeFrame: 6 months
measure: Triglycerides
timeFrame: 6 months
Secondary outcomes:
measure: Psychosocial well-being
timeFrame: Baseline
measure: Family interaction
timeFrame: Baseline
measure: Traditional Mexican Diet Score
timeFrame: 6 months
measure: Food intake
timeFrame: 6 months
measure: Lifestyle
timeFrame: 6 months
Other outcomes:
Locations:
city: Cd. Obregon
country: Mexico
facility: Instituto Tecnologico de Sonora
state: Sonora
Study officials:
affiliation: Instituto Tecnologico de Sonora
name: Ana Renteria Mexia, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.