Sustainable-psycho-nutritional Intervention Program and Its Effects on Water and Carbon Footprint, Metabolic Biomarkers, and Gut Microbiota in Mexican Population: a m-Health Randomized Clinical Trial

Status: Unknown
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Mexico is going through a major environmental and nutritional crisis, which is related to unsustainable dietary behaviors. Sustainable diets could solve both problems together. However, in Mexico and the world, an intervention program oriented to promoting sustainable diets has not been designed. This study protocol aims to design a 3-stages, 15 weeks, sustainable-psycho-nutritional digital intervention program whose objective is to promote the adherence of the Mexican population to a sustainable diet and to evaluate its effects on dietary water and carbon footprints, metabolic biomarkers, and gut microbiota of this population. The behavior change wheel model and the guide for digital interventions design will be followed. In stage 1, the program will be designed using the sustainable diets model, and the behavior change wheel model. A sustainable food guide, sustainable recipes, and food plans as well as a mobile application will be developed. In stage 2, the intervention will be carried out for 7 weeks, and a follow-up period of 7 weeks, in a sample of Mexican young adults (18 to 35 years) randomly divided into an experimental group (n=50) and a control group (n=50). The nutritional care process model will be used. Anthropometric, biochemical, clinical, dietary, environmental, socioeconomic level and cultural aspects, nutritional-sustainable knowledge, behavioral aspects, and physical activity will be considered. Thirteen behavioral objectives will be included using successive approaches in online workshops twice a week. The population will be monitored using the mobile application that will include behavioral change techniques. In stage 3, the effects of the intervention will be assessed on the dietary water and carbon footprint, lipid profile, serum glucose, and gut microbiota composition of the evaluated population. It is expected to find improvements in health outcomes and a decrease in dietary water and carbon footprints. With this study, the first theoretical-methodological approach to the sustainable-psycho-nutrition approach will be generated.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 35
Healthy Volunteers: t
View:

• Being between 18 and 35 years old

• Being Mexican

• Reside in the South of Jalisco for at least 1 year

• Levels of physical activity below what is recommended and what is established as a criterion for inclusion in the study

• Consuming amounts of food below or above that established as criteria for inclusion in the study or in a lesser or greater frequency than recommended, according to the type of food

• Have a Smartphone

• Not having consumed antibiotics at least 3 months before the intervention

• Have a BMI between 18.5 and 40

• Not having a medical diagnosis of chronic disease under pharmacological treatment

• Not having a medical diagnosis of gastrointestinal disease

Locations
Other Locations
Mexico
Instituto de Investigaciones en Comportamiento Alimentario y Nutrición (IICAN), University of Guadalajara
Ciudad Guzmán
Time Frame
Start Date: 2022-10-01
Completion Date: 2023-12
Participants
Target number of participants: 112
Treatments
Experimental: Experimental Group
Will be evaluated at baseline and will be intervened for 7 weeks, receiving educational workshops twice a week, addressing the target behaviors. They will also be prescribed a personalized food plan, will receive daily messages through the mobile application, and will have a doubt resolution chat. They will have a digital forum to post photos and comments about their food intake, and physical activity performance, and to like and comment on other participants' photos. They will be asked to enter food records and photos of their food intake into the mobile application, for which they will receive points for performing the expected behavior in a token economy. They will have access to their data for auto-monitoring. In week 8, the experimental group will be evaluated and divided into two sub-groups. One will be completely stopped intervening (n = 25) and one will continue receiving messages through the mobile app, but will no longer have workshops and food plan prescriptions (n = 25).
No_intervention: Control Group
The control group will be evaluated at baseline and will not be intervened. Anyway, they will be evaluated at weeks 8 (as monitoring) and 15, at the end of the intervention.
Sponsors
Collaborators: Tecnológico Nacional de México, campus Ciudad Guzmán, Universidad de Granada
Leads: University of Guadalajara

This content was sourced from clinicaltrials.gov