Sustainable-psycho-nutritional Intervention Program and Its Effects on Health Outcomes and the Environment

NCT05457439 | Unknown

• 1 other identifier: CIP/T/04/22
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gut Microbiota; Hyperglycemia; Hypercholesterolemia; HDLC; Hypertriglyceridemia; Eating Behavior; Body Composition; Acanthosis Nigricans; Blood Pressure; Food Intake; Physical Activity; Diet Quality

Keywords

Sustainable Diets; Behavior Change; Gut Microbiota; Environmental Impact of Diets; Nutritional and Environmental Education; Mexican Population; Water Footprint; Carbon Footprint; Eating Behavior; m-Health

Outcome Measures

Primary Outcomes (16)

• Change from Baseline Gut Microbiota at week 8 and 15

  Identification of Firmicutes, Bacteroidetes, Lactobacillus, Bifidobacterium, Faecalibacterium prausnitzii, Akkermansia muciniphila, Prevotella copri, Bilophila wadsworthia, Clostridium coccoides, and Streptococcus thermophilus relative abundance by qPCR with specific primers

  Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15)

• Change from Baseline Glucose Levels at week 8 and 15

  Determination of glucose levels by colorimetric enzymatic methods

  Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15)

• Change from Baseline LDL Cholesterol Levels at week 8 and 15

  Determination of LDL Cholesterol Levels by colorimetric enzymatic methods

  Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15)

• Change from Baseline HDL Cholesterol Levels at week 8 and 15

  Determination of HDL Cholesterol Levels by colorimetric enzymatic methods

  Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15)

• Change from Baseline Total Cholesterol Levels at week 8 and 15

  Determination of Total Cholesterol Levels by colorimetric enzymatic methods

  Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15)

• Change from Baseline Triglycerides Levels at week 8 and 15

  Determination of Triglycerides Levels by colorimetric enzymatic methods

  Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15)

• Change from Baseline Systolic and Diastolic Blood Presure at week 8 and 15

  Blood pressure will be evaluated with a sphygmomanometer and following the Mexican normativity

  Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15)

• Change from Baseline Acanthosis Nigricans at week 8 and 15

  Clinical signs of insulin resistance (acanthosis nigricans) will be evaluated by physical exploration, searching for hyperpigmentation and thickening of the skin with velvety, in visible flex areas

  Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15)

• Change from Baseline weight at week 8 and 15

  The weight will be evaluated with an Omron® bioimpedance scale (HBF-511T-E/HBF-511B-E), following validated techniques

  Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15)

• Change from Baseline Body Fat Percentage at week 8 and 15

  The percentage of body fat will be evaluated with an Omron® bioimpedance scale (HBF-511T-E/HBF-511B-E), following validated techniques

  Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15)

• Change from Baseline Food Intake at week 8 and 15

  Caloric-nutritional and food intake will be assessed through average data taken from 24-hour recalls, dietary records, and by a validated adapted Food Frequency Questionnaire (CFCA).

  Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15)

• Change from Baseline Diet Quality at week 8 and 15

  Diet quality will be analyzed by an adapted version of the Mexican Diet Quality Index (ICDMx).

  Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15)

• Change from Baseline Physical Activity at week 8 and 15

  The IPAQ questionnaire will be used, and the type, frequency, intensity, and duration will be evaluated

  Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15)

• Change from Baseline Dietary Water Footprint at week 8 and 15

  Dietary water footprint (total, green, blue, and grey) will be calculated using the Water Footprint Assessment method in its version for Mexico's context

  Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15)

• Change from Baseline Dietary Carbon Footprint at week 8 and 15

  Dietary carbon footprint is also going to be calculated using the Life Cycle Assessment method considering food production and processing greenhouse gas emissions as food system boundaries

  Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15)

• Change from Baseline Nutritional-sustainable knowledge at week 8 and 15

  Will be evaluated through a designed questionnaire, based on the psychological capacity presented in the COM-B model

  Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15)

Secondary Outcomes (10)

• Change from Signs of nutrient deficiencies or excess at week 8 and 15

  Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15)

• Change from Baseline Muscle Mass at week 8 and 15

  Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15)

• Change from Baseline Visceral Fat at week 8 and 15

  Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15)

• Change from Baseline Body Mass Index (BMI) at week 8 and 15

  Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15)

• Change from Baseline Waist Circumference at week 8 and 15

  Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15)

Study Arms (2)

Experimental Group

EXPERIMENTAL

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).

Behavioral: Sustainable diet promotion through behavioral change intervention

Control Group

NO INTERVENTION

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.

Interventions

Sustainable diet promotion through behavioral change intervention BEHAVIORAL

15 weeks digital intervention to promote sustainable diets through workshops, and behavioral change techniques in a mobile application, to decrease environmental impact of diets and improve health.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Being between 18 and 35 years old
• Being Mexican
• Reside in the South of Jalisco for at least 1 year
• 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

You may not qualify if:

• Not signing the informed consent
• Not accepting to donate blood and/or stool samples
• Not being able to stand up to take anthropometric data
• Consume adequate levels of the foods to be promoted in the intervention program
• Being pregnant or lactating
• Suffer from a chronic disease such as type 2 diabetes mellitus, arterial hypertension, dyslipidemia, under medication
• Suffering from an autoimmune disease such as type 1 diabetes, hypo or hyperthyroidism
• Having a gastrointestinal disease such as Crohn's disease, ulcerative colitis, etc.
• Having used antibiotics less than 3 months ago
• Taking antidepressant medications or corticosteroids
• Consume probiotics or nutritional supplements, except protein powder

Sponsors & Collaborators

• University of Guadalajara: lead
• Universidad de Granada: collaborator
• Tecnológico Nacional de México, campus Ciudad Guzmán: collaborator

Study Sites (1)

Instituto de Investigaciones en Comportamiento Alimentario y Nutrición (IICAN), University of Guadalajara

Ciudad Guzmán, Jalisco, 49000, Mexico

Location

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MeSH Terms

Conditions

Hyperglycemia; Hypercholesterolemia; Hypertriglyceridemia; Feeding Behavior; Acanthosis Nigricans; Motor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Behavior, Animal; Behavior; Melanosis; Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Fatima E Housni, PhD

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: July 14, 2022
• Study Start: October 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)