Physical Activity Clinical Trial
Official title:
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
Verified date | November 2023 |
Source | University of Guadalajara |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 112 |
Est. completion date | December 2023 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Not signing the informed consent - Not accepting to donate blood and/or stool samples - Not being able to stand up to take anthropometric data - Perform levels of physical activity above the minimum established as criteria for inclusion in the study - 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 |
Country | Name | City | State |
---|---|---|---|
Mexico | Instituto de Investigaciones en Comportamiento Alimentario y Nutrición (IICAN), University of Guadalajara | Ciudad Guzmán | Jalisco |
Lead Sponsor | Collaborator |
---|---|
University of Guadalajara | Tecnológico Nacional de México, campus Ciudad Guzmán, Universidad de Granada |
Mexico,
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* Note: There are 66 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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 | Change from Signs of nutrient deficiencies or excess at week 8 and 15 | Signs of nutrient deficiencies or excess will also be evaluated in relation to hair, nails, mouth, tongue, edema, and mucous membranes appearance | Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15) | |
Secondary | Change from Baseline Muscle Mass at week 8 and 15 | The muscle mass 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) | |
Secondary | Change from Baseline Visceral Fat at week 8 and 15 | The visceral 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) | |
Secondary | Change from Baseline Body Mass Index (BMI) at week 8 and 15 | The BMI will be calculated considering weight/height2 | Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15) | |
Secondary | Change from Baseline Waist Circumference at week 8 and 15 | The waist circumference will be evaluated using a Lufkin® metal tape measure, following validated techniques | Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15) | |
Secondary | Change from Baseline Hips Circumference at week 8 and 15 | The hips circumference will be evaluated using a Lufkin® metal tape measure, following validated techniques | Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15) | |
Secondary | Height evaluation | The height will be evaluated with a Smartmet® stadiometer, following validated techniques | Baseline (week 0) | |
Secondary | Change from Baseline Eating behavior at week 8 and 15 | Eating behavior will be assessed through questions about food preparation, food shopping places, food preferences, and about following specific diets at the moment of the evaluation. Those aspects will be evaluated through a designed questionnaire. | Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15) | |
Secondary | Psychological aspects (COM-B model aspects) | Psychological aspects such as motivation, capability, and opportunity will be assessed through a questionnaire. | Baseline (week 0) | |
Secondary | Food allergies and intolerances | Will be assessed through a designed questionnaire. | Baseline (week 0) |
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