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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Change from Baseline LDL Cholesterol Levels at week 8 and 15
研究概览
简要总结
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.
详细描述
- Introduction:
The change from the traditional Mexican diet to a Western diet, generated by the nutritional transition, has not only generated a prevalence of more than 75% of metabolic alterations (obesity, type 2 diabetes, cardiovascular diseases, dyslipidemia) and in the gut microbiota of the Mexican population, but it has also generated the water and carbon footprint of their diet to be the highest in the world with more than 8,000 Liters per person per day (L p-1d-1) and 6.01 Kg CO2eq p-1d-1, respectively. This is linked to the aggravation of climate change, with increases of more than 1.0 ºC in the average atmospheric temperatures and the current water crisis that Mexico is going through, which affects 85% of the territory and has been referred to as the worst water drought in history, affecting the water supply of millions of Mexicans.
One of the proposals for the joint solution of these problems has been the adoption of sustainable and territorial diets, which in Mexico could be carried out through the recovery of its traditional diet, both pre-Hispanic and colonized, which, prepared with low-fat culinary techniques and low content of animal products, can be considered as an appropriate option from a nutritional, cultural, economic and environmental perspective, dimensions that must be present for a diet to be considered as sustainable.
However, to achieve the adoption of a particular diet, it is necessary to modify the eating behavior of the population. To modify both dietary and unsustainable behaviors in a population, there are multiple strategies, among which intervention programs have stood out. However, to date and both nationally and internationally, no intervention program whose objective is to promote both adequate nutrition to improve health and reduce the environmental impact of dietary behaviors, has been reported. This respecting cultural, social, economic, and psychological aspects of the population.
Based on the above, this study protocol aims to design a three-stage 15 weeks intervention program, based on the guide to designing interventions of the behavior change wheel model, which includes both nutritional and sustainability elements, in the sense of considering unsustainable dietary behaviors of the Mexican population, in addition to taking into account their social, cultural and economic aspects. In addition to these axes, the basis of behavioral modification intervention programs is psychology. Therefore, it is proposed to design a sustainable-psycho-nutritional intervention program, whose objective is to promote the adherence of the population to sustainable diets. But, in addition, it is proposed to evaluate its effects on environmental indicators, metabolic biomarkers, and gut microbiota, as well as clinical aspects and body composition in a Mexican population sample. Because of the effectiveness of technologies use in nutritional and environmental interventions, the intervention program will be a digital one, for which a mobile application is being designed to evaluate and monitor the intervened population. Therefore, this will be a m-Health intervention program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change from Baseline LDL Cholesterol Levels at week 8 and 15
时间窗: Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15)
Determination of LDL Cholesterol Levels by colorimetric enzymatic methods
Change from Baseline Gut Microbiota at week 8 and 15
时间窗: Baseline (week 0), monitoring measure (week 8) and end of intervention (week 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
Change from Baseline Systolic and Diastolic Blood Presure at week 8 and 15
时间窗: Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15)
Blood pressure will be evaluated with a sphygmomanometer and following the Mexican normativity
Change from Baseline Dietary Water Footprint at week 8 and 15
时间窗: Baseline (week 0), monitoring measure (week 8) and end of intervention (week 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
Change from Baseline Nutritional-sustainable knowledge at week 8 and 15
时间窗: Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15)
Will be evaluated through a designed questionnaire, based on the psychological capacity presented in the COM-B model
Change from Baseline Glucose Levels at week 8 and 15
时间窗: Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15)
Determination of glucose levels by colorimetric enzymatic methods
Change from Baseline HDL Cholesterol Levels at week 8 and 15
时间窗: Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15)
Determination of HDL Cholesterol Levels by colorimetric enzymatic methods
Change from Baseline Total Cholesterol Levels at week 8 and 15
时间窗: Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15)
Determination of Total Cholesterol Levels by colorimetric enzymatic methods
Change from Baseline Triglycerides Levels at week 8 and 15
时间窗: Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15)
Determination of Triglycerides Levels by colorimetric enzymatic methods
Change from Baseline Body Fat Percentage at week 8 and 15
时间窗: Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15)
The percentage of body fat will be evaluated with an Omron® bioimpedance scale (HBF-511T-E/HBF-511B-E), following validated techniques
Change from Baseline Acanthosis Nigricans at week 8 and 15
时间窗: Baseline (week 0), monitoring measure (week 8) and end of intervention (week 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
Change from Baseline weight at week 8 and 15
时间窗: Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15)
The weight will be evaluated with an Omron® bioimpedance scale (HBF-511T-E/HBF-511B-E), following validated techniques
Change from Baseline Food Intake at week 8 and 15
时间窗: Baseline (week 0), monitoring measure (week 8) and end of intervention (week 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).
Change from Baseline Diet Quality at week 8 and 15
时间窗: Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15)
Diet quality will be analyzed by an adapted version of the Mexican Diet Quality Index (ICDMx).
Change from Baseline Physical Activity at week 8 and 15
时间窗: Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15)
The IPAQ questionnaire will be used, and the type, frequency, intensity, and duration will be evaluated
Change from Baseline Dietary Carbon Footprint at week 8 and 15
时间窗: Baseline (week 0), monitoring measure (week 8) and end of intervention (week 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
次要结局
- 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 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 Eating behavior 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 Waist Circumference at week 8 and 15(Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15))
- Food allergies and intolerances(Baseline (week 0))
- Change from Baseline Hips Circumference at week 8 and 15(Baseline (week 0), monitoring measure (week 8) and end of intervention (week 15))
- Height evaluation(Baseline (week 0))
- Psychological aspects (COM-B model aspects)(Baseline (week 0))
研究者
Fatima Ezzahra Housni
Principal Investigator
University of Guadalajara