Clinical trial NCT04204538: Dietary Practices and Metabolic Syndrome in the Young Adult Population of Rwanda
Official title: Evaluation of Dietary Practices and Assessment of Nutritional Status and Associated Risk Factors for Metabolic Syndrome in the Young Adult Population of Rwanda
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Syndrome
Nutritional Status
Diet Habit
Keywords: Food Frequency Questionnaire
Dietary patterns
Risk factors
metabolic syndrome
Nutritional transition
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: University of Rwanda
name: Institut de Recherche en Sciences de la Sante, Burkina Faso
First posted: 2019-12-19
Enrollment: 1247
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be selected randomly from the general population. Eligible subjects who agree to participate (informed consent) will be enrolled in the study.

Brief summary: Policy makers in Rwanda have recently highlighted the importance of promoting healthy diets and lifestyle in response to rapidly increasing rates of obesity. This project will provide evidence on shifts in diet and nutritional status in urban dwellers as compared to the traditional diet and lifestyle in rural areas as a basis for a targeted public health policy for Rwanda.

Detailed description: Adequate diet has been known for many years to be a major lever to significantly decrease the risk for non-communicable diseases (NCD). However, mainly due to urbanization and improved economic status in low and middle income countries (LMICs), the traditional largely plant-based diets are being replaced by more energy-dense and nutrient poor diets, incorporating more animal foods and processed foods and fat, and with a decrease in consumption of fruits and vegetables and other plant based foods. This diet change together with a sedentary lifestyle are typical phenomena in LMICs that are driving the so-called nutrition transition that is typically accompanied by an increase in obesity and in NCD like metabolic syndrome, diabetes, cardiovascular diseases and cancer. In Rwanda, NCD lead to 36% of total deaths. Cancers, diabetes, cardiovascular diseases, and chronic respiratory diseases account for 82% of NCD deaths. The major risk factor is the raised blood pressure (34.4%) and the probability of dying between ages 30 and 70 years from those four main NCD is estimated to 19%.

The Government of Rwanda has installed an operational NCD unit in the Ministry of Health with a view to developing preventive strategies vis-à-vis the nutrition transition process in the country. It has been shown already that there is a need for adopting dietary behaviour change to prevent the epidemic of chronic diseases.

The aim of this PhD work is to contribute in generating evidence needed to develop targeted prevention strategies for NCD in a broader framework of informed health policy making in Rwanda.

Specific objectives:

1. To identify the changes in eating habits of different socio- economic subgroups in adults living in Kigali, in comparison to their peers in rural areas;
2. To assess nutritional status and body composition using several methods (BMI, skinfold thicknesses, sitting height and body build, fat and fat free mass), with the ultimate objective to establish population-body composition-derived BMI cut-offs for overweight and obesity in this population;
3. To assess and compare the prevalence of common risk factors for non-communicable disease (high BMI, low fruit and vegetable consumption, low physical activity and high blood pressure) between rural and urban areas;
4. To evaluate people's nutrition knowledge, aptitude and capacity (KAP), perception of obesity and normal weight and food insecurity levels as risks factors for adherence to healthy dietary practices and life style;
5. To generate information to be used by governments to improve dietary habits and physical activity through targeted interventions.

The data collected in a cross sectional study design. Validated questionnaires will be used to get information on socio-economic characteristics, dietary practices, physical activity, other lifestyle factors and psycho-social and emotional indicators.

Eligibility criteria: Inclusion Criteria:

* Permanent residence of the selected urban or rural villages
* Holding a valid health insurance card
* Aged between 18 and 35 years
* Signing informed consent form
* Registration in city demographic system, since study participants will be selected from population registration cards at village level,
* Accept enumerators for home visit and data collection
* Accept to visit the laboratory for blood sample collection,
* Not suffering from any chronic disease such as VIH/ AIDS, diabetes, asthma, etc.

Exclusion Criteria:

* Lactating, pregnant, and recently delivering (less than six month-postpartum) women
* Physical disabilities that can prevent participants from working
* Mental disability such as clinically diagnosed depression, anxiety disorders, eating disorders and addictive behaviors.

Primary outcomes:
measure: Prevalence of the different dietary patterns
timeFrame: Through study completion (an average of 6 months)
measure: Prevalence of large waist circumference
timeFrame: Through study completion (an average of 6 months)
measure: Prevalence of high triglyceride concentrations
timeFrame: Through study completion (an average of 6 months)
measure: Prevalence of high-density lipoprotein (HDL) cholesterol
timeFrame: Through study completion (an average of 6 months)
measure: Prevalence of high blood pressure
timeFrame: Through study completion (an average of 6 months)
measure: Prevalence of high levels of fasting blood sugar
timeFrame: Through study completion (an average of 6 months)
measure: Prevalence of participants with nutrition knowledge
timeFrame: Through study completion (an average of 6 months)
Secondary outcomes:
measure: Prevalence of Food Insecure Households
timeFrame: Through study completion (an average of 6 months)
Other outcomes:
Locations:
city: Kigali
country: Rwanda
facility: University of Rwanda
Study officials:
affiliation: University Ghent
name: Stefaan De Henauw, Md. PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Souheila Abbeddou, MSc. PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rwanda
name: Hilda Vasanthakaalam, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut de Recherche en Sciences de la Sante, Ouagadougou, Burkina Faso
name: Jerome Some, Md. PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Janjua NZ, Mahmood B, Bhatti JA, Khan MI. Association of household and community socioeconomic position and urbanicity with underweight and overweight among women in Pakistan. PLoS One. 2015 Apr 2;10(4):e0122314. doi: 10.1371/journal.pone.0122314. eCollection 2015.