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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04204538
Other study ID # EC/2019/1577
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2021
Est. completion date December 31, 2023

Study information

Verified date February 2024
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1247
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Dietary habits
Data collected using food frequency questionnaire
Risk factors associated with metabolic syndrome
Data collected on nutritional status, biochemical indicators and other risk factors associated with metabolic syndrome

Locations

Country Name City State
Rwanda University of Rwanda Kigali

Sponsors (3)

Lead Sponsor Collaborator
University Ghent Institut de Recherche en Sciences de la Sante, Burkina Faso, University of Rwanda

Country where clinical trial is conducted

Rwanda, 

References & Publications (4)

Boutayeb A. The double burden of communicable and non-communicable diseases in developing countries. Trans R Soc Trop Med Hyg. 2006 Mar;100(3):191-9. doi: 10.1016/j.trstmh.2005.07.021. Epub 2005 Nov 4. — View Citation

Bowen L, Ebrahim S, De Stavola B, Ness A, Kinra S, Bharathi AV, Prabhakaran D, Reddy KS. Dietary intake and rural-urban migration in India: a cross-sectional study. PLoS One. 2011;6(6):e14822. doi: 10.1371/journal.pone.0014822. Epub 2011 Jun 22. — View 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. — View Citation

Swinburn BA, Kraak VI, Allender S, Atkins VJ, Baker PI, Bogard JR, Brinsden H, Calvillo A, De Schutter O, Devarajan R, Ezzati M, Friel S, Goenka S, Hammond RA, Hastings G, Hawkes C, Herrero M, Hovmand PS, Howden M, Jaacks LM, Kapetanaki AB, Kasman M, Kuhnlein HV, Kumanyika SK, Larijani B, Lobstein T, Long MW, Matsudo VKR, Mills SDH, Morgan G, Morshed A, Nece PM, Pan A, Patterson DW, Sacks G, Shekar M, Simmons GL, Smit W, Tootee A, Vandevijvere S, Waterlander WE, Wolfenden L, Dietz WH. The Global Syndemic of Obesity, Undernutrition, and Climate Change: The Lancet Commission report. Lancet. 2019 Feb 23;393(10173):791-846. doi: 10.1016/S0140-6736(18)32822-8. Epub 2019 Jan 27. No abstract available. Erratum In: Lancet. 2019 Feb 23;393(10173):746. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of the different dietary patterns Dietary patterns will be identified using exploratory factor analysis on the food groups collected using the semi-quantitative Food Frequency Questionnaire. The dietary pattern identified will differ from plant_based diet and legume_based diet to western diet. Through study completion (an average of 6 months)
Primary Prevalence of large waist circumference Large waist circumference [> 89 centimeters for women and >102 centimeters for men] Through study completion (an average of 6 months)
Primary Prevalence of high triglyceride concentrations High triglyceride level [>150 milligrams per deciliter (mg/dL)] Through study completion (an average of 6 months)
Primary Prevalence of high-density lipoprotein (HDL) cholesterol Reduced high-density lipoprotein (HDL) cholesterol [< 40 mg/dL in men or < 50 mg/dL in women] Through study completion (an average of 6 months)
Primary Prevalence of high blood pressure Increased blood pressure [> 130/85 mm Hg] Through study completion (an average of 6 months)
Primary Prevalence of high levels of fasting blood sugar Elevated fasting blood sugar [>100 mg/dL] Through study completion (an average of 6 months)
Primary Prevalence of participants with nutrition knowledge Nutritional knowledge of macronutrients, micronutrients, water intake, diet and disease will be collected using a multiple choice answers. Each question had one mark for every correct response chosen. Using a marking scheme for nutritional knowledge test the scores were rated on score percentages using eight cut off points, with scores less than 20% indicating a bad nutritional knowledge, 50-59% satisfactory and Excellent for those scoring 80% and more. Through study completion (an average of 6 months)
Secondary Prevalence of Food Insecure Households The Household Food Insecurity Access (HFIA) Score is a continuous measure of the degree of food insecurity in the household and is based on a set of questions that encompass three domains of food insecurity: (1) anxiety and uncertainty about the household food supply; (2) insufficient quality; and (3) insufficient food intake and its physical consequences (Coates et al. 2007).
Each household receives a score from 0-27 based on a simple sum of the frequency of occurrence of each food insecurity condition, where 'never' = 0 points, 'rarely' = 1 point, 'sometimes' = 2 points, and 'often' = 3 points. The higher the score, the higher the degree of household food insecurity experienced in the previous four weeks.
Through study completion (an average of 6 months)
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