Metabolic Syndrome Clinical Trial
— NutriTransitOfficial title:
Evaluation of Dietary Practices and Assessment of Nutritional Status and Associated Risk Factors for Metabolic Syndrome in the Young Adult Population of Rwanda
Verified date | February 2024 |
Source | University Ghent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Rwanda | University of Rwanda | Kigali |
Lead Sponsor | Collaborator |
---|---|
University Ghent | Institut de Recherche en Sciences de la Sante, Burkina Faso, University of Rwanda |
Rwanda,
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
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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