Metabolic SyndromeNutriTransitNCT04204538
Dietary Practices and Metabolic Syndrome in the Young Adult Population of Rwanda
An observational study of Metabolic Syndrome and Nutritional Status, run by University Ghent at 1 site in Rwanda.
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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Nutritional Status, Diet Habit
- What is being tested?
- Dietary habits and Risk factors associated with metabolic syndrome
- How many people
- 1,247 participants
- Where
- 1 siteRwanda
- Study dates
- 1 Nov 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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:
- 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;
- 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;
- 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;
- 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;
- 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.
- Conditions
- Metabolic Syndrome, Nutritional Status, Diet Habit
- Being tested
- Dietary habits, Risk factors associated with metabolic syndrome
- Keywords
- Food Frequency Questionnaire, Dietary patterns, Risk factors, metabolic syndrome, Nutritional transition
- Medical subject headings
- Metabolic Syndrome, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary habitsOther
Data collected using food frequency questionnaire
Risk factors associated with metabolic syndromeOther
Data collected on nutritional status, biochemical indicators and other risk factors associated with metabolic syndrome
| Study group | Role | What they receive |
|---|---|---|
| Urban | Young adults living in urban communities of Rwanda Receives: Other: Dietary habits; Other: Risk factors associated with metabolic syndrome | |
| Rural | Young adults living in rural communities of Rwanda Receives: Other: Dietary habits; Other: Risk factors associated with metabolic syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion (an average of 6 months)
Prevalence of large waist circumference
Large waist circumference [> 89 centimeters for women and >102 centimeters for men]
Measured: Through study completion (an average of 6 months)
Prevalence of high triglyceride concentrations
High triglyceride level [>150 milligrams per deciliter (mg/dL)]
Measured: Through study completion (an average of 6 months)
Prevalence of high-density lipoprotein (HDL) cholesterol
Reduced high-density lipoprotein (HDL) cholesterol [< 40 mg/dL in men or < 50 mg/dL in women]
Measured: Through study completion (an average of 6 months)
Prevalence of high blood pressure
Increased blood pressure [> 130/85 mm Hg]
Measured: Through study completion (an average of 6 months)
Prevalence of high levels of fasting blood sugar
Elevated fasting blood sugar [>100 mg/dL]
Measured: Through study completion (an average of 6 months)
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.
Measured: Through study completion (an average of 6 months)
Secondary outcomes (1)
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.
Measured: Through study completion (an average of 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start1 Nov 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,247 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rwanda, Institut de Recherche en Sciences de la Sante, Burkina Faso
- Responsible party
- Sponsor
- Investigators
- Stefaan De Henauw, Md. PhD, Principal investigator, University GhentSouheila Abbeddou, MSc. PhD, Principal investigator, University GhentHilda Vasanthakaalam, PhD, Principal investigator, University of RwandaJerome Some, Md. PhD, Principal investigator, Institut de Recherche en Sciences de la Sante, Ouagadougou, Burkina Faso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204538
- Sponsor's protocol ID
- EC/2019/1577
- Acronym
- NutriTransit
- Status last verified
- Feb 2024
- First submitted
- 27 Nov 2019
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21731604Boutayeb 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.
PubMed 16274715Swinburn 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.
PubMed 30700377Janjua 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.
PubMed 25835540
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04204538
- Acronym / sponsor ID
- NutriTransit / EC/2019/1577
- Conditions
- Metabolic Syndrome, Nutritional Status, Diet Habit
- Keywords
- Food Frequency Questionnaire, Dietary patterns, Risk factors, metabolic syndrome, Nutritional transition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,247 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- University of Rwanda, Institut de Recherche en Sciences de la Sante, Burkina Faso
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 19 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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;
- 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;
- 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;
- 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;
- 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urban | – | Other: Dietary habits, Other: Risk factors associated with metabolic syndromeYoung adults living in urban communities of Rwanda |
| Rural | – | Other: Dietary habits, Other: Risk factors associated with metabolic syndromeYoung adults living in rural communities of Rwanda |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary habitsData collected using food frequency questionnaire | Other | Rural, Urban |
| Risk factors associated with metabolic syndromeData collected on nutritional status, biochemical indicators and other risk factors associated with metabolic syndrome | Other | Rural, Urban |
Primary outcome
Prevalence of the different dietary patterns
Time frame: Through study completion (an average of 6 months)
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.
Prevalence of large waist circumference
Time frame: Through study completion (an average of 6 months)
Large waist circumference [> 89 centimeters for women and >102 centimeters for men]
Prevalence of high triglyceride concentrations
Time frame: Through study completion (an average of 6 months)
High triglyceride level [>150 milligrams per deciliter (mg/dL)]
Prevalence of high-density lipoprotein (HDL) cholesterol
Time frame: Through study completion (an average of 6 months)
Reduced high-density lipoprotein (HDL) cholesterol [< 40 mg/dL in men or < 50 mg/dL in women]
Prevalence of high blood pressure
Time frame: Through study completion (an average of 6 months)
Increased blood pressure [> 130/85 mm Hg]
Prevalence of high levels of fasting blood sugar
Time frame: Through study completion (an average of 6 months)
Elevated fasting blood sugar [>100 mg/dL]
Prevalence of participants with nutrition knowledge
Time frame: Through study completion (an average of 6 months)
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.
1 secondary outcome
Prevalence of Food Insecure Households
Time frame: Through study completion (an average of 6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Background: PubMed 21731604Bowen 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.
- Background: PubMed 16274715Boutayeb 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.
- Background: PubMed 30700377Swinburn 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.
- Background: PubMed 25835540Janjua 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefaan De Henauw, Md. PhD principal investigator
University Ghent
Souheila Abbeddou, MSc. PhD principal investigator
University Ghent
Hilda Vasanthakaalam, PhD principal investigator
University of Rwanda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome and Nutritional Status, run by University Ghent at 1 site in Rwanda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of the different dietary patterns (time frame: Through study completion (an average of 6 months)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04204538, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.