NCT04204538

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,247

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 19, 2019

Completed
1.9 years until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

2.2 years

First QC Date

November 27, 2019

Last Update Submit

February 6, 2024

Conditions

Keywords

Food Frequency QuestionnaireDietary patternsRisk factorsmetabolic syndromeNutritional transition

Outcome Measures

Primary Outcomes (7)

  • 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)

  • 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)

  • Prevalence of high triglyceride concentrations

    High triglyceride level \[\>150 milligrams per deciliter (mg/dL)\]

    Through study completion (an average of 6 months)

  • Prevalence of high-density lipoprotein (HDL) cholesterol

    Reduced high-density lipoprotein (HDL) cholesterol \[\< 40 mg/dL in men or \< 50 mg/dL in women\]

    Through study completion (an average of 6 months)

  • Prevalence of high blood pressure

    Increased blood pressure \[\> 130/85 mm Hg\]

    Through study completion (an average of 6 months)

  • Prevalence of high levels of fasting blood sugar

    Elevated fasting blood sugar \[\>100 mg/dL\]

    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.

    Through study completion (an average of 6 months)

Secondary Outcomes (1)

  • Prevalence of Food Insecure Households

    Through study completion (an average of 6 months)

Study Arms (2)

Urban

Young adults living in urban communities of Rwanda

Other: Dietary habitsOther: Risk factors associated with metabolic syndrome

Rural

Young adults living in rural communities of Rwanda

Other: Dietary habitsOther: Risk factors associated with metabolic syndrome

Interventions

Data collected using food frequency questionnaire

RuralUrban

Data collected on nutritional status, biochemical indicators and other risk factors associated with metabolic syndrome

RuralUrban

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rwanda

Kigali, Rwanda

Location

Related Publications (4)

  • 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.

    PMID: 21731604BACKGROUND
  • 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.

    PMID: 16274715BACKGROUND
  • 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.

    PMID: 30700377BACKGROUND
  • 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.

    PMID: 25835540BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples

MeSH Terms

Conditions

Metabolic SyndromeFeeding Behavior

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehavior, AnimalBehavior

Study Officials

  • Stefaan De Henauw, Md. PhD

    University Ghent

    PRINCIPAL INVESTIGATOR
  • Souheila Abbeddou, MSc. PhD

    University Ghent

    PRINCIPAL INVESTIGATOR
  • Hilda Vasanthakaalam, PhD

    University of Rwanda

    PRINCIPAL INVESTIGATOR
  • Jerome Some, Md. PhD

    Institut de Recherche en Sciences de la Sante, Ouagadougou, Burkina Faso

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2019

First Posted

December 19, 2019

Study Start

November 1, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

February 7, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations