NCT04202107

Brief Summary

The burden of non-communicable diseases (NCDs) in Rwanda is adding to the health burden in the country which is facing the nutritional transition and the double burden of malnutrition. Diet is an established risk factor in NCDs, hence the importance to assess accurately the changes in dietary habits occurring in the population. The objective is to develop and validate a food frequency questionnaire in Rwanda.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

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
20 days until next milestone

First Posted

Study publicly available on registry

December 17, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

January 30, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

November 15, 2022

Status Verified

November 1, 2022

Enrollment Period

1.9 years

First QC Date

November 27, 2019

Last Update Submit

November 14, 2022

Conditions

Keywords

Dietary assessmentFood Frequency Questionnairemulti-pass 24 hour food recallsemi-quantitative

Outcome Measures

Primary Outcomes (8)

  • Median proportion of energy intake from carbohydrates assessed by the 24 hour recalls

    Median proportion of energy intake from carbohydrates (starch from grains and tubers such as corn, pasta, rice, potatoes, breads), natural sugars from fruits and juices, and added sugars found in soft drinks, candy, fruit drinks, and desserts) assessed by the 24 hour recalls Adults should get 45 percent to 65 percent of their calories from carbohydrates

    One year

  • Median proportion of energy intake from carbohydrates assessed by the Food Frequency Questionnaire

    Median proportion of energy intake from carbohydrates (starch from grains and tubers such as corn, pasta, rice, potatoes, breads), natural sugars from fruits and juices, and added sugars found in soft drinks, candy, fruit drinks, and desserts) assessed by the Food Frequency Questionnaire. Adults should get 45 percent to 65 percent of their calories from carbohydrates

    One year

  • Median proportion of energy intake from fat assessed by the 24 hour recalls

    Median proportion of energy intake from fat (Butter, margarine, vegetable oils, whole milk, visible fat on meat and poultry products, invisible fat in fish, shellfish, some plant products such as seeds and nuts, and bakery products) assessed by the 24 hour recalls. Adults should get 20 percent to 35 percent of their calories from fat

    One year

  • Median proportion of energy intake from fat assessed by the Food Frequency Questionnaire

    Median proportion of energy intake from fat (Butter, margarine, vegetable oils, whole milk, visible fat on meat and poultry products, invisible fat in fish, shellfish, some plant products such as seeds and nuts, and bakery products) assessed by the Food Frequency Questionnaire. Adults should get 20 percent to 35 percent of their calories from fat

    One year

  • Median proportion of energy intake from proteins assessed by the 24 hour recalls

    Median proportion of energy intake from proteins (from animal sources, such as meat, poultry, fish, eggs, milk, cheese, and yogurt; and proteins from plants, legumes, grains, nuts, seeds, and vegetables) assessed by the 24 hour recalls. Adults should get 10 to 35 percent of their calories from protein

    One year

  • Median proportion of energy intake from proteins assessed by the Food Frequency Questionnaire

    Median proportion of energy intake from proteins (from animal sources, such as meat, poultry, fish, eggs, milk, cheese, and yogurt; and proteins from plants, legumes, grains, nuts, seeds, and vegetables) assessed by the Food Frequency Questionnaire. Adults should get 10 to 35 percent of their calories from protein

    One year

  • Median daily intake of fibers assessed by the 24 hour recalls

    Median daily intake of fibers (in gram; Includes dietary fiber naturally present in grains, such as found in oats, wheat, or unmilled rice; and functional fiber synthesized or isolated from plants or animals) assessed by the 24 hour recalls. The recommended intake for total fiber for adults 50 years and younger is set at 38 grams for men and 25 grams for women

    One year

  • Median daily intake of fibers assessed by the Food Frequency Questionnaire

    Median daily intake of fibers (in gram; Includes dietary fiber naturally present in grains, such as found in oats, wheat, or unmilled rice; and functional fiber synthesized or isolated from plants or animals) assessed by the Food Frequency Questionnaire. The recommended intake for total fiber for adults 50 years and younger is set at 38 grams for men and 25 grams for women

    One year

Study Arms (2)

Urban

Men and women between 18 and 49 years of age living in the selected urban communities in Rwanda and who are familiar with the diet. Participants in this study should be acquainted with cooking practices to be able to cite all the ingredients that are used in the preparation of the dishes/ meals

Other: Food Frequency QuestionnaireOther: 24 Hour food recall

Rural

Men and women between 18 and 49 years of age living in the selected urban communities in Rwanda and who are familiar with the diet. Participants in this study should be acquainted with cooking practices to be able to cite all the ingredients that are used in the preparation of the dishes/ meals

Other: Food Frequency QuestionnaireOther: 24 Hour food recall

Interventions

Food frequency questionnaires (FFQs) are a common method for measuring dietary intake in large epidemiological studies, in particular in low literacy settings were diaries and food history would not be viable.

RuralUrban

Standardized and validated approach of collecting all foods, beverages, and supplements consumed during the past 24 hours

RuralUrban

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

In total, 100 participants will be selected from 100 households (one per household) in urban villages (mainly in Kigali) and the same number of participants from rural communities of Rwanda will be recruited in the validation study.

You may qualify if:

  • Permanent residence of the selected urban or rural villages
  • Holding a valid health insurance card
  • Aged between 18 and 49 years
  • Signing informed consent form
  • Familiar with the diet and cooking practices
  • 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 for one year

You may not qualify if:

  • Mental disorders 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, Bharathi AV, Kinra S, Destavola B, Ness A, Ebrahim S. Development and evaluation of a semi-quantitative food frequency questionnaire for use in urban and rural India. Asia Pac J Clin Nutr. 2012;21(3):355-60.

    PMID: 22705424BACKGROUND
  • Cade J, Thompson R, Burley V, Warm D. Development, validation and utilisation of food-frequency questionnaires - a review. Public Health Nutr. 2002 Aug;5(4):567-87. doi: 10.1079/PHN2001318.

    PMID: 12186666BACKGROUND
  • Aglago EK, Landais E, Nicolas G, Margetts B, Leclercq C, Allemand P, Aderibigbe O, Agueh VD, Amuna P, Annor GA, El Ati J, Coates J, Colaiezzi B, Compaore E, Delisle H, Faber M, Fungo R, Gouado I, El Hamdouchi A, Hounkpatin WA, Konan AG, Labzizi S, Ledo J, Mahachi C, Maruapula SD, Mathe N, Mbabazi M, Mirembe MW, Mizehoun-Adissoda C, Nzi CD, Pisa PT, El Rhazi K, Zotor F, Slimani N. Evaluation of the international standardized 24-h dietary recall methodology (GloboDiet) for potential application in research and surveillance within African settings. Global Health. 2017 Jun 19;13(1):35. doi: 10.1186/s12992-017-0260-6.

    PMID: 28629424BACKGROUND
  • Shridhar K, Satija A, Dhillon PK, Agrawal S, Gupta R, Bowen L, Kinra S, Bharathi AV, Prabhakaran D, Srinath Reddy K, Ebrahim S; Indian Migration Study group. Association between empirically derived dietary patterns with blood lipids, fasting blood glucose and blood pressure in adults - the India migration study. Nutr J. 2018 Feb 8;17(1):15. doi: 10.1186/s12937-018-0327-0.

    PMID: 29422041BACKGROUND

Related Links

Study Officials

  • Stefaan De Henauw, Md. PhD

    University Ghent

    PRINCIPAL INVESTIGATOR
  • Souheila Abbeddou, MSc. PhD

    UGent

    PRINCIPAL INVESTIGATOR
  • Jerome Some, Md. PhD

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

    PRINCIPAL INVESTIGATOR
  • Hilda Vasanthakaalam, PhD

    University of Rwanda

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2019

First Posted

December 17, 2019

Study Start

January 30, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

November 15, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations