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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04202107
Other study ID # EC/2019/1578
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 30, 2020
Est. completion date December 31, 2021

Study information

Verified date November 2022
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

In many developing countries, including Rwanda, the lack of developed and validated questionnaires is among major challenges for dietary assessment in nutritional surveys. Questionnaires are mostly borrowed from other communities. This can increase the error range due to low adaptation to local context, especially when they are not validated and may not have similar objectives. One Food Frequency Questionnaire (FFQ) does not capture dietary history in two different countries or regions, unless their diets are similar. Besides, the diet changes with time, where new foods are introduced in diet and others may disappear. In Rwanda, one FFQ has been developed to cover only the eastern part of the country, but none for the entire country (Cade et al., 2001; FAO, 2018). It is then very important to develop and validate an update and general FFQ that can be used across the country to measure the dietary intake to have a better interpretation of the study findings from the Rwandan context. The overall objective is to develop and validate a semi-quantitative FFQ that can be used to assess the food and nutrient intake in urban and rural communities of Rwanda. Specific objectives include: 1. To collect data on diet intake of selected participants by using a 24-H recall questionnaire that includes pictures on the approximate quantities consumed in each occasion. 2. To develop a list of food items from commonly consumed food by study participants using the compiled 24-h recall questionnaire to use for an FFQ development. Additionally, an open question format to collect information on foods consumed during social gathering and festivals will be used to include unreported foods. FFQ shall include additionally the food portion size, and the frequency of intake over a reference period of one year. 3. To assess the accuracy of the developed FFQ in estimating energy and nutrient intake using the 24-H dietary recall as a benchmark of accuracy.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years to 49 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Mental disorders such as clinically diagnosed depression, anxiety disorders, eating disorders and addictive behaviors

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Food Frequency Questionnaire
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.
24 Hour food recall
Standardized and validated approach of collecting all foods, beverages, and supplements consumed during the past 24 hours

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)

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, Mizéhoun-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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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