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Developing and Validating Food-based Dietary Guidelines and a Healthy Eating Index

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ClinicalTrials.gov Identifier: NCT03394963
Recruitment Status : Not yet recruiting
First Posted : January 9, 2018
Last Update Posted : February 19, 2019
Sponsor:
Collaborators:
Wageningen University
Food and Agriculture Organization (FAO)
International Food Policy Research Institute
Information provided by (Responsible Party):
Tesfaye Hailu, Ethiopian Public Health Institute

Brief Summary:
Among several factors contributing to the occurrence of undernutrition, micronutrient deficiencies, overnutrition, and chronic disease, unhealthy diet is one of the most important factors that need to be addressed to tackle the burden in low- and middle-income countries. To maintain healthy eating in a population, it is crucial to develop and implement country-specific food-based dietary guidelines as well as monitor the adherence of the population with the guidelines. The aim of this study is to generate evidence that will help the development and validation of food-based dietary guidelines and a healthy eating index for Ethiopia. The method to develop Ethiopian food-based dietary guidelines is adapted from the 2015 Dutch food-based dietary guidelines and the Dutch healthy diet index development and validation process, and the 1998 FAO/WHO preparation and use of food-based dietary guidelines. A multidisciplinary technical working will be established to develop FBDGs. The working group will identify key messages for the guidelines that can address priority diet-related public health problems in Ethiopia based on the evidence that will be generated by the PhD student from Wageningen University and Research. The evidence generation will begin by identifying top ten diet-related diseases that lead to high morbidity and mortality in 2016. The nutrition situation (nutritional status, dietary pattern, and nutrient gaps) analysis will be conducted to define the objectives of FBDGs. A systematic review will be conducted by formulating research questions to address the objectives of the FBDGs. The FBDGs will be translated for a specific population subgroup using linear mathematical programming and validated for cultural appropriateness, acceptability, consumer understanding and practicality of the messages. Focus group discussions and key informant interviews will be conducted to validate the FBDGs. The most recent Ethiopian national food consumption survey data collected in 2011 will be used to develop a healthy eating index (HEI). The selection of a healthy eating component of HEI will be done based on the FBDGs. Validation of a healthy eating index will be conducted by comparing the HEI score based on 24-hour recall with the HEI score based on food frequency questionnaire for population characteristics and association with micronutrient intake with or without adjusting for energy and anthropometric measurement. Developing short food frequency questionnaire (FFQ) that can be scored with the index for dietary counseling and public health practice as well as dietary gap assessment for policy recommendation will be part of the study. Validation of FFQ will be conducted by collecting primary data among women of reproductive age in 500 households in rural and urban areas of Ethiopia. The data will be analyzed using the latest version of STATA, SPSS, and NVIVO software. Correlations and other appropriate advanced statistical technique will be applied as needed to answer the objectives of the study. Ethical approval will be received from the medical ethical committee of Wageningen University and Research and scientific and ethical review office of Ethiopian Public Health Institute. This Ph.D. research is supported by the Food Systems for Healthier Diets flagship of the CGIAR- Agriculture for Nutrition and Health Programme coordinated by International Food Policy Research Institute. Food and Agriculture Organization (FAO) and Ethiopian Public Health Institute are collaborators of this project to develop the FBDGs.

Condition or disease Intervention/treatment
Healthy Behavioral: Food-based dietary guidelines for healthier diet

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Other
Official Title: Scientific Foundations for Developing and Validating Food-based Dietary Guidelines and a Healthy Eating Index for Ethiopia
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : October 30, 2021

Intervention Details:
  • Behavioral: Food-based dietary guidelines for healthier diet
    Develop and validate food-based dietary guideline and a healthy eating index


Primary Outcome Measures :
  1. Amount of foods in gram per day from different food groups [ Time Frame: From June 2018 - October 2021 ]
    Country-specific food-based dietary guidelines

  2. Healthy Eating Index [ Time Frame: From June 2018 - October 2021 ]
    Selection of the healthy eating components will be based on the food-based dietary guidelines developed for all Ethiopian above two years. Each component of a healthy eating index will have a minimum score of zero and maximum score between 5 to 20. The components will be scored in a way that a higher value indicates better adherence to the guidelines. The total healthy eating index score will not estimate an absolute energy intake rather it represents an intake per certain energy content. The total healthy eating index score (the sum of each components) ranges from 0 to 100, with higher scores indicating higher diet quality. The healthy eating index components will be categorized into adequacy, optimum, moderation, and ratio based on the healthier options provided in the food group of food-based dietary guidelines.

  3. Calorie gap from different food groups [ Time Frame: From June 2018 - October 2021 ]
    Estimating the dietary gap in different food groups mentioned in the food based dietary guidelines by comparing with world health organization nutrient reference intake for different population group.


Secondary Outcome Measures :
  1. Top 10 diseases based on total number of disability-adjusted life-years (DALYs) among all age and sex in Ethiopia [ Time Frame: From June 2018 - October 2021 ]
    Secondary data analysis from global burden of disease data

  2. Top 10 diseases based on total number of death among all age and sex in Ethiopia [ Time Frame: From June 2018 - October 2021 ]
    Secondary data analysis from global burden of disease data

  3. Current dietary assessment among different population group [ Time Frame: From June 2018 - October 2021 ]
    Secondary data analysis from the national food consumption survey. Estimate inadequate intake of nutrients (vitamin A, zinc, calcium and ...) and calories.

  4. Trend in nutritional status: body mass index (weight in kilogram/ height in meter square) [ Time Frame: From June 2018 - October 2021 ]
    Nutrition trend analysis using demographic and health survey, other national nutrition and health surveys and desktop review of published journals

  5. Height in meter [ Time Frame: From June 2018 - October 2021 ]
    Nutritional status trend analysis such as stunting (height for age < -2 SD of the WHO Child Growth Standards median) analysis using demographic and health survey, other national nutrition and health surveys and desktop review of published journals

  6. Weight in kilogram [ Time Frame: From June 2018 - October 2021 ]
    Nutritional status trend analysis such as wasting (weight for height < -2 SD of the WHO child growth standards median) and underweight (weight for height < -2 SD of the WHO child growth standards median) using demographic and health survey, other national nutrition and health surveys and desktop review of published journals

  7. Cultural acceptability of food-based dietary guidelines [ Time Frame: From June 2018 - October 2021 ]
    Qualitative study

  8. Consumer understanding of food-based dietary guidelines [ Time Frame: From June 2018 - October 2021 ]
    Qualitative study

  9. Implementation feasibility of food-based dietary guidelines [ Time Frame: From June 2018 - October 2021 ]
    Qualitative study



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The FBDGs validation, a HEI and FFQ tools development and validation will target women of reproductive age (15-49 years), are not planning to move from the study and do not have a severe illness at the time of enrolment. Exclusion criteria will be a severe illness.
Criteria

Inclusion Criteria:

  • General population above 2 years of FBDGs development
  • Women of reproductive age (15-49 years) for FBDGs validation
  • Women of reproductive age (15-49 years) for HEI development and validation

Exclusion Criteria:

  • population groups other than women of reproductive age for FBDGs validation, and HEI development and validation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03394963


Contacts
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Contact: Tesfaye Hailu Bekele, PhD student 00251944123108 tesfayehailu.bekele@wur.nl
Contact: Tesfaye Hailu Bekele, PhD student 0031633741363 tesfayehailu.bekele@wur.nl

Locations
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Ethiopia
Ethiopian Public Health Institute
Addis Ababa, Ethiopia, 1242
Sponsors and Collaborators
Ethiopian Public Health Institute
Wageningen University
Food and Agriculture Organization (FAO)
International Food Policy Research Institute
Investigators
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Study Director: Inge D Brouwer, PhD Wageningen University
Study Chair: Edith Feskens, Prof., PhD Wageningen University
Study Chair: Jeanne de Vries, PhD Wageningen University
Publications:
Ng M, Fleming T, Robinson M, Thomson B, Graetz N, Margono C, Mullany EC, Biryukov S, Abbafati C, Abera SF, Abraham JP, Abu-Rmeileh NM, Achoki T, AlBuhairan FS, Alemu ZA, Alfonso R, Ali MK, Ali R, Guzman NA, Ammar W, Anwari P, Banerjee A, Barquera S, Basu S, Bennett DA, Bhutta Z, Blore J, Cabral N, Nonato IC, Chang JC, Chowdhury R, Courville KJ, Criqui MH, Cundiff DK, Dabhadkar KC, Dandona L, Davis A, Dayama A, Dharmaratne SD, Ding EL, Durrani AM, Esteghamati A, Farzadfar F, Fay DF, Feigin VL, Flaxman A, Forouzanfar MH, Goto A, Green MA, Gupta R, Hafezi-Nejad N, Hankey GJ, Harewood HC, Havmoeller R, Hay S, Hernandez L, Husseini A, Idrisov BT, Ikeda N, Islami F, Jahangir E, Jassal SK, Jee SH, Jeffreys M, Jonas JB, Kabagambe EK, Khalifa SE, Kengne AP, Khader YS, Khang YH, Kim D, Kimokoti RW, Kinge JM, Kokubo Y, Kosen S, Kwan G, Lai T, Leinsalu M, Li Y, Liang X, Liu S, Logroscino G, Lotufo PA, Lu Y, Ma J, Mainoo NK, Mensah GA, Merriman TR, Mokdad AH, Moschandreas J, Naghavi M, Naheed A, Nand D, Narayan KM, Nelson EL, Neuhouser ML, Nisar MI, Ohkubo T, Oti SO, Pedroza A, Prabhakaran D, Roy N, Sampson U, Seo H, Sepanlou SG, Shibuya K, Shiri R, Shiue I, Singh GM, Singh JA, Skirbekk V, Stapelberg NJ, Sturua L, Sykes BL, Tobias M, Tran BX, Trasande L, Toyoshima H, van de Vijver S, Vasankari TJ, Veerman JL, Velasquez-Melendez G, Vlassov VV, Vollset SE, Vos T, Wang C, Wang X, Weiderpass E, Werdecker A, Wright JL, Yang YC, Yatsuya H, Yoon J, Yoon SJ, Zhao Y, Zhou M, Zhu S, Lopez AD, Murray CJ, Gakidou E. Global, regional, and national prevalence of overweight and obesity in children and adults during 1980-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2014 Aug 30;384(9945):766-81. doi: 10.1016/S0140-6736(14)60460-8. Epub 2014 May 29. Erratum in: Lancet. 2014 Aug 30;384(9945):746.
Haddad, L.J., et al., Global Nutrition Report 2015: Actions and accountability to advance nutrition and sustainable development. 2015: Intl Food Policy Res Inst.
Initiatives, D., Global Nutrition Report 2017: Nourishing the SDGs. 2017.
ICF, C.S.A.E.a., Ethiopia Demographic and Health Survey 2016: Key Indicators Report. Addis Ababa, Ethiopia, and Rockville, Maryland, USA. CSA and ICF. 2016
EPHI, Ethiopian National Nutrition Program End-Line Survey. 2015.
Mr. Dilnesaw Zerfu, M.A.B., Mr. Mesert W/yohanes, Mr. Girmay Ayana, Mr. Andinet Abera, Mr Biniyam Tesfaye, Mr. Desalegn Kuche, Mr. Solomon Eshetu, Dr. Aweke Kebede, Mrs. Aregash Samuel, Mr. Temesgen Awoke, Mr. Girma Mengistu, Mr. Yosef Beyene, Mrs. Alemnesh Petros, Mr. Mekonen Sisay, Ms Tsehay Assefa, Mr. Tibebu Moges, Mr. Tesfaye Hailu, Dr.Yibeltal Assefa, Dr Amha Kebede, Ethiopian National Micronutrient Survey F.S.a.N. Research, Editor. Spetember 2016, EPHI.
http://www.breastcancer.org/tips/nutrition/healthy_eat. What Does Healthy Eating Mean? 2017 [cited 2017 July].
Worku I, D.M., Minten B, Diet transformation in Ethiopia. 2015.
EPHI, Ethiopia National Food Consumption Survey. 2013.
EPHI, The 2nd BSC Based EPHI's Strategic Management Plan (2015/16 to 2019/20). July 2015.
FMOH, NATIONAL NUTRITION PROGRAM 2016-2020, Addis Ababa Ethiopia JULY 2016.
Gibson, R.S., Principles of nutritional assessment. 2005: Oxford university press, USA.
http://www.fao.org/nutrition/education/food-dietary-guidelines/en/. Food-based dietary guidelines. 2017 [cited 2017 July ].
Vorster, H., P. Love, and C. Browne, Development of food-based dietary guidelines for South Africa: the process. S Afr J Clin Nutr, 2001. 14(3).
Erve, I.v.t., Tulen, C. B. M., Jansen, J., Laar, A. D. E. van, Minnema, R.,Schenk, P. R., Wolvers, D., Rossum, C. T. M. van and Verhagen, H, Overview of Elements within National Food-Based Dietary Guidelines. European Journal of Nutrition & Food Safety, 2017 7(1): p. 1-56.
Joint, F. and W.H. Organization, Vitamin and mineral requirements in human nutrition. 2005.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tesfaye Hailu, Researcher and PhD student, Ethiopian Public Health Institute
ClinicalTrials.gov Identifier: NCT03394963    
Other Study ID Numbers: A4NH-FP1-CoA1
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Once the protocol finalized and published, it will be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tesfaye Hailu, Ethiopian Public Health Institute:
Food-Based Dietary guideline
Healthy Eating Index
Healthy Diet
Protocol
Ethiopia