Clinical trial NCT03394963: Developing and Validating Food-based Dietary Guidelines and a Healthy Eating Index
Official title: Scientific Foundations for Developing and Validating Food-based Dietary Guidelines and a Healthy Eating Index for Ethiopia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Food-Based Dietary guideline
Healthy Eating Index
Healthy Diet
Protocol
Ethiopia
Lead sponsor: Ethiopian Public Health Institute
Sponsor class: OTHER_GOV
Collaborators: name: Wageningen University
name: Food and Agriculture Organization (FAO)
name: International Food Policy Research Institute
First posted: 2018-01-09
Enrollment: 500
Sex: FEMALE
Minimum age (years): 2
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
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.

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.

Detailed description: Triple burden of malnutrition (i.e. protein-energy malnutrition including micronutrient deficiency and overnutrition) is a current global problem. In 2017, 155 out of 677 million children in the world under the age of 5 years were stunted (height for age \< -2 SD of the WHO Child Growth Standards median), 52 million wasted (weight for height \< -2 SD of the WHO child growth standards median) and 41 million overweight (weight for height \> 2 SD of the WHO child growth standards median) with 93 million children at risk of overweight. Out of 5 billion adults worldwide, nearly 2 billion are overweight (BMI \> 25 kg/m2) or obese (BMI \> 30 kg/m2) and one in 12 has a type -2 diabetes mellitus. The mean prevalence of adult obesity in the WHO data set was 7.5 ± 6.0% while adult overweight was much higher at 21.8 ± 10.2% and adult underweight was 13.4 ± 7.0%. The median ratio of overweight to underweight among women age 20 - 49 years was 5.8 in urban and 2.1 in rural areas of low- and middle-income countries (LMICs). Even many poor countries, countries in which underweight persists as a significant problem, had a fairly high prevalence of rural overweight. As compared to the overall Sub-Saharan Africa (SSA), urban prevalence of adult obesity and overweight were higher (12.5 ± 7.0% and 31.8 ± 12.8% respectively), child undernutrition was generally lower (30.4 ± 8.4% for stunting \< -2SD from median height for age,15.5 ± 7.0% for underweight \< -2SD from median weight for age and 12.0 ± 5.0% for wasting \< -2SD from median weight for height) and adult underweight (BMI \< 18.5 kg/m2) was also 10.5%. In addition to this, two billion people living in developing and developed countries are micronutrients deficient; they lack the vital vitamins and minerals needed to grow properly and live healthily. Iron, iodine, vitamin A, zinc, and folate separately or in combination are the priority micronutrient deficiencies for populations in most countries of the world. Micronutrient deficiencies have consequences throughout an individual's lifespan and are perpetuated across the generations. Thus, maternal and child malnutrition in low- and middle-income countries encompasses undernutrition and micronutrient deficiency, with a growing problem of overweight and obesity. The problem of triple burden of malnutrition is especially increasing in low- and middle-income countries mainly due to urbanization, fast economic growth, and changes in dietary pattern and lifestyle.

Ethiopia has a fast growing economy over the past 10 years, and a changing food environment, with declining shares of food expenditures and increased access to non-staples, processed foods, and sugary beverages. Stunting among young children has reduced from 57% in 2000, to 40% in 2014. Nevertheless, levels of stunting are still among the highest in the world and the contribution starts from underweight mothers whose birth outcome is a child with low birth weight. According to 2016 demographic and health survey report, the prevalence of stunting among under 5 children is 38%, wasting 9.9% and underweight 23.6%. The national nutrition survey conducted by Ethiopian Public Health Institute (EPHI) in 2015 also indicated that the prevalence of underweight (BMI\<18.5 kg/m2) and overweight among women of reproductive age are 20% and 13% respectively. Overweight had increased by 10% between 2009 and 2015 according to the national nutrition survey results and other studies. The national micronutrient survey also showed that anemia, vitamin A, zinc, iodine, folate and vitamin B12 are public health problems among all population in Ethiopia. This indicates that, like other LMICs, Ethiopia is suffering from the triple burden of malnutrition.

The unhealthy diet is one of the most important risk factors that need to be addressed to tackle the triple burden of malnutrition in LMICs. The changes in the pattern of dietary risk factors in low- and middle-income countries is characterized by increases in the consumption of animal fat and protein, refined grains, and added sugar. In middle-income countries, from1989 to 2011, the percentage of individuals with consumption frequency of fish 5 + per week has decreased from 93% to 74%, that with consumption frequency of meat 5 + per week has increased from 25% to 51%, consumption frequency of fruits 1 + per week has increased from 48% to 94%, consumption frequency of salty snacks 1 + per week has increase from 22% to 64%, consumption frequency of sweet snacks has increased from 38% to 67%, and from 2004 to 2011, consumption frequency of poultry has increased from 86% to 96%. On the other hand, in Sub-Saharan African (SSA) countries, dietary micronutrient density index (average micronutrient density of the food supply based on 14 micronutrients: calcium, copper, iron, folate, magnesium, niacin, phosphorus, riboflavin, thiamin, vitamin A, vitamin B12, vitamin B6, vitamin C, and zinc using the 2011 global population-weighted Recommended Dietary Allowance \[RDA\]) has declined over the past 50 years. This indicates that there is a policy gap in terms of improving dietary quality for better health, prevention of diet-related diseases, and triple burden of malnutrition in LMICs setting. Promoting healthy eating in low- and middle-income countries can reduce the social inequality among the poor and rich, especially when it targets the disadvantaged population group. In general, healthy global diet can reduce global mortality by 6 - 10%, and greenhouse emission by 29-70%, reduce biodiversity loss and economic benefit up to 31 trillion US dollar and adoption of global dietary guidelines would result in 5.1 million avoided deaths per year \[95% confidence interval (CI), 4.8-5.5 million\] and 79 million years of life saved (CI, 75-83 million).

Besides this, lack of a healthy diet also contributes to the burden of diet-related diseases. Intakes of a diet low in fruits and vegetables and high in sodium are the leading dietary risks factors for non-communicable diseases (NCDs) burden in Ethiopia. Evidence from animal, clinical and epidemiological studies also showed that specific dietary patterns are associated with reduced risk of specific disease. Fruits and vegetables are associated with a reduction of the incidence of an esophagus, lung, stomach, and colorectum cancer and coronary heart diseases. In addition, by promoting a healthy diet, it is also possible to prevent different forms of malnutrition and micronutrient deficiencies.

A healthy diet means eating a variety of foods that can give the nutrients needed to maintain or improve health, feel good, and have adequate energy content. The nutrients include protein, carbohydrates, fat, water, vitamins, and minerals. To maintain healthy eating in a population, it is crucial to develop and implement country-specific food-based dietary guidelines and to enable tracking the adherence of the population to the food-based dietary guidelines.

Indications for dietary transitions are observed in several overall trends of Ethiopian eating habits such as increased energy intake, declining but still a dominant share of cereals in diets, and more purchased foods. Whether diets as a whole are changing towards healthier or unhealthier patterns, and how this differs between and within regions and population subgroups, is unclear. The increase in consumption of unhealthier components might be faster than that of healthy components as in many (187 countries) other countries of the world. In addition, Ethiopia's food production and supply are very vulnerable to climate change and variability (droughts in 2015-2016), which leads to temporal high levels of severe food insecurity and malnutrition which can easily affect the dietary pattern of the population. A national food consumption study conducted by EPHI sheds light on some major dietary gaps, including inadequate intake of vitamin A, calcium, folate and zinc. However, the heterogeneity of dietary patterns and dietary nutrient gaps concerns among the large diversity of consumers remain to be investigated and this heterogeneity currently limits efficient targeting of food-based interventions. Filling this knowledge gap was identified among the priorities of the nutrition research agenda of the country. Research could then support the development of food-based dietary guidelines for the general population above the age of 2 years.

Food-based dietary guidelines is a set of simple advisory statements that gives direction to consumers on healthy eating patterns to promote better nutrition and well-being and to address diet-related conditions. They provide advice on the type of food or food groups that need attention to promote more optimal nutrition and health outcomes for a target population in the country. The overall aim of food-based dietary guidelines is to promote overall health, contribute to the management of specific diet-related diseases and prevention of the risk factors, and to improve micronutrient deficiency and protein-energy malnutrition. Food-based dietary guidelines can be used for dietary advice regarding national food supply planning, better health status, reduced healthcare cost and improve work, growth and learning capacity for different population groups.

Food-based dietary guidelines should be specific to a given country, should be appropriate in terms of socio-demographic profile, nutritional status, health status, and dietary pattern to provide a framework for a healthy diet based on current nutrition recommendations. Country-specific food-based dietary guidelines are relevant due to foods that makeup diet are more than just a collection of nutrients. The nutrients in food interact differently when present as a food and the method of food preparation, processing, and cooking (i.e. food culture) influence the nutritional values of food. Food-based dietary guidelines should target the total diet, including all foods in daily meals and snacks, be based on food commonly consumed and all type of foods. The list of food groups used in FBDGs should be recognizable by consumers, permit the maximum flexibility in food choice to accommodate different eating tradition in a country and the description of food serving size should be in terms of commonly used household measures. Out of 58, only 7 African countries have FBDGs at the moment. Ethiopia is one of those African countries which do not have food-based dietary guidelines. In collaboration with FAO and other key local partners, Wageningen University and Research (WUR) and EPHI planned to develop food-based dietary guidelines for Ethiopian population above 2 years in the coming 4 years (until 2021).

The process for the development of the food-based dietary guidelines will have two major parts; the first part is developing the guidelines and advising how to use it at individual and HH level to improve dietary practice. To do this, establishing a national multidisciplinary technical working group composed of multiple concerned sectors such as ministry of health, ministry of agriculture and natural resources, ministry of livestock and fisheries, ministry of education, universities, research institute and development partners will be crucial to take into account different issues into consideration during the development and translation of the key messages in the FBDGs. The technical committee will agree on the key messages that have to be addressed on the FBDGs for the general population above 2 years based on evidence generated by WUR and EPHI on the wealth of foods, nutrients and health information, and other diet-related evidence and diet modeling. The general guidelines will translate into every day healthy dietary choices for specific population subgroups (women of reproductive age, school-age children, adolescent girls, adults and elderly) based on their dietary reference values. Food guide will be designed using the most commonly consumed foods in different regions of the country. In addition, dietary gap assessment will be done to see how far the FBDGs implementation can be possible in Ethiopia by comparing the current food supply with recommended healthy eating by the population. This will lead additional recommendations for policymakers and technical experts to set agriculture, trade and health target based on the demand formulated on Ethiopian food-based dietary guidelines. During the second part of the process, a healthy eating index will be developed which will be a measure of diet quality and relevant to evaluate the adherence to FBDGs. It is also relevant to determine the risk of diet-related diseases such as arthritis, diverticulitis, CVD, diabetes, common epithelial cancers, with colorectal cancer and mortality risk in Ethiopia for any future research. Therefore, the aim of this study is generating supportive evidence that will be useful for the development and validation of food-based dietary guidelines and a healthy eating index to Ethiopia.

Eligibility 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.

Primary outcomes:
measure: Amount of foods in gram per day from different food groups
timeFrame: From June 2018 - October 2021
measure: Healthy Eating Index
timeFrame: From June 2018 - October 2021
measure: Calorie gap from different food groups
timeFrame: From June 2018 - October 2021
Secondary outcomes:
measure: Top 10 diseases based on total number of disability-adjusted life-years (DALYs) among all age and sex in Ethiopia
timeFrame: From June 2018 - October 2021
measure: Top 10 diseases based on total number of death among all age and sex in Ethiopia
timeFrame: From June 2018 - October 2021
measure: Current dietary assessment among different population group
timeFrame: From June 2018 - October 2021
measure: Trend in nutritional status: body mass index (weight in kilogram/ height in meter square)
timeFrame: From June 2018 - October 2021
measure: Height in meter
timeFrame: From June 2018 - October 2021
measure: Weight in kilogram
timeFrame: From June 2018 - October 2021
measure: Cultural acceptability of food-based dietary guidelines
timeFrame: From June 2018 - October 2021
measure: Consumer understanding of food-based dietary guidelines
timeFrame: From June 2018 - October 2021
measure: Implementation feasibility of food-based dietary guidelines
timeFrame: From June 2018 - October 2021
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: Ethiopian Public Health Institute
Study officials:
affiliation: Wageningen University
name: Inge D Brouwer, PhD
role: STUDY_DIRECTOR
affiliation: Wageningen University
name: Edith Feskens, Prof., PhD
role: STUDY_CHAIR
affiliation: Wageningen University
name: Jeanne de Vries, PhD
role: STUDY_CHAIR
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