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| Name | Class |
|---|---|
| Jimma University | OTHER |
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The goal of this cluster randomized controlled trial is to determine the effect of double duty interventions on double burden of malnutrition, dietary diversity score, and frequency of morbidity among secondary school adolescents in Debre Berhan City, Ethiopia. The main aim is to answer the following questions.
Introduction Double Burden of Malnutrition (DBM) is the simultaneous coexistence of undernutrition along with overweight and obesity within the same individuals, households, and populations at the national and international levels across the life course. For example, when DBM exists at the individual level, it can be occurring in the form of obesity with deficiency of one or more vitamins and minerals, or overweight in an adult who was stunted during childhood. Similarly, at the household level, it may be manifest in the forms of an overweight or anemic woman with underweight adolescents or grandparent. When it exists at the population level, the prevalence of both undernutrition and overweight/obesity can occur in the same community, nation, or region.
Adolescence is a critical period in the life-course of individuals next to infancy due to highly increased growth and development. It is ranging from 10 to 19 years and is a transition period from childhood to adulthood according to WHO. It is a period in which developmental effects related to puberty and brain development lead to new sets of diets, and also a time when increased nutrient intake is required for their rapid growth.
Every person obtains the social, physical, emotional, cognitive, and economic resources that are the groundwork for later life healthiness and welfare during adolescence. These resources outline paths of adolescents into the succeeding generations. Therefore, strategies, interventions, and investments in adolescent health and wellbeing bring benefits today, for decades to come, and for the next generation.
Double-duty interventions (DDIs) are interventions that have the potential to simultaneously tackle the burden of both undernutrition and overnutrition or diet-related NCDs in a comprehensive manner. These interventions can be achieved in three ways. First, though not harming the existing interventions on malnutrition. Second, by retrofitting the existing nutrition interventions to address all sorts of malnutrition. Third, through the development of de novo integrated interventions (starting from the beginning, anew, or a new) aimed at the DBM. These actions reflecting the shared drivers and platforms of contrasting forms of malnutrition.
Double-duty interventions also have the potential to improve nutrition outcomes across the spectrum of malnutrition through integrated initiatives, policies, and programs. It is not a zero-sum game in addressing contrasted and confounded forms of malnutrition in the global population. According to WHO 2017 policy brief, double-duty actions include about ten packages. These packages are categorized as health services packages, social safety nets packages, educational settings packages, agriculture, food systems, and food environments packages.
These selected potential candidates for double-duty interventions from each setting can be summarized into four points. These interventions are optimized strong education and nutrition behavior change communication focused on promotion of healthy diets (adequate adolescent nutrition, dietary diversity), physical activity (doing proper physical exercise, avoiding sitting for log time), prevent undue harm from energy-dense foods (avoiding junk processed foods, avoiding fizzy sweetened drinks, street fast foods, chips, salt, sugar etc.), and regulations on marketing foods from the customer side (e.g., buying of packed foods frequently). For this project, the most important and selected packages will be applied.
The final outcomes expected from this study are:
Research Hypothesis of the Study
After this study has conducted, the following proposed expected outcomes will be achieved.
Methods and Materials of the Study
Study area, period, and setting
This study will be conducted in Debre Berhan Regiopolitan City, North Shoa Zone, Amhara Region, Central Ethiopia. Debre Berhan Regiopolitan city is located 130 km away from Addis Ababa (the capital city of Ethiopia) and 690 km from Bahir Dar (the capital city of the Amhara region). It was founded by Emperor Zara Yakoob, and it is the capital city of North Shoa Zone of Amhara region. The city has coordinated with 9°41'N 39°32'E latitude and longitude, respectively. It is found at, 2840 m above sea level, which makes it the highest city of this size in Africa.
Study Design
This study will be used a six-month two-arm parallel design community-based cluster randomized controlled trial using clusters (kebeles) as a unit of randomization in the city.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The intervention arm will be received the double duty intervention through nutrition behavior change communication approach using a Health Belief Model. |
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| Control | No Intervention | The control arm will not be received the double duty intervention, rather they receive the standard intervention given by the government. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Double duty interventions using nutrition behavior change communication approach | Behavioral | The packages of the double-duty interventions were modified and adapted from the 2017 WHO policy brief report and Hawkes et al., 2020. These interventions are optimized strong education and nutrition behavior change communication focused on promotion of healthy diets (adequate adolescent nutrition, dietary diversity), physical activity (doing moderate intensity physical exercise, avoiding sitting for log time), prevent undue harm from energy-dense foods (avoiding Junk processed foods, avoiding fizzy sweetened drinks, street fast foods, chips, salt, sugar, fats etc.), and regulations on marketing foods from the customer side (e.g., buying of packed foods frequently). |
| Measure | Description | Time Frame |
|---|---|---|
| Proportions of Double Burden of Malnutrition | The proportion of secondary school adolescents with double burden of malnutrition who have received the selected double-duty interventions (DDIs) using an interviewer administered questionnaire. | six months [25 weeks] |
| Measure | Description | Time Frame |
|---|---|---|
| Proportions of High Dietary Diversity Score (taking ≥ 5 food groups from 10 food groups) | The proportion of secondary school adolescents with high dietary diversity score (greater than or equal to 5 food groups from ten food groups) who have received the selected double-duty interventions (DDIs) using an interviewer administered questionnaire. | six months [25 weeks] |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Debre Berhan University | Addis Ababa | Amhara | 445 | Ethiopia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27638762 | Background | Kulkarni VS, Kulkarni VS, Gaiha R. "Double Burden of Malnutrition": Reexamining the Coexistence of Undernutrition and Overweight Among Women in India. Int J Health Serv. 2017 Jan;47(1):108-133. doi: 10.1177/0020731416664666. Epub 2016 Sep 15. | |
| 30876706 | Background | Azzopardi PS, Hearps SJC, Francis KL, Kennedy EC, Mokdad AH, Kassebaum NJ, Lim S, Irvine CMS, Vos T, Brown AD, Dogra S, Kinner SA, Kaoma NS, Naguib M, Reavley NJ, Requejo J, Santelli JS, Sawyer SM, Skirbekk V, Temmerman M, Tewhaiti-Smith J, Ward JL, Viner RM, Patton GC. Progress in adolescent health and wellbeing: tracking 12 headline indicators for 195 countries and territories, 1990-2016. Lancet. 2019 Mar 16;393(10176):1101-1118. doi: 10.1016/S0140-6736(18)32427-9. Epub 2019 Mar 12. |
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Yet, I have no plan to share IPD to other researchers.
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A two-arm parallel cluster randomized control trial
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Due to the nature of the double-duty interventions, participant allocation concealment will not be possible. However, data collectors, participants, and nutrition behavior change communicators will be blinded from the study hypotheses. Besides, by using and labeling a non-identifiable unique number, the data entry clerk will be blinded until data analysis will be finalized.
|
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| Proportions of Frequency of Morbidity | The proportion of secondary school adolescents with frequency of morbidity who have received the selected double-duty interventions (DDIs) using an interviewer administered questionnaire. | six months [25 weeks] |
| Background | WHO. Guideline: Implementing Effective Actions for Improving Adolescent Nutrition [Internet]. 2018. Available from: http://apps.who.int/iris/bitstream/handle/10665/260297/9789241513708-eng.pdf%0Ajsessionid=19D1CBFA434795BA1645CC009FFE99A4?sequence=1 |
| 28436102 | Background | Das JK, Salam RA, Thornburg KL, Prentice AM, Campisi S, Lassi ZS, Koletzko B, Bhutta ZA. Nutrition in adolescents: physiology, metabolism, and nutritional needs. Ann N Y Acad Sci. 2017 Apr;1393(1):21-33. doi: 10.1111/nyas.13330. |
| Background | Nicholson A, Fawzi W, Canavan C, Keshavjee S. Advancing Global Nutrition for Adolescent and Family Health : Innovations in Research and Training. Proceedings of the Harvard Medical School Center for Global Health Delivery-Dubai. 2018, Dubai, United Arab Emirates. 2018. p. 1-75. |
| 27174304 | Background | Patton GC, Sawyer SM, Santelli JS, Ross DA, Afifi R, Allen NB, Arora M, Azzopardi P, Baldwin W, Bonell C, Kakuma R, Kennedy E, Mahon J, McGovern T, Mokdad AH, Patel V, Petroni S, Reavley N, Taiwo K, Waldfogel J, Wickremarathne D, Barroso C, Bhutta Z, Fatusi AO, Mattoo A, Diers J, Fang J, Ferguson J, Ssewamala F, Viner RM. Our future: a Lancet commission on adolescent health and wellbeing. Lancet. 2016 Jun 11;387(10036):2423-78. doi: 10.1016/S0140-6736(16)00579-1. Epub 2016 May 9. No abstract available. |
| 34856192 | Background | Hargreaves D, Mates E, Menon P, Alderman H, Devakumar D, Fawzi W, Greenfield G, Hammoudeh W, He S, Lahiri A, Liu Z, Nguyen PH, Sethi V, Wang H, Neufeld LM, Patton GC. Strategies and interventions for healthy adolescent growth, nutrition, and development. Lancet. 2022 Jan 8;399(10320):198-210. doi: 10.1016/S0140-6736(21)01593-2. Epub 2021 Nov 29. |
| 31852603 | Background | Hawkes C, Ruel MT, Salm L, Sinclair B, Branca F. Double-duty actions: seizing programme and policy opportunities to address malnutrition in all its forms. Lancet. 2020 Jan 11;395(10218):142-155. doi: 10.1016/S0140-6736(19)32506-1. Epub 2019 Dec 15. |
| 28528865 | Background | Hawkes C, Demaio AR, Branca F. Double-duty actions for ending malnutrition within a decade. Lancet Glob Health. 2017 Aug;5(8):e745-e746. doi: 10.1016/S2214-109X(17)30204-8. Epub 2017 May 18. No abstract available. |
| Background | WHO. Double-duty actions for nutrition. Policy Brief. Department of Nutrition for Health and Development World Health Organization. Geneva. Switzerland [Internet]. 2017. Available from: https://apps.who.int/iris/bitstream/handle/10665/255414/WHO-NMH-NHD-17.2-eng.pdf?ua=1 (Accessed on June 10, 2021) |
| 39948109 | Derived | Getacher L, Ademe BW, Belachew T. Effect of double duty interventions on dietary diversity score of adolescents using a cluster randomized controlled trial in Debre Berhan Regiopolitan City, Ethiopia. Sci Rep. 2025 Feb 13;15(1):5381. doi: 10.1038/s41598-025-88324-6. |
| 39703895 | Derived | Getacher L, Ademe BW, Belachew T. Effect of double-duty interventions on double burden of malnutrition among adolescents in Debre Berhan Regiopolitan City, Ethiopia: a cluster randomised controlled trial. J Nutr Sci. 2024 Nov 28;13:e74. doi: 10.1017/jns.2024.68. eCollection 2024. |
| 37545577 | Derived | Getacher L, Ademe BW, Belachew T. Double burden of malnutrition and its associated factors among adolescents in Debre Berhan Regiopolitan City, Ethiopia: a multinomial regression model analysis. Front Nutr. 2023 Jul 18;10:1187875. doi: 10.3389/fnut.2023.1187875. eCollection 2023. |
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D008224 | Lymphoma, Follicular |
| D005247 | Feeding Behavior |
| D044343 | Overnutrition |
| D013851 | Thinness |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001522 | Behavior, Animal |
| D001519 | Behavior |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| D003376 | Counseling |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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