The Effect of Double Duty Interventions on Double Burden of Malnutrition Among School Adolescents in Ethiopia

Overweight Clinical Trial

— DBM  

Official title:

Effect of Double Duty Interventions on Double Burden of Malnutrition, Dietary Diversity Score, and Frequency of Morbidity Among Secondary School Adolescents in Central Ethiopia: Cluster Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05574842
• Other study ID #: 12/345/15
• Status: Completed
• Phase: N/A
• Start date: October 13, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2023
• Source: Debre Berhan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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. 1. What is the effect of double duty interventions on double burden of malnutrition among secondary school adolescents? 2. What is the effect of double duty interventions on dietary diversity score among secondary school adolescents? 3. What is the effect of double duty interventions on among secondary school adolescents?

Description:

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: - The proportion of secondary school adolescents with double burden of malnutrition who have received the selected double-duty interventions (DDIs). - 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). - The proportion of secondary school adolescents with frequency of morbidity who have received the selected double-duty interventions (DDIs). Research Hypothesis of the Study After this study has conducted, the following proposed expected outcomes will be achieved. - The double-duty interventions will be decreased the double burden of malnutrition in adolescents. - The double-duty interventions will be increased dietary diversity score of adolescents. - The double-duty interventions will decrease the frequency of morbidity of adolescents. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 742
• Est. completion date: June 30, 2023
• Est. primary completion date: November 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 19 Years

Eligibility

Inclusion Criteria:

• The study will be targeted secondary school adolescents in the study area.
• Secondary school adolescents who have followed their teaching learning process in the selected secondary schools for at least six months and above in the city during the study period will be included.
• Moreover, adolescents who had no intention of leaving the secondary schools until the end of the study will be included in this study.

Exclusion Criteria:

• Secondary school adolescents who will not be able to respond to an interview and who have physical disability including deformity such as kyphosis, scoliosis, and limb deformity which prevents standing erect will be excluded. Because it is not appropriate for anthropometric measurement.
• Moreover, participants who had confirmed diseases such as diabetes mellitus, hypertension etc., will be excluded from this study to improve the precision of anthropometric measurements and dietary practice.

Related Conditions & MeSH terms

• Diet Habit
• Malnutrition
• Malnutrition; Degree, Moderate
• Overnutrition
• Overweight
• Thinness
• Undernutrition
• Underweight

Intervention

Behavioral:
• Double duty interventions using nutrition behavior change communication approach
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).

Locations

Country	Name	City	State
Ethiopia	Debre Berhan University	Addis Ababa	Amhara

Sponsors (2)

Lead Sponsor	Collaborator
Debre Berhan University	Jimma University

Country where clinical trial is conducted

Ethiopia, 

References & Publications (10)

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. Erratum In: Lancet. 2019 Mar 23;393(10177):1204. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Lancet. 2020 Feb 1;395(10221):338. — View Citation

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. — View Citation

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.

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. — View Citation

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)

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

Outcome

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