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CompletedNCT05574842DBMUpdated Jul 13, 2023

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

An interventional study of Double duty interventions using nutrition behavior change communication approach in Malnutrition; Degree, Moderate, Diet Habit and Undernutrition, sponsored by Debre Berhan University. Completed at 1 site in Ethiopia. Open to participants aged 10 Years to 19 Years. Per ClinicalTrials.gov, last updated 2023-07-13.

Sponsored by Debre Berhan University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
742
Allocation
Randomized
Ages
10 Years to 19 Years
Sex
All
01

Study 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?
Read the detailed 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.

02

Conditions studied

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

Keywords

  • Double burden of malnutrition
  • Double-duty interventions
  • malnutrition
  • nutrition interventions
03

In context

Malnutrition

1,277 studies on the registry are indexed under Malnutrition; 230 are open to participants now.

This study's enrollment of 742 is above the median of 118 across 843 interventional studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

Debre Berhan University is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
742 participants (actual)

Study arms

  • Experimental
    Intervention

    The intervention arm will be received the double duty intervention through nutrition behavior change communication approach using a Health Belief Model.

    Behavioral: Double duty interventions using nutrition behavior change communication approach

  • No intervention
    Control

    The control arm will not be received the double duty intervention, rather they receive the standard intervention given by the government.

Interventions

  • BehavioralDouble 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).

    Also known as: Nutrition education and counselling (NEC), nutrition behavior change communication (NBCC)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: six months [25 weeks]

Secondary outcomes

  1. 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.

    Time frame: six months [25 weeks]

  2. 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.

    Time frame: six months [25 weeks]

07

Study locations

1 site
  • Debre Berhan University
    Addis Ababa, Amhara 445, Ethiopia
08

References and documents

Publications

  • 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. PubMed 27638762 ↗
  • 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. doi: 10.1016/S0140-6736(19)30578-1. PubMed 30876706 ↗
  • 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
  • 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. PubMed 28436102 ↗
  • 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. PubMed 27174304 ↗
  • 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. PubMed 34856192 ↗
  • 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. doi: 10.1016/S0140-6736(20)30065-9. PubMed 31852603 ↗
  • 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. PubMed 28528865 ↗
  • 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)

Individual participant data

Plan to share: No — Yet, I have no plan to share IPD to other researchers.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05574842
Lead sponsor
Debre Berhan University
Collaborators
Jimma University
Responsible party
Lemma Getacher (Principal Investigator, Debre Berhan University) — Principal investigator
First posted
Oct 12, 2022
Start date
Oct 13, 2022
Primary completion
Nov 14, 2022
Completion
Jun 30, 2023
Last update
Jul 13, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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