NCT05574842

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
742

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 12, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

October 13, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

July 13, 2023

Status Verified

July 1, 2023

Enrollment Period

1 month

First QC Date

September 30, 2022

Last Update Submit

July 12, 2023

Conditions

Keywords

Double burden of malnutritionDouble-duty interventionsmalnutritionnutrition interventions

Outcome Measures

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.

    six months [25 weeks]

Secondary Outcomes (2)

  • Proportions of High Dietary Diversity Score (taking ≥ 5 food groups from 10 food groups)

    six months [25 weeks]

  • Proportions of Frequency of Morbidity

    six months [25 weeks]

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

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)
Intervention

Eligibility Criteria

Age10 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Debre Berhan University

Addis Ababa, Amhara, 445, Ethiopia

Location

Related Publications (13)

  • 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.

    PMID: 27638762BACKGROUND
  • 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.

    PMID: 30876706BACKGROUND
  • 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

    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.

    PMID: 28436102BACKGROUND
  • 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.

    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.

    PMID: 27174304BACKGROUND
  • 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.

    PMID: 34856192BACKGROUND
  • 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.

    PMID: 31852603BACKGROUND
  • 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.

    PMID: 28528865BACKGROUND
  • 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)

    BACKGROUND
  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

MalnutritionLymphoma, FollicularFeeding BehaviorOvernutritionThinnessOverweight

Interventions

Nutrition AssessmentCounseling

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBehavior, AnimalBehaviorBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthMental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A two-arm parallel cluster randomized control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 30, 2022

First Posted

October 12, 2022

Study Start

October 13, 2022

Primary Completion

November 14, 2022

Study Completion

June 30, 2023

Last Updated

July 13, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Yet, I have no plan to share IPD to other researchers.

Locations