Clinical trial NCT05574842: The Effect of Double Duty Interventions on Double Burden of Malnutrition Among School Adolescents in Ethiopia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition; Degree, Moderate
Diet Habit
Undernutrition
Overnutrition
Underweight
Overweight
Keywords: Double burden of malnutrition
Double-duty interventions
malnutrition
nutrition interventions
Lead sponsor: Debre Berhan University
Sponsor class: OTHER
Collaborators: name: Jimma University
First posted: 2022-10-12
Enrollment: 742
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A two-arm parallel cluster randomized control trial
Primary purpose: PREVENTION

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. 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?

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportions of Double Burden of Malnutrition
timeFrame: six months [25 weeks]
Secondary outcomes:
measure: Proportions of High Dietary Diversity Score (taking ≥ 5 food groups from 10 food groups)
timeFrame: six months [25 weeks]
measure: Proportions of Frequency of Morbidity
timeFrame: six months [25 weeks]
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: Debre Berhan University
state: Amhara
Study officials:
References:
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