Clinical trial NCT04121559: A Feasibility Study of Delivering Adolescent Nutrition Interventions Through School-Based Platforms in Ethiopia
Official title: A Feasibility Study of Delivering Adolescent Nutrition Interventions Through School-Based Platforms in Ethiopia: A Cluster-Randomized Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Diversity
Keywords: Adolescent Nutrition
Ethiopia
Lead sponsor: International Food Policy Research Institute
Sponsor class: OTHER
Collaborators: name: Addis Continental Institute of Public Health
name: FHI 360
First posted: 2019-10-10
Enrollment: 1712
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Alive \& Thrive (A\&T) is an initiative that supports the scaling up of nutrition interventions to save lives, prevent illnesses, and contribute to healthy growth and development through improved maternal nutrition, breastfeeding and complementary feeding practices. In Ethiopia, A\&T tested the feasibility of implementing a package of locally tailored adolescent nutrition interventions through school-based (flag assemblies, classroom lessons, girls' clubs, peer mentoring, weight and height measurement, and parent-teacher meetings) and community platforms (health post and home visits and community gatherings). The evaluation used a two-arm cluster-randomized, non-masked trial design, consisting of two cross-sectional surveys in 2019 and 2021.

Detailed description: Adolescence is a critical period of physical and psychological development and for achieving human potential. Rapid physical, psychosocial and cognitive growth and development is coupled with increased energy and nutrient requirements (Das et al., 2017; Spear 2002). Poor nutrition during adolescence can have adverse consequences impacting health in adulthood. The significance of nutrition during adolescence is especially important for girls, as poor nutrition can affect their well-being as well as the survival, health and well-being of their children (Das et al. 2017).

A\&T Ethiopia implemented a package of adolescent nutrition interventions through school-based (flag assemblies, classroom lessons, girls' clubs, peer mentoring, weight and height measurement, and parent-teacher meetings) and community platforms (health post and home visits and community gatherings). IFPRI tested the feasibility of the behavior-change interventions and examined their impacts on adolescent girls' diets, compared with standard school and community activities in control areas.

The evaluation used a two-arm cluster-randomized, non-masked trial design, consisting of two cross-sectional surveys of in-school adolescent girls aged 10-14 years enrolled in grades 4-8. The unit of randomization is the primary school which includes grades 1-8. The baseline survey was conducted in October-November 2019 (at the beginning of the school year), and the endline survey took place in March-April 2021 (following the end of first semester classes). In 2020, after 3 months of program implementation, program activities were halted from March to October (over 6 months) due to the COVID-19 pandemic, thus the endline survey was postponed to the following school year after implementation was reinitiated.

The overall study objective was to determine the feasibility of delivering adolescent nutrition interventions primarily through school-based platforms and their impact on the diet of adolescent girls.

Research questions include:

1. What is the program impact on the diet of adolescent girls: (1) dietary diversity, (2) meal frequency, and (3) less consumption of unhealthy foods/junk foods?
2. What is the exposure to adolescent nutrition interventions delivered through school-based platforms?
3. What factors influenced the integration of adolescent nutrition interventions into school-based platforms and their outcomes?

Eligibility criteria: Inclusion Criteria:

* Currently enrolled in primary school grades 4-8
* Parental consent and informed assent received
* Principals, teachers, service providers and primary schools in the areas

Exclusion Criteria:

* Age \<10 years or \>14 years

Primary outcomes:
measure: Dietary diversity among adolescent girls
timeFrame: Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
measure: Minimum dietary diversity among adolescent girls
timeFrame: Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
Secondary outcomes:
measure: Meal frequency
timeFrame: Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
measure: Consumption of unhealthy foods
timeFrame: Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
measure: Exposure to nutrition interventions at school and in the community
timeFrame: Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
measure: Nutrition and handwashing knowledge and practices among adolescent girls and their parents
timeFrame: Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
measure: Nutrition and handwashing knowledge among school science teachers, principals, and HEWs
timeFrame: Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
measure: Delivery of adolescent nutrition interventions by school science teachers, principals, and HEWs
timeFrame: Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
measure: Availability of supporting resources
timeFrame: Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
Other outcomes:
Locations:
city: Washington
country: United States
facility: International Food Policy Research Institute
state: District of Columbia
Study officials:
References:
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.
citation: Spear BA. Adolescent growth and development. J Am Diet Assoc. 2002 Mar;102(3 Suppl):S23-9. doi: 10.1016/s0002-8223(02)90418-9. No abstract available.