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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04121559
Other study ID # PHND-19-0949
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 8, 2019
Est. completion date April 29, 2021

Study information

Verified date February 2022
Source International Food Policy Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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?


Recruitment information / eligibility

Status Completed
Enrollment 1712
Est. completion date April 29, 2021
Est. primary completion date April 29, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 10 Years to 14 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
School Interventions
Classroom lessons on nutrition, dietary diversity, healthy food choices and handwashing. Principals provide messages on nutrition, dietary diversity, healthy food choices and handwashing at flag events or school assemblies. Selected adolescent girls are mentored by science teachers as peer mentors and hold weekly group discussions with other girls to discuss nutrition, dietary diversity, healthy food choices and handwashing. Trained science teachers take anthropometric measurements of adolescent girls to calculate BMI and provide nutrition counseling. Parent-teacher meetings to inform and encourage parents about adolescent nutrition, dietary diversity, healthy snacks, and handwashing.
Community Interventions
Home visits by HEWs and/or community volunteers to discuss with parents about adolescent nutrition, dietary diversity, healthy food choices, and handwashing. Community gatherings by HEWs and meetings with religious leaders to discuss with parents about adolescent nutrition, dietary diversity, healthy food choices, and handwashing.
School System Interventions
Workshop on the adolescent nutrition interventions for school principals, science teachers, HEWs, supervisors, and woreda officers. Biweekly supportive supervision on adolescent nutrition activities for schools and HEWs by school supervisors or woreda health/education office.

Locations

Country Name City State
United States International Food Policy Research Institute Washington District of Columbia

Sponsors (3)

Lead Sponsor Collaborator
International Food Policy Research Institute Addis Continental Institute of Public Health, FHI 360

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Review. — View Citation

Spear BA. Adolescent growth and development. J Am Diet Assoc. 2002 Mar;102(3 Suppl):S23-9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Dietary diversity among adolescent girls Mean number of food groups consumed by adolescent girls on the day preceding the interview. Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
Primary Minimum dietary diversity among adolescent girls Proportion of adolescent girls who consumed 5 or more food groups on the day preceding the interview. Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
Secondary Meal frequency Number of meal/snack times in the previous 24 hours Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
Secondary Consumption of unhealthy foods Consumption of sweets, baked sweets, sweetened beverages, and fried and salty foods in the previous 24 hours Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
Secondary Exposure to nutrition interventions at school and in the community Proportion of adolescent girls exposed to nutrition interventions at school and in the community Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
Secondary Nutrition and handwashing knowledge and practices among adolescent girls and their parents Proportion of adolescent girls and parents with correct knowledge of nutrition and appropriate handwashing practices based on survey responses Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
Secondary Nutrition and handwashing knowledge among school science teachers, principals, and HEWs Proportion of school science teachers, principals, and HEWs with correct knowledge of nutrition and appropriate handwashing practices based on survey responses Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
Secondary Delivery of adolescent nutrition interventions by school science teachers, principals, and HEWs Proportion of school science teachers, principals, and HEWs providing adolescent nutrition interventions at school and in the community based on survey responses Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
Secondary Availability of supporting resources Proportion of primary schools with training and supportive supervision for teachers/staff, educational materials, and healthy food environments based on enumerator observation and survey responses Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
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