NCT04121559

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,712

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

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

October 8, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

October 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2021

Completed
Last Updated

March 10, 2022

Status Verified

February 1, 2022

Enrollment Period

1.6 years

First QC Date

October 8, 2019

Last Update Submit

February 23, 2022

Conditions

Keywords

Adolescent NutritionEthiopia

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (7)

  • Meal frequency

    Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021

  • Consumption of unhealthy foods

    Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021

  • Exposure to nutrition interventions at school and in the community

    Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021

  • Nutrition and handwashing knowledge and practices among adolescent girls and their parents

    Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021

  • Nutrition and handwashing knowledge among school science teachers, principals, and HEWs

    Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021

  • +2 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

A\&T intervention areas: adolescent-nutrition-focused behavior change interventions delivered through government primary schools and communities

Behavioral: School InterventionsBehavioral: Community InterventionsBehavioral: School System Interventions

Control

NO INTERVENTION

Comparison areas: standard activities at government primary schools

Interventions

1. Classroom lessons on nutrition, dietary diversity, healthy food choices and handwashing. 2. Principals provide messages on nutrition, dietary diversity, healthy food choices and handwashing at flag events or school assemblies. 3. 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. 4. Trained science teachers take anthropometric measurements of adolescent girls to calculate BMI and provide nutrition counseling. 5. Parent-teacher meetings to inform and encourage parents about adolescent nutrition, dietary diversity, healthy snacks, and handwashing.

Intervention

1. Home visits by HEWs and/or community volunteers to discuss with parents about adolescent nutrition, dietary diversity, healthy food choices, and handwashing. 2. Community gatherings by HEWs and meetings with religious leaders to discuss with parents about adolescent nutrition, dietary diversity, healthy food choices, and handwashing.

Intervention

1. Workshop on the adolescent nutrition interventions for school principals, science teachers, HEWs, supervisors, and woreda officers. 2. Biweekly supportive supervision on adolescent nutrition activities for schools and HEWs by school supervisors or woreda health/education office.

Intervention

Eligibility Criteria

Age10 Years - 14 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Age \<10 years or \>14 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Food Policy Research Institute

Washington D.C., District of Columbia, 20005, United States

Location

Related Publications (3)

  • 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
  • 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.

    PMID: 11902385BACKGROUND
  • Kim SS, Sununtnasuk C, Berhane HY, Walissa TT, Oumer AA, Asrat YT, Sanghvi T, Frongillo EA, Menon P. Feasibility and impact of school-based nutrition education interventions on the diets of adolescent girls in Ethiopia: a non-masked, cluster-randomised, controlled trial. Lancet Child Adolesc Health. 2023 Oct;7(10):686-696. doi: 10.1016/S2352-4642(23)00168-2. Epub 2023 Sep 1.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2019

First Posted

October 10, 2019

Study Start

October 8, 2019

Primary Completion

April 29, 2021

Study Completion

April 29, 2021

Last Updated

March 10, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

In compliance with donor open access policy requirements, fully anonymized datasets will be made publicly available one year after the end of the project. Metadata and other documentation of data collection procedures (such as the codebook, data collection instruments and interviewer guides/protocols) will also be made publicly available.

Shared Documents
STUDY PROTOCOL
Time Frame
Fully anonymized datasets will be made publicly available one year after the end of the project.

Locations