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A Feasibility Study of Delivering Adolescent Nutrition Interventions Through School-Based Platforms in Ethiopia

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ClinicalTrials.gov Identifier: NCT04121559
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : November 6, 2019
Sponsor:
Collaborators:
Addis Continental Institute of Public Health
FHI 360
Information provided by (Responsible Party):
International Food Policy Research Institute

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 will test the feasibility of implementing a package of locally tailored adolescent nutrition interventions through school-based (in-class curriculum, extracurricular activities, parent-teacher associations and activities, nutrition education discussions by health workers, and school campaigns) and community platforms. The evaluation will use a two-arm cluster-randomized, non-masked trial design, consisting of two surveys and following a sub-sample panel of in-school adolescent girls aged 10-14 years enrolled in grades 4-8.

Condition or disease Intervention/treatment Phase
Dietary Diversity Behavioral: A&T Interventions Not Applicable

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 will develop and test the feasibility of implementing a package of locally tailored adolescent nutrition interventions through school-based (in-class curriculum, extracurricular activities, parent-teacher associations and activities, nutrition education discussions by health workers, and school campaigns) and community platforms. The impacts of these nutrition-focused interventions will be compared with standard school and community activities in control areas.

The evaluation will use a two-arm cluster-randomized, non-masked trial design, consisting of two surveys and following a sub-sample panel of in-school adolescent girls aged 10-14 years enrolled in grades 4-8. The study will be implemented in two regions of Ethiopia, Southern Nations Nationalities and People's Region (SNNPR) and Somali. The unit of randomization is the primary school which includes grades 1-8. 31 schools in SNNPR and 23 schools in Somali will be randomly assigned to intervention/control.

The objectives of the proposed evaluation are to answer the following questions:

  1. Is it feasible to integrate locally relevant adolescent nutrition interventions through school-based platforms?
  2. What are the barriers and opportunities for strengthening school-based nutrition interventions for adolescents?
  3. What are the impacts of interventions on the consumption of quality of diets (dietary diversity and adequate intake of micronutrients, protein, and energy; and less consumption of unhealthy snacks) among adolescent girls?

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1242 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Feasibility Study of Delivering Adolescent Nutrition Interventions Through School-Based Platforms in Ethiopia: A Cluster-Randomized Evaluation
Actual Study Start Date : October 8, 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Child Nutrition

Arm Intervention/treatment
Experimental: Intervention
A&T intervention areas: adolescent-nutrition-focused behavior change interventions delivered through government primary schools and communities
Behavioral: A&T Interventions
  • Classroom sessions/lessons related to nutrition, dietary diversity, healthy food choices and hand washing.
  • School assemblies and discussions facilitated by Health Extension Workers (HEWs) related to nutrition, dietary diversity, healthy food choices and hand washing.
  • Kids club activities addressing nutrition, dietary diversity, healthy food choices and handwashing.
  • Parent-teacher association meetings, HEW-led community discussions, and other community gatherings to inform and encourage parents about adolescent nutrition, dietary diversity, importance of breakfast before school and healthy snacks, and handwashing.
  • Workshop on the adolescent nutrition interventions above for school principals, science teachers, HEWs, supervisors, and woreda officers.
  • Monthly/biweekly supportive supervision on adolescent nutrition activities for schools and HEWs by school supervisors or woreda health/education office.

No Intervention: Control
Comparison areas: standard activities at government primary schools



Primary Outcome Measures :
  1. Dietary diversity among adolescent girls [ Time Frame: Approximately 7 months after baseline in a cross-sectional endline survey scheduled for May-June 2020 ]
    Mean number of food groups consumed by adolescent girls on the day preceding the interview.

  2. Minimum dietary diversity among adolescent girls [ Time Frame: Approximately 7 months after baseline in a cross-sectional endline survey (with a panel subsample) scheduled for May-June 2020 ]
    Proportion of adolescent girls who consumed 5 or more food groups on the day preceding the interview.

  3. Micronutrient, protein and energy adequacy among adolescent girls [ Time Frame: Approximately 7 months after baseline in a cross-sectional endline survey (with a panel subsample) scheduled for May-June 2020 ]
    Proportion of adolescent girls whose micronutrient, protein and energy intakes are equal to or above the dietary reference intake.

  4. Exposure to nutrition interventions at school [ Time Frame: Approximately 7 months after baseline in a cross-sectional endline survey (with a panel subsample) scheduled for May-June 2020 ]
    Proportion of adolescent girls exposed to nutrition interventions at school


Secondary Outcome Measures :
  1. Healthy food choices among adolescent girls [ Time Frame: Approximately 7 months after baseline in a cross-sectional endline survey (with a panel subsample) scheduled for May-June 2020 ]
    Proportion of adolescent girls consuming fewer sugary drinks and salty/fatty processed foods

  2. School attendance among adolescent girls [ Time Frame: Approximately 7 months after baseline in a cross-sectional endline survey (with a panel subsample) scheduled for May-June 2020 ]
    Total number of days attended in the past school year

  3. Nutrition and handwashing knowledge among adolescent girls [ Time Frame: Approximately 7 months after baseline in a cross-sectional endline survey (with a panel subsample) scheduled for May-June 2020 ]
    Proportion of adolescent girls with correct knowledge of nutrition and appropriate handwashing practices based on survey responses

  4. School teacher, principal, and HEW knowledge of dietary diversity, healthy foods/snacks, and handwashing [ Time Frame: Approximately 7 months after baseline in a cross-sectional endline survey (with a panel subsample) scheduled for May-June 2020 ]
    Proportion of school teachers, principals, and HEWs with correct knowledge of dietary diversity, healthy foods/snacks, and appropriate handwashing practices based on survey responses

  5. Availability of supporting resources [ Time Frame: Approximately 7 months after baseline in a cross-sectional endline survey (with a panel subsample) scheduled for May-June 2020 ]
    Proportion of primary schools with educational materials, healthy food environments, and training and supportive supervision for teachers/staff based on enumerator observation and survey responses



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 14 Years   (Child)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04121559


Contacts
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Contact: Sunny S Kim, PhD +1 (202) 862-4611 sunny.kim@cgiar.org
Contact: Purnima Menon, PhD +91 11-66219-276 p.menon@cgiar.org

Locations
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United States, District of Columbia
International Food Policy Research Institute Recruiting
Washington, District of Columbia, United States, 20005
Contact: Sunny S Kim, PhD    202-862-4611    sunny.kim@cgiar.org   
Sponsors and Collaborators
International Food Policy Research Institute
Addis Continental Institute of Public Health
FHI 360

Publications:
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Responsible Party: International Food Policy Research Institute
ClinicalTrials.gov Identifier: NCT04121559     History of Changes
Other Study ID Numbers: PHND-19-0949
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Time Frame: Fully anonymized datasets will be made publicly available one year after the end of the project.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by International Food Policy Research Institute:
Adolescent Nutrition
Ethiopia