Dietary DiversityNCT04121559
A Feasibility Study of Delivering Adolescent Nutrition Interventions Through School-Based Platforms in Ethiopia
A study testing School Interventions, Community Interventions and School System Interventions in people with Dietary Diversity, run by International Food Policy Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 14 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dietary Diversity
- What is being tested?
- School Interventions, Community Interventions and School System Interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,712 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2019to 29 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Currently enrolled in primary school grades 4-8
- Parental consent and informed assent received
- Principals, teachers, service providers and primary schools in the areas
Who cannot join
- Age <10 years or >14 years
Trial locations and contacts
1 site in 1 country.
United States1 site
International Food Policy Research Institute
Washington D.C., District of Columbia, 20005
About this study
Official title: A Feasibility Study of Delivering Adolescent Nutrition Interventions Through School-Based Platforms in Ethiopia: A Cluster-Randomized Evaluation
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.
Read the 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:
- 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?
- What is the exposure to adolescent nutrition interventions delivered through school-based platforms?
- What factors influenced the integration of adolescent nutrition interventions into school-based platforms and their outcomes?
- Conditions
- Dietary Diversity
- Being tested
- School Interventions, Community Interventions, School System Interventions
- Keywords
- Adolescent Nutrition, Ethiopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School InterventionsBehavioural
- 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 InterventionsBehavioural
- 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 InterventionsBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | A\&T intervention areas: adolescent-nutrition-focused behavior change interventions delivered through government primary schools and communities Receives: Behavioral: School Interventions; Behavioral: Community Interventions; Behavioral: School System Interventions |
| Control | No intervention | Comparison areas: standard activities at government primary schools |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary diversity among adolescent girls
Mean number of food groups consumed by adolescent girls on the day preceding the interview.
Measured: 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.
Measured: Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
Secondary outcomes (7)
Meal frequency
Number of meal/snack times in the previous 24 hours
Measured: Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
Consumption of unhealthy foods
Consumption of sweets, baked sweets, sweetened beverages, and fried and salty foods in the previous 24 hours
Measured: 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
Proportion of adolescent girls exposed to nutrition interventions at school and in the community
Measured: 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
Proportion of adolescent girls and parents with correct knowledge of nutrition and appropriate handwashing practices based on survey responses
Measured: 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
Proportion of school science teachers, principals, and HEWs with correct knowledge of nutrition and appropriate handwashing practices based on survey responses
Measured: Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
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
Measured: Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
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
Measured: Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start8 Oct 2019
- Primary completion29 Apr 2021
- Study completion29 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dietary DiversityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,712 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Food Policy Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Addis Continental Institute of Public Health, FHI 360
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121559
- Sponsor's protocol ID
- PHND-19-0949
- Status last verified
- Feb 2022
- First submitted
- 8 Oct 2019
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 28436102Spear 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.
PubMed 11902385Kim 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.
PubMed 37666262
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Delivering Adolescent Nutrition Interventions Through School-Based Platforms in Ethiopia: A Cluster-Randomized Evaluation
- ClinicalTrials.gov ID
- NCT04121559
- Acronym / sponsor ID
- PHND-19-0949
- Conditions
- Dietary Diversity
- Keywords
- Adolescent Nutrition, Ethiopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,712 participants (actual)
- Lead sponsor
- International Food Policy Research InstituteUniversity, hospital or other
- Collaborators
- Addis Continental Institute of Public Health, FHI 360
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 29 Apr 2021 (actual)
- Study completion
- 29 Apr 2021 (actual)
- First posted
- 10 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- What is the exposure to adolescent nutrition interventions delivered through school-based platforms?
- What factors influenced the integration of adolescent nutrition interventions into school-based platforms and their outcomes?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: School Interventions, Behavioral: Community Interventions, Behavioral: School System InterventionsA\&T intervention areas: adolescent-nutrition-focused behavior change interventions delivered through government primary schools and communities |
| Control | No intervention | –Comparison areas: standard activities at government primary schools |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Currently enrolled in primary school grades 4-8
- Parental consent and informed assent received
- Principals, teachers, service providers and primary schools in the areas
Key exclusion criteria (1 listed)
- Age <10 years or >14 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| School Interventions1. 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. | Behavioural | Intervention |
| Community Interventions1. 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. | Behavioural | Intervention |
| School System Interventions1. 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. | Behavioural | Intervention |
Primary outcome
Dietary diversity among adolescent girls
Time frame: Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
Mean number of food groups consumed by adolescent girls on the day preceding the interview.
Minimum dietary diversity among adolescent girls
Time frame: Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
Proportion of adolescent girls who consumed 5 or more food groups on the day preceding the interview.
7 secondary outcomes
Meal frequency
Time frame: Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
Consumption of unhealthy foods
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
Delivery of adolescent nutrition interventions by school science teachers, principals, and HEWs
Time frame: Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
Availability of supporting resources
Time frame: Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Background: PubMed 28436102Das 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.
- Background: PubMed 11902385Spear 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.
- Derived from this study: PubMed 37666262Kim 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing School Interventions, Community Interventions and School System Interventions in people with Dietary Diversity, run by International Food Policy Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary diversity among adolescent girls (time frame: Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04121559, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.