Nutrition DisordersNCT03423472
Improving Infant Nutrition in Southern Ethiopia
A study testing Orange Fleshed Sweet Potato (OFSP) agriculture promotion and nutrition education on vitamin A intake, Healthy Baby Toolkit and Standart of care in people with Nutrition Disorders, run by Emory University at 2 sites in 2 countries.
Trial summary
This cluster randomized controlled trial will test the effect of the promotion of vitamin A-rich orange flesh sweet potato (OFSP) production and nutrition education on vitamin A and energy intake, including any added value of the Healthy Baby Toolkit. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nutrition Disorders
- What is being tested?
- Orange Fleshed Sweet Potato (OFSP) agriculture promotion and nutrition education on vitamin A intake, Healthy Baby Toolkit and Standart of care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 605 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 8 Feb 2018to 1 Mar 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participation in a Healthy Living Club (only a criteria for those in partial or full intervention arms)
- Infant aged birth to 5 months
- Primary caregiver and head of household (if different from primary caregiver) available and provides consent for survey
Who cannot join
- 1. Serious health problem (for example, HIV/AIDS or congenital defect)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Ethiopia1 site
International Potato Center (CIP)
Sīdamo, Southern Nations, Nationalities, and Peoples' Region (snnpr)
About this study
Official title: Evaluation of Orange Fleshed Sweet Potato Promotion and the Healthy Baby Toolkit in Southern Ethiopia: a Cluster Randomized Controlled Trial
This cluster randomized controlled trial will test the effect of the promotion of vitamin A-rich orange flesh sweet potato (OFSP) production and nutrition education on vitamin A and energy intake, including any added value of the Healthy Baby Toolkit.
Read the detailed description
Child stunting and vitamin A deficiency are persistent public health problems in Ethiopia.
Quality Diets for Better Health (QDBH) is a European Union-funded project led by the International Potato Center (CIP), in partnership with People in Need (PIN), Emory University and with support of governmental organizations and local universities. The 54 month-project strives to improve diet quality, primarily of women and young children, through the promotion of vitamin A-rich orange flesh sweetpotato (OFSP) production and nutrition education in 41 kebeles (communities) in SNNPR, reaching an estimated 15000 households. In addition, households in a subset of communities will receive a Healthy Baby Toolkit, consisting of a marked bowl, slotted spoon, and illustrated counseling card. The Healthy Baby Toolkit is designed to promote optimal complementary feeding practices of infants and young children 6 to 23 months, namely meal volume, meal frequency, and meal thickness.
As part of this project, Emory University will conduct a longitudinal, cluster randomized controlled trial in 20 kebeles to test the effect of the project on vitamin A and energy intake, including any added value of the Healthy Baby Toolkit.
- Conditions
- Nutrition Disorders
- Being tested
- Orange Fleshed Sweet Potato (OFSP) agriculture promotion and nutrition education on vitamin A intake, Healthy Baby Toolkit, Standart of care
- Keywords
- Nutrition, Women, Young children, Ethiopia, Vitamin A, Orange flesh sweet potato
- Medical subject headings
- Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orange Fleshed Sweet Potato (OFSP) agriculture promotion and nutrition education on vitamin A intakeBehavioural
Support to farmers to grow and store OFSP in the form of agricultural extension, community based trainings and supplies, while simultaneously increasing community demand for OFSP through community-based Healthy Living Clubs. The Clubs promote OFSP, provide nutrition education, and conduct community mobilization events and social marketing of OFSP and OFSP-based processed products. Special emphasis is on women and children < 2y; especially diet diversity and vitamin A intake.
Healthy Baby ToolkitBehavioural
The toolkit consists of a demarcated bowl, a slotted spoon, and a counseling card. The demarcations on the bowl guide caregivers on age-specific meal volume and frequency. The slotted spoon promotes thicker food consistency - and therefore nutrient density - by cuing caregivers when food drips through the slots. The counseling card relies on images rather than text to reinforce messages of the previous two instruments, promote dietary diversity, and promote hygienic food preparation.
Standart of careBehavioural
Government standard of care for nutrition education through the Health Development Army
| Study group | Role | What they receive |
|---|---|---|
| Full intervention | Experimental | Healthy Baby Toolkit (HBT) in addition to Orange Fleshed Sweet Potato (OFSP) agriculture promotion and education on family nutrition, with special emphasis on women and children < 2y; especially diet diversity and vitamin A intake Receives: Behavioral: Orange Fleshed Sweet Potato (OFSP) agriculture promotion and nutrition education on vitamin A intake; Behavioral: Healthy Baby Toolkit; Behavioral: Standart of care |
| Partial intervention | Active comparator | Orange Fleshed Sweet Potato (OFSP) agriculture promotion and education on family nutrition, with special emphasis on women and children < 2y; especially diet diversity and vitamin A intake Receives: Behavioral: Orange Fleshed Sweet Potato (OFSP) agriculture promotion and nutrition education on vitamin A intake; Behavioral: Standart of care |
| Control | Other | Government standard of care for nutrition education through the Health Development Army Receives: Behavioral: Standart of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vitamin A intake of young children
Multiple linear regression will be used to explore the effect of intervention status on vitamin A intake, while controlling for covariates and assessing interaction. The Ethiopian Food Composition Tables I-IV will be used to derive the data from dietary data collected at midline and at endline.
Measured: Baseline, approximately 6 months at midline, and approximately 1 year at endline
Change in energy intake of young children
Multiple linear regression will be used to explore the effect of intervention status on energy intake, while controlling for covariates and assessing interaction. The Ethiopian Food Composition Tables I-IV will be used to derive the data from dietary data collected at midline and at endline.
Measured: Baseline, approximately 6 months at midline, and approximately 1 year at endline
Secondary outcomes (2)
Validation of survey-based indicators of meal volume for children ages 6 to 11 months
Nutrient intake data collected at midline and endline will be compared with caregiver responses to indicator questions using combinations of the following: Bland Altman plots, Pearson's correlation, sensitivity and specificity, and/or Receiver Operating Characteristic Curves.
Measured: Approximately 6 months at midline, and approximately 1 year at endline
Validation of survey-based indicators of food consistency for children ages 6 to 11 months
Nutrient density data collected at midline and endline will be compared with caregiver responses to indicator questions using combinations of the following: Bland Altman plots, Pearson's correlation, sensitivity and specificity, and/or Receiver Operating Characteristic Curves.
Measured: Approximately 6 months at midline, and approximately 1 year at endline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start8 Feb 2018
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition DisordersStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- 605 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Webb Girard, Emory University
- Investigators
- Amy Girard, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423472
- Sponsor's protocol ID
- IRB00099964
- Status last verified
- Apr 2019
- First submitted
- 20 Dec 2017
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Orange Fleshed Sweet Potato Promotion and the Healthy Baby Toolkit in Southern Ethiopia: a Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03423472
- Acronym / sponsor ID
- IRB00099964
- Conditions
- Nutrition Disorders
- Keywords
- Nutrition, Women, Young children, Ethiopia, Vitamin A, Orange flesh sweet potato
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 605 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 6 Feb 2018 (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.
This cluster randomized controlled trial will test the effect of the promotion of vitamin A-rich orange flesh sweet potato (OFSP) production and nutrition education on vitamin A and energy intake, including any added value of the Healthy Baby Toolkit.
Detailed description
Child stunting and vitamin A deficiency are persistent public health problems in Ethiopia.
Quality Diets for Better Health (QDBH) is a European Union-funded project led by the International Potato Center (CIP), in partnership with People in Need (PIN), Emory University and with support of governmental organizations and local universities. The 54 month-project strives to improve diet quality, primarily of women and young children, through the promotion of vitamin A-rich orange flesh sweetpotato (OFSP) production and nutrition education in 41 kebeles (communities) in SNNPR, reaching an estimated 15000 households. In addition, households in a subset of communities will receive a Healthy Baby Toolkit, consisting of a marked bowl, slotted spoon, and illustrated counseling card. The Healthy Baby Toolkit is designed to promote optimal complementary feeding practices of infants and young children 6 to 23 months, namely meal volume, meal frequency, and meal thickness.
As part of this project, Emory University will conduct a longitudinal, cluster randomized controlled trial in 20 kebeles to test the effect of the project on vitamin A and energy intake, including any added value of the Healthy Baby Toolkit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Full intervention | Experimental | Behavioral: Orange Fleshed Sweet Potato (OFSP) agriculture promotion and nutrition education on vitamin A intake, Behavioral: Healthy Baby Toolkit, Behavioral: Standart of careHealthy Baby Toolkit (HBT) in addition to Orange Fleshed Sweet Potato (OFSP) agriculture promotion and education on family nutrition, with special emphasis on women and children < 2y; especially diet diversity and vitamin A intake |
| Partial intervention | Active comparator | Behavioral: Orange Fleshed Sweet Potato (OFSP) agriculture promotion and nutrition education on vitamin A intake, Behavioral: Standart of careOrange Fleshed Sweet Potato (OFSP) agriculture promotion and education on family nutrition, with special emphasis on women and children < 2y; especially diet diversity and vitamin A intake |
| Control | Other | Behavioral: Standart of careGovernment standard of care for nutrition education through the Health Development Army |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Participation in a Healthy Living Club (only a criteria for those in partial or full intervention arms)
- Infant aged birth to 5 months
- Primary caregiver and head of household (if different from primary caregiver) available and provides consent for survey
Key exclusion criteria (1 listed)
- 1. Serious health problem (for example, HIV/AIDS or congenital defect)
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 |
|---|---|---|
| Orange Fleshed Sweet Potato (OFSP) agriculture promotion and nutrition education on vitamin A intakeSupport to farmers to grow and store OFSP in the form of agricultural extension, community based trainings and supplies, while simultaneously increasing community demand for OFSP through community-based Healthy Living Clubs. The Clubs promote OFSP, provide nutrition education, and conduct community mobilization events and social marketing of OFSP and OFSP-based processed products. Special emphasis is on women and children < 2y; especially diet diversity and vitamin A intake. | Behavioural | Full intervention, Partial intervention |
| Healthy Baby ToolkitThe toolkit consists of a demarcated bowl, a slotted spoon, and a counseling card. The demarcations on the bowl guide caregivers on age-specific meal volume and frequency. The slotted spoon promotes thicker food consistency - and therefore nutrient density - by cuing caregivers when food drips through the slots. The counseling card relies on images rather than text to reinforce messages of the previous two instruments, promote dietary diversity, and promote hygienic food preparation. | Behavioural | Full intervention |
| Standart of careGovernment standard of care for nutrition education through the Health Development Army | Behavioural | Control, Full intervention, Partial intervention |
Primary outcome
Change in vitamin A intake of young children
Time frame: Baseline, approximately 6 months at midline, and approximately 1 year at endline
Multiple linear regression will be used to explore the effect of intervention status on vitamin A intake, while controlling for covariates and assessing interaction. The Ethiopian Food Composition Tables I-IV will be used to derive the data from dietary data collected at midline and at endline.
Change in energy intake of young children
Time frame: Baseline, approximately 6 months at midline, and approximately 1 year at endline
Multiple linear regression will be used to explore the effect of intervention status on energy intake, while controlling for covariates and assessing interaction. The Ethiopian Food Composition Tables I-IV will be used to derive the data from dietary data collected at midline and at endline.
2 secondary outcomes
Validation of survey-based indicators of meal volume for children ages 6 to 11 months
Time frame: Approximately 6 months at midline, and approximately 1 year at endline
Validation of survey-based indicators of food consistency for children ages 6 to 11 months
Time frame: Approximately 6 months at midline, and approximately 1 year at endline
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 4 Apr 2019.
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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.
Amy Girard principal investigator
Emory University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orange Fleshed Sweet Potato (OFSP) agriculture promotion and nutrition education on vitamin A intake, Healthy Baby Toolkit and Standart of care in people with Nutrition Disorders, run by Emory University at 2 sites in 2 countries.
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 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Ethiopia. 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?
Change in vitamin A intake of young children (time frame: Baseline, approximately 6 months at midline, and approximately 1 year at endline). 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?
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 4 Apr 2019.