UndernutritionNCT02302729
Early Child Development and Nutrition in Guatemala
A study testing Micronutrients and Responsive feeding in people with Undernutrition, run by University of Maryland, Baltimore at 1 site in Guatemala.
Trial summary
Over 200 million children under the age of 5 years in low and middle-income countries do not reach their developmental potential, largely due to lack of adequate nutrients and lack of psychosocial stimulation. Stunting (length-for-age < -2 z-scores) is an indication of chronic undernutrition. Read more about this study
- Who is it for?
- Ages 6 months to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Undernutrition
- What is being tested?
- Micronutrients and Responsive feeding
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,730 participants
- Where
- 1 siteGuatemala
- Study dates
- 16 Feb 2015to 8 Dec 2015
- 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 6 months to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child speaks Spanish.
- Child is age 6-12 months or age 36-48 months.
- Child must be undernourished (length and height for age < -1 z-score).
- Child does not have any obvious health or developmental problems that would interfere with growth, nutrition, or development.
- Child will remain in the area for the subsequent year.
- Parent or legal guardian of the child is age 18 years or older.
- Parent or legal guardian speaks and understands Spanish.
- Parent or legal guardian lives with child in study community.
Who cannot join
- Child is not age 6-12 months or 36-48 months.
- Child has severe stunting (length and height for age < -3 z-scores).
- Child has identified conditions that could interfere with their development and growth.
- Child is severely anemic (hemoglobin < 7).
Trial locations and contacts
1 site in 1 country.
Guatemala1 site
APEVIHS (Association for the Prevention and Study of HIV/AIDS)
Retalhuleu
About this study
Official title: Professor, Department of Pediatrics, University of Maryland School of Medicine
Over 200 million children under the age of 5 years in low and middle-income countries do not reach their developmental potential, largely due to lack of adequate nutrients and lack of psychosocial stimulation. Stunting (length-for-age < -2 z-scores) is an indication of chronic undernutrition. Guatemala has the high rates of stunting in the Western Hemisphere (over 40%). This trial examines the effect of providing a micronutrient powder manufactured in Guatemala vs. placebo and an early learning environment vs. no early learning environment on the growth, health, and development of young children in Guatemala.
Read the detailed description
The plan is to implement a clustered randomized placebo controlled trial with an infant phase (6-12 months of age) and a preschool phase (36-48 months of age). For the infant phase, the investigators will use ProPAN (Process for the Promotion of Child Feeding) in the development of the evaluation and intervention, with modifications as necessary for the Guatemalan context. ProPAN is a tool developed and distributed by the Pan American Health Organization to develop, implement, and evaluate interventions and programs to improve infant and young child diet and feeding. ProPAN includes four modules:
Module 1: Assessment Module 2: Testing Recipes and Recommendations Module 3: Intervention Module 4: Monitoring and Evaluation
For the preschool phase, the investigators will use an evidence-based school readiness intervention (Little By Little) that has been shown to be effective with Hispanic preschoolers. The intervention will be implemented through the Association for the Prevention and Study of HIV/AIDS who will train and supervise the community health workers. By working directly with a local non-profit organization, the project will be well positioned to inform strategies to scale up the intervention on a community wide basis, if beneficial effects are shown.
The project examines the effects of an integrated intervention that includes both micronutrient powder added to food and responsive feeding for infants or school readiness for preschoolers. The primary aim is to examine how an integrated micronutrients + responsive feeding/school readiness intervention changes the development (primary outcome), growth and micronutrient status (secondary outcomes) of young children. The investigators will focus on infants (6-12 months) when the risk for micronutrient deficiencies is high, as they transition from breast feeding to complementary feeding and the family diet. The investigators will focus on preschoolers (36-48 months) to examine if micronutrients + a school readiness intervention can improve children's school readiness skills. The design includes neighborhood clusters randomized into four groups: 1) micronutrients plus responsive feeding/school readiness 2) micronutrients only, 3) placebo plus responsive feeding/school readiness, and 4) placebo only.
The investigators will test the following hypotheses:
- Children in the two micronutrients groups have better change from baseline in development (primary outcome), growth and micronutrient status (secondary oitcomes), than children in the two placebo groups.
- Mothers and children in the two responsive feeding/school readiness groups have better change from baseline measures of child development than those in the two control groups.
- The impact of the responsive feeding/school readiness intervention is greater in the micronutrient groups than in the placebo groups. Children in the micronutrients plus responsive feeding/school readiness group have better change from baseline in development than children in any of the other three groups.
- Conditions
- Undernutrition
- Being tested
- Micronutrients, Responsive feeding, Placebo
- Keywords
- Micronutrient intervention, Responsive feeding intervention, School readiness intervention
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicronutrientsDietary supplement
Nutrient Quantity Nutrient Quantity Zinc 9 mg Copper 0.3 mg Iron 12.5 mg Vitamin D3 5 mg Folic Acid 160 mcg Vitamin E 5 mg Iodine 90 mcg Calcium 200 mg Vitamin A 250 mg Phosphorus 150 mg Vitamin C 40 mg Magnesium 40 mg Vitamin B12 0.9 mcg Selenium 17 mcg Thiamine 0.5 mg Manganese 0.17 mg Niacin 0.5 mg Biotin 8 mg Riboflavin 6 mg Vitamin B5 1.8 mg Vitamin B6 0.5 mg
Responsive feedingBehavioural
Strategy
Mother ensures that feeding area is set up with infant and mother able to see one another.
Mother mirrors the infant's facial expressions to attract the infant's attention.
Mother interprets infant's behavior with a positive voice, "Oh, you like the spinach." Mother extends infant's behavior by saying, "Oh the cereal is all gone" and doing a consistent hand signal Mother models eating, makes positive comments in a nurturing tone. Mother offers finger food or use of utensil
PlaceboDietary supplement
Riboflavin Vitamin B2
| Study group | Role | What they receive |
|---|---|---|
| Micronutrients No responsive feeding | Experimental | Micronutrient powder and no responsive feeding Receives: Dietary Supplement: Micronutrients |
| Placebo and Responsive Feeding | Placebo comparator | Placebo (vitamin B2) and Responsive Feeding Receives: Behavioral: Responsive feeding; Dietary Supplement: Placebo |
| Micronutrients and Responsive caregiving | Experimental | Micronutrients and Responsive feeding intervention Receives: Dietary Supplement: Micronutrients; Behavioral: Responsive feeding |
| Placebo and No responsive caregiving | Placebo comparator | Placebo and No responsive caregiving Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive, motor, social-emotional development from baseline to 12 months
Cognitive and social-emotional assessments
Measured: Baseline, 12 months
Secondary outcomes (2)
Change in Growth from baseline to 12 months
Weight, length/height
Measured: Baseline, 12 months
Change in micronutrient status from baseline to 12 months
Blood draw
Measured: Baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study start16 Feb 2015
- Primary completion8 Dec 2015
- Study completion8 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UndernutritionStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,730 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Association for the Study and Prevention of HIV/AIDS
- Responsible party
- Principal investigator, Maureen Black, University of Maryland, Baltimore
- Investigators
- Maureen M Black, Ph.D., Principal investigator, Uniersity of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302729
- Sponsor's protocol ID
- HP-00061322
- Status last verified
- Aug 2019
- First submitted
- 31 Oct 2014
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Unable to connect to PubMed to validate , last attempt on November 19, 2014 at 3:47 PM EST
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Professor, Department of Pediatrics, University of Maryland School of Medicine
- ClinicalTrials.gov ID
- NCT02302729
- Acronym / sponsor ID
- HP-00061322
- Conditions
- Undernutrition
- Keywords
- Micronutrient intervention, Responsive feeding intervention, School readiness intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,730 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Association for the Study and Prevention of HIV/AIDS
- Study start
- 16 Feb 2015 (actual)
- Primary completion
- 8 Dec 2015 (actual)
- Study completion
- 8 Dec 2015 (actual)
- First posted
- 27 Nov 2014 (estimated)
- 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.
Over 200 million children under the age of 5 years in low and middle-income countries do not reach their developmental potential, largely due to lack of adequate nutrients and lack of psychosocial stimulation. Stunting (length-for-age < -2 z-scores) is an indication of chronic undernutrition. Guatemala has the high rates of stunting in the Western Hemisphere (over 40%). This trial examines the effect of providing a micronutrient powder manufactured in Guatemala vs. placebo and an early learning environment vs. no early learning environment on the growth, health, and development of young children in Guatemala.
Detailed description
The plan is to implement a clustered randomized placebo controlled trial with an infant phase (6-12 months of age) and a preschool phase (36-48 months of age). For the infant phase, the investigators will use ProPAN (Process for the Promotion of Child Feeding) in the development of the evaluation and intervention, with modifications as necessary for the Guatemalan context. ProPAN is a tool developed and distributed by the Pan American Health Organization to develop, implement, and evaluate interventions and programs to improve infant and young child diet and feeding. ProPAN includes four modules:
Module 1: Assessment Module 2: Testing Recipes and Recommendations Module 3: Intervention Module 4: Monitoring and Evaluation
For the preschool phase, the investigators will use an evidence-based school readiness intervention (Little By Little) that has been shown to be effective with Hispanic preschoolers. The intervention will be implemented through the Association for the Prevention and Study of HIV/AIDS who will train and supervise the community health workers. By working directly with a local non-profit organization, the project will be well positioned to inform strategies to scale up the intervention on a community wide basis, if beneficial effects are shown.
The project examines the effects of an integrated intervention that includes both micronutrient powder added to food and responsive feeding for infants or school readiness for preschoolers. The primary aim is to examine how an integrated micronutrients + responsive feeding/school readiness intervention changes the development (primary outcome), growth and micronutrient status (secondary outcomes) of young children. The investigators will focus on infants (6-12 months) when the risk for micronutrient deficiencies is high, as they transition from breast feeding to complementary feeding and the family diet. The investigators will focus on preschoolers (36-48 months) to examine if micronutrients + a school readiness intervention can improve children's school readiness skills. The design includes neighborhood clusters randomized into four groups: 1) micronutrients plus responsive feeding/school readiness 2) micronutrients only, 3) placebo plus responsive feeding/school readiness, and 4) placebo only.
The investigators will test the following hypotheses:
- Children in the two micronutrients groups have better change from baseline in development (primary outcome), growth and micronutrient status (secondary oitcomes), than children in the two placebo groups.
- Mothers and children in the two responsive feeding/school readiness groups have better change from baseline measures of child development than those in the two control groups.
- The impact of the responsive feeding/school readiness intervention is greater in the micronutrient groups than in the placebo groups. Children in the micronutrients plus responsive feeding/school readiness group have better change from baseline in development than children in any of the other three groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Micronutrients No responsive feeding | Experimental | Dietary Supplement: MicronutrientsMicronutrient powder and no responsive feeding |
| Placebo and Responsive Feeding | Placebo comparator | Behavioral: Responsive feeding, Dietary Supplement: PlaceboPlacebo (vitamin B2) and Responsive Feeding |
| Micronutrients and Responsive caregiving | Experimental | Dietary Supplement: Micronutrients, Behavioral: Responsive feedingMicronutrients and Responsive feeding intervention |
| Placebo and No responsive caregiving | Placebo comparator | Dietary Supplement: PlaceboPlacebo and No responsive caregiving |
Who may qualify
- Ages
- 6 months to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Child speaks Spanish.
- Child is age 6-12 months or age 36-48 months.
- Child must be undernourished (length and height for age < -1 z-score).
- Child does not have any obvious health or developmental problems that would interfere with growth, nutrition, or development.
- Child will remain in the area for the subsequent year.
Key exclusion criteria (4 listed)
- Child is not age 6-12 months or 36-48 months.
- Child has severe stunting (length and height for age < -3 z-scores).
- Child has identified conditions that could interfere with their development and growth.
- Child is severely anemic (hemoglobin < 7).
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 |
|---|---|---|
| MicronutrientsNutrient Quantity Nutrient Quantity Zinc 9 mg Copper 0.3 mg Iron 12.5 mg Vitamin D3 5 mg Folic Acid 160 mcg Vitamin E 5 mg Iodine 90 mcg Calcium 200 mg Vitamin A 250 mg Phosphorus 150 mg Vitamin C 40 mg Magnesium 40 mg Vitamin B12 0.9 mcg Selenium 17 mcg Thiamine 0.5 mg Manganese 0.17 mg Niacin 0.5 mg Biotin 8 mg Riboflavin 6 mg Vitamin B5 1.8 mg Vitamin B6 0.5 mg | Dietary supplement | Micronutrients No responsive feeding, Micronutrients and Responsive caregiving |
| Responsive feedingStrategy Mother ensures that feeding area is set up with infant and mother able to see one another. Mother mirrors the infant's facial expressions to attract the infant's attention. Mother interprets infant's behavior with a positive voice, "Oh, you like the spinach." Mother extends infant's behavior by saying, "Oh the cereal is all gone" and doing a consistent hand signal Mother models eating, makes positive comments in a nurturing tone. Mother offers finger food or use of utensil | Behavioural | Micronutrients and Responsive caregiving, Placebo and Responsive Feeding |
| PlaceboRiboflavin Vitamin B2 | Dietary supplement | Placebo and No responsive caregiving, Placebo and Responsive Feeding |
Primary outcome
Change in cognitive, motor, social-emotional development from baseline to 12 months
Time frame: Baseline, 12 months
Cognitive and social-emotional assessments
2 secondary outcomes
Change in Growth from baseline to 12 months
Time frame: Baseline, 12 months
Change in micronutrient status from baseline to 12 months
Time frame: Baseline, 12 months
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 16 Aug 2019.
- BackgroundUnable to connect to PubMed to validate , last attempt on November 19, 2014 at 3:47 PM EST
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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.
Maureen M Black, Ph.D. principal investigator
Uniersity of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micronutrients and Responsive feeding in people with Undernutrition, run by University of Maryland, Baltimore at 1 site in Guatemala.
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 8 inclusion and 4 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 16 Aug 2019. 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 Guatemala. 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. Some participants in this study may receive a placebo. 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 cognitive, motor, social-emotional development from baseline to 12 months (time frame: Baseline, 12 months). 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 NCT02302729, which also lists 1 linked publication.
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 16 Aug 2019.