Development, ChildINICIONCT07383428
The INICIO-Guatemala Study
A study testing Nutri-INICIO and Mediational Intervention for Sensitizing Caregivers (MISC in people with Development, Child, run by University of North Carolina, Chapel Hill at 1 site in Guatemala.
Trial summary
The goal of this randomized controlled trial (RCT) is to evaluate an intestinal health-targeted nutritional intervention and a caregiver training program, individually and combined, on childhood neurodevelopment (ND) in rural southwest Guatemala. Read more about this study
- Who is it for?
- Ages 0 days to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Development, Child
- What is being tested?
- Nutri-INICIO and Mediational Intervention for Sensitizing Caregivers (MISC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteGuatemala
- Study dates
- 2 Jul 2026to 15 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 days to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant woman in the second trimester of pregnancy
- Pregnant woman =>15 years of age
- Plan to live in the study area during pregnancy and up to 24 months after giving birth
- Newborns born to enrolled women will join the study at birth
Who cannot join
- Pregnant woman less than 15 years of age
- Planning to move during the study
- Not willing or able to participate in the interventions, including following instructions for preparing the food, completing the adherence forms, participating in the caregiving sessions
- Women who do not sign the consent form for their or their child's participation
- Infants who require a hospital stay after birth of 21 days or longer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Guatemala1 site, 1 recruiting
- Recruiting
Fundacion para la Salud Integral de los Guatemaltecos
Coatepeque, Departamento de Quetzaltenango
Neudy Rojop, +505-3794-4597, Neudy Rojop <neudy.rojop.fsigcu@gmail.com>
About this study
Official title: IGHID 12601 - Improving Neurodevelopment With an Intestinal Health and Caregivers' Intervention in the surOeste, Guatemala: The INICIO-Guatemala Study
The goal of this randomized controlled trial (RCT) is to evaluate an intestinal health-targeted nutritional intervention and a caregiver training program, individually and combined, on childhood neurodevelopment (ND) in rural southwest Guatemala.
The main questions it aims to answer are: what is the impact of an intestinal-targeted nutritional intervention on child ND and what is the added benefit of a caregiver intervention on child ND.
Read more
The primary endpoint is the Mullen Scales of Early Learning (MSEL) Early Learning Composite (ELC) Score at 24 months. Secondary endpoints include MSEL subdomain scores (gross motor, fine motor, expressive language, receptive language, visual reception).
Researchers will compare child ND between the four study arms using a factorial design: (1) intestinal health-targeted nutritional intervention, (2) caregiving training program, (3) combined intestinal health-targeted nutritional intervention and caregiving training program, and (4) active control.
Participants will be randomized as mother-child dyads at 6 months of age and followed until 24 months of age.
Read the detailed description
The investigators plan to enroll 400 pregnant women during the second trimester of pregnancy; randomization of mother-child dyads into the four study groups will occur at 6 months of infant age; infants will be followed through 24 months of age. Randomization will occur using a 2×2 factorial design into the four groups. The nutritional intervention, Nutri-INICIO, is a fortified maize-bean-rice bran porridge intended to improve intestinal health and growth. The caregiver intervention, the Mediational Intervention for Sensitizing Caregivers (MISC), consists of twice-monthly, video-feedback-based training sessions from 12-24 months to enhance responsive caregiving.
- Conditions
- Development, Child
- Being tested
- Nutri-INICIO, Mediational Intervention for Sensitizing Caregivers (MISC, Active Control
- Keywords
- Nutritional intervention, Microbiome, Caregiving, Rice bran, Bean flour
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutri-INICIODietary supplement
Nutri-INICIO, is a fortified maize-bean-rice bran porridge intended to improve intestinal health and growth. Caregivers will be instructed on Nutri-INICIO preparation methods. Children 6-11 months old will receive a 20 gram daily serving, children 12-17 months old will receive a 30 gram daily serving, children 18-24 months old will receive a 40 gram daily serving. The investigators will ensure receipt of the essential components of the ministry of health childcare package including micronutrient supplementation and anti-parasite prophylaxis. Participants will also receive anemia screening and treatment as appropriate.
Mediational Intervention for Sensitizing Caregivers (MISCBehavioural
The Mediational Intervention for Sensitizing Caregivers (MISC) consists of twice-monthly, video-feedback-based training sessions from 12-24 months to enhance responsive caregiving. The investigators will ensure receipt of the essential components of the ministry of health childcare package including micronutrient supplementation and anti-parasite prophylaxis. Participants will also receive anemia screening and treatment as appropriate.
Active ControlOther
The control group will receive the same number of visits as the experimental groups and the investigators will ensure receipt of the essential components of the ministry of health childcare package including micronutrient supplementation and anti-parasite prophylaxis. Participants will also receive anemia screening and treatment as appropriate.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional Intervention | Experimental | Children in this arm will receive the Nutri-INICIO intervention between 6 and 24 months of age. Receives: Dietary Supplement: Nutri-INICIO |
| Caregiver Intervention | Experimental | Caregivers of child participants in this arm will be trained in the Mediational Intervention for Sensitizing Caregivers (MISC) between 12 and 24 months of child age. Receives: Behavioral: Mediational Intervention for Sensitizing Caregivers (MISC |
| Nutritional Intervention and Caregiver Intervention | Experimental | Children in this arm will receive the Nutri-INICIO intervention between 6 and 24 months of age and their caregivers will be trained in the MISC between 12 and 24 months of child age. Receives: Dietary Supplement: Nutri-INICIO; Behavioral: Mediational Intervention for Sensitizing Caregivers (MISC |
| Active Control | Active comparator | Children in this arm will receive the same number of study visits as the experimental groups and will receive essential components of the Minister of Health's childcare package, including micronutrient supplementation. Receives: Other: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mullen Scales of Early Learning (MSEL) Early Learning Composite Score (ELC)
Comprehensive neurodevelopment score, combining scores from the four "cognitive" domains of fine motor, visual reception, receptive language, and expressive language. Z-scores for each of the 4 domains will be calculated by regressing raw score for age. The mean of those four Z-scores will make up the Early Learning Composite Z-score. The score will range from -3 to +3, with the higher score indicating more advanced neurodevelopment.
Measured: 24 months of age
Secondary outcomes (5)
Mullen Scales of Early Learning Gross Motor Domain
The MSEL gross motor domain measures the child's gross motor development. A Z-score will calculated by regressing raw score for age. The score will range from -3 to +3, with the higher score indicating more advanced gross motor development.
Measured: 24 months
Mullen Scales of Early Learning Fine Motor Domain
The MSEL fine motor domain measures the child's find motor development. A Z-score will calculated by regressing raw score for age. The score will range from -3 to +3, with the higher score indicating more advanced fine motor development.
Measured: 24 months
Mullen Scales of Early Learning Visual Reception Domain
The MSEL visual reception domain measures the child's find motor development. A Z-score will calculated by regressing raw score for age. The score will range from -3 to +3, with the higher score indicating more advanced fine motor development.
Measured: 24 months
Mullen Scales of Early Learning Receptive Language Domain
The MSEL receptive language domain measures the child's find motor development. A Z-score will calculated by regressing raw score for age. The score will range from -3 to +3, with the higher score indicating more advanced receptive language development.
Measured: 24 months
Mullen Scales of Early Learning Expressive Language Domain
The MSEL expressive language domain measures the child's find motor development. A Z-score will calculated by regressing raw score for age. The score will range from -3 to +3, with the higher score indicating more advanced expressive language development.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start2 Jul 2026
- Primary completion15 Jun 2030 (estimated)
- Study completion15 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Development, ChildStudies 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
- Factorial
- Model description
- 2x2
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Sylvia Becker-Dreps, MD, MPH, Principal investigator, University of North Carolina, Chapel HillAmy K Connery, PsyD, Principal investigator, University of Colorado School of MedicineDiva Mirella Barrientos Giron, MD, Principal investigator, Fundacion para la Salud Integral de los Guatemaltecos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383428
- Sponsor's protocol ID
- 26-0089
- Other IDs
- R01HD116306
- Acronym
- INICIO
- Status last verified
- Jul 2026
- First submitted
- 26 Jan 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared at the time of publication. The data from this study will be made publicly available on the NICHD Data and Specimen Hub (DASH) (https://dash.nichd.nih.gov/) .
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IGHID 12601 - Improving Neurodevelopment With an Intestinal Health and Caregivers' Intervention in the surOeste, Guatemala: The INICIO-Guatemala Study
- ClinicalTrials.gov ID
- NCT07383428
- Acronym / sponsor ID
- INICIO / 26-0089
- Conditions
- Development, Child
- Keywords
- Nutritional intervention, Microbiome, Caregiving, Rice bran, Bean flour
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 2 Jul 2026 (actual)
- Primary completion
- 15 Jun 2030 (estimated)
- Study completion
- 15 Jun 2030 (estimated)
- First posted
- 3 Feb 2026 (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.
The goal of this randomized controlled trial (RCT) is to evaluate an intestinal health-targeted nutritional intervention and a caregiver training program, individually and combined, on childhood neurodevelopment (ND) in rural southwest Guatemala.
The main questions it aims to answer are: what is the impact of an intestinal-targeted nutritional intervention on child ND and what is the added benefit of a caregiver intervention on child ND.
The primary endpoint is the Mullen Scales of Early Learning (MSEL) Early Learning Composite (ELC) Score at 24 months. Secondary endpoints include MSEL subdomain scores (gross motor, fine motor, expressive language, receptive language, visual reception).
Researchers will compare child ND between the four study arms using a factorial design: (1) intestinal health-targeted nutritional intervention, (2) caregiving training program, (3) combined intestinal health-targeted nutritional intervention and caregiving training program, and (4) active control.
Participants will be randomized as mother-child dyads at 6 months of age and followed until 24 months of age.
Detailed description
The investigators plan to enroll 400 pregnant women during the second trimester of pregnancy; randomization of mother-child dyads into the four study groups will occur at 6 months of infant age; infants will be followed through 24 months of age. Randomization will occur using a 2×2 factorial design into the four groups. The nutritional intervention, Nutri-INICIO, is a fortified maize-bean-rice bran porridge intended to improve intestinal health and growth. The caregiver intervention, the Mediational Intervention for Sensitizing Caregivers (MISC), consists of twice-monthly, video-feedback-based training sessions from 12-24 months to enhance responsive caregiving.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 2x2
| Arm | Type | Receives |
|---|---|---|
| Nutritional Intervention | Experimental | Dietary Supplement: Nutri-INICIOChildren in this arm will receive the Nutri-INICIO intervention between 6 and 24 months of age. |
| Caregiver Intervention | Experimental | Behavioral: Mediational Intervention for Sensitizing Caregivers (MISCCaregivers of child participants in this arm will be trained in the Mediational Intervention for Sensitizing Caregivers (MISC) between 12 and 24 months of child age. |
| Nutritional Intervention and Caregiver Intervention | Experimental | Dietary Supplement: Nutri-INICIO, Behavioral: Mediational Intervention for Sensitizing Caregivers (MISCChildren in this arm will receive the Nutri-INICIO intervention between 6 and 24 months of age and their caregivers will be trained in the MISC between 12 and 24 months of child age. |
| Active Control | Active comparator | Other: Active ControlChildren in this arm will receive the same number of study visits as the experimental groups and will receive essential components of the Minister of Health's childcare package, including micronutrient supplementation. |
Who may qualify
- Ages
- 0 days to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Pregnant woman in the second trimester of pregnancy
- Pregnant woman =>15 years of age
- Plan to live in the study area during pregnancy and up to 24 months after giving birth
- Newborns born to enrolled women will join the study at birth
Key exclusion criteria (5 listed)
- Pregnant woman less than 15 years of age
- Planning to move during the study
- Not willing or able to participate in the interventions, including following instructions for preparing the food, completing the adherence forms, participating in the caregiving sessions
- Women who do not sign the consent form for their or their child's participation
- Infants who require a hospital stay after birth of 21 days or longer
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 |
|---|---|---|
| Nutri-INICIONutri-INICIO, is a fortified maize-bean-rice bran porridge intended to improve intestinal health and growth. Caregivers will be instructed on Nutri-INICIO preparation methods. Children 6-11 months old will receive a 20 gram daily serving, children 12-17 months old will receive a 30 gram daily serving, children 18-24 months old will receive a 40 gram daily serving. The investigators will ensure receipt of the essential components of the ministry of health childcare package including micronutrient supplementation and anti-parasite prophylaxis. Participants will also receive anemia screening and treatment as appropriate. | Dietary supplement | Nutritional Intervention, Nutritional Intervention and Caregiver Intervention |
| Mediational Intervention for Sensitizing Caregivers (MISCThe Mediational Intervention for Sensitizing Caregivers (MISC) consists of twice-monthly, video-feedback-based training sessions from 12-24 months to enhance responsive caregiving. The investigators will ensure receipt of the essential components of the ministry of health childcare package including micronutrient supplementation and anti-parasite prophylaxis. Participants will also receive anemia screening and treatment as appropriate. | Behavioural | Caregiver Intervention, Nutritional Intervention and Caregiver Intervention |
| Active ControlThe control group will receive the same number of visits as the experimental groups and the investigators will ensure receipt of the essential components of the ministry of health childcare package including micronutrient supplementation and anti-parasite prophylaxis. Participants will also receive anemia screening and treatment as appropriate. | Other | Active Control |
Primary outcome
Mullen Scales of Early Learning (MSEL) Early Learning Composite Score (ELC)
Time frame: 24 months of age
Comprehensive neurodevelopment score, combining scores from the four "cognitive" domains of fine motor, visual reception, receptive language, and expressive language. Z-scores for each of the 4 domains will be calculated by regressing raw score for age. The mean of those four Z-scores will make up the Early Learning Composite Z-score. The score will range from -3 to +3, with the higher score indicating more advanced neurodevelopment.
5 secondary outcomes
Mullen Scales of Early Learning Gross Motor Domain
Time frame: 24 months
Mullen Scales of Early Learning Fine Motor Domain
Time frame: 24 months
Mullen Scales of Early Learning Visual Reception Domain
Time frame: 24 months
Mullen Scales of Early Learning Receptive Language Domain
Time frame: 24 months
Mullen Scales of Early Learning Expressive Language Domain
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared at the time of publication. The data from this study will be made publicly available on the NICHD Data and Specimen Hub (DASH) (https://dash.nichd.nih.gov/) .
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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.
Sylvia Becker-Dreps, MD, MPH principal investigator
University of North Carolina, Chapel Hill
Amy K Connery, PsyD principal investigator
University of Colorado School of Medicine
Diva Mirella Barrientos Giron, MD principal investigator
Fundacion para la Salud Integral de los Guatemaltecos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutri-INICIO and Mediational Intervention for Sensitizing Caregivers (MISC in people with Development, Child, run by University of North Carolina, Chapel Hill 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 24 Jul 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neudy Rojop, MPH (+502-3794-4597, neudy.rojop.fsigcu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mullen Scales of Early Learning (MSEL) Early Learning Composite Score (ELC) (time frame: 24 months of age). 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 24 Jul 2026.