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MalnutritionNCT02509936

Promoting Physical Growth and Positive Development in Severely Stunted Guatemalan Children

A study testing Home-based nutrition education and Standard-of-care nutrition support in people with Malnutrition and Developmental Disabilities, run by Wuqu' Kawoq, Maya Health Alliance at 1 site in Guatemala.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study seeks to evaluate the impact of an intensive home-based education intervention targeting severely stunted Guatemalan children for catch up growth and improved development. Half of the children in the study will receive standard of care, which includes micronutrient supplementation and a food ration. Read more about this study

Who is it for?
Ages 6 to 24 months
Conditions the study is for
Malnutrition, Developmental Disabilities
What is being tested?
Home-based nutrition education and Standard-of-care nutrition support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
324 participants
Where
1 siteGuatemala
Study dates
Aug 2015to Oct 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 24 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Child aged 6-24 months at time of enrollment
  • Height/length for age Z score of less than -2.5
  • Child lives with parent/legal guardian

Who cannot join

  • Presence of acute malnutrition (weight for length/height Z score of less than -2)
  • Presence of other severe medical illness (e.g. congenital heart disease, genetic abnormality)

Trial locations and contacts

1 site in 1 country.

Guatemala1 site
  • Wuqu' Kawoq

    Tecpán Guatemala, Departamento de Chimaltenango

Other trials in Guatemala

About this study

Official title: Crowd Funding and Social Networks as a Novel Mechanism to Promote Sustainable Physical Growth and Positive Psychosocial and Neurodevelopmental Outcomes in Severely Stunted Guatemalan Children

This study seeks to evaluate the impact of an intensive home-based education intervention targeting severely stunted Guatemalan children for catch up growth and improved development. Half of the children in the study will receive standard of care, which includes micronutrient supplementation and a food ration. The other half of children in the study will receive, in addition to the above, home-based dietary assessment and individualized parental nutrition education.

Being tested
Home-based nutrition education, Standard-of-care nutrition support
Medical subject headings
Malnutrition, Developmental Disabilities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Home-based nutrition educationBehavioural

    Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.

  • Standard-of-care nutrition supportDietary supplement

    Subjects will be provided with a standard food ration and with a multiple micronutrient powder dietary supplement (Chispitas)

Study groups in NCT02509936
Study groupRoleWhat they receive
Standard of Care ArmActive comparatorIn this arm enrolled children will receive the national standard of care for growth support, which includes growth monitoring, a food ration, and a multiple micronutrient powder supplement.
Receives: Dietary Supplement: Standard-of-care nutrition support
Home-based EducationExperimentalIn the intervention arm, children will receive the national standard of care for growth support, which includes growth monitoring, a food ration, and a multiple micronutrient powder supplement. In addition, they will receive monthly home visits from a community health promoter who will provide detailed dietary assessments and individualized dietary coaching and education to parents.
Receives: Behavioral: Home-based nutrition education; Dietary Supplement: Standard-of-care nutrition support

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Height/Length for Age Z Score

    Change in height/length over 6 months. Tool used is the WHO Child Growth Reference Standards. Change values calculated as: 6 month (z-score) minus Baseline (z-score).

    Measured: Baseline, 6 months

Secondary outcomes (9)
  1. Cognitive Development

    Change in cognitive development Z score over 6 months. Tool used: Bayley III Cognitive Development Observational Checklist. Z-scores derived internally from the entire baseline measurement data set for the study. A z-score of 0 is equal to the mean cognitive score for the study population at baseline. Lower numbers indicate values lower than the baseline study population mean mean and higher numbers indicate values higher than this mean. Higher values above zero are indicative of cognitive scores higher than mean baseline score for the study population. Lower values below zero are indicative of cognitive scores lower than mean baseline score for the study population. For outcomes, change values are calculated as 6 month (z-score) minus Baseline (z-score)

    Measured: Baseline, 6 months

  2. Socioemotional Development

    Change in socioemotional development score over 6 months. Tool used: Bayley III Socioemotional Development Parent Questionnaire. Z-scores derived internally from the entire baseline measurement data set for the study. A z-score of 0 is equal to the mean socioemotional score for the study population at baseline. Lower numbers indicate values lower than the baseline study population mean mean and higher numbers indicate values higher than this mean. Higher values above zero are indicative of socioemotional scores higher than mean baseline score for the study population. Lower values below zero are indicative of socioemotional scores lower than mean baseline score for the study population. For outcomes, change values are calculated as 6 month (z-score) minus Baseline (z-score)

    Measured: Baseline, 6 months

  3. Gross Motor Development

    Change in gross motor development score over 6 months. Tool used: Bayley III Gross Motor Observational Checklist. Z-scores derived internally from the entire baseline measurement data set for the study. A z-score of 0 is equal to the mean gross motor score for the study population at baseline. Lower numbers indicate values lower than the baseline study population mean mean and higher numbers indicate values higher than this mean. Higher values above zero are indicative of gross motor scores higher than mean baseline score for the study population. Lower values below zero are indicative of gross motor scores lower than mean baseline score for the study population. For outcomes, change values are calculated as 6 month (z-score) minus Baseline (z-score)

    Measured: Baseline, 6 months

  4. Fine Motor Development

    Change in fine motor development score over 6 months. Tool used: Bayley III Fine Motor Observational Checklist. Z-scores derived internally from the entire baseline measurement data set for the study. A z-score of 0 is equal to the mean fine motor score for the study population at baseline. Lower numbers indicate values lower than the baseline study population mean mean and higher numbers indicate values higher than this mean. Higher values above zero are indicative of fine motor scores higher than mean baseline score for the study population. Lower values below zero are indicative of fine motor scores lower than mean baseline score for the study population. For outcomes, change values are calculated as 6 month (z-score) minus Baseline (z-score)

    Measured: Baseline, 6 months

  5. Receptive Language Development

    Change in receptive language development score over 6 months. Tool used: Bayley III Receptive Language Observational Checklist. Z-scores derived internally from the entire baseline measurement data set for the study. A z-score of 0 is equal to the mean receptive language score for the study population at baseline. Lower numbers indicate values lower than the baseline study population mean mean and higher numbers indicate values higher than this mean. Higher values above zero are indicative of receptive language scores higher than mean baseline score for the study population. Lower values below zero are indicative of receptive language scores lower than mean baseline score for the study population. For outcomes, change values are calculated as 6 month (z-score) minus Baseline (z-score)

    Measured: Baseline, 6 months

  6. Expressive Language Development

    Change in expressive language development score over 6 months. Tool used: Bayley III Expressive Language Observational Checklist. Z-scores derived internally from the entire baseline measurement data set for the study. A z-score of 0 is equal to the mean expressive language score for the study population at baseline. Lower numbers indicate values lower than the baseline study population mean mean and higher numbers indicate values higher than this mean. Higher values above zero are indicative of expressive language scores higher than mean baseline score for the study population. Lower values below zero are indicative of expressive language scores lower than mean baseline score for the study population. For outcomes, change values are calculated as 6 month (z-score) minus Baseline (z-score)

    Measured: Baseline, 6 months

  7. Minimum Diet Diversity

    Number of participants meeting the age appropriate minimum number of food groups consumed per day. This is defined according to the WHO's Infant and Young Child Feeding Indicators guidelines as greater or equal to 4 food groups consumed in the last 24 - hour period. The 7 possible food groups are: (1) grains, roots, tubers; (2) legumes, nuts; (3) dairy products; (4) flesh foods; (5) eggs; (6) vitamin A-rich fruits and vegetables; (7) other fruits and vegetables.

    Measured: 0 months, 6 months

  8. Minimum Meal Frequency

    Number of participants meetings the age-appropriate number of solid meals per day. This is defined according to the WHO's Infant and Young Child Feeding Indicators guidelines as 2 solid meals in the last 24-hour period for breastfed infants 6-8 months old; 3 solid meals in the last 24-hour period for breastfed infants 9 months or older; 4 solid meals in the last 24-hour period for non-breastfed infants.

    Measured: 0 months, 6 months

  9. Minimum Acceptable Diet

    Number of participants who meet both minimum diet diversity and minimum meal frequency indicators. Minimum diet diversity and minimum meal frequency are both defined according to the WHO's Infant and Young Child Feeding Indicators guidelines. See the entries for minimum diet diversity and minimum meal frequency in this record for more details.

    Measured: 0 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionOct 2016
  4. Study completionOct 2016

Resources

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
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
324 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02509936
Sponsor's protocol ID
WK-2015-003
Status last verified
Nov 2019
First submitted
17 Jul 2015
Last updated
26 Nov 2019
Data monitoring committee
No

Publications

  • Martinez B, Cardona S, Rodas P, Lubina M, Gonzalez A, Farley Webb M, Grazioso MDP, Rohloff P. Developmental outcomes of an individualised complementary feeding intervention for stunted children: a substudy from a larger randomised controlled trial in Guatemala. BMJ Paediatr Open. 2018 Oct 3;2(1):e000314. doi: 10.1136/bmjpo-2018-000314. eCollection 2018.

    PubMed 30306144
  • Martinez B, Webb MF, Gonzalez A, Douglas K, Grazioso MDP, Rohloff P. Complementary feeding intervention on stunted Guatemalan children: a randomised controlled trial. BMJ Paediatr Open. 2018 Apr 27;2(1):e000213. doi: 10.1136/bmjpo-2017-000213. eCollection 2018.

    PubMed 29719876

Questions about this trial

What is this clinical trial studying?

A study testing Home-based nutrition education and Standard-of-care nutrition support in people with Malnutrition and Developmental Disabilities, run by Wuqu' Kawoq, Maya Health Alliance 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 3 inclusion and 2 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 26 Nov 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. 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?

Yes. Results are posted in the registry (first posted 26 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Height/Length for Age Z Score (time frame: Baseline, 6 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 NCT02509936, which also lists 2 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 26 Nov 2019.

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