Developmental Disabilities, Malnutrition
Conditions
Brief 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. The other half of children in the study will receive, in addition to the above, home-based dietary assessment and individualized parental nutrition education.
Interventions
BEHAVIORALHome-based nutrition education
Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.
DIETARY_SUPPLEMENTStandard-of-care nutrition support
Subjects will be provided with a standard food ration and with a multiple micronutrient powder dietary supplement (Chispitas)
Sponsors
Universidad del Valle, Guatemala
Grand Challenges Canada
Wuqu' Kawoq, Maya Health Alliance
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 24 Months
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Height/Length for Age Z Score | Baseline, 6 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Socioemotional Development | Baseline, 6 months | 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) |
| Gross Motor Development | Baseline, 6 months | 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) |
| Fine Motor Development | Baseline, 6 months | 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) |
| Receptive Language Development | Baseline, 6 months | 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) |
| Cognitive Development | Baseline, 6 months | 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) |
| Minimum Diet Diversity | 0 months, 6 months | 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. |
| Minimum Meal Frequency | 0 months, 6 months | 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. |
| Minimum Acceptable Diet | 0 months, 6 months | 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. |
| Expressive Language Development | Baseline, 6 months | 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) |
Countries
Guatemala
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Arm In this arm enrolled children received the national standard of care for growth support, which includes growth monitoring, a food ration, and a multiple micronutrient powder supplement.
Standard-of-care nutrition support: Subjects were provided with a standard food ration and with a multiple micronutrient powder dietary supplement (Chispitas) | 163 |
| Home-based Education In the intervention arm, children received the national standard of care for growth support, which includes growth monitoring, a food ration, and a multiple micronutrient powder supplement. In addition, they received monthly home visits from a community health promoter who provided detailed dietary assessments and individualized dietary coaching and education to parents.
Home-based nutrition education: Health promoters used 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.
Standard-of-care nutrition support: Subjects were provided with a standard food ration and with a multiple micronutrient powder dietary supplement (Chispitas) | 161 |
| Total | 324 |
Baseline characteristics
| Characteristic | Standard of Care Arm | Home-based Education | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 163 Participants | 161 Participants | 324 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 15.1 Months STANDARD_DEVIATION 5.2 | 15.8 Months STANDARD_DEVIATION 5.2 | 15.4 Months STANDARD_DEVIATION 5.2 |
| Length/height for age | -3.41 Z score STANDARD_DEVIATION 0.74 | -3.47 Z score STANDARD_DEVIATION 0.73 | -3.43 Z score STANDARD_DEVIATION 0.73 |
| Region of Enrollment Guatemala | 163 participants | 161 participants | 324 participants |
| Sex: Female, Male Female | 73 Participants | 69 Participants | 142 Participants |
| Sex: Female, Male Male | 90 Participants | 92 Participants | 182 Participants |
| Weight for age Z score | -1.92 Z score STANDARD_DEVIATION 0.79 | -1.95 Z score STANDARD_DEVIATION 0.76 | -1.93 Z score STANDARD_DEVIATION 0.77 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 163 | 0 / 161 |
| serious Total, serious adverse events | 0 / 163 | 0 / 161 |
Outcome results
Primary
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).
Time frame: Baseline, 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care Arm | Change in Height/Length for Age Z Score | -0.02 Z scores | Standard Deviation 0.45 |
| Home-based Education | Change in Height/Length for Age Z Score | 0.05 Z scores | Standard Deviation 0.48 |
Secondary
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)
Time frame: Baseline, 6 months
Population: Due to expense constraints, a subset of subjects (consecutively recruited during the first 5 months (n=210 enrolled vs. 324 enrolled in study overall)) were invited to participate in the psychometric substudy. Subsequently, only 147 completed both time point assessments, and 47 were excluded for aging-out of the Z score internal reference norms.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard of Care Arm | Cognitive Development | 0.38 Z score |
| Home-based Education | Cognitive Development | 0.28 Z score |
Secondary
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)
Time frame: Baseline, 6 months
Population: Due to expense constraints, a subset of subjects (consecutively recruited during the first 5 months (n=210 enrolled vs. 324 enrolled in study overall)) were invited to participate in the psychometric substudy. Subsequently, only 147 completed both time point assessments, and 47 were excluded for aging-out of the Z score internal reference norms.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard of Care Arm | Expressive Language Development | 0.63 Z score |
| Home-based Education | Expressive Language Development | 0.69 Z score |
Secondary
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)
Time frame: Baseline, 6 months
Population: Due to expense constraints, a subset of subjects (consecutively recruited during the first 5 months (n=210 enrolled vs. 324 enrolled in study overall)) were invited to participate in the psychometric substudy. Subsequently, only 147 completed both time point assessments, and 47 were excluded for aging-out of the Z score internal reference norms.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard of Care Arm | Fine Motor Development | 0.27 Z score |
| Home-based Education | Fine Motor Development | 0.4 Z score |
Secondary
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)
Time frame: Baseline, 6 months
Population: Due to expense constraints, a subset of subjects (consecutively recruited during the first 5 months (n=210 enrolled vs. 324 enrolled in study overall)) were invited to participate in the psychometric substudy. Subsequently, only 147 completed both time point assessments, and 47 were excluded for aging-out of the Z score internal reference norms.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard of Care Arm | Gross Motor Development | 0.51 Z score |
| Home-based Education | Gross Motor Development | 0.70 Z score |
Secondary
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.
Time frame: 0 months, 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care Arm | Minimum Acceptable Diet | 104 Participants |
| Home-based Education | Minimum Acceptable Diet | 123 Participants |
Secondary
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.
Time frame: 0 months, 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care Arm | Minimum Diet Diversity | 115 Participants |
| Home-based Education | Minimum Diet Diversity | 135 Participants |
Secondary
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.
Time frame: 0 months, 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care Arm | Minimum Meal Frequency | 131 Participants |
| Home-based Education | Minimum Meal Frequency | 129 Participants |
Secondary
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)
Time frame: Baseline, 6 months
Population: Due to expense constraints, a subset of subjects (consecutively recruited during the first 5 months (n=210 enrolled vs. 324 enrolled in study overall)) were invited to participate in the psychometric substudy. Subsequently, only 147 completed both time point assessments, and 47 were excluded for aging-out of the Z score internal reference norms.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard of Care Arm | Receptive Language Development | 0.56 Z score |
| Home-based Education | Receptive Language Development | 0.49 Z score |
Secondary
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)
Time frame: Baseline, 6 months
Population: Due to expense constraints, a subset of subjects (consecutively recruited during the first 5 months (n=210 enrolled vs. 324 enrolled in study overall)) were invited to participate in the psychometric substudy. Subsequently, only 147 completed both time point assessments, and 47 were excluded for aging-out of the Z score internal reference norms.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard of Care Arm | Socioemotional Development | 0.44 Z score |
| Home-based Education | Socioemotional Development | 0.20 Z score |