Trial Outcomes & Findings for Promoting Physical Growth and Positive Development in Severely Stunted Guatemalan Children (NCT NCT02509936)
NCT ID: NCT02509936
Last Updated: 2019-11-26
Results Overview
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).
COMPLETED
NA
324 participants
Baseline, 6 months
2019-11-26
Participant Flow
Participant milestones
| Measure |
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)
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
163
|
161
|
|
Overall Study
COMPLETED
|
151
|
145
|
|
Overall Study
NOT COMPLETED
|
12
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Promoting Physical Growth and Positive Development in Severely Stunted Guatemalan Children
Baseline characteristics by cohort
| Measure |
Standard of Care Arm
n=163 Participants
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)
|
Home-based Education
n=161 Participants
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)
|
Total
n=324 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
163 Participants
n=5 Participants
|
161 Participants
n=7 Participants
|
324 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
15.1 Months
STANDARD_DEVIATION 5.2 • n=5 Participants
|
15.8 Months
STANDARD_DEVIATION 5.2 • n=7 Participants
|
15.4 Months
STANDARD_DEVIATION 5.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Region of Enrollment
Guatemala
|
163 participants
n=5 Participants
|
161 participants
n=7 Participants
|
324 participants
n=5 Participants
|
|
Weight for age Z score
|
-1.92 Z score
STANDARD_DEVIATION 0.79 • n=5 Participants
|
-1.95 Z score
STANDARD_DEVIATION 0.76 • n=7 Participants
|
-1.93 Z score
STANDARD_DEVIATION 0.77 • n=5 Participants
|
|
Length/height for age
|
-3.41 Z score
STANDARD_DEVIATION 0.74 • n=5 Participants
|
-3.47 Z score
STANDARD_DEVIATION 0.73 • n=7 Participants
|
-3.43 Z score
STANDARD_DEVIATION 0.73 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 monthsChange 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).
Outcome measures
| Measure |
Standard of Care Arm
n=151 Participants
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)
|
Home-based Education
n=145 Participants
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)
|
|---|---|---|
|
Change in Height/Length for Age Z Score
|
-0.02 Z scores
Standard Deviation 0.45
|
0.05 Z scores
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 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.
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)
Outcome measures
| Measure |
Standard of Care Arm
n=53 Participants
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)
|
Home-based Education
n=47 Participants
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)
|
|---|---|---|
|
Cognitive Development
|
0.38 Z score
Interval 0.05 to 0.72
|
0.28 Z score
Interval -0.14 to 0.71
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 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.
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)
Outcome measures
| Measure |
Standard of Care Arm
n=53 Participants
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)
|
Home-based Education
n=47 Participants
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)
|
|---|---|---|
|
Socioemotional Development
|
0.44 Z score
Interval 0.07 to 0.81
|
0.20 Z score
Interval -0.13 to 0.53
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 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.
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)
Outcome measures
| Measure |
Standard of Care Arm
n=53 Participants
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)
|
Home-based Education
n=47 Participants
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)
|
|---|---|---|
|
Gross Motor Development
|
0.51 Z score
Interval 0.18 to 0.85
|
0.70 Z score
Interval 0.3 to 1.1
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 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.
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)
Outcome measures
| Measure |
Standard of Care Arm
n=53 Participants
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)
|
Home-based Education
n=47 Participants
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)
|
|---|---|---|
|
Fine Motor Development
|
0.27 Z score
Interval -0.09 to 0.63
|
0.4 Z score
Interval 0.04 to 0.76
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 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.
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)
Outcome measures
| Measure |
Standard of Care Arm
n=53 Participants
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)
|
Home-based Education
n=47 Participants
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)
|
|---|---|---|
|
Receptive Language Development
|
0.56 Z score
Interval 0.21 to 0.92
|
0.49 Z score
Interval 0.11 to 0.86
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 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.
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)
Outcome measures
| Measure |
Standard of Care Arm
n=53 Participants
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)
|
Home-based Education
n=47 Participants
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)
|
|---|---|---|
|
Expressive Language Development
|
0.63 Z score
Interval 0.34 to 0.93
|
0.69 Z score
Interval 0.38 to 0.99
|
SECONDARY outcome
Timeframe: 0 months, 6 monthsNumber 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.
Outcome measures
| Measure |
Standard of Care Arm
n=151 Participants
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)
|
Home-based Education
n=145 Participants
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)
|
|---|---|---|
|
Minimum Diet Diversity
|
115 Participants
|
135 Participants
|
SECONDARY outcome
Timeframe: 0 months, 6 monthsNumber 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.
Outcome measures
| Measure |
Standard of Care Arm
n=151 Participants
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)
|
Home-based Education
n=145 Participants
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)
|
|---|---|---|
|
Minimum Meal Frequency
|
131 Participants
|
129 Participants
|
SECONDARY outcome
Timeframe: 0 months, 6 monthsNumber 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.
Outcome measures
| Measure |
Standard of Care Arm
n=151 Participants
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)
|
Home-based Education
n=145 Participants
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)
|
|---|---|---|
|
Minimum Acceptable Diet
|
104 Participants
|
123 Participants
|
Adverse Events
Standard of Care Arm
Home-based Education
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place