Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Promoting Physical Growth and Positive Development in Severely Stunted Guatemalan Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02509936
Recruitment Status : Completed
First Posted : July 28, 2015
Results First Posted : November 26, 2019
Last Update Posted : November 26, 2019
Sponsor:
Collaborators:
Universidad del Valle, Guatemala
Grand Challenges Canada
Information provided by (Responsible Party):
Wuqu' Kawoq, Maya Health Alliance

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Malnutrition
Developmental Disabilities
Interventions Behavioral: Home-based nutrition education
Dietary Supplement: Standard-of-care nutrition support
Enrollment 324
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard of Care Arm Home-based Education
Hide Arm/Group Description

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)

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)

Period Title: Overall Study
Started 163 161
Completed 151 145
Not Completed 12 16
Arm/Group Title Standard of Care Arm Home-based Education Total
Hide Arm/Group Description

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)

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 of all reporting groups
Overall Number of Baseline Participants 163 161 324
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 163 participants 161 participants 324 participants
<=18 years
163
 100.0%
161
 100.0%
324
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 163 participants 161 participants 324 participants
15.1  (5.2) 15.8  (5.2) 15.4  (5.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 163 participants 161 participants 324 participants
Female
73
  44.8%
69
  42.9%
142
  43.8%
Male
90
  55.2%
92
  57.1%
182
  56.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Guatemala Number Analyzed 163 participants 161 participants 324 participants
163 161 324
Weight for age Z score   [1] 
Mean (Standard Deviation)
Unit of measure:  Z score
Number Analyzed 163 participants 161 participants 324 participants
-1.92  (0.79) -1.95  (0.76) -1.93  (0.77)
[1]
Measure Description: A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values above zero are indicative of higher than normal weight for age. Lower values below zero are indicative of lower than normal weight for age.
Length/height for age   [1] 
Mean (Standard Deviation)
Unit of measure:  Z score
Number Analyzed 163 participants 161 participants 324 participants
-3.41  (0.74) -3.47  (0.73) -3.43  (0.73)
[1]
Measure Description: A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values above zero are indicative of higher than normal length/height for age. Lower values below zero are indicative of lower than normal length/height for age.
1.Primary Outcome
Title Change in Height/Length for Age Z Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard of Care Arm Home-based Education
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 151 145
Mean (Standard Deviation)
Unit of Measure: Z scores
-0.02  (0.45) 0.05  (0.48)
2.Secondary Outcome
Title Cognitive Development
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Standard of Care Arm Home-based Education
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 53 47
Mean (95% Confidence Interval)
Unit of Measure: Z score
0.38
(0.05 to 0.72)
0.28
(-0.14 to 0.71)
3.Secondary Outcome
Title Socioemotional Development
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Standard of Care Arm Home-based Education
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 53 47
Mean (95% Confidence Interval)
Unit of Measure: Z score
0.44
(0.07 to 0.81)
0.20
(-0.13 to 0.53)
4.Secondary Outcome
Title Gross Motor Development
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Standard of Care Arm Home-based Education
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 53 47
Mean (95% Confidence Interval)
Unit of Measure: Z score
0.51
(0.18 to 0.85)
0.70
(0.3 to 1.1)
5.Secondary Outcome
Title Fine Motor Development
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Standard of Care Arm Home-based Education
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 53 47
Mean (95% Confidence Interval)
Unit of Measure: Z score
0.27
(-0.09 to 0.63)
0.4
(0.04 to 0.76)
6.Secondary Outcome
Title Receptive Language Development
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Standard of Care Arm Home-based Education
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 53 47
Mean (95% Confidence Interval)
Unit of Measure: Z score
0.56
(0.21 to 0.92)
0.49
(0.11 to 0.86)
7.Secondary Outcome
Title Expressive Language Development
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Standard of Care Arm Home-based Education
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 53 47
Mean (95% Confidence Interval)
Unit of Measure: Z score
0.63
(0.34 to 0.93)
0.69
(0.38 to 0.99)
8.Secondary Outcome
Title Minimum Diet Diversity
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard of Care Arm Home-based Education
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 151 145
Measure Type: Count of Participants
Unit of Measure: Participants
115
  76.2%
135
  93.1%
9.Secondary Outcome
Title Minimum Meal Frequency
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard of Care Arm Home-based Education
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 151 145
Measure Type: Count of Participants
Unit of Measure: Participants
131
  86.8%
129
  89.0%
10.Secondary Outcome
Title Minimum Acceptable Diet
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard of Care Arm Home-based Education
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 151 145
Measure Type: Count of Participants
Unit of Measure: Participants
104
  68.9%
123
  84.8%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard of Care Arm Home-based Education
Hide Arm/Group Description

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)

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)

All-Cause Mortality
Standard of Care Arm Home-based Education
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Standard of Care Arm Home-based Education
Affected / at Risk (%) Affected / at Risk (%)
Total   0/163 (0.00%)   0/161 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard of Care Arm Home-based Education
Affected / at Risk (%) Affected / at Risk (%)
Total   0/163 (0.00%)   0/161 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Peter Rohloff
Organization: Wuqu' Kawoq | Maya Health Alliance
Phone: 6174473034
EMail: peter@wuqukawoq.org
Layout table for additonal information
Responsible Party: Wuqu' Kawoq, Maya Health Alliance
ClinicalTrials.gov Identifier: NCT02509936    
Other Study ID Numbers: WK-2015-003
First Submitted: July 17, 2015
First Posted: July 28, 2015
Results First Submitted: August 19, 2019
Results First Posted: November 26, 2019
Last Update Posted: November 26, 2019