Promoting Physical Growth and Positive Development in Severely Stunted Guatemalan Children

• 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: Wuqu' Kawoq, Maya Health Alliance
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Standard of Care Arm	Home-based Education
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

Baseline Characteristics

Arm/Group Title		Standard of Care Arm	Home-based Education	Total
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
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.

Outcome Measures

1. Primary Outcome

Title	Change in Height/Length for Age Z Score
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care Arm	Home-based Education
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care Arm	Home-based Education
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care Arm	Home-based Education
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care Arm	Home-based Education
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%

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Standard of Care Arm	Home-based Education
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	--/--	--/--
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%)
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%)

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Dr Peter Rohloff
• Organization: Wuqu' Kawoq | Maya Health Alliance
• Phone: 6174473034
• EMail: peter@wuqukawoq.org

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• 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