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Locally Prepared Supplement to Support Growth and Brain Health

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ClinicalTrials.gov Identifier: NCT03017209
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : May 10, 2019
Sponsor:
Collaborators:
Massachusetts General Hospital
Global Food & Nutrition Inc.
Information provided by (Responsible Party):
Tufts University

Study Description
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Brief Summary:
This study is a randomized controlled trial with a main goal to assess the effects of a locally-prepared food for prevention of malnutrition and stunting, in comparison with standard village practices and also a widely available aid food supplement in 8-12 villages in Guinea-Bissau. The supplement intervention will be for 24-30 weeks. The primary outcome will be cognitive tests of executive function. Secondary outcomes will be changes in standard anthropometric benchmarks of growth, hemoglobin and skin carotenoids in young children living in villages in rural Guinea-Bissau. This is a within-village randomization at the level of the family, and all children will receive a dietary intervention.

Condition or disease Intervention/treatment Phase
Malnutrition, Child Cognitive Function Dietary Supplement: Locally-prepared bar Dietary Supplement: USAID Corn Soy Blend Plus Other: Placebo Not Applicable

Detailed Description:

Up to 1050 children aged 15 months to 6.99 years, and older children if in 1st grade elementary school, in 8-12 villages in the Oio and Cachau regions of Guinea-Bissau will be recruited for this study along with their maternal caregiver and father. Child ages will be based on the official birth records which families possess. The mothers/primary caregivers and fathers of the children will also be recruited for simple outcome assessments. Villages will be a convenience sample chosen from villages within the network of our local research partner International Partnership for Human Development. Each village in this region has one school and one community health center per village, which will be involved in supplement distribution and some outcome assessments.

Families with enrolling children will be randomized within 8-12 villages to receive 1 of 3 supplements and if any family (defined based on the father of the children since this is a polygamous community) has more than one enrolling child all those children will be randomized to the same supplement arm.

  • One supplement will be the locally-prepared bar
  • One will be an isocaloric amount of porridge prepared with USAIDs Corn Soy Blend Plus, prepared as recommended in a 10:3 ratio with fortified vegetable oil.
  • One supplement will be an isocaloric amount of cooked rice with vegetable oil, which is the typical local breakfast.

Villagers will be informed of the randomization after baseline testing is complete.

Following baseline measurements in children of anthropometry and body composition, grip strength, cognition, hemoglobin, and skin carotenoids, children will receive their intervention for 24-30 weeks and the same measurements taken at baseline will be repeated during the last study week. The flexible end data is given to accommodate the local rainy season and its impact on transportation. Please note that cell phone access to villages is not influenced by local weather, thus communication regarding safety issues with community health workers will remain possible throughout the entire trial.

Addendum: The pre-planned primary method of analysis was a per-protocol analysis, predefined as children consuming ≥75% of their supplement. However, a clerical error in this clinical trial registration did not describe this predetermined focus on a per-protocol population. The registration implies an intention-to-treat (ITT) analysis by default. Investigators therefore revised our analytical approach to designate the ITT cohort as the primary cohort of interest. The secondary cohort of interest is the predefined per-protocol cohort (children consuming ≥75% of their supplement).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1059 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Study on a Locally Prepared Food Supplement to Support Growth and Brain Health
Actual Study Start Date : January 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Locally-prepared bar
The bar is similar to one tested recently in a pilot study and is a locally prepared bar designed to facilitate growth and cognitive development. It will provide 300 kcal/day and will have ≈20-30% of energy from protein (of which 25-50% is from an animal protein source), 20-35% from total carbohydrate and ≈40-60% from fat. The bar will be fortified with vitamins and minerals to meet USAID recommendations for moderate malnutrition and Dietary Reference Intake recommendations for at-risk and healthy children of the ages studied, and at the same time will not exceed Upper Level nutrient recommendations for any micronutrient. Ingredients in the bar will be a combination of local products and imported shelf-stable ingredients.
 Dietary Supplement: Locally-prepared bar
School children in first grade will receive their supplement 5 days a week in the morning before school starts. Younger children will receive the supplement 5 days a week in the morning at the community health center, distributed by community health workers. The teachers and community health workers will record amount of supplement consumption daily during the study, and will report the information weekly to the local research team throughout the intervention period.
Active Comparator: USAID Corn Soy Blend Plus
The usual-intervention condition will be 300 kcal/day of USAID Corn Soy Blend Plus cooked in the usual manner with fortified vegetable oil (10:3 ratio) and sugar. The community health workers or other designated villagers will prepare the supplement freshly each intervention day using locally accepted standards for hygiene, and a quality control process for ratios of ingredients assigned by the research team to ensure consistent composition.
 Dietary Supplement: USAID Corn Soy Blend Plus
School children in first grade will receive their supplement 5 days a week in the morning before school starts. Younger children will receive the supplement 5 days a week in the morning at the community health center, distributed by community health workers. The teachers and community health workers will record amount of supplement consumption daily during the study, and will report the information weekly to the local research team throughout the intervention period.
Placebo Comparator: Locally-purchased rice
The placebo condition will be 300 kcal/day of locally-purchased rice cooked with a small amount of oil (10:2 ratio), which mimics the usual breakfast of children in this region. The community health workers or other designated villagers will prepare the rice freshly each intervention day using locally accepted standards for hygiene, and a quality control process for ratios of ingredients assigned by the research team to ensure consistent composition.
 Other: Placebo
School children in first grade will receive their supplement 5 days a week in the morning before school starts. Younger children will receive the supplement 5 days a week in the morning at the community health center, distributed by community health workers. The teachers and community health workers will record amount of supplement consumption daily during the study, and will report the information weekly to the local research team throughout the intervention period.
Other Name: Locally-purchased rice


Outcome Measures
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Primary Outcome Measures :
  1. Change in cognitive function measured using executive functions tasks in children ages 15 months to 3 years [ Time Frame: baseline and 24-30 weeks after baseline testing ]

Secondary Outcome Measures :
  1. Hemoglobin [ Time Frame: baseline and 24-30 weeks after baseline testing ]
  2. Changes in z-scores for weight (WAZ) [ Time Frame: baseline and 24-30 weeks after baseline testing ]
  3. Changes in z-scores for height (HAZ) [ Time Frame: baseline and 24-30 weeks after baseline testing ]
  4. Cognitive tests for children >3 years old [ Time Frame: baseline and 24-30 weeks after baseline testing ]
    Looking to see changes in executive function who attend supplement distribution at least 75% of the days it is offered.

  5. Mid-upper arm circumference [ Time Frame: baseline and 24-30 weeks after baseline testing ]
  6. Cerebral blood flow [ Time Frame: baseline and 24-30 weeks after baseline testing ]
    By infrared spectroscopy

  7. % Lean tissue and lean growth [ Time Frame: baseline and 24-30 weeks after baseline testing ]
  8. Changes in weight for height Z scores [ Time Frame: baseline and 24-30 weeks after baseline testing ]

Other Outcome Measures:
  1. Carotenoids [ Time Frame: baseline and 24-30 weeks after baseline testing ]
    By Resonance Raman Spectroscopy

  2. Grip strength [ Time Frame: baseline and 24-30 weeks after baseline testing ]
    Using a dynamometer

  3. Weight of female-caregivers and fathers [ Time Frame: baseline and 24-30 weeks after baseline testing ]
  4. Head circumference of child [ Time Frame: baseline and 24-30 weeks after baseline testing ]
  5. Height of female-caregivers and fathers [ Time Frame: baseline and 24-30 weeks after baseline testing ]
  6. Mid upper arm circumference of female caregivers [ Time Frame: baseline and 24-30 weeks after baseline testing ]

Eligibility Criteria
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Ages Eligible for Study:   15 Months to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Parent or legal guardian provides consent for all children <7 years and the parent plus the child provide consent for any child > 7 years.
  • Age 15 months to 6.99 years old or any age enrolled in first grade in the same village.
  • The family plans to remain in the village for the duration of the study (up to 30 weeks) based on self-report by a parent;
  • The child does not have any known food allergies as reported by the mother or guardian.

Exclusion Criteria: If any child is identified as malnourished at baseline, defined as a mid-upper arm circumference in the red zone of the paper tape, the child will be excluded from the study due to malnutrition, and the parents will be advised to take the child to the nearest malnutrition clinic.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017209


Locations
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Guinea-Bissau
International Partnership for Health Development
Bissau, Guinea-Bissau, 1000
Sponsors and Collaborators
Tufts University
Massachusetts General Hospital
Global Food & Nutrition Inc.
Investigators
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Principal Investigator: Susan B Roberts, PHD Tufts University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Tufts University
ClinicalTrials.gov Identifier: NCT03017209    
Other Study ID Numbers: 12356
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Malnutrition
Child Nutrition Disorders
Nutrition Disorders