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Effectiveness and Cost-Effectiveness of Four Formulations of Food Supplements for the Prevention of Wasting and Stunting in Burkina Faso (FAQR-Burkina)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Tufts University
Sponsor:
Collaborators:
United States Agency for International Development (USAID)
ACDI/VOCA
Save the Children
Institut de Recherche en Sciences de la Sante, Burkina Faso
Information provided by (Responsible Party):
Tufts University
ClinicalTrials.gov Identifier:
NCT02071563
First received: September 23, 2013
Last updated: November 4, 2015
Last verified: November 2015
  Purpose

This research will serve as a follow-up on the review of Title II commodities performed by the Food Aid Quality Review at Tufts University in October 2011. The study in Burkina Faso will test the relative effectiveness and cost effectiveness of four supplementary foods in the prevention of MAM and stunting in normal programmatic settings.

The aims of this study are to:

  1. To compare the effectiveness of four alternative supplementary food commodities in preventing stunting and wasting, and promoting linear growth in children 6 - 23 months in the context of a preventive supplementary feeding program in Burkina Faso.
  2. To estimate the relative cost of implementing the supplementary feeding program using each commodity
  3. To estimate the relative cost/effectiveness of implementing the program using each commodity.

Condition Intervention
Child Malnutrition
Dietary Supplement: CSB14
Dietary Supplement: RUSF1
Dietary Supplement: SC+

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Food Aid Quality Review Phase II Effectiveness Study: Preventing MAM and Stunting in Burkina Faso

Resource links provided by NLM:


Further study details as provided by Tufts University:

Primary Outcome Measures:
  • Incidence of MAM and Stunting [ Time Frame: Monthly for 18 months ]

    Primary outcomes to be measured are incidence of MAM and incidence of stunting during the 18 months of preventive supplementation (age 6 months to 23 months).

    Stunting will be defined as less than -2 SD of Height-for-Age Z-score and MAM will be defined as less than -2 SD Weight-for-Height (length) Z-score



Estimated Enrollment: 6000
Study Start Date: March 2014
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CSB14
Isocaloric amount and cost-effectiveness of CSB14 (with whey protein concentrate and enhanced micronutrient profile), prepared with fortified vegetable oil (FVO).
Dietary Supplement: CSB14
Active Comparator: RUSF1
Isocaloric amount and cost-effectiveness of Ready-to Use Supplementary Food 1(RUSF1), USAID's Lipid-Based Nutrient Supplement (LNS) product
Dietary Supplement: RUSF1
Active Comparator: SC+
Isocaloric amount and cost-effectiveness of Supercereal Plus (SC+), the FBF used by WFP, which has an enhanced nutrient profile, dairy ingredient (non-fat dry milk), and oil already embedded into the flour
Dietary Supplement: SC+
No Intervention: CSB+
Isocaloric amount and cost-effectiveness of Supercereal/CSB+ prepared with FVO.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months to 23 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

The subjects are as follows:

Beneficiary Children that are weighed and measured Beneficiary Mothers/Caretakers that participate in interviews, focus group discussions, and in-home observations Health and Nutrition Promoters (HNP) that participate in individual interviews and FGD Community Health Agents that participate in individual interviews PVO staff members that participate in individual interviews Village Elders/Headmen Store owners/Market Vendors that participate in individual interviews

Beneficiary Children (Children 6 -23 months old)

  • Inclusion Criteria

    • Child enrolled in the ViM program to receive ration from a Food Distribution Point

  • Exclusion Criteria

    • Children who are over 6 months of age when the study begins
    • Children receiving food rations from another organization (e.g. World Food Programme or UNICEF)

Beneficiary Mothers/Caretakers (Mothers/Caretakers of Children 6 -23 months old)

  • Inclusion Criteria

    • Beneficiary Mother/Caretaker whose child turns 6 months old and is enrolled in ViM program to receive ration during the study period
    • Beneficiary Mother/Caretaker has no age restrictions for inclusion (Note: Mothers/caretakers will be asked to participate regardless of age and consented appropriately; it is possible some mothers may be minors)
    • Subject who is voluntarily willing to participate and indicates by signing (or marking with a thumbprint) the consent form.
  • Exclusion Criteria • Beneficiary Mothers/Caretakers who participate in an interview, observation or FGD once for this study will not be eligible again for participation

Health and Nutrition Promoters (HNP) Inclusion Criteria

  • HNP who covers the catchment area of the FDPs
  • Subject who is voluntarily willing to participate by signing the consent form

Community Health Agents (CHA) Inclusion Criteria

  • Community Health Agents serving within the catchment area for the FDPs
  • Community Health Agents that have been present during the study period
  • Subject who is voluntarily willing to participate and indicates by signing the consent form

PVO Staff Members Inclusion Criteria

  • All staff members from ACDI/VOCA and Save the Children who are directly involved in the ViM program
  • Subject who is voluntarily willing to participate and indicates by signing the consent form Exclusion Criteria
  • PVO Staff members who joined too recently to have experience of the program change (new commodities)

Village Elders/Headmen Inclusion Criteria

  • Village elder/headmen in study commune
  • Subject who is voluntarily willing to participate and indicates by signing the consent form Exclusion Criteria
  • Village elder/headmen whose community is not involved in the feeding program

Store Owners/Market Vendor Inclusion Criteria

  • Store owner/market vendor in study communes who trades in the relevant products (food vendors)
  • Subject who is voluntarily willing to participate and indicates by signing the consent form Exclusion Criteria
  • Vendors who do not sell food.

The withdrawal/termination criterion for this study is not applicable as the subject's participation will not be terminated by the investigator, and there are no necessary precautions applied to those who withdraw.

Study subjects may not participate in another research study that provides supplementary food as a food ration to children between 6-23 months.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02071563

Contacts
Contact: Beatrice L Rogers, PhD 617-636-3703 beatrice.rogers@tufts.edu

Locations
Burkina Faso
Recruiting
Kaya, Sanmatenga, Burkina Faso
Contact: Ilana Cliffer, MPH         
Sponsors and Collaborators
Tufts University
United States Agency for International Development (USAID)
ACDI/VOCA
Save the Children
Institut de Recherche en Sciences de la Sante, Burkina Faso
Investigators
Principal Investigator: Beatrice L Rogers, PhD Tufts University
  More Information

Additional Information:
Responsible Party: Tufts University
ClinicalTrials.gov Identifier: NCT02071563     History of Changes
Other Study ID Numbers: AID-016-Burkina Faso
Study First Received: September 23, 2013
Last Updated: November 4, 2015

Additional relevant MeSH terms:
Malnutrition
Child Nutrition Disorders
Nutrition Disorders

ClinicalTrials.gov processed this record on March 29, 2017