NCT01873196

Brief Summary

This research will test alternative methods of ensuring compliance with recommended preparation and targeting of supplementary foods for malnourished children under five years of age. The hypotheses that the proposed study intends to test are as follows:

  1. 1.With appropriate behavior change communication (BCC) and social support, and with provision of CSB and FVO in the correct proportions, it is possible to get women to prepare CSB with oil in the recommended ratio of 100:30, and in quantities just sufficient for the target child.
  2. 2.Providing CSB to Beneficiary Mothers/Caretakers pre-packaged bags of 2 kg with appropriate messaging and with instructions to direct the food to children and to prepare the CSB with oil in the recommended ratio and feed as instructed will result in better compliance.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,811

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 10, 2013

Completed
21 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Last Updated

February 4, 2015

Status Verified

February 1, 2015

Enrollment Period

1 year

First QC Date

April 22, 2013

Last Update Submit

February 2, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in average percent of oil by volume in the porridge as prepared

    Having samples of prepared porridge taken from beneficiary mothers analyzed for percentage of oil content. This will allow us to know if the mothers are preparing the porridge in the appropriate ration of 100g CSB: 30g oil.

    Baseline (July 2013), Phase I (October 2013) 3 months, Phase II (January 2014) 6 months

Study Arms (4)

Receive extra oil

EXPERIMENTAL

This arm will receive enough oil to prepare the CSB they receive in the newly recommended proportion of 100g CSB: 30g oil. They will receive education and instructions on the new method of preparation.

Behavioral: Receive extra oil

Control-No extra oil received

NO INTERVENTION

This group will continue to receive only 1L of oil with their CSB has they already have been. They also will not receive any new education.

Receives behavior changed messages on CSB package

EXPERIMENTAL

Group receiving CSB repackaged into 2kg packages with messages on package on how to prepare. Only in Phase II.

Behavioral: Receives behavior changed messages on CSB package

Control-No repackaged CSB

NO INTERVENTION

Interventions

Receive extra oil
Receives behavior changed messages on CSB package

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Child enrolled in Supplementary Feeding Program (SFP) to receive ration (CSB13 and FVO) from 1 of the 16 Food Distribution Points
  • Child has an SFP ration card
  • Subject's whose mother/caretaker or CSB preparer was contacted to participate in taste test FGD
  • Subject's whose mother/caretaker is voluntarily willing to consent to their child's participation in taste tests

You may not qualify if:

  • \- All children enrolled in the SFP in the selected program change FDPs are eligible
  • Beneficiary Mothers/Caretakers (Mothers/Caretakers of Children Under five years old,U5):
  • Beneficiary Mother/Caretaker enrolled in Supplementary Feeding Program (SFP) to receive ration (CSB13 and FVO) for her child from 1 of the 16 Food Distribution Points
  • Beneficiary Child has an SFP ration card
  • Subject who is voluntarily willing to participate by signing the consent form (or if minor, adult is willing to sign on their behalf). Note: This should will only come after the subject has been educated on all that appertains to their her involvement in this study, the consent script read aloud for them and given the chance to make her own non-coerced, non-persuaded and autonomous decision.
  • \- Beneficiary Mothers/Caretakers who were interviewed once for this study will not be interviewed a second time during a later Phase of the study.
  • Care Group Lead Mothers
  • Lead mother who covers the catchment area of the selected 16 FDP's
  • Lead mother has been present during the program change period
  • Subject who is voluntarily willing to participate by signing the consent form
  • \- None
  • Health Care Workers (Health Surveillance Agents, Health Promoters, Resource Persons)
  • Health Care Workers serving within the catchment area for the 16 FDPs
  • Health Care Worker has been present during the study period
  • Subject who is voluntarily willing to participate by signing the consent form
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Blantyre, Malawi

Location

Related Publications (1)

  • Wilner L, Suri DJ, Langlois BK, Walton SM, Rogers BL. Effective delivery of social and behavior change communication through a Care Group model in a supplementary feeding program. J Health Popul Nutr. 2017 Sep 12;36(1):34. doi: 10.1186/s41043-017-0111-3.

MeSH Terms

Conditions

Child Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Beatrice L Rogers, PhD

    Tufts University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2013

First Posted

June 10, 2013

Study Start

July 1, 2013

Primary Completion

July 1, 2014

Last Updated

February 4, 2015

Record last verified: 2015-02

Locations