NCT00751582

Brief Summary

Supplementary feeding and intensive IEC at the community level will effectively reduce moderate PEM compared to the control children within 3 months . Intensive nutrition education at the household level will reduce by at least one third of the prevalence of moderate malnutrition (40% of present level) within a short period of 3 months

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 1998

Shorter than P25 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

Study Start

First participant enrolled

July 1, 1998

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 1998

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 1998

Completed
9.5 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2008

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 12, 2008

Completed
Last Updated

March 22, 2016

Status Verified

September 1, 2008

Enrollment Period

4 months

First QC Date

May 17, 2008

Last Update Submit

March 20, 2016

Conditions

Malnutrition

Keywords

nutritioneducationsupplementation

Outcome Measures

Primary Outcomes (1)

  • Weight and length to assess nutritional status of the children

    6 months

Study Arms (2)

2

EXPERIMENTAL

Food supplementation and nutrition education

Dietary Supplement: Food supplementation and nutrition educationOther: Control Group

1

EXPERIMENTAL

Nutrition Education only

Behavioral: Nutrition education

Interventions

Food supplementation and nutrition educationDIETARY_SUPPLEMENT

Food supplementation and nutrition education for three months

Also known as: PUSHTI PACKET
2
Nutrition educationBEHAVIORAL

Nutrition education for children for three months

Also known as: PUSHTI PACKET
1
Control GroupOTHER

No Nutrition Education

2

Eligibility Criteria

Age6 Months - 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Less than 2 years moderately malnourished children

You may not qualify if:

  • Nourished children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICDDRB

Dhaka, 1212, Bangladesh

Location

MeSH Terms

Conditions

Malnutrition

Interventions

Dietary SupplementsNutrition AssessmentControl Groups

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthEpidemiologic Research DesignResearch DesignMethods

Study Officials

  • Swapan K Roy, PhD, FRCP

    Senior Scientist, ICDDR,B

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 17, 2008

First Posted

September 12, 2008

Study Start

July 1, 1998

Primary Completion

November 1, 1998

Study Completion

November 1, 1998

Last Updated

March 22, 2016

Record last verified: 2008-09

Locations

BA(1)