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Clinical Trials/NCT01303016
NCT01303016
Unknown
N/A

Improving Nutrition and Health Outcomes in Intibuca, Honduras

Shoulder to Shoulder0 sites639 target enrollmentMay 2010

Overview

Phase
N/A
Intervention
Not specified
Conditions
Malnutrition
Sponsor
Shoulder to Shoulder
Enrollment
639
Primary Endpoint
Height and weight
Last Updated
15 years ago

Overview

Brief Summary

The purpose of this research study is to better understand how to prevent malnutrition in children under age 5 years in Intibuca, Honduras. A randomized community trial design was used to implement a nutrition program, including a complementary nutrition supplement, educational sessions, and growth and health monitoring integrated into the basic primary care package, to participants living in communities in the intervention group. Participants living in the control group communities will receive the nutrition supplement for one year following the study.

Registry
clinicaltrials.gov
Start Date
May 2010
End Date
December 2011
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Shoulder to Shoulder

Eligibility Criteria

Inclusion Criteria

  • Children between the ages of 6 months and under 5 years at the time enrollment who reside in Concepcion.

Exclusion Criteria

  • Children with congenital anomalies, mental retardation, severe physical handicap, undernutrition caused by medical conditions that contribute to undernutrition such as heart disease, kidney failure, face and throat problems that interfere with swallowing, medical problems interfering with the absorption of food, and chronic diseases such as tuberculosis, etc.
  • Plans to move or change place of residence outside the intervention region in the next 2 months.
  • Children whose weight for age z score falls below -
  • Children whose weight for age z score is above 3.

Outcomes

Primary Outcomes

Height and weight

Time Frame: Every other month for 12 months

Participating children are measured and weighed by trained staff every other month during the 12 month intervention.

Hemoglobin

Time Frame: Baseline, month 6, and month 12

Hemoglobin values are measured using a One STAT Site M meter instrument and recorded to the nearest g/dL at baseline, month 6, and month 12 of the intervention.

Retinol binding protein, transferrin receptor, and C-Reactive Protein

Time Frame: Baseline, month 6, and month 12

Retinol binding protein, transferrin, and C-Reactive Protein are measured from dried blood spots collected at baseline, month 6, and month 12 of the intervention.

Secondary Outcomes

  • Food insecurity(Baseline, month 6, and month 12)
  • Health outcomes(Baseline, month 6, and month 12)
  • Acceptability/Sustainability of nutrition supplement(Baseline, month 3, and month 8)

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