Evaluation of an Infant Feeding Intervention for HIV-exposed Haitian Infants

NCT01434238 | Completed

• 1 other identifier: IRB 0907000316
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this quasi-experimental study is to evaluate the effectiveness of an infant feeding intervention in improving growth and anemia outcomes among HIV-exposed infants 6-12 months of age.

Conditions

Lack of; Care, Infant (Child), Malnutrition

Keywords

infant feeding; HIV; growth; anemia

Outcome Measures

Primary Outcomes (2)

• Change in prevalence of growth faltering during the intervention

  Change in weight-for-age, length-for-age and weight-for-length \<-2 SD based on WHO 2006 Growth Standard

  end of intervention (approximately 12 months of age)

• Change in prevalence of growth faltering post-intervention

  Change in weight-for-age, length-for-age and weight-for-length \<-2 SD based on WHO 2006 Growth Standard

  Six-months post-intervention (approximately 18 months of age)

Secondary Outcomes (2)

• Change in prevalence of anemia during intervention

  end of intervention (approximately 12 months of age)

• Dietary intake

  end of intervention (approximately 12 months of age)

Study Arms (1)

Intervention participant

EXPERIMENTAL

Other: Counseling and nutrition supplement

Interventions

Counseling and nutrition supplement OTHER

24-week intervention that includes a) a daily ration of fortified lipid-based nutrient supplement and b) nutrition counseling delivered through biweekly group and individualized sessions. Dietary supplement is a locally- produced lipid-based nutrient spread (Meds and Foods for Kid, Cap Haitian, Haiti) that in a 65g daily ration provides 345 kcal energy and single allowance of key micronutrients for the 6-12 month age group.

Intervention participant

Eligibility Criteria

• Age: 6 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Confirmed maternal HIV-infection
• Age 5.5-6.5 months at intervention start
• Weight-for-length z-score \> -3 SD (WHO 2006 reference)

You may not qualify if:

• Confirmed or suspected allergy to peanuts
• Participation in a concurrent clinical trial at GHESKIO

Sponsors & Collaborators

• Cornell University: lead
• Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic: collaborator
• Weill Medical College of Cornell University: collaborator
• University of Virginia: collaborator

Study Sites (1)

GHESKIO Centres

Port-au-Prince, Quest, Haiti

Location

Related Publications (1)

• Heidkamp RA, Stoltzfus RJ, Fitzgerald DW, Pape JW. Growth in late infancy among HIV-exposed children in urban Haiti is associated with participation in a clinic-based infant feeding support intervention. J Nutr. 2012 Apr;142(4):774-80. doi: 10.3945/jn.111.155275. Epub 2012 Feb 29.

  PMID: 22378328 DERIVED

MeSH Terms

Conditions

Malnutrition; Anemia

Interventions

Counseling

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Rebecca Heidkamp, PhD

  Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2011
• First Posted: September 14, 2011
• Study Start: June 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: May 1, 2010
• Last Updated: September 15, 2011

Record last verified: 2011-09

Locations

HA (1)