Improving Nutrition and Health Outcomes in Intibuca, Honduras (MANI I) - Full Text View

Purpose

The purpose of this research study is to assess what impact an integrated educational and feeding intervention delivered to infants and children has on growth (weight and height), development (cognitive and gross motor), nutrition (dietary behaviors, food insecurity, and micronutrient status - folate, iron, zinc, vitamin A, vitamin D), and morbidity (respiratory and diarrheal) outcomes. A randomized community trial was used to implement a nutrition intervention program consisting of monthly education sessions, a lipid-based nutrition supplement, and food vouchers for local staples.

Condition	Intervention
Malnutrition Undernutrition	Dietary Supplement: Lipid-based nutritional supplement

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Improving Nutrition and Health Outcomes in Intibuca, Honduras

Resource links provided by NLM:

MedlinePlus related topics: B Vitamins Dietary Supplements Malnutrition

U.S. FDA Resources

Further study details as provided by Shoulder to Shoulder:

Primary Outcome Measures:

Change from baseline in height at 12 months [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
Participating children were measured by trained staff every month during the 12 month intervention.
Change from baseline in hemoglobin status at 12 months [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
Hemoglobin status was measured from blood samples taken by finger pricks at baseline, month 6, and month 12 of the intervention.
Change from baseline in serum transferrin status at 12 months [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
Serum transferritin was measured from blood samples taken by finger pricks at baseline, month 6, and month 12 of the intervention.
Change from baseline in C-Reactive Protein levels at 12 months [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
C-Reactive Protein was measured from dried blood spots collected at baseline, month 6, and month 12 of the intervention.
Change from baseline in weight at 12 months [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
Participating children were weighed by trained staff every month during the 12 month intervention.

Secondary Outcome Measures:

Change from baseline in zinc levels at 12 months [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
Zinc status was measured from blood samples taken by finger pricks at baseline, month 6, and month 12 of the intervention.
Change from baseline in food insecurity status at 12 months [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
Assessment teams administered a scored questionnaire at baseline and month 12 of the intervention.
Change from baseline in dietary intake based on 24-Hour Food Recall at 12 months [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
Assessment teams administered a 24-Hour Food Recall every month of the intervention.
Change from baseline in various health outcomes at 12 months [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
Assessment teams administered a scored questionnaire every month of the intervention.
Change from baseline in acceptability of nutrition supplement at 12 months [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
Assessment teams administered a scored questionnaire at baseline, month 6, and month 12 of the intervention
Change from baseline in folate status at 12 months [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
Folate status was measured from blood samples taken by finger pricks at baseline, month 6, and month 12 of the intervention.
Change from baseline in vitamin B12 status at 12 months [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
Vitamin B12 was measured from blood samples taken by finger pricks at baseline, month 6, and month 12 of the intervention.

Enrollment:	300
Study Start Date:	March 2009
Study Completion Date:	April 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Nutrition intervention Receives a month's supply of the nutrition supplement, Plumpy'doz®, in addition to food voucher for each month. Participants were also allowed to attend monthly educational sessions.	Dietary Supplement: Lipid-based nutritional supplement After gradual introduction of the lipid-based nutritional supplement, daily dose per child is as follows: 3 teaspoons 3 x day for children younger than 12 months 4.5 teaspoons 3 x day for children older than 12 months Other Name: Plumpy'doz®
No Intervention: Control Receives food vouchers each month.	Dietary Supplement: Lipid-based nutritional supplement After gradual introduction of the lipid-based nutritional supplement, daily dose per child is as follows: 3 teaspoons 3 x day for children younger than 12 months 4.5 teaspoons 3 x day for children older than 12 months Other Name: Plumpy'doz®

Eligibility

Ages Eligible for Study:	5 Months to 18 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

All healthy children between the ages of 5-18 months old and their mothers who are residents of the municipalities of Santa Lucia, Magdalena and San Antonio who do not present any of the medical conditions listed in the exclusion criteria.
Mothers have understood and signed consent forms to enable their children to participate in the study. They were willing to have their child participate in one or more blood draws, bi-monthly sessions: 1) nutrition classes and food voucher and lipid-based nutritional supplement and 2) height/weight monitoring, dietary intake questionnaire, and health outcome information. As well as the additional data assessments necessary to be considered active participants in the study.

Exclusion Criteria:

Children with congenital anomalies, mental retardation, severe physical handicap, under-nutrition caused by medical conditions that contribute to under-nutrition such as heart disease, kidney failure, face and throat problems that interfere with swallowing, medical problems interfering with the absorption of food, chronic diseases such as tuberculosis, etc.
Children with a known allergy to peanuts and eggs will also be excluded from the study, 30% of children with known allergies to nuts also have an allergy to eggs.
Plans to move or change their place of residence outside of the study region in the next 2 months would make them ineligible.
Mothers who are younger than 16 years of age will be excluded from the study. Women younger than 16 might not understand the consent process and the importance of following the guidelines established in the research, therefore we chose not to include this group as "eligible" participants.
Children who are <= -2 standard deviations below the norm for z score for weight for age. These children are severely malnourished and need to be carefully followed under the supervision of a qualified health care provider.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01312987

Sponsors and Collaborators

Shoulder to Shoulder

Mathile Institute for the Advancement of Human Nutrition

Investigators

Principal Investigator:

Jeff Heck, MD

Shoulder to Shoulder

More Information

No publications provided

Responsible Party:	Jeff Heck, MD, Executive Director, Shoulder to Shoulder
ClinicalTrials.gov Identifier:	NCT01312987 History of Changes
Other Study ID Numbers:	MANI I, Shoulder to Shoulder
Study First Received:	March 5, 2011
Last Updated:	July 31, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on May 22, 2013