Improving Nutrition and Health Outcomes in Intibuca, Honduras (MANI I)

NCT01312987 | Completed DMC

• 1 other identifier: MANI I, Shoulder to Shoulder
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Malnutrition; Undernutrition

Outcome Measures

Primary Outcomes (5)

• Change from baseline in height at 12 months

  Participating children were measured by trained staff every month during the 12 month intervention.

  Baseline to month 12

• Change from baseline in hemoglobin status at 12 months

  Hemoglobin status was measured from blood samples taken by finger pricks at baseline, month 6, and month 12 of the intervention.

  Baseline to month 12

• Change from baseline in serum transferrin status at 12 months

  Serum transferritin was measured from blood samples taken by finger pricks at baseline, month 6, and month 12 of the intervention.

  Baseline to month 12

• Change from baseline in C-Reactive Protein levels at 12 months

  C-Reactive Protein was measured from dried blood spots collected at baseline, month 6, and month 12 of the intervention.

  Baseline to month 12

• Change from baseline in weight at 12 months

  Participating children were weighed by trained staff every month during the 12 month intervention.

  Baseline to month 12

Secondary Outcomes (7)

• Change from baseline in zinc levels at 12 months

  Baseline to month 12

• Change from baseline in food insecurity status at 12 months

  Baseline to month 12

• Change from baseline in dietary intake based on 24-Hour Food Recall at 12 months

  Baseline to month 12

• Change from baseline in various health outcomes at 12 months

  Baseline to month 12

• Change from baseline in acceptability of nutrition supplement at 12 months

  Baseline to month 12

Study Arms (2)

Nutrition intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

Receives food vouchers each month.

Dietary Supplement: Lipid-based nutritional supplement

Interventions

Lipid-based nutritional supplement DIETARY_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

Also known as: Plumpy'doz®

Control; Nutrition intervention

Eligibility Criteria

• Age: 5 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shoulder to Shoulder: lead
• The Mathile Institute for the Advancement of Human Nutrition: collaborator

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Jeff Heck, MD

  Shoulder to Shoulder

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 5, 2011
• First Posted: March 11, 2011
• Study Start: March 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: August 2, 2011

Record last verified: 2011-07