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

NCT ID: NCT01312987

Last Updated: 2011-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2010-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Lipid-based nutritional supplement

Intervention Type: 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

Control

Receives food vouchers each month.

Group Type: NO_INTERVENTION

Lipid-based nutritional supplement

Intervention Type: 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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Plumpy'doz®

Eligibility Criteria

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.

• 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.

• Minimum Eligible Age: 5 Months
• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Mathile Institute for the Advancement of Human Nutrition

OTHER

Sponsor Role: collaborator

Shoulder to Shoulder

OTHER

Sponsor Role: lead

Responsible Party

Shoulder to Shoulder

Principal Investigators

Jeff Heck, MD

Role: PRINCIPAL_INVESTIGATOR

Shoulder to Shoulder

Other Identifiers

MANI I, Shoulder to Shoulder

Identifier Type: -

Identifier Source: org_study_id