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

Shoulder to Shoulder

Status: Completed

Conditions: Malnutrition; Undernutrition

Treatments: Dietary Supplement: Lipid-based nutritional supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT01312987

MANI I, Shoulder to Shoulder

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 5 to 18 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Nutrition intervention

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Lipid-based nutritional supplement

Control

No Intervention group

Description:

Receives food vouchers each month.

Treatment:

Dietary Supplement: Lipid-based nutritional supplement