Clinical trial NCT01312987: Improving Nutrition and Health Outcomes in Intibuca, Honduras (MANI I)
Official title: Improving Nutrition and Health Outcomes in Intibuca, Honduras
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Undernutrition
Lead sponsor: Shoulder to Shoulder
Sponsor class: OTHER
Collaborators: name: The Mathile Institute for the Advancement of Human Nutrition
First posted: 2011-03-11
Enrollment: 300
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Change from baseline in height at 12 months
timeFrame: Baseline to month 12
measure: Change from baseline in hemoglobin status at 12 months
timeFrame: Baseline to month 12
measure: Change from baseline in serum transferrin status at 12 months
timeFrame: Baseline to month 12
measure: Change from baseline in C-Reactive Protein levels at 12 months
timeFrame: Baseline to month 12
measure: Change from baseline in weight at 12 months
timeFrame: Baseline to month 12
Secondary outcomes:
measure: Change from baseline in zinc levels at 12 months
timeFrame: Baseline to month 12
measure: Change from baseline in food insecurity status at 12 months
timeFrame: Baseline to month 12
measure: Change from baseline in dietary intake based on 24-Hour Food Recall at 12 months
timeFrame: Baseline to month 12
measure: Change from baseline in various health outcomes at 12 months
timeFrame: Baseline to month 12
measure: Change from baseline in acceptability of nutrition supplement at 12 months
timeFrame: Baseline to month 12
measure: Change from baseline in folate status at 12 months
timeFrame: Baseline to month 12
measure: Change from baseline in vitamin B12 status at 12 months
timeFrame: Baseline to month 12
Other outcomes:
Locations:
Study officials:
affiliation: Shoulder to Shoulder
name: Jeff Heck, MD
role: PRINCIPAL_INVESTIGATOR
References: