Smile-Kids: Study on Complementary Feeding Transition

Study Overview
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Brief Summary
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The importance of families in the development of infants is well documented. Previous studies found that the prevalence of overweight and obesity is growing concerns in Portugal (Padez, Fernandes, Mourão, Moreira, & Rosado, 2004) and in the world (Ogden et al., 2014). More, there is evidence that habits acquired in early life might track into adulthood (Lien, Lytle, & Klepp, 2001; Lytle, Seifert, Greenstein, & McGovern, 2000; te Velde, Twisk, & Brug, 2007). Therefore, there is a need to lock overweight and obesity in early childhood in order to contribute to health gains during the entire life cycle. The main purpose of this research is to evaluate the impact of an intervention program based on parenting skills and feeding practices, on infant's growth, development and adherence to new foods in early infancy Methods: 58 infants, 4-12 months from 25 nursery schools participated in this randomized trial and were randomly allocated to intervention and control group. Infant outcomes were performed at baseline and post-intervention and included anthropometry, dietary assessment and temperament. In addition maternal and family outcomes such as anxiety, dietary intake were also assessed at both times. An intervention program was developed and Implemented according to two terms: educators' training with the researchers and the intervention with parents and infants developed by trained educators. The training program was developed between December 2013 and February 2014, according to the topics of healthy eating and nutrition and development of the infant. The control group received the standard care. It is expected that this intervention program is able to promote healthy feeding practices to parents and nursery teachers. The results will be disseminated to the stakeholders and policymakers that work closely to the topic of this study. This will include papers' publication, participation in national and international meetings, contributing to the advance of research in this health area.

Conditions
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Infant, Health Promotion, Nursery, Educators

Intervention / Treatment
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* Behavioral: Intervention taught by trained educators


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants with 4-12 months Exclusion Criteria: Infants with disability

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Received the intervention program. | Behavioral: Intervention taught by trained educators<br> <br> |
| No Intervention: Control group<br>received the standard care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight of the infant | Weight was measured with no clothes and no shoes, using standardized procedures, | 4 months up to 12 months of age | 
| Length of the infant | Length was measured according to standardized procedures. | 4 months up to 12 months of age | 
| Body Mass Index (BMI) of the infant | BMI was computed as the ratio weight/length2 | 4 months up to 12 months of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary intake of infants | We used a questionnaires (2 day food record) to have data of dietary intake. | 4 months up to 12 months of age | 
| Temperament of the infant | Temperament was gathered with a questionnaire. | 4 months up to 12 months of age | 
| Family characteristics | Characteristics of infants´family, with a questionnaire about family income and dietary intake (Frequency Feeding Questionnaire) | 4 months up to 12 months of age |