NCT Number: NCT02580123
Smile-Kids: Study on Complementary Feeding Transition
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.
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Notify MeKey information
Conditions
Age range
4 month–12 month
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Infants with 4-12 months
Exclusion criteria
- Infants with disability
Treatment and study plan
Primary outcomes
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Weight of the infant
Time frame: 4 months up to 12 months of age
Weight was measured with no clothes and no shoes, using standardized procedures,
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Length of the infant
Time frame: 4 months up to 12 months of age
Length was measured according to standardized procedures.
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Body Mass Index (BMI) of the infant
Time frame: 4 months up to 12 months of age
BMI was computed as the ratio weight/length2
Secondary outcomes
-
Dietary intake of infants
Time frame: 4 months up to 12 months of age
We used a questionnaires (2 day food record) to have data of dietary intake.
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Temperament of the infant
Time frame: 4 months up to 12 months of age
Temperament was gathered with a questionnaire.
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Family characteristics
Time frame: 4 months up to 12 months of age
Characteristics of infants´family, with a questionnaire about family income and dietary intake (Frequency Feeding Questionnaire)
Sponsors and collaborators
Lead sponsor
University of Minho
Other
Registry information
Important dates
- Study start
- 2012
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Oct 20, 2015
- Registry last updated
- Oct 20, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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