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Completed

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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Key information

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

Intervention taught by trained educators

Behavioral

Primary outcomes

  1. 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,

  2. Length of the infant

    Time frame: 4 months up to 12 months of age

    Length was measured according to standardized procedures.

  3. 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

  1. 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.

  2. Temperament of the infant

    Time frame: 4 months up to 12 months of age

    Temperament was gathered with a questionnaire.

  3. 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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