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Smile-Kids: Study on Complementary Feeding Transition

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02580123
Enrollment
53
Registered
2015-10-20
Start date
2012-05-31
Completion date
2014-07-31
Last updated
2015-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Educators, Health Promotion, Infant, Nursery

Brief summary

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.

Interventions

BEHAVIORALIntervention taught by trained educators

Sponsors

University of Minho
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Months to 12 Months
Healthy volunteers
Yes

Inclusion criteria

* Infants with 4-12 months

Exclusion criteria

* Infants with disability

Design outcomes

Primary

MeasureTime frameDescription
Weight of the infant4 months up to 12 months of ageWeight was measured with no clothes and no shoes, using standardized procedures,
Length of the infant4 months up to 12 months of ageLength was measured according to standardized procedures.
Body Mass Index (BMI) of the infant4 months up to 12 months of ageBMI was computed as the ratio weight/length2

Secondary

MeasureTime frameDescription
Dietary intake of infants4 months up to 12 months of ageWe used a questionnaires (2 day food record) to have data of dietary intake.
Temperament of the infant4 months up to 12 months of ageTemperament was gathered with a questionnaire.
Family characteristics4 months up to 12 months of ageCharacteristics of infants´family, with a questionnaire about family income and dietary intake (Frequency Feeding Questionnaire)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026