Clinical trial NCT02580123: Smile-Kids: Study on Complementary Feeding Transition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant
Health Promotion
Nursery
Educators
Lead sponsor: University of Minho
Sponsor class: OTHER
First posted: 2015-10-20
Enrollment: 53
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Infants with 4-12 months

Exclusion Criteria:

* Infants with disability

Primary outcomes:
measure: Weight of the infant
timeFrame: 4 months up to 12 months of age
measure: Length of the infant
timeFrame: 4 months up to 12 months of age
measure: Body Mass Index (BMI) of the infant
timeFrame: 4 months up to 12 months of age
Secondary outcomes:
measure: Dietary intake of infants
timeFrame: 4 months up to 12 months of age
measure: Temperament of the infant
timeFrame: 4 months up to 12 months of age
measure: Family characteristics
timeFrame: 4 months up to 12 months of age
Other outcomes:
Locations:
Study officials:
References:
citation: Padez C, Fernandes T, Mourao I, Moreira P, Rosado V. Prevalence of overweight and obesity in 7-9-year-old Portuguese children: trends in body mass index from 1970-2002. Am J Hum Biol. 2004 Nov-Dec;16(6):670-8. doi: 10.1002/ajhb.20080.
citation: Ogden CL, Carroll MD, Flegal KM. Prevalence of obesity in the United States. JAMA. 2014 Jul;312(2):189-90. doi: 10.1001/jama.2014.6228. No abstract available.
citation: Lien N, Lytle LA, Klepp KI. Stability in consumption of fruit, vegetables, and sugary foods in a cohort from age 14 to age 21. Prev Med. 2001 Sep;33(3):217-26. doi: 10.1006/pmed.2001.0874.
citation: Lytle LA, Seifert S, Greenstein J, McGovern P. How do children's eating patterns and food choices change over time? Results from a cohort study. Am J Health Promot. 2000 Mar-Apr;14(4):222-8. doi: 10.4278/0890-1171-14.4.222.
citation: te Velde SJ, Twisk JW, Brug J. Tracking of fruit and vegetable consumption from adolescence into adulthood and its longitudinal association with overweight. Br J Nutr. 2007 Aug;98(2):431-8. doi: 10.1017/S0007114507721451. Epub 2007 Apr 16.