Smile-Kids: Study on Complementary Feeding Transition

Health Promotion Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02580123
• Other study ID #: Smile-kids
• Status: Completed
• Phase: N/A
• First received: April 13, 2015
• Last updated: October 17, 2015
• Start date: May 2012
• Est. completion date: July 2014

Study information

• Verified date: October 2015
• Source: University of Minho
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Ethics Subcommittee for Life and Health Sciences (SECVS) from University of Minho
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Months to 12 Months

Eligibility

Inclusion Criteria:

• Infants with 4-12 months

Exclusion Criteria:

• Infants with disability

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Educators
• Health Promotion
• Infant
• Nursery

Intervention

Behavioral:
• Intervention taught by trained educators

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Minho

References & Publications (5)

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. — View 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. — View 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. — View Citation

Padez C, Fernandes T, Mourão 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. — View 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. Epub 2007 Apr 16. Erratum in: Br J Nutr. 2007 Oct;98(4):871. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight of the infant	Weight was measured with no clothes and no shoes, using standardized procedures,	4 months up to 12 months of age	Yes
Primary	Length of the infant	Length was measured according to standardized procedures.	4 months up to 12 months of age	Yes
Primary	Body Mass Index (BMI) of the infant	BMI was computed as the ratio weight/length2	4 months up to 12 months of age	Yes
Secondary	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	Yes
Secondary	Temperament of the infant	Temperament was gathered with a questionnaire.	4 months up to 12 months of age	Yes
Secondary	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	Yes