Smile-Kids: Study on Complementary Feeding Transition

NCT02580123 | Completed

• 1 other identifier: Smile-kids
• Study Type: interventional
• Target: 53
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infant; Health Promotion; Nursery; Educators

Outcome Measures

Primary Outcomes (3)

• Weight of the infant

  Weight was measured with no clothes and no shoes, using standardized procedures,

  4 months up to 12 months of age

• Length of the infant

  Length was measured according to standardized procedures.

  4 months up to 12 months of age

• Body Mass Index (BMI) of the infant

  BMI was computed as the ratio weight/length2

  4 months up to 12 months of age

Secondary Outcomes (3)

• Dietary intake of infants

  4 months up to 12 months of age

• Temperament of the infant

  4 months up to 12 months of age

• Family characteristics

  4 months up to 12 months of age

Study Arms (2)

Experimental group

EXPERIMENTAL

Received the intervention program.

Behavioral: Intervention taught by trained educators

Control group

NO INTERVENTION

received the standard care

Interventions

Intervention taught by trained educators BEHAVIORAL

Experimental group

Eligibility Criteria

• Age: 4 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants with 4-12 months

You may not qualify if:

• Infants with disability

Sponsors & Collaborators

• University of Minho: lead

Related Publications (5)

• 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.

  PMID: 15495229 RESULT

• 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.

  PMID: 25005661 RESULT

• 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.

  PMID: 11522162 RESULT

• 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.

  PMID: 10915532 RESULT

• 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.

  PMID: 17433126 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 13, 2015
• First Posted: October 20, 2015
• Study Start: May 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 20, 2015

Record last verified: 2015-10