Smile-Kids: Study on Complementary Feeding Transition

NCT ID: NCT02580123

Last Updated: 2015-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Infant Health Promotion Nursery Educators

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Experimental group

Received the intervention program.

Group Type EXPERIMENTAL

Intervention taught by trained educators

Intervention Type BEHAVIORAL

Control group

received the standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intervention taught by trained educators

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Infants with 4-12 months

Exclusion Criteria

* Infants with disability
Minimum Eligible Age

4 Months

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Minho

OTHER

Sponsor Role lead

Responsible Party

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Helena Rafaela Vieira do Rosario

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type RESULT
PMID: 15495229 (View on PubMed)

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.

Reference Type RESULT
PMID: 25005661 (View on PubMed)

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.

Reference Type RESULT
PMID: 11522162 (View on PubMed)

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.

Reference Type RESULT
PMID: 10915532 (View on PubMed)

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.

Reference Type RESULT
PMID: 17433126 (View on PubMed)

Other Identifiers

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Smile-kids

Identifier Type: -

Identifier Source: org_study_id

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