Smile-Kids: Study on Complementary Feeding Transition

October 17, 2015 updated by: Helena Rafaela Vieira do Rosario, University of Minho

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months to 1 year (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Infants with 4-12 months

Exclusion Criteria:

  • Infants with disability

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Received the intervention program.
No Intervention: Control group
received the standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight of the infant
Time Frame: 4 months up to 12 months of age
Weight was measured with no clothes and no shoes, using standardized procedures,
4 months up to 12 months of age
Length of the infant
Time Frame: 4 months up to 12 months of age
Length was measured according to standardized procedures.
4 months up to 12 months of age
Body Mass Index (BMI) of the infant
Time Frame: 4 months up to 12 months of age
BMI was computed as the ratio weight/length2
4 months up to 12 months of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary intake of infants
Time Frame: 4 months up to 12 months of age
We used a questionnaires (2 day food record) to have data of dietary intake.
4 months up to 12 months of age
Temperament of the infant
Time Frame: 4 months up to 12 months of age
Temperament was gathered with a questionnaire.
4 months up to 12 months of age
Family characteristics
Time Frame: 4 months up to 12 months of age
Characteristics of infants´family, with a questionnaire about family income and dietary intake (Frequency Feeding Questionnaire)
4 months up to 12 months of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

April 13, 2015

First Submitted That Met QC Criteria

October 17, 2015

First Posted (Estimate)

October 20, 2015

Study Record Updates

Last Update Posted (Estimate)

October 20, 2015

Last Update Submitted That Met QC Criteria

October 17, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • Smile-kids

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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