Smile-Kids: Study on Complementary Feeding Transition

Sponsor
University of Minho (Other)
Overall Status
Completed
CT.gov ID
NCT02580123
Collaborator
(none)
53
2
26

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Intervention taught by trained educators
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
53 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Study Start Date :
May 1, 2012
Actual Primary Completion Date :
Jul 1, 2014
Actual Study Completion Date :
Jul 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental group

Received the intervention program.

Behavioral: Intervention taught by trained educators

No Intervention: Control group

received the standard care

Outcome Measures

Primary Outcome Measures

  1. Weight of the infant [4 months up to 12 months of age]

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

  2. Length of the infant [4 months up to 12 months of age]

    Length was measured according to standardized procedures.

  3. Body Mass Index (BMI) of the infant [4 months up to 12 months of age]

    BMI was computed as the ratio weight/length2

Secondary Outcome Measures

  1. Dietary intake of infants [4 months up to 12 months of age]

    We used a questionnaires (2 day food record) to have data of dietary intake.

  2. Temperament of the infant [4 months up to 12 months of age]

    Temperament was gathered with a questionnaire.

  3. Family characteristics [4 months up to 12 months of age]

    Characteristics of infants´family, with a questionnaire about family income and dietary intake (Frequency Feeding Questionnaire)

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Months to 12 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Infants with 4-12 months
Exclusion Criteria:
  • Infants with disability

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Minho

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Helena Rafaela Vieira do Rosario, Dr, University of Minho
ClinicalTrials.gov Identifier:
NCT02580123
Other Study ID Numbers:
  • Smile-kids
First Posted:
Oct 20, 2015
Last Update Posted:
Oct 20, 2015
Last Verified:
Oct 1, 2015

Study Results

No Results Posted as of Oct 20, 2015