- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02580123
Smile-Kids: Study on Complementary Feeding Transition
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Infants with 4-12 months
Exclusion Criteria:
- Infants with disability
Study Plan
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
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: Br J Nutr. 2007 Oct;98(4):871.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Smile-kids
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