N/A
N=306
Intervention for the Prevention of Obesity in Preschool
Childhood Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01539070 ↗Enrolled (actual)
306
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment — -0.8; -5.5; 0.1; -1.9 servings/week — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Eating and physical activity counseling (Behavioral)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Coordinación de Investigación en Salud, Mexico
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment |
-0.8; -5.5; 0.1; -1.9; -0.6; -3.5 | <0.05 sig |
| PRIMARY Change in Children´s Time of Physical Activity From Baseline to 3 Months by Intervention Assignment |
2.9; 9.5; -0.3; -0.1; -2.76; -1.97 | <0.05 sig |
| PRIMARY Change in Score z of Body Mass Index From Baseline to 3 Months by Intervention Assignment |
-0.26; -0.44 | <0.05 sig |
| SECONDARY Number of Families That Completed 3 Month Follow-up in Intervention Group and Usual Care Group |
99; 99 | — |
Summary
The purpose of this study is to develop, implement and evaluate an intervention focused to change feeding practices and patterns of physical activity of preschool children through providing motivational counseling to the mother. The aim is to prevent obesity in children aged 2 to 4 years 11 months with risk of overweight or with overweight.
Eligibility Criteria
Inclusion Criteria
- Children between 2 and 4 years and 11 months of age at the beginning of the study.
- Overweight children, defined as a BMI score of z > = 1.5 and < +3 based on the WHO standards.
- The children's parents accept participation in the study.
Exclusion Criteria
- Families who plan on changing their address during the study.
- Families whose doctor considers them to be inappropriate for participation in the intervention, as with emotional or mental alterations.
- Children who require a special diet for medical reasons or children with limited motor functioning.
Data sourced from ClinicalTrials.gov (NCT01539070). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.