Clinical Trials Directory

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UnknownNCT01878994

Evaluation of a Family Intervention Program for the Management of Overweight or Obese Children

Evaluation of Family Intervention Program for the Treatment of Overweight or Obese Children (Nereu Program): Randomized Clinical Trial

Status
Unknown
Phase
Phase 4
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Academic / Other
Sex
All
Age
6 Years – 12 Years
Healthy volunteers
Accepted

Summary

Objectives: To evaluate the effectiveness of the Nereu program compared to standard care (advice on increased physical activity and nutrition) such as a health intervention tool for the childhood obesity management Methods/Design: The study design is a randomized controlled multicenter clinical trial using two types of treatment. Population and sample: Children 6 to 12 years with overweight or obesity, according to the z score of body mass index (BMI z) \>= 1 for age and gender defined by International Obesity Task Force (IOTF). It is considered necessary to recruit 100 children: 50 control group (CG) and 50 Intervention (IG). Study Intervention: Nereu Group: 8 month intervention with 3 weekly training sessions doing physical exercise for children and a weekly session for parents of physical activity and healthy eating habits and behaviour strategies, that involves both parental and child participation. The control group will receive a monthly session of healthy physical and eating habits. Main Outcome Measures: Improvement of BMI z, physical activity and nutrition habits, behaviour components and quality life related to health at the end, 6 and 12 months after intervention.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCounselling group
BEHAVIORALNereu group

Timeline

Start date
2013-01-01
Primary completion
2014-06-01
Completion
2015-12-01
First posted
2013-06-17
Last updated
2013-06-17

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT01878994. Inclusion in this directory is not an endorsement.