Evaluation of a Family Intervention Program for the Management of Overweight or Obese Children
NCT01878994 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2013-06-17
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
- Overweight
- Obesity
- Children
Interventions
- BEHAVIORAL
-
Counselling group
- BEHAVIORAL
-
Nereu group
Sponsors & Collaborators
-
Associació NEREU
collaborator UNKNOWN -
INEFC-Lleida
collaborator OTHER -
USR-ICS. Atenció Primària Lleida
collaborator UNKNOWN -
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
lead OTHER
Principal Investigators
-
Noemí Serra · INEFC-LLEIDA, University of Lleida
-
Concepció Teixidó · Institut Català de la Salut - Atenció primaria - Lleida
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Years
- Max Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-01-31
- Primary Completion
- 2014-06-30
- Completion
- 2015-12-31
Countries
- Spain
Study Locations
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