Obesity Clinical Trial
— NEREUOfficial title:
Evaluation of Family Intervention Program for the Treatment of Overweight or Obese Children (Nereu Program): Randomized Clinical Trial
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 2015 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Years to 12 Years |
Eligibility |
Inclusion Criteria: - Children aged between 6 to 12 years old - Overweight or obese according to the IOTF criteria Exclusion Criteria: - Medical co-morbidities: Diabetes mellitus or hypercholesterolemia or cardiovascular disease that could be contraindicate the sport practice. - Use of medication that might have an effect on weight loss. - previous enrolment in another similar treatment program based on reducing obesity. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Spain | USR- Lleida. Atenció primaria. IDIAP Jordi Gol | Lleida |
Lead Sponsor | Collaborator |
---|---|
Jordi Gol i Gurina Foundation | Associació NEREU, INEFC- Lleida, USR-ICS. Atenció Primària Lleida |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline in Body mass index z score (BMIz) | Weight is measured to the nearest of 0.1 kg using an electronic scale and height (Ht) to the nearest of 0.1 cm with a stadiometer, in lightly dressed and without shoes. The BMIz is calculated according z score of BMI adjusted by age and gender (IOTF). | 4 times: at baseline, at the end of the intervention (8 months later of the baseline), 6 and 12 months post intervention | No |
Secondary | Change from baseline in Physical activity habits | To measure physical activity will be used an Actigraph accelerometers (GT3X+ models), it will be wear by participants during all day for seven consecutive days. | 4 times: at baseline, at the end of the intervention (8 months later of the baseline), 6 and 12 months post intervention | No |
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