Evaluation of a Family Intervention Program for the Management of Overweight or Obese Children (NEREU)
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.
Behavioral: Counselling group
Behavioral: Nereu group
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Evaluation of Family Intervention Program for the Treatment of Overweight or Obese Children (Nereu Program): Randomized Clinical Trial|
- Change from Baseline in Body mass index z score (BMIz) [ Time Frame: 4 times: at baseline, at the end of the intervention (8 months later of the baseline), 6 and 12 months post intervention ] [ Designated as safety issue: No ]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).
- Change from baseline in Physical activity habits [ Time Frame: 4 times: at baseline, at the end of the intervention (8 months later of the baseline), 6 and 12 months post intervention ] [ Designated as safety issue: No ]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.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: Counselling Group
Each family will receive a single monthly meeting, a total of 8 with 10 minutes duration each one. The sessions will take place in the consultation of the paediatrician and it will be delivered by the child's nurse or/and paediatrician. The sessions' contents are about promotion of healthy eating and physical activity habits.
|Behavioral: Counselling group|
Experimental: Nereu Group
The Nereu treatment program is an intensive family-based behavioural multi-component lifestyle intervention. Consist in an intensive treatment of 8 months duration (from October to May, that is, an academic year). The intervention is a multidisciplinary intervention consisting in 4 structured components: (a) physical activity training for children, (b) family theoretical and practical sessions for parents, (c) behaviour strategies, that involves both parental and child participation (d) weekend extra activities.
|Behavioral: Nereu group|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01878994
|Contact: Conepció Teixidó, Phdemail@example.com|
|Contact: Noemí Serra, Mrsfirstname.lastname@example.org|
|USR- Lleida. Atenció primaria. IDIAP Jordi Gol||Recruiting|
|Lleida, Spain, 25001|
|Contact: Conxita Teixidó, Dra email@example.com|
|Principal Investigator:||Noemí Serra||INEFC-LLEIDA, University of Lleida|
|Principal Investigator:||Concepció Teixidó||Institut Català de la Salut - Atenció primaria - Lleida|