Evaluation of a Family Intervention Program for the Management of Overweight or Obese Children (NEREU)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01878994|
Recruitment Status : Unknown
Verified June 2013 by Jordi Gol i Gurina Foundation.
Recruitment status was: Recruiting
First Posted : June 17, 2013
Last Update Posted : June 17, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Overweight Obesity Children||Behavioral: Counselling group Behavioral: Nereu group||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Evaluation of Family Intervention Program for the Treatment of Overweight or Obese Children (Nereu Program): Randomized Clinical Trial|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||December 2015|
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
- 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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01878994
|Contact: Conepció Teixidó, Phdfirstname.lastname@example.org|
|Contact: Noemí Serra, Mrsemail@example.com|
|USR- Lleida. Atenció primaria. IDIAP Jordi Gol||Recruiting|
|Lleida, Spain, 25001|
|Contact: Conxita Teixidó, Dra firstname.lastname@example.org|
|Principal Investigator:||Noemí Serra||INEFC-LLEIDA, University of Lleida|
|Principal Investigator:||Concepció Teixidó||Institut Català de la Salut - Atenció primaria - Lleida|