Clinical trial NCT01878994: Evaluation of a Family Intervention Program for the Management of Overweight or Obese Children
Official title: Evaluation of Family Intervention Program for the Treatment of Overweight or Obese Children (Nereu Program): Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Overweight
Obesity
Children
Keywords: Overweight
Obesity
Children
Behaviour
Physical Activity
Nutrition
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Associació NEREU
name: INEFC-Lleida
name: USR-ICS. Atenció Primària Lleida
First posted: 2013-06-17
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in Body mass index z score (BMIz)
timeFrame: 4 times: at baseline, at the end of the intervention (8 months later of the baseline), 6 and 12 months post intervention
Secondary outcomes:
measure: Change from baseline in Physical activity habits
timeFrame: 4 times: at baseline, at the end of the intervention (8 months later of the baseline), 6 and 12 months post intervention
Other outcomes:
Locations:
city: Lleida
country: Spain
facility: USR- Lleida. Atenció primaria. IDIAP Jordi Gol
Study officials:
affiliation: INEFC-LLEIDA, University of Lleida
name: Noemí Serra
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Català de la Salut - Atenció primaria - Lleida
name: Concepció Teixidó
role: PRINCIPAL_INVESTIGATOR
References:
citation: Serra-Paya N, Ensenyat A, Castro-Vinuales I, Real J, Sinfreu-Bergues X, Zapata A, Mur JM, Galindo-Ortego G, Sole-Mir E, Teixido C. Effectiveness of a Multi-Component Intervention for Overweight and Obese Children (Nereu Program): A Randomized Controlled Trial. PLoS One. 2015 Dec 14;10(12):e0144502. doi: 10.1371/journal.pone.0144502. eCollection 2015.
citation: Serra-Paya N, Ensenyat A, Real J, Castro-Vinuales I, Zapata A, Galindo G, Sole-Mir E, Bosch-Munoz J, Mur JM, Teixido C. Evaluation of a family intervention programme for the treatment of overweight and obese children (Nereu Programme): a randomized clinical trial study protocol. BMC Public Health. 2013 Oct 23;13:1000. doi: 10.1186/1471-2458-13-1000.