Evaluation of a Family Intervention Program for the Management of Overweight or Obese Children
- Conditions
- OverweightObesityChildren
- Interventions
- Behavioral: Counselling groupBehavioral: Nereu group
- Registration Number
- NCT01878994
- Lead Sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Children aged between 6 to 12 years old
- Overweight or obese according to the IOTF 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Counselling Group 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. Nereu Group 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.
- Primary Outcome Measures
Name Time Method Change from Baseline in Body mass index z score (BMIz) 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).
- Secondary Outcome Measures
Name Time Method Change from baseline in Physical activity habits 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.
Trial Locations
- Locations (1)
USR- Lleida. Atenció primaria. IDIAP Jordi Gol
🇪🇸Lleida, Spain