Evaluation of a Family Intervention Program for the Management of Overweight or Obese Children

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Family Intervention Program for the Treatment of Overweight or Obese Children (Nereu Program): Randomized Clinical Trial

Conditions
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Overweight, Obesity, Children

Intervention / Treatment
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* Behavioral: Counselling group
* Behavioral: Nereu group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Counselling Group<br>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<br> <br> |
| Experimental: Nereu Group<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overweight, Obesity, Children, Behaviour, Physical Activity, Nutrition