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| Name | Class |
|---|---|
| Associació NEREU | UNKNOWN |
| INEFC-Lleida | OTHER |
| USR-ICS. Atenció Primà ria Lleida | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Counselling Group | Placebo Comparator | 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. |
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| Nereu Group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Counselling group | Behavioral |
| ||
| Nereu group |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Conepció Teixidó, Phd | Contact | cteixido.lleida.ics@gencat.cat | ||
| Noemà Serra, Mrs | Contact | nserra@inefc.es |
| Name | Affiliation | Role |
|---|---|---|
| Noemà Serra | INEFC-LLEIDA, University of Lleida | Principal Investigator |
| Concepció Teixidó | Institut Català de la Salut - Atenció primaria - Lleida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USR- Lleida. Atenció primaria. IDIAP Jordi Gol | Recruiting | Lleida | Lleida | 25001 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26658988 | Derived | 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. | |
| 24153001 |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D001519 | Behavior |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| 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. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |