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

NCT01878994 | Unknown Phase 4

• 1 other identifier: PI12/02220
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity; Children

Keywords

Overweight; Obesity; Children; Behaviour; Physical Activity; Nutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

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.

Behavioral: Counselling group

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.

Behavioral: Nereu group

Interventions

Counselling group BEHAVIORAL

Counselling Group

Nereu group BEHAVIORAL

Nereu Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged between 6 to 12 years old
• Overweight or obese according to the IOTF criteria

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Associació NEREU: collaborator
• INEFC-Lleida: collaborator
• USR-ICS. Atenció Primària Lleida: collaborator

Study Sites (1)

USR- Lleida. Atenció primaria. IDIAP Jordi Gol

Lleida, Lleida, 25001, Spain

RECRUITING

Related Publications (2)

• 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.

  PMID: 26658988 DERIVED

• 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.

  PMID: 24153001 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Noemí Serra

  INEFC-LLEIDA, University of Lleida

  PRINCIPAL INVESTIGATOR

• Concepció Teixidó

  Institut Català de la Salut - Atenció primaria - Lleida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Conepció Teixidó, Phd

CONTACT

cteixido.lleida.ics@gencat.cat

Noemí Serra, Mrs

CONTACT

nserra@inefc.es

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2013
• First Posted: June 17, 2013
• Study Start: January 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2015
• Last Updated: June 17, 2013

Record last verified: 2013-06

Locations

ES (1)