Physical Activity Consultation in the Management of Adolescent Overweight

NCT02941770 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2019-04-19

No results posted yet for this study

Summary

The prevalence of pediatric obesity makes this condition a worldwide public health concern. Physical Activity (PA) is recognized as having many health benefits, many of them related to obesity and its comorbidities. Despite of all the efforts, the majority of the overweight children/adolescents still present low levels of PA and high levels of sedentary behaviors. Thus, it seems that the greatest challenge is to influence behavior change in order to increase PA exposure in this population. PA consultation can be a cost-effective way of enhancing PA and improve weight status among overweight children.

The main objective of this study is to analyze if the inclusion of a PA consultation in a multidisciplinary program for the management of adolescent overweight improves body mass index (BMI) z-score, PA levels and sedentary behavior outcomes at six and twelve months, compared to those attending only the Pediatric and the Dietetic consultations.

This study was designed as a non-randomized, controlled clinical trial with six months duration and follow-up at the 12th month, that will include overweight adolescents (BMI ≥ p85) aged 12 to 17, attending the Clinic for the first time, and accepted to be enrolled. Those with (i) major pathologies (other than obesity or its related comorbidities), (ii) inability to perform regular PA, (iii) mental disorders, (iv) smoking habits, (v) under any kind of prescription (other than antihypertensives or metformin), or (vi) being involved in another weight loss program will be excluded. According to the sample size calculation, we expect to recruit 129 participants that will be allocated in three groups by consecutive sampling: (i) control group - standard care (Pediatric and Dietitian consultations); (ii) intervention group I - standard care plus PA consultation; (iii) intervention group II - 2 weekly exercise sessions additionally to the standard care and PA consultations..

Conditions

Interventions

BEHAVIORAL

Physical activity behavior change

Physical activity consultation will consist in a patient-centered, one-to-one session based on the transtheoretical model and will use motivational interview in order to strengthen individual's intrinsic motivation to achieve a positive PA behavior change. In these sessions the following topics will be explored: (i) explore and resolve ambivalence; (ii) identify difficulties/barriers, and benefits of behavior change; (iii) find their own means and their own solutions for step over the identified barriers; (iv) enhancement of autonomy and self-efficacy.

OTHER

Exercise

Experimental group II will participate accordingly with their availability in two exercise sessions per week (≈60 min/session) directed by one exercise physiologist. The ability to exercise will be assessed in order to customize the exercise plan. All the sessions will include: 10 minutes of warm-up, 5 minutes of agility exercises, 15 minutes of resistance training (including the major upper and lower muscles, 12-15 sets of 15 repetitions), 20 minutes of aerobic exercise, and 10 minutes of cool-down (50-80% heart rate reserve - Polar Vantage NV, Polar Electro Oy, Kempele, Finland). All the participants will have to attend at least 80% of the scheduled sessions.

Sponsors & Collaborators

  • University of Lisbon

    lead OTHER

Principal Investigators

  • Helena Fonseca, MD, PhD · Pediatric Obesity Clinic, Department of Pediatrics, Hospital de Santa Maria, Lisbon, Portugal

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Portugal

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02941770 on ClinicalTrials.gov