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Physical Activity Consultation in the Management of Adolescent Overweight (PAC-MAnO)

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ClinicalTrials.gov Identifier: NCT02941770
Recruitment Status : Active, not recruiting
First Posted : October 21, 2016
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
A. Videira-Silva, University of Lisbon

Brief 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..


Condition or disease Intervention/treatment Phase
Overweight Behavioral: Physical activity behavior change Other: Exercise Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of a Physical Activity Consultation in the Management of Adolescent Overweight, Including Anthropometry, Physical Activity Levels, Cardiorespiratory Fitness, and Endothelial Health
Actual Study Start Date : October 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control group

Clinic standard care protocol:

  • Baseline evaluation session with a Pediatrician for initial screening;
  • Appointment with a Dietitian;
  • A brochure with physical activity guidelines for youth with examples of physical exercises.
Experimental: Intervention group I
  • Clinic standard care protocol;
  • Physical activity consultation (Physical activity behavior change);
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.

Experimental: Intervention group II
  • Clinic standard care protocol;
  • Physical activity consultation;
  • 2 exercise sessions per week (≈60 min/session) directed by one Exercise Physiologist.
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.




Primary Outcome Measures :
  1. Body mass index (BMI) z-score [ Time Frame: 12 months ]
  2. Physical activity (PA) levels [ Time Frame: 12 months ]
  3. Sedentary behavior [ Time Frame: 12 months ]
    Questionnaire ASAQ (Adolescent Sedentary Activity Questionnaire)


Secondary Outcome Measures :
  1. Cardiorespiratory fitness (CRF) [ Time Frame: 12 months ]
    Maximal (Cycle ergometer and gas analyser) and submaximal (step) testes

  2. Carotid intima-media thickness (cIMT) [ Time Frame: 12 months ]
  3. Pulse wave velocity (PWV) [ Time Frame: 12 months ]
  4. Body composition [ Time Frame: 12 months ]
  5. Lipid profile (TC, LDL-C, HDL-C) [ Time Frame: 12 months ]
  6. Glucose metabolism (Glucose, Insulin, HOMA-IR) [ Time Frame: 12 months ]
  7. inflammation (C-RP) [ Time Frame: 12 months ]
  8. Cost-effectiveness (CE) [ Time Frame: 12 months ]
    CE will be estimated for the standard intervention, and for both the intervention groups. CE ratio = C/E, (where C = cost of each intervention [human and material resources in €]; and E = effectiveness of each intervention [BMI z-score outcome]. The lowest CE ratio will represent the most cost-effective intervention.



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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Coming from the Lisbon region;
  • A BMI ≥ p85 for gender and age;
  • Attending the Clinic for the first time;
  • Accepted to be enrolled.

Exclusion Criteria:

  • Major pathologies (other than obesity or its related comorbidities);
  • Inability to perform regular PA;
  • Mental disorders;
  • Smoking habits;
  • Under any kind of prescription (other than antihypertensives or metformin);
  • Being involved in another weight loss program.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02941770


Locations
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Portugal
Hospital de Santa Maria
Lisbon, Portugal, 1649-035
Sponsors and Collaborators
University of Lisbon
Investigators
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Study Director: Helena Fonseca, MD, PhD Pediatric Obesity Clinic, Department of Pediatrics, Hospital de Santa Maria, Lisbon, Portugal

Publications:

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Responsible Party: A. Videira-Silva, PhD student, University of Lisbon
ClinicalTrials.gov Identifier: NCT02941770     History of Changes
Other Study ID Numbers: 1332/CC1942016
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by A. Videira-Silva, University of Lisbon:
Adolescents
Overweight
Obesity
Weight Loss
Physical activity consultation
Cardiorespiratory fitness
Endothelial structure
Endothelial function

Additional relevant MeSH terms:
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Overweight
Pediatric Obesity
Body Weight
Signs and Symptoms
Obesity
Overnutrition
Nutrition Disorders