Physical Activity Consultation in the Management of Adolescent Overweight

NCT02941770 | Unknown

• 1 other identifier: 1332/CC1942016
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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..

Conditions

Overweight

Keywords

Adolescents; Overweight; Obesity; Weight Loss; Physical activity consultation; Cardiorespiratory fitness; Endothelial structure; Endothelial function

Outcome Measures

Primary Outcomes (3)

• Body mass index (BMI) z-score

  12 months

• Physical activity (PA) levels

  12 months

• Sedentary behavior

  Questionnaire ASAQ (Adolescent Sedentary Activity Questionnaire)

  12 months

Secondary Outcomes (8)

• Cardiorespiratory fitness (CRF)

  12 months

• Carotid intima-media thickness (cIMT)

  12 months

• Pulse wave velocity (PWV)

  12 months

• Body composition

  12 months

• Lipid profile (TC, LDL-C, HDL-C)

  12 months

Study Arms (3)

Control group

NO INTERVENTION

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.

Intervention group I

EXPERIMENTAL

* Clinic standard care protocol; * Physical activity consultation (Physical activity behavior change);

Behavioral: Physical activity behavior change

Intervention group II

EXPERIMENTAL

* 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; Other: Exercise

Interventions

Physical activity behavior change BEHAVIORAL

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.

Intervention group I; Intervention group II

Exercise OTHER

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.

Intervention group II

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Lisbon: lead

Study Sites (1)

Hospital de Santa Maria

Lisbon, 1649-035, Portugal

Location

Related Publications (10)

• McCallum Z, Wake M, Gerner B, Baur LA, Gibbons K, Gold L, Gunn J, Harris C, Naughton G, Riess C, Sanci L, Sheehan J, Ukoumunne OC, Waters E. Outcome data from the LEAP (Live, Eat and Play) trial: a randomized controlled trial of a primary care intervention for childhood overweight/mild obesity. Int J Obes (Lond). 2007 Apr;31(4):630-6. doi: 10.1038/sj.ijo.0803509. Epub 2006 Dec 12.

  PMID: 17160087 BACKGROUND

• Henderson M, Daneman D, Huot C, McGrath J, Lambert M, Hux J, Booth GL, Hanley A. The impact of exercise consultation on activity levels and metabolic markers in obese adolescents: a pilot study. Int J Pediatr Endocrinol. 2010;2010:681510. doi: 10.1155/2010/681510. Epub 2010 Sep 26.

  PMID: 20976257 BACKGROUND

• Kelishadi R, Malekahmadi M, Hashemipour M, Soghrati M, Soghrati M, Mirmoghtadaee P, Ghatrehsamani S, Poursafa P, Khavarian N. Can a trial of motivational lifestyle counseling be effective for controlling childhood obesity and the associated cardiometabolic risk factors? Pediatr Neonatol. 2012 Apr;53(2):90-7. doi: 10.1016/j.pedneo.2012.01.005. Epub 2012 Mar 3.

  PMID: 22503255 BACKGROUND

• Walpole B, Dettmer E, Morrongiello BA, McCrindle BW, Hamilton J. Motivational interviewing to enhance self-efficacy and promote weight loss in overweight and obese adolescents: a randomized controlled trial. J Pediatr Psychol. 2013 Oct;38(9):944-53. doi: 10.1093/jpepsy/jst023. Epub 2013 May 13.

  PMID: 23671058 BACKGROUND

• Flattum C, Friend S, Story M, Neumark-Sztainer D. Evaluation of an individualized counseling approach as part of a multicomponent school-based program to prevent weight-related problems among adolescent girls. J Am Diet Assoc. 2011 Aug;111(8):1218-23. doi: 10.1016/j.jada.2011.05.008.

  PMID: 21802570 BACKGROUND

• Videira-Silva A, de Freitas F, Sardinha LB, Fonseca H. Effect and safety of a physical exercise-based intervention on body composition and cardiometabolic health of adolescents with severe obesity. Secondary analysis from the PAC-MAnO trial. Obes Pillars. 2025 Jun 26;16:100190. doi: 10.1016/j.obpill.2025.100190. eCollection 2025 Dec.

  PMID: 40688482 DERIVED

• Videira-Silva A, Santos I, Freaza D, Gameiro M, Sardinha LB, Fonseca H. Dietary content and combined training, but not daily physical activity, are associated with 6-month bone mineral changes in adolescents with obesity: A Secondary analysis of the PAC-MAnO trial. Eur J Pediatr. 2024 Sep;183(9):3969-3978. doi: 10.1007/s00431-024-05659-4. Epub 2024 Jun 27.

  PMID: 38937331 DERIVED

• Videira-Silva A, Sardinha LB, Fonseca H. Atherosclerosis Prevention in Adolescents with Obesity: The Role of Moderate-Vigorous Physical Activity. Int J Environ Res Public Health. 2022 Nov 23;19(23):15537. doi: 10.3390/ijerph192315537.

  PMID: 36497620 DERIVED

• Videira-Silva A, Hetherington-Rauth M, Sardinha LB, Fonseca H. Combined high-intensity interval training as an obesity-management strategy for adolescents. Eur J Sport Sci. 2023 Jan;23(1):109-120. doi: 10.1080/17461391.2021.1995508. Epub 2021 Nov 12.

  PMID: 34663193 DERIVED

• Videira-Silva A, Sardinha L, Fonseca H. Effect of a Physical Activity Consultation in the Management of Adolescent Overweight (the PAC-MAnO project): study rationale, design and methods. BMJ Paediatr Open. 2018 Jul 15;2(1):e000214. doi: 10.1136/bmjpo-2017-000214. eCollection 2018.

  PMID: 30094347 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Helena Fonseca, MD, PhD

  Pediatric Obesity Clinic, Department of Pediatrics, Hospital de Santa Maria, Lisbon, Portugal

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: October 19, 2016
• First Posted: October 21, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 19, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)