NCT02024061

Brief Summary

The purpose of this study is to analyse if a multidisciplinary approach including peers is effective in the treatment of obesity in adolescence.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 31, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

1.7 years

First QC Date

December 12, 2013

Last Update Submit

July 19, 2017

Conditions

ObesityPhysical ActivitySedentary Lifestyle

Keywords

AdolescentsObesityPhysical activitySedentary behaviorPsychosocial health

Outcome Measures

Primary Outcomes (4)

  • Change in BMI z-score

    BMI z-score will be calculated through height and weight measured with standardised procedures

    Baseline, 4, 8 and 12 mo

  • Change in % Fat Mass

    The % of Fat Mass will be measured through dual energy x-ray absorptiometry.

    Baseline, 6 and 12 mo

  • Change in the Physical Activity Level

    The Physical Activity Level will be assessed by actigraphy (Actigraph GT3x).

    Baseline, 4, 8 and 12 mo

  • Change in Sedentary behavior

    The sedentary behavior will be assessed by actigraphy (Actigraph GT3x) and by questionnaires (ASAQ)

    Baseline, 4, 8 and 12 mo

Secondary Outcomes (1)

  • Changes in psychosocial health

    Baseline, 4, 8 and 12 mo

Study Arms (2)

Peer support

EXPERIMENTAL

The intervention will be similar with the exception that in the experimental group during the interventions (Interactive Sessions, Physical activity sessions and holiday camps), the presence of peers is predominant, indispensable and motivational in the context and the dynamics of development of activities. A team composed by a paediatrician and five exercise physiologists will conduct the delivery of the intervention. They all have previous training in adolescent obesity, resulting from their involvement in the adolescent obesity consult at the Hospital of Santa Maria.

Behavioral: Peer support

Regular treatment

ACTIVE COMPARATOR

The intervention will be similar with the exception that in the experimental group during the interventions (IS, PA sessions and holiday camps), the presence of peers is predominant, indispensible and motivational in the context and the dynamics of development of activities. A team composed by a paediatrician and five exercise physiologists will conduct the delivery of the intervention. They all have previous training in adolescent obesity, resulting from their involvement in the adolescent obesity consult at the Hospital of Santa Maria.

Behavioral: Regular treatment

Interventions

Peer supportBEHAVIORAL
Peer support
Regular treatmentBEHAVIORAL

The participants in this arm will receive the regular obesity treatment provided by the hospital and university (interactive sessions and physical activity).

Regular treatment

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Obese adolescents with BMI greater than or equal to the 95th percentile
  • Aged between 14 and 17
  • Caucasian
  • Agree to the commitment.

You may not qualify if:

  • Adolescents with serious illnesses
  • Other factors preventing the engagement in regular PA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Consulta de Obesidade na Adolescência, Hospital Santa Maria

Lisbon, 1649-035, Portugal

Location

Universidade Lusófona Humanidades e Tecnologias

Lisbon, 1749-024, Portugal

Location

Related Publications (17)

  • ONOCOP, Study of the Pediatric and Adolescent Obesity Prevalence in Mainland Portugal - EPOBI. 2009, National Observatory of Obesity and Weight Control: Vilamoura - Portugal.

    BACKGROUND

  • Council on Sports Medicine and Fitness; Council on School Health. Active healthy living: prevention of childhood obesity through increased physical activity. Pediatrics. 2006 May;117(5):1834-42. doi: 10.1542/peds.2006-0472.

    PMID: 16651347BACKGROUND

  • August GP, Caprio S, Fennoy I, Freemark M, Kaufman FR, Lustig RH, Silverstein JH, Speiser PW, Styne DM, Montori VM; Endocrine Society. Prevention and treatment of pediatric obesity: an endocrine society clinical practice guideline based on expert opinion. J Clin Endocrinol Metab. 2008 Dec;93(12):4576-99. doi: 10.1210/jc.2007-2458. Epub 2008 Sep 9.

    PMID: 18782869BACKGROUND

  • Kohn M, Rees JM, Brill S, Fonseca H, Jacobson M, Katzman DK, Loghmani ES, Neumark-Sztainer D, Schneider M. Preventing and treating adolescent obesity: a position paper of the Society for Adolescent Medicine. J Adolesc Health. 2006 Jun;38(6):784-7. doi: 10.1016/j.jadohealth.2006.03.001. No abstract available.

    PMID: 16761338BACKGROUND

  • Oude Luttikhuis H, Baur L, Jansen H, Shrewsbury VA, O'Malley C, Stolk RP, Summerbell CD. Interventions for treating obesity in children. Cochrane Database Syst Rev. 2009 Jan 21;(1):CD001872. doi: 10.1002/14651858.CD001872.pub2.

    PMID: 19160202BACKGROUND

  • Lobstein T, Baur L, Uauy R; IASO International Obesity TaskForce. Obesity in children and young people: a crisis in public health. Obes Rev. 2004 May;5 Suppl 1:4-104. doi: 10.1111/j.1467-789X.2004.00133.x. No abstract available.

    PMID: 15096099BACKGROUND

  • Singh AS, Mulder C, Twisk JW, van Mechelen W, Chinapaw MJ. Tracking of childhood overweight into adulthood: a systematic review of the literature. Obes Rev. 2008 Sep;9(5):474-88. doi: 10.1111/j.1467-789X.2008.00475.x. Epub 2008 Mar 5.

    PMID: 18331423BACKGROUND

  • Must A, Jacques PF, Dallal GE, Bajema CJ, Dietz WH. Long-term morbidity and mortality of overweight adolescents. A follow-up of the Harvard Growth Study of 1922 to 1935. N Engl J Med. 1992 Nov 5;327(19):1350-5. doi: 10.1056/NEJM199211053271904.

    PMID: 1406836BACKGROUND

  • Olshansky SJ, Passaro DJ, Hershow RC, Layden J, Carnes BA, Brody J, Hayflick L, Butler RN, Allison DB, Ludwig DS. A potential decline in life expectancy in the United States in the 21st century. N Engl J Med. 2005 Mar 17;352(11):1138-45. doi: 10.1056/NEJMsr043743.

    PMID: 15784668BACKGROUND

  • Fonseca H, Palmeira AL,Martins SS. Adolescent obesity: what we know and what we do. in Society for Adolescent Medicine Annual Meeting. 2008. Greensboro, EUA.

    BACKGROUND

  • Barlow SE; Expert Committee. Expert committee recommendations regarding the prevention, assessment, and treatment of child and adolescent overweight and obesity: summary report. Pediatrics. 2007 Dec;120 Suppl 4:S164-92. doi: 10.1542/peds.2007-2329C.

    PMID: 18055651BACKGROUND

  • Teixeira PJ, Silva MN, Mata J, Palmeira AL, Markland D. Motivation, self-determination, and long-term weight control. Int J Behav Nutr Phys Act. 2012 Mar 2;9:22. doi: 10.1186/1479-5868-9-22.

    PMID: 22385818BACKGROUND

  • Fonseca H, Martins SS, Palmeira, AL. Institute: Assessment and treatment of overweight adolescents based on self-determination theory: A multidisciplinary program. in Society for Adolescent Medicine - 2010 Annual Meeting. 2010. Toronto - Canada.

    BACKGROUND

  • Dishion TJ, Dodge KA. Peer contagion in interventions for children and adolescents: moving towards an understanding of the ecology and dynamics of change. J Abnorm Child Psychol. 2005 Jun;33(3):395-400. doi: 10.1007/s10802-005-3579-z.

    PMID: 15957566BACKGROUND

  • Fonseca H, Palmeira AL, Martins S, Ferreira PD. Short- and medium-term impact of a residential weight-loss camp for overweight adolescents. Int J Adolesc Med Health. 2014;26(1):33-8. doi: 10.1515/ijamh-2012-0107.

    PMID: 23241665BACKGROUND

  • Ascenso A, Palmeira A, Pedro LM, Martins S, Fonseca H. Physical activity and cardiorespiratory fitness, but not sedentary behavior, are associated with carotid intima-media thickness in obese adolescents. Eur J Pediatr. 2016 Mar;175(3):391-8. doi: 10.1007/s00431-015-2654-x. Epub 2015 Oct 21.

    PMID: 26490566DERIVED

  • Fonseca H, Palmeira AL, Martins SC, Falcato L, Quaresma A. Managing paediatric obesity: a multidisciplinary intervention including peers in the therapeutic process. BMC Pediatr. 2014 Apr 3;14:89. doi: 10.1186/1471-2431-14-89.

    PMID: 24693926DERIVED

Related Links

MeSH Terms

Conditions

ObesityMotor ActivitySedentary Behavior

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Helena R Fonseca, MD, PhD

    Faculty of Medicine, University of Lisbon

    PRINCIPAL INVESTIGATOR

  • Antonio L Palmeira, PhD

    U. Lusófona Humanidades e Tecnologias

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 12, 2013

First Posted

December 31, 2013

Study Start

September 1, 2012

Primary Completion

June 1, 2014

Study Completion

October 1, 2014

Last Updated

July 21, 2017

Record last verified: 2017-07

Locations

PT(2)