ObesityTOPNCT02024061
Treatment of Pediatric Obesity (TOP) - A Multidisciplinary Approach Involving Adolescents and Their Peers
A study testing Peer support and Regular treatment in people with Obesity and Physical Activity, run by Grupo Lusófona at 2 sites in Portugal.
Trial summary
The purpose of this study is to analyse if a multidisciplinary approach including peers is effective in the treatment of obesity in adolescence. Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Physical Activity, Sedentary Lifestyle
- What is being tested?
- Peer support and Regular treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 2 sitesPortugal
- Study dates
- Sep 2012to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Obese adolescents with BMI greater than or equal to the 95th percentile
- Aged between 14 and 17
- Caucasian
- Agree to the commitment.
Who cannot join
- Adolescents with serious illnesses
- Other factors preventing the engagement in regular PA
Trial locations and contacts
2 sites in 1 country.
Portugal2 sites
Consulta de Obesidade na Adolescência, Hospital Santa Maria
Lisbon, 1649-035
Universidade Lusófona Humanidades e Tecnologias
Lisbon, 1749-024
About this study
Official title: Tratamento da Obesidade Pedi ́Atrica (TOP) - Uma Abordagem Multidisciplinar Envolvendo Pais e Pares
The purpose of this study is to analyse if a multidisciplinary approach including peers is effective in the treatment of obesity in adolescence.
Read the detailed description
One in every 3 Portuguese adolescents is overweight (14% obese) (ONOCOP, 2009). Several institutions state that prevention is of upmost importance to deal with this epidemic (Council on Sports Medicine and Fitness; Council on School Health, 2006, August et al, 2008, Kohn et al, 2006), but public health stakeholders should also increase their efforts to treat those who already have excessive weight (Oude Luttikhuis et al, 2009). Several facts support this need, namely that obesity in adolescence: a) has a significant impact on both physical and psychosocial health (Lobstein et al, 2004); b) is an independent risk factor for adult obesity (Singh et al, 2008); c) is an independent risk factor for all cause mortality in adulthood - a more powerful predictor than being overweight in adult (Must et al, 1992); and d) is a major threat to the steady rise in life expectancy that occurred during the past two centuries (Olshansky et al, 2005).
Albeit this cumulative knowledge, treatment options remain elusive. A Cochrane review (Oude Luttikhuis et al, 2009) concluded that combined behavioral lifestyle interventions, when compared to standard care or self-help, provide significant and clinically meaningful reductions on weight in adolescents; and that the interventions should consider psychosocial determinants for behavior change and strategies to improve clinician-family interaction, in order to improve the desired outcomes.
The team of the TOP project has been working in this subject since 2004: the consult for obese adolescents of the Hospital de Santa Maria (HSM), a result of the collaboration between the two proponent Institutions. This has allowed the inclusion of exercise specialists in the obese adolescent' consult of the HSM, leading to an unusual (Fonseca et al, 2008), but surely necessary (Barlow et al, 2007), multidisciplinary program where, in the same Unit, adolescents are evaluated and receive medical, dietary and physical activity counselling. In compliance with the latest recommendations (Oude Luttikhuis et al, 2009), we use behavior change techniques directed not only to the adolescent but also to their parents, using the self-determination theory (SDT) rationale and motivational interviewing techniques (Teixeira et al, 2012), a treatment protocol that has been recognized by the Society for Adolescent Medicine (Fonseca et al, 2010).
Based on our previous experience and on recent literature that claims for the inclusion of peers as co-adjuvant on the weight management tasks, we hypothesize that: a) a larger and more frequent contact with the treatment staff; and b) the inclusion of peers as co-adjuvant on the weight management tasks in the TOP is necessary. Indeed, literature shows that adolescent' health related behaviors are associated with peer behaviors, in what Dishion named Social Contagion (Dishion \& Dodge, 2005). Additionally, we think that regular physical activity (PA) and interactive educative sessions can provide the background to promote these two factors (Fonseca et al, 2012).
Therefore, the primary objective of this project is to develop, implement, and evaluate a treatment for adolescent obesity, which will use PA and interactive sessions to promote weight management skills, through the increase of contact time between the adolescent, parents, peers and treatment staff.
The primary outcomes will be body composition related variables, PA and sedentary behaviors. We will also look for putative moderators and mediators, derived from the behavior change rationales followed in the project, which will help understand and predict how the program has influenced the outcomes.
This project holds unique characteristics which comply with the latest recommendations for the treatment of adolescent obesity, and others that we have not been able to find in the literature: a) the inclusion of peers explicitly on the treatment protocol; b) the clinical setting of the treatment, with "real-life" subjects; c) objective measurements of the outcomes; d) the long-term treatment; and e) a well established rational (SDT and experiential learning) for the behavior change and to analyze the causal relations between predictors and outcomes.
This research is expected to contribute with increased knowledge about treatment options for adolescent obesity, specifically about the potential role of the inclusion of peers and increased time of contact through PA and interactive sessions. We also expect to contribute in a significant and clinically meaningful way to the weight management of the intervened adolescents. And, as HSM is a central hospital and a part of a medical university, the accumulated knowledge of the project will certainly be efficiently widespread to several other hospitals and obesity centers.
- Conditions
- Obesity, Physical Activity, Sedentary Lifestyle
- Being tested
- Peer support, Regular treatment
- Keywords
- Adolescents, Obesity, Physical activity, Sedentary behavior, Psychosocial health
- Medical subject headings
- Obesity, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer supportBehavioural
Regular treatmentBehavioural
The participants in this arm will receive the regular obesity treatment provided by the hospital and university (interactive sessions and physical activity).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Regular treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI z-score
BMI z-score will be calculated through height and weight measured with standardised procedures
Measured: Baseline, 4, 8 and 12 mo
Change in % Fat Mass
The % of Fat Mass will be measured through dual energy x-ray absorptiometry.
Measured: Baseline, 6 and 12 mo
Change in the Physical Activity Level
The Physical Activity Level will be assessed by actigraphy (Actigraph GT3x).
Measured: Baseline, 4, 8 and 12 mo
Change in Sedentary behavior
The sedentary behavior will be assessed by actigraphy (Actigraph GT3x) and by questionnaires (ASAQ)
Measured: Baseline, 4, 8 and 12 mo
Secondary outcomes (1)
Changes in psychosocial health
Quality of life, well-being and self-regulation variables will be measured by validated psychometric questionnaires.
Measured: Baseline, 4, 8 and 12 mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startSep 2012
- Primary completionJun 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Lusófona
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia, University of Lisbon
- Responsible party
- Principal investigator, Antonio Palmeira, Grupo Lusófona
- Investigators
- Helena R Fonseca, MD, PhD, Principal investigator, Faculty of Medicine, University of LisbonAntonio L Palmeira, PhD, Principal investigator, U. Lusófona Humanidades e Tecnologias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02024061
- Sponsor's protocol ID
- PTDC/DES/113591/2009
- Acronym
- TOP
- Status last verified
- Jul 2017
- First submitted
- 12 Dec 2013
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
ONOCOP, Study of the Pediatric and Adolescent Obesity Prevalence in Mainland Portugal - EPOBI. 2009, National Observatory of Obesity and Weight Control: Vilamoura - Portugal.
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.
PubMed 16651347August 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.
PubMed 18782869Kohn 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.
PubMed 16761338Oude 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.
PubMed 19160202Lobstein 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.
PubMed 15096099Singh 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.
PubMed 18331423Must 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.
PubMed 1406836Olshansky 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.
PubMed 15784668Fonseca H, Palmeira AL,Martins SS. Adolescent obesity: what we know and what we do. in Society for Adolescent Medicine Annual Meeting. 2008. Greensboro, EUA.
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.
PubMed 18055651Teixeira 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.
PubMed 22385818Fonseca 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.
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.
PubMed 15957566Fonseca 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.
PubMed 23241665
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tratamento da Obesidade Pedi ́Atrica (TOP) - Uma Abordagem Multidisciplinar Envolvendo Pais e Pares
- ClinicalTrials.gov ID
- NCT02024061
- Acronym / sponsor ID
- TOP / PTDC/DES/113591/2009
- Conditions
- Obesity, Physical Activity, Sedentary Lifestyle
- Keywords
- Adolescents, Obesity, Physical activity, Sedentary behavior, Psychosocial health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Grupo LusófonaUniversity, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia, University of Lisbon
- Study start
- Sep 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 31 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to analyse if a multidisciplinary approach including peers is effective in the treatment of obesity in adolescence.
Detailed description
One in every 3 Portuguese adolescents is overweight (14% obese) (ONOCOP, 2009). Several institutions state that prevention is of upmost importance to deal with this epidemic (Council on Sports Medicine and Fitness; Council on School Health, 2006, August et al, 2008, Kohn et al, 2006), but public health stakeholders should also increase their efforts to treat those who already have excessive weight (Oude Luttikhuis et al, 2009). Several facts support this need, namely that obesity in adolescence: a) has a significant impact on both physical and psychosocial health (Lobstein et al, 2004); b) is an independent risk factor for adult obesity (Singh et al, 2008); c) is an independent risk factor for all cause mortality in adulthood - a more powerful predictor than being overweight in adult (Must et al, 1992); and d) is a major threat to the steady rise in life expectancy that occurred during the past two centuries (Olshansky et al, 2005).
Albeit this cumulative knowledge, treatment options remain elusive. A Cochrane review (Oude Luttikhuis et al, 2009) concluded that combined behavioral lifestyle interventions, when compared to standard care or self-help, provide significant and clinically meaningful reductions on weight in adolescents; and that the interventions should consider psychosocial determinants for behavior change and strategies to improve clinician-family interaction, in order to improve the desired outcomes.
The team of the TOP project has been working in this subject since 2004: the consult for obese adolescents of the Hospital de Santa Maria (HSM), a result of the collaboration between the two proponent Institutions. This has allowed the inclusion of exercise specialists in the obese adolescent' consult of the HSM, leading to an unusual (Fonseca et al, 2008), but surely necessary (Barlow et al, 2007), multidisciplinary program where, in the same Unit, adolescents are evaluated and receive medical, dietary and physical activity counselling. In compliance with the latest recommendations (Oude Luttikhuis et al, 2009), we use behavior change techniques directed not only to the adolescent but also to their parents, using the self-determination theory (SDT) rationale and motivational interviewing techniques (Teixeira et al, 2012), a treatment protocol that has been recognized by the Society for Adolescent Medicine (Fonseca et al, 2010).
Based on our previous experience and on recent literature that claims for the inclusion of peers as co-adjuvant on the weight management tasks, we hypothesize that: a) a larger and more frequent contact with the treatment staff; and b) the inclusion of peers as co-adjuvant on the weight management tasks in the TOP is necessary. Indeed, literature shows that adolescent' health related behaviors are associated with peer behaviors, in what Dishion named Social Contagion (Dishion \& Dodge, 2005). Additionally, we think that regular physical activity (PA) and interactive educative sessions can provide the background to promote these two factors (Fonseca et al, 2012).
Therefore, the primary objective of this project is to develop, implement, and evaluate a treatment for adolescent obesity, which will use PA and interactive sessions to promote weight management skills, through the increase of contact time between the adolescent, parents, peers and treatment staff.
The primary outcomes will be body composition related variables, PA and sedentary behaviors. We will also look for putative moderators and mediators, derived from the behavior change rationales followed in the project, which will help understand and predict how the program has influenced the outcomes.
This project holds unique characteristics which comply with the latest recommendations for the treatment of adolescent obesity, and others that we have not been able to find in the literature: a) the inclusion of peers explicitly on the treatment protocol; b) the clinical setting of the treatment, with "real-life" subjects; c) objective measurements of the outcomes; d) the long-term treatment; and e) a well established rational (SDT and experiential learning) for the behavior change and to analyze the causal relations between predictors and outcomes.
This research is expected to contribute with increased knowledge about treatment options for adolescent obesity, specifically about the potential role of the inclusion of peers and increased time of contact through PA and interactive sessions. We also expect to contribute in a significant and clinically meaningful way to the weight management of the intervened adolescents. And, as HSM is a central hospital and a part of a medical university, the accumulated knowledge of the project will certainly be efficiently widespread to several other hospitals and obesity centers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer support | Experimental | Behavioral: Peer supportThe 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. |
| Regular treatment | Active comparator | Behavioral: Regular treatmentThe 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. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Obese adolescents with BMI greater than or equal to the 95th percentile
- Aged between 14 and 17
- Caucasian
- Agree to the commitment.
Key exclusion criteria (2 listed)
- Adolescents with serious illnesses
- Other factors preventing the engagement in regular PA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer support | Behavioural | Peer support |
| Regular treatmentThe participants in this arm will receive the regular obesity treatment provided by the hospital and university (interactive sessions and physical activity). | Behavioural | Regular treatment |
Primary outcome
Change in BMI z-score
Time frame: Baseline, 4, 8 and 12 mo
BMI z-score will be calculated through height and weight measured with standardised procedures
Change in % Fat Mass
Time frame: Baseline, 6 and 12 mo
The % of Fat Mass will be measured through dual energy x-ray absorptiometry.
Change in the Physical Activity Level
Time frame: Baseline, 4, 8 and 12 mo
The Physical Activity Level will be assessed by actigraphy (Actigraph GT3x).
Change in Sedentary behavior
Time frame: Baseline, 4, 8 and 12 mo
The sedentary behavior will be assessed by actigraphy (Actigraph GT3x) and by questionnaires (ASAQ)
1 secondary outcome
Changes in psychosocial health
Time frame: Baseline, 4, 8 and 12 mo
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- BackgroundONOCOP, Study of the Pediatric and Adolescent Obesity Prevalence in Mainland Portugal - EPOBI. 2009, National Observatory of Obesity and Weight Control: Vilamoura - Portugal.
- Background: PubMed 16651347Council 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.
- Background: PubMed 18782869August 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.
- Background: PubMed 16761338Kohn 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.
- Background: PubMed 19160202Oude 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.
- Background: PubMed 15096099Lobstein 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.
- Background: PubMed 18331423Singh 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.
- Background: PubMed 1406836Must 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.
- Background: PubMed 15784668Olshansky 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.
- BackgroundFonseca 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: PubMed 18055651Barlow 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.
- Background: PubMed 22385818Teixeira 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.
- Website that was used for the recruitment, currently under development to include the results and publications of the studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helena R Fonseca, MD, PhD principal investigator
Faculty of Medicine, University of Lisbon
Antonio L Palmeira, PhD principal investigator
U. Lusófona Humanidades e Tecnologias
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer support and Regular treatment in people with Obesity and Physical Activity, run by Grupo Lusófona at 2 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BMI z-score (time frame: Baseline, 4, 8 and 12 mo). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02024061, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.