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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02941770 |
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Date of registration:
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19/10/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Physical Activity Consultation in the Management of Adolescent Overweight
PAC-MAnO |
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Scientific title:
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The Effect of a Physical Activity Consultation in the Management of Adolescent Overweight, Including Anthropometry, Physical Activity Levels, Cardiorespiratory Fitness, and Endothelial Health |
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Date of first enrolment:
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October 2016 |
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Target sample size:
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165 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02941770 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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N/A
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Countries of recruitment
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Portugal
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Contacts
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Name:
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Helena Fonseca, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pediatric Obesity Clinic, Department of Pediatrics, Hospital de Santa Maria, Lisbon, Portugal |
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Key inclusion & exclusion criteria
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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.
Age minimum:
12 Years
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Overweight
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Intervention(s)
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Behavioral: Physical activity behavior change
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Other: Exercise
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Primary Outcome(s)
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Sedentary behavior
[Time Frame: 12 months]
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Body mass index (BMI) z-score
[Time Frame: 12 months]
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Physical activity (PA) levels
[Time Frame: 12 months]
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Secondary Outcome(s)
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inflammation (C-RP)
[Time Frame: 12 months]
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Cardiorespiratory fitness (CRF)
[Time Frame: 12 months]
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Carotid intima-media thickness (cIMT)
[Time Frame: 12 months]
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Lipid profile (TC, LDL-C, HDL-C)
[Time Frame: 12 months]
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Glucose metabolism (Glucose, Insulin, HOMA-IR)
[Time Frame: 12 months]
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Pulse wave velocity (PWV)
[Time Frame: 12 months]
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Body composition
[Time Frame: 12 months]
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Cost-effectiveness (CE)
[Time Frame: 12 months]
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Secondary ID(s)
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1332/CC1942016
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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