OverweightNCT02309034
Aquatic and Land Physical Training Effects on Cardiometabolic Risk Factors in Adolescents With Overweight and Obesity
A study testing Jump exercise, Aquatic exercise and Nutritional guidance in people with Overweight and Obesity, run by Hospital de Clinicas de Porto Alegre.
Trial summary
Objective: To compare the results of two types of low-impact exercise training, in and out of the water, with the control group, regarding cardiometabolic risk factors in overweight adolescents; and to investigate the changes resulting from interventions in biochemical, anthropometric, psychological variables and body… Read more about this study
- Who is it for?
- Ages 10 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Jump exercise, Aquatic exercise and Nutritional guidance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Sep 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 10 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pubescent and post-pubescent adolescents are included, of both gender, who have overweight or obese, and waist / height ratio greater than 0.50
- Without disabling the practice of physical exercise conditions and not using medications that may affect the outcome of the present study, such as medications to control cholesterol for hormone treatments and diuretics
Who cannot join
- Those adolescents who become pregnant during the training will be deleted
About this study
Official title: Aquatic and Land Physical Training Effects on Cardiometabolic Risk Factors in Adolescents With Overweight and Obesity: a Randomized Controlled Clinical Trial.
Objective: To compare the results of two types of low-impact exercise training, in and out of the water, with the control group, regarding cardiometabolic risk factors in overweight adolescents; and to investigate the changes resulting from interventions in biochemical, anthropometric, psychological variables and body composition.
Experimental design: Randomized clinical trial with overweight and obesity adolescents.
Read more
Local Search: College of Physical Education of Federal University of Rio Grande do Sul and Hospital de Clinicas de Porto Alegre, city of Porto Alegre, Rio Grande do Sul State, Brazil.
Participants: Took part in the study 75 overweight and obesity adolescents, pubertal and post-pubertal, recruted by announcement in the most important newspapers of Porto Alegre city.
Intervention: Adolescents that acepted to participate in the study, and authorized by their parents, were randomized into three groups: Group Land / Jump, with three weekly sessions Jump; Water / hidrogimnastic group, with three weekly sessions of hidrogminastic; Control group that not participate in physical exercise intervention. The intervention will last 12 weeks and three groups participate in weekly sessions of nutritional guidance. Assessments occur at the beginning of the intervention program and 72 hours after the 12th week of the program. The results of all study variables among the three groups in the two time points, and in each group between the two periods, will compared.
Measures: Anthropometric, biochemical and blood pressure evaluations, in addition to applying instruments for assessing quality of life, body image and mental health by experienced evaluators, as well as blood draws conducted by an experienced gatherer's Hospital de Clínicas de Porto Alegre.
Expected Results: In the study, are been expected to verify that the exercise programs, aquatic and land, associated with nutritional guidance, are efficient to modify positively the outcomes studied.
Read the detailed description
Methods:
The sample will be selected intentionally with 75 subjects. Those who agree to participate in the study will be randomly allocated into three groups by a blinded evaluator for the study, which will use online www.randomizer.org the software as follows: aqua + nutritional counseling, jump + nutritional counseling, group control (nutritional counseling only), all with 12-week duration.
The study examine the effects obtained by the three groups on outcomes of cardiometabolic risk factors (waist circumference, blood pressure, HDL-cholesterol, triglycerides, fasting glucose), outcomes of amount and distribution of body fat (sum of skinfolds - triceps subscapular, suprailiac, abdominal and mid thigh - by bioelectrical impedance body fat percentage and waist / height), and psychological variables (quality of life, body image and mental health). In addition, nutritional counseling at weekly sessions will be used as a control variable. Characterization data of the sample (age, sex, weight, height, and waist / height) and other biochemical endpoints also comprise the study (total cholesterol, LDL-cholesterol, fasting insulin, HOMA-IR, QUICK, and high-sensitivity C- reactive protein will be collected).
All measurements follow standard and validated procedures for the population object of study.
To the chronic effect analysis, blood samples will be collected two times, before and after training period, with 12 hours fasting. To avoid the acute effect of the exercises, the measurements will done 72 hours after the 12th week.
A sample of 5 ml of blood per antecubital vein will collected. The sample will be collected at the school for experienced gatherer, and will be taken immediately to the laboratory in order to ensure that analyzes are performed on the same day.
The health-related quality of life will assessed using the questionnaire on pediatric quality of life PedsQL 4.0, adolescents and their parents.
For analysis of body satisfaction instrument Body Shape Questionnaire BSQ will used. To ascertain the perception of body image will applied to Scale Silhouettes of Stunkard.
Mental health will assessed using the Strengths and Difficulties Questionnaires SDQ.
For classification of maturational stage, will held assessment of sexual maturation stages proposed by Tanner, determined by self-assessment of the stage of development of pubic hair, avoiding major constraint adolescents.
Intervention with exercise:
The groups will perform physical training activities three times a week after school for 12 weeks, with interval training sessions varying intensities according to the scale of perceived exertion Borg, with duration ranging between 24 and 32 minute main part. Classes will taught by a physical education teacher with the aid of monitors, area students.
Nutrition education classes will held at the school, by nutritionist, with a weekly, totaling 12 meetings.
Training Protocol Both trainings will be conducted simultaneously with each group in their midst, in order to avoid possible interference on the voice command, ambient temperature, relative humidity and time of accomplishment from training.
- Conditions
- Overweight, Obesity
- Being tested
- Jump exercise, Aquatic exercise, Nutritional guidance
- Keywords
- Overweight, Obesity, Cardiometabolic risk factors, Adolescents, Exercise
- Medical subject headings
- Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jump exerciseBehavioural
Also called Rebound exercises
Land Group / Jump (LG): Will hold weekly classes of nutritional guidance and three weekly sessions of jump, for 12 weeks, divided into warm up, main aerobics and relaxation.
Aquatic exerciseBehavioural
Also called Hydrogimnastic
Group Water / Water aerobics (WG): Will hold weekly classes of nutritional guidance and three weekly sessions of water, for 12 weeks, divided into warm up, main aerobics and relaxation.
Nutritional guidanceOther
Also called Nutritional counseling
Control Group (CG): take part only of weekly classes of nutritional guidance, in addition to a closed group on Facebook in order to encourage them and increase attention to the group.
| Study group | Role | What they receive |
|---|---|---|
| Jump exercise | Experimental | rebound exercises. Receives: Behavioral: Jump exercise; Other: Nutritional guidance |
| Aquatic exercise | Experimental | Hydrogimnastic. Receives: Behavioral: Aquatic exercise; Other: Nutritional guidance |
| Nutritional guidance | Active comparator | Nutritional counseling classes. Receives: Other: Nutritional guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
Measured: baseline, 12th week
Secondary outcomes (6)
Waist circumference
Measured: baseline, 12th week
Blood Pressure
Measured: baseline, 12th week
HDL-cholesterol
Measured: baseline, 12th week
Triglycerides
Measured: baseline, 12th week
Fasting glycemia
Measured: baseline, 12th week
Body Fat Percentage
Bioeletrical Impedance
Measured: baseline, 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Responsible party
- Sponsor
- Investigators
- Beatriz D Schaan, PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309034
- Sponsor's protocol ID
- 140485
- Status last verified
- Dec 2014
- First submitted
- 3 Dec 2014
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aquatic and Land Physical Training Effects on Cardiometabolic Risk Factors in Adolescents With Overweight and Obesity: a Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT02309034
- Acronym / sponsor ID
- 140485
- Conditions
- Overweight, Obesity
- Keywords
- Overweight, Obesity, Cardiometabolic risk factors, Adolescents, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Study start
- Sep 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 5 Dec 2014 (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.
Objective: To compare the results of two types of low-impact exercise training, in and out of the water, with the control group, regarding cardiometabolic risk factors in overweight adolescents; and to investigate the changes resulting from interventions in biochemical, anthropometric, psychological variables and body composition.
Experimental design: Randomized clinical trial with overweight and obesity adolescents.
Local Search: College of Physical Education of Federal University of Rio Grande do Sul and Hospital de Clinicas de Porto Alegre, city of Porto Alegre, Rio Grande do Sul State, Brazil.
Participants: Took part in the study 75 overweight and obesity adolescents, pubertal and post-pubertal, recruted by announcement in the most important newspapers of Porto Alegre city.
Intervention: Adolescents that acepted to participate in the study, and authorized by their parents, were randomized into three groups: Group Land / Jump, with three weekly sessions Jump; Water / hidrogimnastic group, with three weekly sessions of hidrogminastic; Control group that not participate in physical exercise intervention. The intervention will last 12 weeks and three groups participate in weekly sessions of nutritional guidance. Assessments occur at the beginning of the intervention program and 72 hours after the 12th week of the program. The results of all study variables among the three groups in the two time points, and in each group between the two periods, will compared.
Measures: Anthropometric, biochemical and blood pressure evaluations, in addition to applying instruments for assessing quality of life, body image and mental health by experienced evaluators, as well as blood draws conducted by an experienced gatherer's Hospital de Clínicas de Porto Alegre.
Expected Results: In the study, are been expected to verify that the exercise programs, aquatic and land, associated with nutritional guidance, are efficient to modify positively the outcomes studied.
Detailed description
Methods:
The sample will be selected intentionally with 75 subjects. Those who agree to participate in the study will be randomly allocated into three groups by a blinded evaluator for the study, which will use online www.randomizer.org the software as follows: aqua + nutritional counseling, jump + nutritional counseling, group control (nutritional counseling only), all with 12-week duration.
The study examine the effects obtained by the three groups on outcomes of cardiometabolic risk factors (waist circumference, blood pressure, HDL-cholesterol, triglycerides, fasting glucose), outcomes of amount and distribution of body fat (sum of skinfolds - triceps subscapular, suprailiac, abdominal and mid thigh - by bioelectrical impedance body fat percentage and waist / height), and psychological variables (quality of life, body image and mental health). In addition, nutritional counseling at weekly sessions will be used as a control variable. Characterization data of the sample (age, sex, weight, height, and waist / height) and other biochemical endpoints also comprise the study (total cholesterol, LDL-cholesterol, fasting insulin, HOMA-IR, QUICK, and high-sensitivity C- reactive protein will be collected).
All measurements follow standard and validated procedures for the population object of study.
To the chronic effect analysis, blood samples will be collected two times, before and after training period, with 12 hours fasting. To avoid the acute effect of the exercises, the measurements will done 72 hours after the 12th week.
A sample of 5 ml of blood per antecubital vein will collected. The sample will be collected at the school for experienced gatherer, and will be taken immediately to the laboratory in order to ensure that analyzes are performed on the same day.
The health-related quality of life will assessed using the questionnaire on pediatric quality of life PedsQL 4.0, adolescents and their parents.
For analysis of body satisfaction instrument Body Shape Questionnaire BSQ will used. To ascertain the perception of body image will applied to Scale Silhouettes of Stunkard.
Mental health will assessed using the Strengths and Difficulties Questionnaires SDQ.
For classification of maturational stage, will held assessment of sexual maturation stages proposed by Tanner, determined by self-assessment of the stage of development of pubic hair, avoiding major constraint adolescents.
Intervention with exercise:
The groups will perform physical training activities three times a week after school for 12 weeks, with interval training sessions varying intensities according to the scale of perceived exertion Borg, with duration ranging between 24 and 32 minute main part. Classes will taught by a physical education teacher with the aid of monitors, area students.
Nutrition education classes will held at the school, by nutritionist, with a weekly, totaling 12 meetings.
Training Protocol Both trainings will be conducted simultaneously with each group in their midst, in order to avoid possible interference on the voice command, ambient temperature, relative humidity and time of accomplishment from training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Jump exercise | Experimental | Behavioral: Jump exercise, Other: Nutritional guidancerebound exercises. |
| Aquatic exercise | Experimental | Behavioral: Aquatic exercise, Other: Nutritional guidanceHydrogimnastic. |
| Nutritional guidance | Active comparator | Other: Nutritional guidanceNutritional counseling classes. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Pubescent and post-pubescent adolescents are included, of both gender, who have overweight or obese, and waist / height ratio greater than 0.50
- Without disabling the practice of physical exercise conditions and not using medications that may affect the outcome of the present study, such as medications to control cholesterol for hormone treatments and diuretics
Key exclusion criteria (1 listed)
- Those adolescents who become pregnant during the training will be deleted
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 |
|---|---|---|
| Jump exerciseAlso: Rebound exercisesLand Group / Jump (LG): Will hold weekly classes of nutritional guidance and three weekly sessions of jump, for 12 weeks, divided into warm up, main aerobics and relaxation. | Behavioural | Jump exercise |
| Aquatic exerciseAlso: HydrogimnasticGroup Water / Water aerobics (WG): Will hold weekly classes of nutritional guidance and three weekly sessions of water, for 12 weeks, divided into warm up, main aerobics and relaxation. | Behavioural | Aquatic exercise |
| Nutritional guidanceAlso: Nutritional counselingControl Group (CG): take part only of weekly classes of nutritional guidance, in addition to a closed group on Facebook in order to encourage them and increase attention to the group. | Other | Aquatic exercise, Jump exercise, Nutritional guidance |
Primary outcome
Body Mass Index
Time frame: baseline, 12th week
6 secondary outcomes
Waist circumference
Time frame: baseline, 12th week
Blood Pressure
Time frame: baseline, 12th week
HDL-cholesterol
Time frame: baseline, 12th week
Triglycerides
Time frame: baseline, 12th week
Fasting glycemia
Time frame: baseline, 12th week
Body Fat Percentage
Time frame: baseline, 12th week
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 5 Dec 2014.
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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.
Beatriz D Schaan, PhD principal investigator
Federal University of Rio Grande do Sul
Questions about this trial
What is this clinical trial studying?
A study testing Jump exercise, Aquatic exercise and Nutritional guidance in people with Overweight and Obesity, run by Hospital de Clinicas de Porto Alegre.
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 2 inclusion and 1 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 5 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Body Mass Index (time frame: baseline, 12th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2014.