NCT02309034

Brief 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 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2014

Completed
Last Updated

December 5, 2014

Status Verified

December 1, 2014

Enrollment Period

Same day

First QC Date

December 3, 2014

Last Update Submit

December 4, 2014

Conditions

Keywords

OverweightObesityCardiometabolic risk factorsAdolescentsExercise

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index

    baseline, 12th week

Secondary Outcomes (6)

  • Waist circumference

    baseline, 12th week

  • Blood Pressure

    baseline, 12th week

  • HDL-cholesterol

    baseline, 12th week

  • Triglycerides

    baseline, 12th week

  • Fasting glycemia

    baseline, 12th week

  • +1 more secondary outcomes

Study Arms (3)

Jump exercise

EXPERIMENTAL

rebound exercises.

Behavioral: Jump exerciseOther: Nutritional guidance

Aquatic exercise

EXPERIMENTAL

Hydrogimnastic.

Behavioral: Aquatic exerciseOther: Nutritional guidance

Nutritional guidance

ACTIVE COMPARATOR

Nutritional counseling classes.

Other: Nutritional guidance

Interventions

Jump exerciseBEHAVIORAL

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.

Also known as: Rebound exercises
Jump exercise

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.

Also known as: Hydrogimnastic
Aquatic exercise

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.

Also known as: Nutritional counseling
Aquatic exerciseJump exerciseNutritional guidance

Eligibility Criteria

Age10 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Those adolescents who become pregnant during the training will be deleted

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

OverweightObesityMotor Activity

Interventions

Aquatic TherapyNutrition Assessment

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitationData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Beatriz D Schaan, PhD

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2014

First Posted

December 5, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

December 5, 2014

Record last verified: 2014-12