Personalized Exercise for Adolescents With Diabetes

May 19, 2014 updated by: Melissa Faulkner, University of Arizona
This study aims to determine the likely benefits of a study that would use the novel techniques both of writing an exercise "prescription" and of including the family and/or community in sticking to the exercise prescription by youths with diabetes, who often suffer eventual cardiovascular complications that might be lessened by the exercise.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Diabetes mellitus (DM) is now the sixth leading cause of death in the U.S., primarily due to cardiovascular (CV) complications. People with DM have a 2 to 4 times increased risk for heart disease. An increasing number of adolescents are diagnosed with DM, predisposing them to CV morbidity and mortality in early adulthood. Using a comparison group pretest-posttest design, the Primary Aim of this investigation is to determine the feasibility of conducting a novel personalized exercise prescription (PEP) intervention with 20 adolescents who have type 1 DM and 20 adolescents with type 2 DM. We will explore the influence of DM-specific family social support, exercise self-efficacy, and benefits and barriers to exercise on adherence to PEP. The Secondary Aim is to explore possible changes in physiological (i.e., cardiorespiratory fitness, heart rate variability, metabolic control, and lipid profile) and psychological outcomes (i.e., diabetes quality of life [QOL]) of the PEP intervention in adolescents with type 1 or type 2 DM. Long-term benefits of exercise for persons with DM include decreased risk factors for CV disease, improved well-being, and increased life expectancy. The current decline in physical activity during adolescence is problematic, particularly for those with DM, who have an added risk for future CV disease. The limited research available on the efficacy of exercise interventions with youths who have type 1 DM indicates improvements in cardiorespiratory fitness, lipid profile, and glucose regulation. No published exercise intervention research with adolescents who have type 2 DM is available. However, exercise interventions with overweight youth have shown increased heart rate variability and cardiorespiratory fitness. Although numerous studies have examined various school-based strategies to promote more physically active lives in youth populations, no studies have examined the feasibility of conducting individualized, culturally focused exercise prescriptions for adolescents with type 1 or type 2 DM that incorporate family support in a home or community setting. Nor have studies addressed the possible psychosocial and physiological outcomes of these personalized approaches. This investigation will extend the principal investigator's program of research that identified differences in CV risks for adolescents with type 1 vs. type 2 DM. Determining factors that influence the conduct and outcomes of individualized exercise interventions for adolescents with DM can potentially lead to the development of programs that promote adherence to exercise, avert complications, and improve QOL and overall health.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85721
        • University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 19 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adolescents aged 12 to 19
  • With a diagnosis of type 1 or type 2 DM
  • Score on Physical Activity Recall (PAR) Scale of 36 metabolic equivalents (METs) or less to ensure enrollment of youths who are not already engaged in a regular exercise or sports program
  • Have a parent (guardian) who also agrees to attend personalized exercise program (PEP) training, participate in exercising and provide ongoing encouragement and support for PEP, and who does not have any positive responses to the Physical Activity Readiness Questionnaire (PAR-Q). The decision to use a value for METs < 36 is based upon current PAR data from the PI's R01 that revealed a mean score of 34.7 ± 3.1 for teens with type 1 DM and 33.5 ± 1.4 for teens with type 2 DM. Mean scores for both groups reflect activity levels that are well below the current recommendation of 60 minutes of moderate to vigorous exercise on most days of the week.

Exclusion criteria:

Subjects will be excluded if they:

  • Are in a school grade that is not appropriate to age within 2 years (this is to control for overt delays in cognition, literacy, and psychological or behavioral functioning)
  • Have developed diabetes as a secondary condition to treatment for another chronic condition (i.e., cancer)
  • Have known cardiac defects
  • Are pregnant females.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: Exercise prescription
Each adolescents with type 1 or type 2 diabetes received individual fitness testing and a personalized exercise program prescription developed by an exercise physiologist. Pretest and posttest measures of glucose control and cardiorespiratory fitness, heart rate variability, metabolic control, lipid profile, body composition, and inflammatory markers, as well as psychological outcomes (i.e., diabetes quality of life) were completed.
Behavioral: PEP intervention
This study will explore the feasibility of adherence to a personalized exercise prescription (PEP) in adolescents with type 1 or type 2 diabetes. The PEP intervention consists of a 2-hour group education session and a 16-week personalized exercise plan implemented in the home or community setting with the use of parental support and care ambassadors. Care ambassadors will maintain consistency of interactions with specific families for the duration of the PEP intervention. This consistency will aid in establishing rapport with the adolescents and parents to answer any questions and provide guidance for adhering to the PEP plan. The PEP intervention will be mutually planned with each teen and parent based upon the assessment of the teen's personal and cultural choices, including family and community resources. Exercise frequency, duration, and intensity for the teen with diabetes will be documented with a MTI ActiGraph accelerometer (Fort Walton Beach, FL).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
exercise adherence
Time Frame: Longitudinal and following the 16-week intervention
Longitudinal and following the 16-week intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
cardiorespiratory fitness
Time Frame: Following the 16-week intervention
Following the 16-week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Arizona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2007

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2010

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 29, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RNR009267B
  • 7R21NR009267-02 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings