DiabetesPhase 1NCT00686283
Personalized Exercise for Adolescents With Diabetes
A Phase 1 study testing PEP intervention in people with Diabetes, run by University of Arizona at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 to 19 years
- Conditions the study is for
- Diabetes
- What is being tested?
- PEP intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Jul 2010
- Phase
- Phase 1
- 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 12 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diabetes
- Being tested
- PEP intervention
- Keywords
- Adolescents, Diabetes, Exercise
- Medical subject headings
- Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEP interventionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Exercise prescription | Other | 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. Receives: Behavioral: PEP intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
exercise adherence
Measured: Longitudinal and following the 16-week intervention
Secondary outcomes (1)
cardiorespiratory fitness
Measured: Following the 16-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2008 (estimated)
- Study startAug 2007
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Faulkner, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00686283
- Sponsor's protocol ID
- RNR009267B
- Other IDs
- 7R21NR009267-02
- Status last verified
- May 2014
- First submitted
- 20 May 2008
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Michaliszyn SF, Higgins M, Faulkner MS. Patterns of Physical Activity Adherence by Adolescents With Diabetes or Obesity Enrolled in a Personalized Community-Based Intervention. Diabetes Educ. 2018 Dec;44(6):519-530. doi: 10.1177/0145721718805693. Epub 2018 Oct 11.
PubMed 30306834Faulkner MS, Michaliszyn SF, Hepworth JT, Wheeler MD. Personalized exercise for adolescents with diabetes or obesity. Biol Res Nurs. 2014 Jan;16(1):46-54. doi: 10.1177/1099800413500064. Epub 2013 Aug 20.
PubMed 23965300Michaliszyn SF, Faulkner MS. Physical activity and sedentary behavior in adolescents with type 1 diabetes. Res Nurs Health. 2010 Oct;33(5):441-9. doi: 10.1002/nur.20393.
PubMed 20672318
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Exercise for Adolescents With Diabetes
- ClinicalTrials.gov ID
- NCT00686283
- Acronym / sponsor ID
- RNR009267B
- Conditions
- Diabetes
- Keywords
- Adolescents, Diabetes, Exercise
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 29 May 2008 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise prescription | Other | Behavioral: PEP interventionEach 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. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| PEP interventionThis 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). | Behavioural | Exercise prescription |
Primary outcome
exercise adherence
Time frame: Longitudinal and following the 16-week intervention
1 secondary outcome
cardiorespiratory fitness
Time frame: Following the 16-week intervention
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 20 May 2014.
- Derived from this study: PubMed 30306834Michaliszyn SF, Higgins M, Faulkner MS. Patterns of Physical Activity Adherence by Adolescents With Diabetes or Obesity Enrolled in a Personalized Community-Based Intervention. Diabetes Educ. 2018 Dec;44(6):519-530. doi: 10.1177/0145721718805693. Epub 2018 Oct 11.
- Derived from this study: PubMed 23965300Faulkner MS, Michaliszyn SF, Hepworth JT, Wheeler MD. Personalized exercise for adolescents with diabetes or obesity. Biol Res Nurs. 2014 Jan;16(1):46-54. doi: 10.1177/1099800413500064. Epub 2013 Aug 20.
- Derived from this study: PubMed 20672318Michaliszyn SF, Faulkner MS. Physical activity and sedentary behavior in adolescents with type 1 diabetes. Res Nurs Health. 2010 Oct;33(5):441-9. doi: 10.1002/nur.20393.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PEP intervention in people with Diabetes, run by University of Arizona at 1 site in United States.
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 5 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 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
exercise adherence (time frame: Longitudinal and following the 16-week intervention). 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 NCT00686283, which also lists 3 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 20 May 2014.