Adolescent BehaviorNCT03684512
Promotion of Physical Activity in Adolescents With Intellectual and Developmental Disabilities
A study testing Group Exercise Sessions, Individual Support Sessions and Facebook Group in people with Adolescent Behavior and Intellectual Disability, run by University of Kansas at 1 site in United States.
Trial summary
The objective of this study is to compare the effect of two strategies to increase MVPA in adolescents with intellectual and developmental disabilities (IDD): a single level intervention delivered to the adolescent only, and a multi-level intervention delivered to both the adolescent and a parent . Read more about this study
- Who is it for?
- Ages 10 to 21 years
- Conditions the study is for
- Adolescent Behavior, Intellectual Disability, Down Syndrome
- What is being tested?
- Group Exercise Sessions, Individual Support Sessions and Facebook Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2019to 28 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Mild to moderate IDD (IQ of 74-40).
- Sufficient functional ability to understand directions, communicate preferences, wants, and needs through spoken language.
- Living at home with a parent or guardian who is willing to participate in the intervention, with no plans to change this living situation and/or to leave the study area in the next 18 mos.
- Wireless internet access in the home.
Who cannot join
- Unable to participate in moderate to vigorous physical activity (MVPA).
- Pregnancy during the previous 6 mos., currently lactating, or planned pregnancy in the following 18 mos.
- Unwilling to be randomized.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Individual and Family-based Approaches to Increase Physical Activity in Adolescents With IDD
The objective of this study is to compare the effect of two strategies to increase MVPA in adolescents with intellectual and developmental disabilities (IDD): a single level intervention delivered to the adolescent only, and a multi-level intervention delivered to both the adolescent and a parent .
Read the detailed description
We will study adolescents with mild to moderate IDD. Each participant will have 1 designated parent who supports the participant during the physical activity (PA) intervention and in the adolescent and parent arm does the physical activity with the participant. Approximately 29 participants/yr. over 4 yrs. will be randomized in a 1:1 allocation to a remote group-based program of MVPA delivered to the adolescent (AO) or a multi-level intervention delivered to both the adolescent and a parent (A+P). Both interventions will be 12 mos. (6 mos. active intervention, 6 mos. maintenance intervention) with a 6 mos. no-contact follow-up targeted to increase MVPA to the recommended 60 min/d. Both intervention will include real-time MVPA sessions delivered to groups of 5-7 adolescents in their homes using video conferencing software (ZoomTM) with homework assignments designed to increase MVPA on the non-group session days. Parents of adolescents in the A+P group will be asked to participate in the group video MVPA sessions and homework activity, and to attend sessions (0-6 mos. 2 session/mo.; 7-12 mos. 1 session/mo.) with their adolescent and the health coach designed to educate/support parents regarding the role of MVPA in health and function and strategies for increasing MVPA and decreasing sedentary time in both their adolescent and themselves. All participants will monitor their daily PA using a Fitbit wireless activity tracker.
- Being tested
- Group Exercise Sessions, Individual Support Sessions, Facebook Group
- Medical subject headings
- Adolescent Behavior, Intellectual Disability, Down Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Exercise SessionsBehavioural
Remote exercise sessions delivered over group video conference
Individual Support SessionsBehavioural
Individual education/support/feedback sessions delivered over video chat
Facebook GroupBehavioural
Facebook group for parents to provide additional support and education
| Study group | Role | What they receive |
|---|---|---|
| Adolescent Only | Experimental | Remote based physical activity intervention delivered to adolescents only. Adolescents will be asked to attend weekly group exercise sessions, individual support sessions, and monitor their daily physical activity. Receives: Behavioral: Group Exercise Sessions; Behavioral: Individual Support Sessions |
| Adolescent and Parent | Active comparator | Remote based physical activity intervention delivered to adolescents and their parent. Adolescents and a parent will be asked to attend weekly group exercise sessions, individual support sessions, and monitor their daily physical activity. Parents will have access to a Parent Facebook group. Receives: Behavioral: Group Exercise Sessions; Behavioral: Individual Support Sessions; Behavioral: Facebook Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Adolescent Physical Activity From Baseline to 6 Months
Moderate to vigorous physical activity was assessed using an ActiGraph accelerometer worn during waking hours for 7 consecutive days, with the exception of bathing, and swimming. Data were considered valid if they wore the accelerometer for at least 8 hours on 3 days, including 1 weekend day.
Measured: Change from baseline to 6 months
Secondary outcomes (8)
Change in Adolescent Moderate to Vigorous Physical Activity From Baseline to 18 Months
Moderate to vigorous physical activity was assessed using an ActiGraph accelerometer worn during waking hours for 7 consecutive days, with the exception of bathing, and swimming. Data were considered valid if they wore the accelerometer for at least 8 hours on 3 days, including 1 weekend day.
Measured: Change from baseline to 18 months
Change in Parent Physical Activity
Moderate to Vigorous Physical Activity in parents of participants will be assessed at baseline, 3, 6, 12, and 18 months using an ActiGraph accelerometer over 7 days
Measured: Change from baseline to 18 months
Change in Sedentary Time
Sedentary Time in adolescents with IDD will be assessed at baseline, 3, 6, 12, and 18 months, using an ActiGraph accelerometer over 7 days.
Measured: Change from baseline to 18 months
Change in Parent Sedentary Time
Sedentary Time in parents of participants will be assessed at baseline, 3, 6, 12, and 18 months, using an ActiGraph accelerometer over 7 days.
Measured: Change from baseline to 18 months
Change in Cardiovascular Fitness
Cardiovascular fitness will be assessed by treadmill at baseline, 3, 6, 12, and 18 months
Measured: Change from baseline to 18 months
Change in Muscular Strength
Assessed at baseline, 6, 12, and 18 months by chest press and leg press
Measured: Change from baseline to 18 months
Change in Motor Ability
Assessed by the Gross Motor Quotient and Percentile obtained from Test of Gross Motor Development-second edition
Measured: Change from baseline to 18 months
Change in Quality of Life
Assessed a using the PedsQL 4.0 Generic Core Scale designed to measure health-related quality of life in healthy children and adolescents and in those with chronic health conditions
Measured: Change from baseline to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start7 Jan 2019
- Primary completion29 Oct 2021
- Study completion28 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Lauren T Ptomey, Principal investigator, University of KansasJoseph Donnelly, Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684512
- Sponsor's protocol ID
- STUDY00140784
- Other IDs
- R01HD094704
- Status last verified
- Jun 2023
- First submitted
- 24 Sep 2018
- Last updated
- 3 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ptomey LT, Washburn RA, Lee J, Sherman JR, Rice AM, Danon JC, White DA, Szabo-Reed AN, Helsel BC, Donnelly JE. An Individual versus Parent Supported Physical Activity Intervention in Adolescents with Intellectual Disabilities. Med Sci Sports Exerc. 2024 Dec 1;56(12):2256-2266. doi: 10.1249/MSS.0000000000003515. Epub 2024 Jul 4.
PubMed 38967389Ptomey LT, Washburn RA, Lee J, Greene JL, Szabo-Reed AN, Sherman JR, Danon JC, Osborne LN, Little TD, Donnelly JE. Individual and family-based approaches to increase physical activity in adolescents with intellectual and developmental disabilities: Rationale and design for an 18 month randomized trial. Contemp Clin Trials. 2019 Sep;84:105817. doi: 10.1016/j.cct.2019.105817. Epub 2019 Jul 22.
PubMed 31344519
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual and Family-based Approaches to Increase Physical Activity in Adolescents With IDD
- ClinicalTrials.gov ID
- NCT03684512
- Acronym / sponsor ID
- STUDY00140784
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 29 Oct 2021 (actual)
- Study completion
- 28 Oct 2022 (actual)
- First posted
- 25 Sep 2018 (actual)
- Results
- Posted 3 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to compare the effect of two strategies to increase MVPA in adolescents with intellectual and developmental disabilities (IDD): a single level intervention delivered to the adolescent only, and a multi-level intervention delivered to both the adolescent and a parent .
Detailed description
We will study adolescents with mild to moderate IDD. Each participant will have 1 designated parent who supports the participant during the physical activity (PA) intervention and in the adolescent and parent arm does the physical activity with the participant. Approximately 29 participants/yr. over 4 yrs. will be randomized in a 1:1 allocation to a remote group-based program of MVPA delivered to the adolescent (AO) or a multi-level intervention delivered to both the adolescent and a parent (A+P). Both interventions will be 12 mos. (6 mos. active intervention, 6 mos. maintenance intervention) with a 6 mos. no-contact follow-up targeted to increase MVPA to the recommended 60 min/d. Both intervention will include real-time MVPA sessions delivered to groups of 5-7 adolescents in their homes using video conferencing software (ZoomTM) with homework assignments designed to increase MVPA on the non-group session days. Parents of adolescents in the A+P group will be asked to participate in the group video MVPA sessions and homework activity, and to attend sessions (0-6 mos. 2 session/mo.; 7-12 mos. 1 session/mo.) with their adolescent and the health coach designed to educate/support parents regarding the role of MVPA in health and function and strategies for increasing MVPA and decreasing sedentary time in both their adolescent and themselves. All participants will monitor their daily PA using a Fitbit wireless activity tracker.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adolescent Only | Experimental | Behavioral: Group Exercise Sessions, Behavioral: Individual Support SessionsRemote based physical activity intervention delivered to adolescents only. Adolescents will be asked to attend weekly group exercise sessions, individual support sessions, and monitor their daily physical activity. |
| Adolescent and Parent | Active comparator | Behavioral: Group Exercise Sessions, Behavioral: Individual Support Sessions, Behavioral: Facebook GroupRemote based physical activity intervention delivered to adolescents and their parent. Adolescents and a parent will be asked to attend weekly group exercise sessions, individual support sessions, and monitor their daily physical activity. Parents will have access to a Parent Facebook group. |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Mild to moderate IDD (IQ of 74-40).
- Sufficient functional ability to understand directions, communicate preferences, wants, and needs through spoken language.
- Living at home with a parent or guardian who is willing to participate in the intervention, with no plans to change this living situation and/or to leave the study area in the next 18 mos.
- Wireless internet access in the home.
Key exclusion criteria (3 listed)
- Unable to participate in moderate to vigorous physical activity (MVPA).
- Pregnancy during the previous 6 mos., currently lactating, or planned pregnancy in the following 18 mos.
- Unwilling to be randomized.
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 |
|---|---|---|
| Group Exercise SessionsRemote exercise sessions delivered over group video conference | Behavioural | Adolescent Only, Adolescent and Parent |
| Individual Support SessionsIndividual education/support/feedback sessions delivered over video chat | Behavioural | Adolescent Only, Adolescent and Parent |
| Facebook GroupFacebook group for parents to provide additional support and education | Behavioural | Adolescent and Parent |
Primary outcome
Change in Adolescent Physical Activity From Baseline to 6 Months
Time frame: Change from baseline to 6 months
Moderate to vigorous physical activity was assessed using an ActiGraph accelerometer worn during waking hours for 7 consecutive days, with the exception of bathing, and swimming. Data were considered valid if they wore the accelerometer for at least 8 hours on 3 days, including 1 weekend day.
8 secondary outcomes
Change in Adolescent Moderate to Vigorous Physical Activity From Baseline to 18 Months
Time frame: Change from baseline to 18 months
Change in Parent Physical Activity
Time frame: Change from baseline to 18 months
Change in Sedentary Time
Time frame: Change from baseline to 18 months
Change in Parent Sedentary Time
Time frame: Change from baseline to 18 months
Change in Cardiovascular Fitness
Time frame: Change from baseline to 18 months
Change in Muscular Strength
Time frame: Change from baseline to 18 months
Change in Motor Ability
Time frame: Change from baseline to 18 months
Change in Quality of Life
Time frame: Change from baseline to 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38967389Ptomey LT, Washburn RA, Lee J, Sherman JR, Rice AM, Danon JC, White DA, Szabo-Reed AN, Helsel BC, Donnelly JE. An Individual versus Parent Supported Physical Activity Intervention in Adolescents with Intellectual Disabilities. Med Sci Sports Exerc. 2024 Dec 1;56(12):2256-2266. doi: 10.1249/MSS.0000000000003515. Epub 2024 Jul 4.
- Derived from this study: PubMed 31344519Ptomey LT, Washburn RA, Lee J, Greene JL, Szabo-Reed AN, Sherman JR, Danon JC, Osborne LN, Little TD, Donnelly JE. Individual and family-based approaches to increase physical activity in adolescents with intellectual and developmental disabilities: Rationale and design for an 18 month randomized trial. Contemp Clin Trials. 2019 Sep;84:105817. doi: 10.1016/j.cct.2019.105817. Epub 2019 Jul 22.
- Individual participant dataSharing planned: Undecided
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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.
Lauren T Ptomey principal investigator
University of Kansas
Joseph Donnelly principal investigator
University of Kansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Exercise Sessions, Individual Support Sessions and Facebook Group in people with Adolescent Behavior and Intellectual Disability, run by University of Kansas 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 3 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 3 Jul 2023. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Adolescent Physical Activity From Baseline to 6 Months (time frame: Change from baseline to 6 months). 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 NCT03684512, which also lists 2 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 3 Jul 2023.