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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD094704 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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 .
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group Exercise Sessions | Behavioral | Remote exercise sessions delivered over group video conference |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline to 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lauren T Ptomey | University of Kansas | Principal Investigator |
| Joseph Donnelly | University of Kansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas | Lawrence | Kansas | 66045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38967389 | Derived | 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. | |
| 31344519 | Derived | Ptomey 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. |
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Dyads of adolescents with intellectual disabilities and a parent.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adolescent and Parent (A+P) | 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. Group Exercise Sessions: Remote exercise sessions delivered over group video conference Individual Support Sessions: Individual education/support/feedback sessions delivered over video chat Facebook Group: Facebook group for parents to provide additional support and education |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 17, 2020 |
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| Individual Support Sessions | Behavioral | Individual education/support/feedback sessions delivered over video chat |
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| Facebook Group | Behavioral | Facebook group for parents to provide additional support and education |
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| 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 | 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. | 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. | 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 | Change from baseline to 18 months |
| Change in Muscular Strength | Assessed at baseline, 6, 12, and 18 months by chest press and leg press | 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 | 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 | Change from baseline to 18 months |
| FG001 | Adolescent Only (AO) | 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. Group Exercise Sessions: Remote exercise sessions delivered over group video conference Individual Support Sessions: Individual education/support/feedback sessions delivered over video chat |
| Completed 6 Months |
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| Completed 12 Month Active Intervention |
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| COMPLETED |
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| NOT COMPLETED |
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Participants were adolescents with an intellectual disability and a parent. Note 4 parents (AO: 2, A+P: 2) had 2 children who enrolled in the study together.
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| ID | Title | Description |
|---|---|---|
| BG000 | Adolescent Only (AO): Adolescents | Remote based physical activity intervention delivered to adolescents only. Adolescents will be asked to attend weekly group exercise sessions and monitor their daily physical activity. Group Exercise Sessions: Remote exercise sessions delivered over group video conference |
| BG001 | Adolescent Only (AO): Parents | Parents had adolescents who were randomized to the AO intervention. Parents were not asked to do anything in the intervention. |
| BG002 | Adolescent and Parent (A+P): Adolescents | 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. Group Exercise Sessions: Remote exercise sessions delivered over group video conference Individual Support Sessions: Individual education/support/feedback sessions delivered over video chat Facebook Group: Facebook group for parents to provide additional support and education |
| BG003 | Adolescent and Parent (A+P): Parents | Parents had adolescents who were randomized to the A+P intervention. Parents were asked to attend weekly group exercise session, individual support sessions and had access to a parent facebook group. Group Exercise Sessions: Remote exercise sessions delivered over group video conference Individual Support Sessions: Individual education/support/feedback sessions delivered over video chat Facebook Group: Facebook group for parents to provide additional support and education |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Moderate To Vigorous Physical Activity | For participants in which valid accelerometer data was obtained. | Mean | Standard Deviation | minutes per day |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Adolescents who had valid accelerometer data at both baseline and 6 months | Posted | Mean | Standard Deviation | minutes per day | Change from baseline to 6 months |
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| Secondary | 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. | Adolescents who had valid accelerometer data at both baseline and 18 months | Posted | Mean | Standard Deviation | minutes per day | Change from baseline to 18 months |
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| Secondary | 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 | Not Posted | Change from baseline to 18 months | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Change from baseline to 18 months | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Change from baseline to 18 months | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Change in Cardiovascular Fitness | Cardiovascular fitness will be assessed by treadmill at baseline, 3, 6, 12, and 18 months | Not Posted | Change from baseline to 18 months | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Change in Muscular Strength | Assessed at baseline, 6, 12, and 18 months by chest press and leg press | Not Posted | Change from baseline to 18 months | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Change in Motor Ability | Assessed by the Gross Motor Quotient and Percentile obtained from Test of Gross Motor Development-second edition | Not Posted | Change from baseline to 18 months | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | 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 | Not Posted | Change from baseline to 18 months | Participants |
18 months
Adverse events were only collected from the adolescent.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adolescent Only | 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. Group Exercise Sessions: Remote exercise sessions delivered over group video conference Individual Support Sessions: Individual education/support/feedback sessions delivered over video chat | 0 | 59 | 2 | 59 | 1 | 59 |
| EG001 | Adolescent and Parent | 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. Group Exercise Sessions: Remote exercise sessions delivered over group video conference Individual Support Sessions: Individual education/support/feedback sessions delivered over video chat Facebook Group: Facebook group for parents to provide additional support and education | 0 | 57 | 1 | 57 | 2 | 57 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID 19 Hospitalization | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Pancreatitis | Endocrine disorders | Non-systematic Assessment |
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| Tubulointerstitial Nephritis | Renal and urinary disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash from Fitbit Watch | Product Issues | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lauren Ptomey | University of Kansas Medical Center | 913-588-7983 | lptomey@kumc.edu |
| Apr 4, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000294 | Adolescent Behavior |
| D008607 | Intellectual Disability |
| D004314 | Down Syndrome |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
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