Adolescent Behavior, Down Syndrome, Intellectual Disability, Physical Activity
Conditions
Brief 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 .
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.
Interventions
BEHAVIORALGroup Exercise Sessions
Remote exercise sessions delivered over group video conference
BEHAVIORALIndividual Support Sessions
Individual education/support/feedback sessions delivered over video chat
BEHAVIORALFacebook Group
Facebook group for parents to provide additional support and education
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Kansas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Adolescent Physical Activity From Baseline to 6 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Parent Physical Activity | Change from baseline to 18 months | 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 in Sedentary Time | Change from baseline to 18 months | 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 in Parent Sedentary Time | Change from baseline to 18 months | 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 in Adolescent Moderate to Vigorous Physical Activity From Baseline to 18 Months | Change 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 in Muscular Strength | Change from baseline to 18 months | Assessed at baseline, 6, 12, and 18 months by chest press and leg press |
| Change in Motor Ability | Change from baseline to 18 months | Assessed by the Gross Motor Quotient and Percentile obtained from Test of Gross Motor Development-second edition |
| Change in Quality of Life | Change from baseline to 18 months | 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 in Cardiovascular Fitness | Change from baseline to 18 months | Cardiovascular fitness will be assessed by treadmill at baseline, 3, 6, 12, and 18 months |
Countries
United States
Participant flow
Pre-assignment details
Dyads of adolescents with intellectual disabilities and a parent.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 59 |
| Adolescent Only (AO): Parents Parents had adolescents who were randomized to the AO intervention. Parents were not asked to do anything in the intervention. | 57 |
| 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 | 57 |
| 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 | 55 |
| Total | 228 |
Baseline characteristics
| Characteristic | Adolescent Only (AO): Adolescents | Adolescent Only (AO): Parents | Adolescent and Parent (A+P): Adolescents | Adolescent and Parent (A+P): Parents | Total |
|---|---|---|---|---|---|
| Age, Continuous | 15.4 years STANDARD_DEVIATION 3.1 | 47.7 years STANDARD_DEVIATION 7.45 | 15.6 years STANDARD_DEVIATION 2.9 | 48.6 years STANDARD_DEVIATION 7.05 | 31.8 years STANDARD_DEVIATION 17.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 3 Participants | 5 Participants | 3 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 55 Participants | 54 Participants | 52 Participants | 52 Participants | 213 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Moderate To Vigorous Physical Activity | 22.15 minutes per day STANDARD_DEVIATION 29.17 | 17.67 minutes per day STANDARD_DEVIATION 18.02 | 17.01 minutes per day STANDARD_DEVIATION 15.61 | 16.96 minutes per day STANDARD_DEVIATION 18.3 | 19.83 minutes per day STANDARD_DEVIATION 20.95 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 0 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 7 Participants | 4 Participants | 4 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 1 Participants | 8 Participants | 3 Participants | 19 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 43 Participants | 46 Participants | 45 Participants | 48 Participants | 182 Participants |
| Sex: Female, Male Female | 31 Participants | 52 Participants | 29 Participants | 51 Participants | 163 Participants |
| Sex: Female, Male Male | 28 Participants | 5 Participants | 28 Participants | 4 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 57 |
| other Total, other adverse events | 1 / 59 | 2 / 57 |
| serious Total, serious adverse events | 2 / 59 | 1 / 57 |
Outcome results
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.
Time frame: Change from baseline to 6 months
Population: Adolescents who had valid accelerometer data at both baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adolescent Only (AO) | Change in Adolescent Physical Activity From Baseline to 6 Months | -3.2 minutes per day | Standard Deviation 14.8 |
| Adolescent and Parent (A+P) | Change in Adolescent Physical Activity From Baseline to 6 Months | -0.6 minutes per day | Standard Deviation 12.5 |
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.
Time frame: Change from baseline to 18 months
Population: Adolescents who had valid accelerometer data at both baseline and 18 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adolescent Only (AO) | Change in Adolescent Moderate to Vigorous Physical Activity From Baseline to 18 Months | -1.5 minutes per day | Standard Deviation 28.5 |
| Adolescent and Parent (A+P) | Change in Adolescent Moderate to Vigorous Physical Activity From Baseline to 18 Months | 7.6 minutes per day | Standard Deviation 21.8 |
Secondary
Change in Cardiovascular Fitness
Cardiovascular fitness will be assessed by treadmill at baseline, 3, 6, 12, and 18 months
Time frame: Change from baseline to 18 months
Secondary
Change in Motor Ability
Assessed by the Gross Motor Quotient and Percentile obtained from Test of Gross Motor Development-second edition
Time frame: Change from baseline to 18 months
Secondary
Change in Muscular Strength
Assessed at baseline, 6, 12, and 18 months by chest press and leg press
Time frame: Change from baseline to 18 months
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
Time frame: Change from baseline to 18 months
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.
Time frame: Change from baseline to 18 months
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
Time frame: Change from baseline to 18 months
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.
Time frame: Change from baseline to 18 months