Trial Outcomes & Findings for Promotion of Physical Activity in Adolescents With Intellectual and Developmental Disabilities (NCT NCT03684512)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

116 participants

Primary outcome timeframe

Change from baseline to 6 months

Results posted on

2023-07-03

Participant Flow

Dyads of adolescents with intellectual disabilities and a parent.

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	57	59
Overall Study Completed 6 Months	47	54
Overall Study Completed 12 Month Active Intervention	40	48
Overall Study COMPLETED	37	45
Overall Study NOT COMPLETED	20	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

For participants in which valid accelerometer data was obtained.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adolescent Only (AO): Adolescents n=59 Participants 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	Adolescent Only (AO): Parents n=57 Participants Parents had adolescents who were randomized to the AO intervention. Parents were not asked to do anything in the intervention.	Adolescent and Parent (A+P): Adolescents n=57 Participants 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	Adolescent and Parent (A+P): Parents n=55 Participants 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	Total n=228 Participants Total of all reporting groups
Age, Continuous	15.4 years STANDARD_DEVIATION 3.1 • n=59 Participants	47.7 years STANDARD_DEVIATION 7.45 • n=57 Participants	15.6 years STANDARD_DEVIATION 2.9 • n=57 Participants	48.6 years STANDARD_DEVIATION 7.05 • n=55 Participants	31.8 years STANDARD_DEVIATION 17.2 • n=228 Participants
Sex: Female, Male Female	31 Participants n=59 Participants	52 Participants n=57 Participants	29 Participants n=57 Participants	51 Participants n=55 Participants	163 Participants n=228 Participants
Sex: Female, Male Male	28 Participants n=59 Participants	5 Participants n=57 Participants	28 Participants n=57 Participants	4 Participants n=55 Participants	65 Participants n=228 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=59 Participants	3 Participants n=57 Participants	5 Participants n=57 Participants	3 Participants n=55 Participants	15 Participants n=228 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	55 Participants n=59 Participants	54 Participants n=57 Participants	52 Participants n=57 Participants	52 Participants n=55 Participants	213 Participants n=228 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=59 Participants	0 Participants n=57 Participants	0 Participants n=57 Participants	0 Participants n=55 Participants	0 Participants n=228 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=59 Participants	0 Participants n=57 Participants	0 Participants n=57 Participants	0 Participants n=55 Participants	0 Participants n=228 Participants
Race (NIH/OMB) Asian	2 Participants n=59 Participants	3 Participants n=57 Participants	0 Participants n=57 Participants	0 Participants n=55 Participants	5 Participants n=228 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=59 Participants	0 Participants n=57 Participants	0 Participants n=57 Participants	0 Participants n=55 Participants	1 Participants n=228 Participants
Race (NIH/OMB) Black or African American	6 Participants n=59 Participants	7 Participants n=57 Participants	4 Participants n=57 Participants	4 Participants n=55 Participants	21 Participants n=228 Participants
Race (NIH/OMB) White	43 Participants n=59 Participants	46 Participants n=57 Participants	45 Participants n=57 Participants	48 Participants n=55 Participants	182 Participants n=228 Participants
Race (NIH/OMB) More than one race	7 Participants n=59 Participants	1 Participants n=57 Participants	8 Participants n=57 Participants	3 Participants n=55 Participants	19 Participants n=228 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=59 Participants	0 Participants n=57 Participants	0 Participants n=57 Participants	0 Participants n=55 Participants	0 Participants n=228 Participants
Moderate To Vigorous Physical Activity	22.15 minutes per day STANDARD_DEVIATION 29.17 • n=52 Participants • For participants in which valid accelerometer data was obtained.	17.67 minutes per day STANDARD_DEVIATION 18.02 • n=51 Participants • For participants in which valid accelerometer data was obtained.	17.01 minutes per day STANDARD_DEVIATION 15.61 • n=44 Participants • For participants in which valid accelerometer data was obtained.	16.96 minutes per day STANDARD_DEVIATION 18.30 • n=47 Participants • For participants in which valid accelerometer data was obtained.	19.83 minutes per day STANDARD_DEVIATION 20.95 • n=194 Participants • For participants in which valid accelerometer data was obtained.

PRIMARY outcome

Timeframe: Change from baseline to 6 months

Population: Adolescents who had valid accelerometer data at both baseline and 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.