Trial Outcomes & Findings for Computerized Health Education to Promote Physical Activity (NCT NCT00242658)

Results Overview

Minutes of physical activity measured by the 7-Day Physical Activity Recall (7-Day PAR), which is an interviewer-administered self-report physical activity measure of minutes spent in moderate and vigorous intensity leisure and non-leisure activities over the preceding 7 days. It was administered to study participants at baseline and 6 months.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

394 participants

Primary outcome timeframe

6 months

Results posted on

2012-11-12

Participant Flow

Participant milestones

Participant milestones
Measure	Tailored Physical Activity Intervention Group The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants' needs; they also included an activity prescription.	No Tailored Physical Activity Intervention Group The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.
Overall Study STARTED	187	207
Overall Study COMPLETED	165	188
Overall Study NOT COMPLETED	22	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Tailored Physical Activity Intervention Group The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants' needs; they also included an activity prescription.	No Tailored Physical Activity Intervention Group The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.
Overall Study Lost to Follow-up	22	19

Baseline Characteristics

Computerized Health Education to Promote Physical Activity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tailored Physical Activity Intervention Group n=187 Participants The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants' needs; they also included an activity prescription.	No Tailored Physical Activity Intervention Group n=207 Participants The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.	Total n=394 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	187 Participants n=5 Participants	207 Participants n=7 Participants	394 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	44.1 years STANDARD_DEVIATION 11.2 • n=5 Participants	48.4 years STANDARD_DEVIATION 11.1 • n=7 Participants	46.4 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	167 Participants n=5 Participants	165 Participants n=7 Participants	332 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	42 Participants n=7 Participants	62 Participants n=5 Participants
Region of Enrollment United States	187 participants n=5 Participants	207 participants n=7 Participants	394 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Minutes of physical activity measured by the 7-Day Physical Activity Recall (7-Day PAR), which is an interviewer-administered self-report physical activity measure of minutes spent in moderate and vigorous intensity leisure and non-leisure activities over the preceding 7 days. It was administered to study participants at baseline and 6 months.

Outcome measures

Outcome measures
Measure	Tailored Physical Activity Intervention Group n=187 Participants The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants' needs; they also included an activity prescription.	No Tailored Physical Activity Intervention Group n=207 Participants The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.
7-Day Physical Activity Recall (7-Day PAR)	54.85 minutes Interval 6.45 to 103.24	44.89 minutes Interval 3.19 to 86.59

SECONDARY outcome

Timeframe: Baseline and 6 months

Behavioral processes were assessed by asking participants to rate their responses to 24 statements on a Likert scale (1 = never to 5 = repeatedly) to statements such as, "I tell myself I am able to be physically active if I want to. To create the overall measure, individual items are averaged. Higher numbers represent greater use of behavioral processes of change, so that the overall scale retains a maximum of 5.0 and minimum value of 1.0. The scale values are not numerical, they represent scores on the scale, where 5=repeatedly and 1=never.

Outcome measures

Outcome measures
Measure	Tailored Physical Activity Intervention Group n=187 Participants The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants' needs; they also included an activity prescription.	No Tailored Physical Activity Intervention Group n=207 Participants The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.
Change in Behavioral Processes of Change Between Baseline and 6 Months	0.52 Scores on a Scale 95% Confidence Interval 0 • Interval 0.42 to 0.62	0.18 Scores on a Scale 95% Confidence Interval 0 • Interval 0.1 to 0.27

Adverse Events

Tailored Physical Activity Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Tailored Physical Activity Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chris Sciamanna, MD, MPH

Penn State Milton S. Hershey Medical Center

Phone: 717-531-8161

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place