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Trial Outcomes & Findings for The Clinical Referral to Activity Study (NCT NCT04743856)

NCT ID: NCT04743856

Last Updated: 2025-11-19

Results Overview

Change between 0 and 12 months for y/n meeting the 150 minute/week moderate-vigorous activity goal based on minutes of activity from accelerometer

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

54 participants

Primary outcome timeframe

12 months versus baseline

Results posted on

2025-11-19

Participant Flow

Participants enrolled between March 2022 and June 2023.

Participants were requirement to complete baseline measures for the primary outcome using accelerometer. Participants who withdrew, were found to not be meeting eligibility criteria, or did not completing the measure after consenting were not randomized and were administratively withdrawn.

Participant milestones

Participant milestones
Measure
PAT (Physical activity monitor)
Participants will receive a physical activity tracker and encouragement to increase physical activity. PAT: Participants will receive a physical activity tracker and encouragement to increase activity.
ActiveGOALSv2
Participants will receive the ActiveGOALS online program with an integrated activity tracker. ActiveGOALSv2: 13 weekly self-guided sessions on problem solving and goal setting related to increasing physical activity, and weekly remote coaching support. Once a month support materials sent monthly from months 4-12 of intervention.
Overall Study
STARTED
27
27
Overall Study
COMPLETED
20
20
Overall Study
NOT COMPLETED
7
7

Reasons for withdrawal

Reasons for withdrawal
Measure
PAT (Physical activity monitor)
Participants will receive a physical activity tracker and encouragement to increase physical activity. PAT: Participants will receive a physical activity tracker and encouragement to increase activity.
ActiveGOALSv2
Participants will receive the ActiveGOALS online program with an integrated activity tracker. ActiveGOALSv2: 13 weekly self-guided sessions on problem solving and goal setting related to increasing physical activity, and weekly remote coaching support. Once a month support materials sent monthly from months 4-12 of intervention.
Overall Study
Lost to Follow-up
6
7
Overall Study
Withdrawal by Subject
1
0

Baseline Characteristics

The Clinical Referral to Activity Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
PAT (Physical Activity Monitor)
n=27 Participants
Participants will receive a physical activity tracker and encouragement to increase physical activity. PAT: Participants will receive a physical activity tracker and encouragement to increase activity.
ActiveGOALSv2
n=27 Participants
Participants will receive the ActiveGOALS online program with an integrated activity tracker. ActiveGOALSv2: 13 weekly self-guided sessions on problem solving and goal setting related to increasing physical activity, and weekly remote coaching support. Once a month support materials sent monthly from months 4-12 of intervention.
Total
n=54 Participants
Total of all reporting groups
Age, Continuous
57.01 years
STANDARD_DEVIATION 8.31
57.7 years
STANDARD_DEVIATION 9.26 • n=4 Participants
57.36 years
STANDARD_DEVIATION 8.73 • n=8 Participants
Sex: Female, Male
Female
24 Participants
20 Participants
n=4 Participants
44 Participants
n=8 Participants
Sex: Female, Male
Male
3 Participants
7 Participants
n=4 Participants
10 Participants
n=8 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
1 Participants
n=4 Participants
1 Participants
n=8 Participants
Race (NIH/OMB)
Asian
1 Participants
0 Participants
n=4 Participants
1 Participants
n=8 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
0 Participants
n=4 Participants
0 Participants
n=8 Participants
Race (NIH/OMB)
Black or African American
6 Participants
6 Participants
n=4 Participants
12 Participants
n=8 Participants
Race (NIH/OMB)
White
19 Participants
19 Participants
n=4 Participants
38 Participants
n=8 Participants
Race (NIH/OMB)
More than one race
1 Participants
1 Participants
n=4 Participants
2 Participants
n=8 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
0 Participants
n=4 Participants
0 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
1 Participants
n=4 Participants
1 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
27 Participants
26 Participants
n=4 Participants
53 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
0 Participants
n=4 Participants
0 Participants
n=8 Participants
Meeting Activity Goal
14 Participants
17 Participants
n=4 Participants
31 Participants
n=8 Participants
Average Moderate-Vigorous Activity
29.6 minutes/day
STANDARD_DEVIATION 22.6
34.83 minutes/day
STANDARD_DEVIATION 23.48 • n=4 Participants
32.3 minutes/day
STANDARD_DEVIATION 23.00 • n=8 Participants
Average Light Activity
338.5 minutes/day
STANDARD_DEVIATION 86.7
354.1 minutes/day
STANDARD_DEVIATION 94.1 • n=4 Participants
346.5 minutes/day
STANDARD_DEVIATION 90.10 • n=8 Participants
Average Sedentary
455.91 minutes/day
STANDARD_DEVIATION 66.10
463.27 minutes/day
STANDARD_DEVIATION 112.57 • n=4 Participants
459.65 minutes/day
STANDARD_DEVIATION 91.90 • n=8 Participants
Average Step Counts
4564 steps/day
STANDARD_DEVIATION 2141
5023 steps/day
STANDARD_DEVIATION 2222 • n=4 Participants
4797 steps/day
STANDARD_DEVIATION 2174 • n=8 Participants
Systolic Blood Pressure
122.6 mmHG
STANDARD_DEVIATION 17.1
120.6 mmHG
STANDARD_DEVIATION 11.9 • n=4 Participants
121.6 mmHG
STANDARD_DEVIATION 14.6 • n=8 Participants
Body Weight
216.8 pounds
STANDARD_DEVIATION 29.9
207.4 pounds
STANDARD_DEVIATION 33.1 • n=4 Participants
212.0 pounds
STANDARD_DEVIATION 31.6 • n=8 Participants
Waist Circumference
112.8 centimeters
STANDARD_DEVIATION 16.2
108.2 centimeters
STANDARD_DEVIATION 10.6 • n=4 Participants
110.5 centimeters
STANDARD_DEVIATION 13.7 • n=8 Participants
Fasting Blood Glucose
96.7 mg/dl
STANDARD_DEVIATION 14.5
102.6 mg/dl
STANDARD_DEVIATION 16.5 • n=4 Participants
99.7 mg/dl
STANDARD_DEVIATION 15.7 • n=8 Participants
HbA1c
5.42 mmol/mol
STANDARD_DEVIATION 0.46
5.62 mmol/mol
STANDARD_DEVIATION 0.55 • n=4 Participants
5.52 mmol/mol
STANDARD_DEVIATION 0.52 • n=8 Participants
LDL Cholesterol
116.4 mg/dl
STANDARD_DEVIATION 43.5
118.9 mg/dl
STANDARD_DEVIATION 43.4 • n=4 Participants
117.6 mg/dl
STANDARD_DEVIATION 43.1 • n=8 Participants
HDL Cholesterol
54.7 mg/dl
STANDARD_DEVIATION 13.0
53.0 mg/dl
STANDARD_DEVIATION 15.7 • n=4 Participants
53.9 mg/dl
STANDARD_DEVIATION 14.3 • n=8 Participants
Insulin
15.9 mg/dl
STANDARD_DEVIATION 15.1
16.0 mg/dl
STANDARD_DEVIATION 10.1 • n=4 Participants
16.0 mg/dl
STANDARD_DEVIATION 12.7 • n=8 Participants
Triglycerides
128.9 mg/dl
STANDARD_DEVIATION 54.1
162.1 mg/dl
STANDARD_DEVIATION 108.8 • n=4 Participants
145.5 mg/dl
STANDARD_DEVIATION 86.7 • n=8 Participants
Blood Pressure Diastolic
79 mmHG
STANDARD_DEVIATION 11
79 mmHG
STANDARD_DEVIATION 9 • n=4 Participants
79 mmHG
STANDARD_DEVIATION 10 • n=8 Participants

PRIMARY outcome

Timeframe: 12 months versus baseline

Population: Due to participant drop out, incomplete monitor data at 12 months and loss to follow-up there were less people at the 12 month visit with valid monitor data

Change between 0 and 12 months for y/n meeting the 150 minute/week moderate-vigorous activity goal based on minutes of activity from accelerometer

Outcome measures

Outcome measures
Measure
PAT (Physical activity monitor)
n=27 Participants
Participants will receive a physical activity tracker and encouragement to increase physical activity. PAT: Participants will receive a physical activity tracker and encouragement to increase activity.
ActiveGOALSv2
n=27 Participants
Participants will receive the ActiveGOALS online program with an integrated activity tracker. ActiveGOALSv2: 13 weekly self-guided sessions on problem solving and goal setting related to increasing physical activity, and weekly remote coaching support. Once a month support materials sent monthly from months 4-12 of intervention.
Change From Baseline in Meeting the Aerobic Activity Goal at 12 Months
Baseline meeting goal
11 Participants
16 Participants
Change From Baseline in Meeting the Aerobic Activity Goal at 12 Months
12 months meeting goal
11 Participants
13 Participants

PRIMARY outcome

Timeframe: 12 months versus baseline

Population: there were less participants with valid data at the 12 month timepoint due to incomplete monitor data, loss to follow-up, and participant withdraw

Objectively measured change in step counts between 0 and 12 months using ActiGraph accelerometer

Outcome measures

Outcome measures
Measure
PAT (Physical activity monitor)
n=27 Participants
Participants will receive a physical activity tracker and encouragement to increase physical activity. PAT: Participants will receive a physical activity tracker and encouragement to increase activity.
ActiveGOALSv2
n=27 Participants
Participants will receive the ActiveGOALS online program with an integrated activity tracker. ActiveGOALSv2: 13 weekly self-guided sessions on problem solving and goal setting related to increasing physical activity, and weekly remote coaching support. Once a month support materials sent monthly from months 4-12 of intervention.
Change From Baseline in Step Counts at 12 Months
12 month Adjusted Estimates
4533.67 steps/day
Standard Error 416.42
5680.49 steps/day
Standard Error 416.41
Change From Baseline in Step Counts at 12 Months
Baseline Adjusted Estimates
4574.21 steps/day
Standard Error 421.86
5028.41 steps/day
Standard Error 413.78

SECONDARY outcome

Timeframe: 1 week recording; measured at baseline, 6 and 12 months

Objectively measured sedentary behavior over all timepoints for 12 months using ActiGraph accelerometer

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 week recording; measured at baseline, 6 and 12 months

Objectively measured moderate-vigorous activity over all timepoints for 12 months using ActiGraph accelerometer

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 week recording; measured at baseline, 6 and 12 months

Objectively measured Light activity over all timepoints for 12 months using ActiGraph accelerometer

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 week recording; measured at baseline, 6 and 12 months

Objectively measured Step counts over all timepoints for 12 months using ActiGraph accelerometer

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: measured at 6 and 12 months

patient experience survey designed for this study with the help of patient partners to gather feedback from participants. Feedback will be used in the development of future interventions

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: measured at baseline, 6 and 12 months

Taken by trained clinic staff using a validated automated blood pressure cuff after participant is seated in an upright position for 5 minutes. Two measure will be taken and the average of the two measures will be used. If the measures are not within 5 mmHG, a third measure will be taken.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: measured at baseline, 6 and 12 months

will be measured in clinic by trained staff using a validated scale. Participants will be asked to take shoes off and wear light clothes. Average of two measures will be used; if weight is more than .5 pounds different, a third will be taken.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: measured at baseline, 6 and 12 months

will be measured above the iliac crest in clinic by trained staff. Two measures will be taken and averaged; if measures are more than 1 cm different a third measure will be taken.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: measured at baseline, 6 and 12 months

A fasting blood draw will be taken after 12-16 hours fast.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: measured at baseline, 6 and 12 months

A fasting blood draw will be taken after 12-16 hours fast.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: measured at baseline, 6 and 12 months

A fasting blood draw will be taken after 12-16 hours fast.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: measured at baseline, 6 and 12 months

A fasting blood draw will be taken after 12-16 hours fast.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: measured at baseline, 6 and 12 months

EuroQAL Visual Analogue Scale (EQ-VAS)-Self-reported perception of health on a 0 (lowest possible) to 100 (highest possible) scale.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: measured at baseline, 6 and 12 months

A fasting blood draw will be taken after 12-16 hours fast.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: measured at baseline, 6 and 12 months

A fasting blood draw will be taken after 12-16 hours fast.

Outcome measures

Outcome data not reported

Adverse Events

PAT (Physical activity monitor)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

ActiveGOALSv2

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

Bonny Rockette-Wagner

University of Pittsburgh

Phone: 4126240188

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place