Trial Outcomes & Findings for The Clinical Referral to Activity Study (NCT NCT04743856)
NCT ID: NCT04743856
Last Updated: 2026-05-12
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
2026-05-12
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eligibility criteria, or did not completing the measure after consenting were not randomized and were administratively withdrawn.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
| 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
| 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
| 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 • n=1512 Participants
|
57.7 years
STANDARD_DEVIATION 9.26 • n=504 Participants
|
57.36 years
STANDARD_DEVIATION 8.73 • n=2016 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=1512 Participants
|
20 Participants
n=504 Participants
|
44 Participants
n=2016 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=1512 Participants
|
7 Participants
n=504 Participants
|
10 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=1512 Participants
|
6 Participants
n=504 Participants
|
12 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=1512 Participants
|
19 Participants
n=504 Participants
|
38 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
2 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=1512 Participants
|
26 Participants
n=504 Participants
|
53 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Meeting Activity Goal
|
14 Participants
n=1512 Participants
|
18 Participants
n=504 Participants
|
32 Participants
n=2016 Participants
|
|
Average Moderate-Vigorous Activity
|
29.6 minutes/day
STANDARD_DEVIATION 22.6 • n=1512 Participants
|
34.83 minutes/day
STANDARD_DEVIATION 23.48 • n=504 Participants
|
32.3 minutes/day
STANDARD_DEVIATION 23.00 • n=2016 Participants
|
|
Average Light Activity
|
338.5 minutes/day
STANDARD_DEVIATION 86.7 • n=1512 Participants
|
354.1 minutes/day
STANDARD_DEVIATION 94.1 • n=504 Participants
|
346.5 minutes/day
STANDARD_DEVIATION 90.10 • n=2016 Participants
|
|
Average Sedentary
|
455.91 minutes/day
STANDARD_DEVIATION 66.10 • n=1512 Participants
|
463.27 minutes/day
STANDARD_DEVIATION 112.57 • n=504 Participants
|
459.65 minutes/day
STANDARD_DEVIATION 91.90 • n=2016 Participants
|
|
Average Step Counts
|
4564 steps/day
STANDARD_DEVIATION 2141 • n=1512 Participants
|
5023 steps/day
STANDARD_DEVIATION 2222 • n=504 Participants
|
4797 steps/day
STANDARD_DEVIATION 2174 • n=2016 Participants
|
|
Systolic Blood Pressure
|
122.6 mmHG
STANDARD_DEVIATION 17.1 • n=1512 Participants
|
120.6 mmHG
STANDARD_DEVIATION 11.9 • n=504 Participants
|
121.6 mmHG
STANDARD_DEVIATION 14.6 • n=2016 Participants
|
|
Body Weight
|
216.8 pounds
STANDARD_DEVIATION 29.9 • n=1512 Participants
|
207.4 pounds
STANDARD_DEVIATION 33.1 • n=504 Participants
|
212.0 pounds
STANDARD_DEVIATION 31.6 • n=2016 Participants
|
|
Waist Circumference
|
112.8 centimeters
STANDARD_DEVIATION 16.2 • n=1512 Participants
|
108.2 centimeters
STANDARD_DEVIATION 10.6 • n=504 Participants
|
110.5 centimeters
STANDARD_DEVIATION 13.7 • n=2016 Participants
|
|
Fasting Blood Glucose
|
96.7 mg/dl
STANDARD_DEVIATION 14.5 • n=1512 Participants
|
102.6 mg/dl
STANDARD_DEVIATION 16.5 • n=504 Participants
|
99.7 mg/dl
STANDARD_DEVIATION 15.7 • n=2016 Participants
|
|
HbA1c
|
5.42 mmol/mol
STANDARD_DEVIATION 0.46 • n=1512 Participants
|
5.62 mmol/mol
STANDARD_DEVIATION 0.55 • n=504 Participants
|
5.52 mmol/mol
STANDARD_DEVIATION 0.52 • n=2016 Participants
|
|
LDL Cholesterol
|
116.4 mg/dl
STANDARD_DEVIATION 43.5 • n=1512 Participants
|
118.9 mg/dl
STANDARD_DEVIATION 43.4 • n=504 Participants
|
117.6 mg/dl
STANDARD_DEVIATION 43.1 • n=2016 Participants
|
|
HDL Cholesterol
|
54.7 mg/dl
STANDARD_DEVIATION 13.0 • n=1512 Participants
|
53.0 mg/dl
STANDARD_DEVIATION 15.7 • n=504 Participants
|
53.9 mg/dl
STANDARD_DEVIATION 14.3 • n=2016 Participants
|
|
Insulin
|
15.9 mg/dl
STANDARD_DEVIATION 15.1 • n=1512 Participants
|
16.0 mg/dl
STANDARD_DEVIATION 10.1 • n=504 Participants
|
16.0 mg/dl
STANDARD_DEVIATION 12.7 • n=2016 Participants
|
|
Triglycerides
|
128.9 mg/dl
STANDARD_DEVIATION 54.1 • n=1512 Participants
|
162.1 mg/dl
STANDARD_DEVIATION 108.8 • n=504 Participants
|
145.5 mg/dl
STANDARD_DEVIATION 86.7 • n=2016 Participants
|
|
Blood Pressure Diastolic
|
79 mmHG
STANDARD_DEVIATION 11 • n=1512 Participants
|
79 mmHG
STANDARD_DEVIATION 9 • n=504 Participants
|
79 mmHG
STANDARD_DEVIATION 10 • n=2016 Participants
|
PRIMARY outcome
Timeframe: 12 months versus baselinePopulation: 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
| 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
|
14 Participants
|
18 Participants
|
|
Change From Baseline in Meeting the Aerobic Activity Goal at 12 Months
12 months meeting goal
|
11 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: 12 months versus baselinePopulation: 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
| 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: baseline, 6 and 12 monthsPopulation: there were less participants with valid data at the 6 month and 12 month timepoint due to incomplete monitor data, loss to follow-up, and participant withdraw
Objectively measured sedentary behavior at each timepoint using ActiGraph accelerometer worn for 1 week, data for a given timepoint was averaged using only valid days during that week to assess average minutes/day. Valid days are days the monitor was worn for 10 or more hours.
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.
|
|---|---|---|
|
Sedentary Behavior Minutes Over All Timepoints for 12 Months
Baseline
|
457.42 minutes
Standard Error 17.84
|
461.00 minutes
Standard Error 17.52
|
|
Sedentary Behavior Minutes Over All Timepoints for 12 Months
6 months
|
496.83 minutes
Standard Error 26.05
|
456.61 minutes
Standard Error 27.96
|
|
Sedentary Behavior Minutes Over All Timepoints for 12 Months
12 months
|
464.21 minutes
Standard Error 23.15
|
446.26 minutes
Standard Error 23.29
|
SECONDARY outcome
Timeframe: baseline, 6 and 12 monthsPopulation: there were less participants with valid data at the 6 month and 12 month timepoint due to incomplete monitor data, loss to follow-up, and participant withdraw
Objectively measured moderate-vigorous activity at each timepoint using ActiGraph accelerometer worn for 1 week, data for a given timepoint was averaged using only valid days during that week to assess average minutes/day. Valid days are days the monitor was worn for 10 or more hours.
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.
|
|---|---|---|
|
Moderate-vigorous Activity Minutes Over All Timepoints for 12 Months
6-months
|
27.41 minutes
Standard Error 4.87
|
33.37 minutes
Standard Error 5.05
|
|
Moderate-vigorous Activity Minutes Over All Timepoints for 12 Months
Baseline
|
29.73 minutes
Standard Error 4.46
|
34.82 minutes
Standard Error 4.39
|
|
Moderate-vigorous Activity Minutes Over All Timepoints for 12 Months
12-months
|
30.31 minutes
Standard Error 5.17
|
38.54 minutes
Standard Error 5.10
|
SECONDARY outcome
Timeframe: baseline, 6 and 12 monthsPopulation: there were less participants with valid data at the 6 month and 12 month timepoint due to incomplete monitor data, loss to follow-up, and participant withdraw
Objectively measured Light activity at each timepoint using ActiGraph accelerometer worn for 1 week, data for a given timepoint was averaged using only valid days during that week to assess average minutes/day. Valid days are days the monitor was worn for 10 or more hours.
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.
|
|---|---|---|
|
Light Activity Minutes Over All Timepoints for 12 Months
Baseline
|
338.37 minutes
Standard Error 17.45
|
353.69 minutes
Standard Error 17.14
|
|
Light Activity Minutes Over All Timepoints for 12 Months
6 months
|
325.93 minutes
Standard Error 18.34
|
359.25 minutes
Standard Error 19.05
|
|
Light Activity Minutes Over All Timepoints for 12 Months
12 months
|
324.94 minutes
Standard Error 16.31
|
372.73 minutes
Standard Error 16.51
|
SECONDARY outcome
Timeframe: baseline, 6 and 12 monthsPopulation: there were less participants with valid data at the 6 month and 12 month timepoint due to incomplete monitor data, loss to follow-up, and participant withdraw
Objectively measured Step counts at each timepoint using ActiGraph accelerometer worn for 1 week, data for a given timepoint was averaged using only valid days during that week to assess average steps/day. Valid days are days the monitor was worn for 10 or more hours.
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.
|
|---|---|---|
|
Step Counts Over All Timepoints for 12 Months
Baseline
|
4583.96 step counts
Standard Error 421.21
|
5024.89 step counts
Standard Error 414.15
|
|
Step Counts Over All Timepoints for 12 Months
6-months
|
4436.42 step counts
Standard Error 465.66
|
5104.16 step counts
Standard Error 480.55
|
|
Step Counts Over All Timepoints for 12 Months
12-months
|
4350.15 step counts
Standard Error 402.44
|
5724.75 step counts
Standard Error 405.29
|
SECONDARY outcome
Timeframe: measured at 6 and 12 monthsPopulation: No participants completed the optional questions related to participant experience
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 monthsPopulation: there were less participants with valid data at the 6 and 12 month timepoint due to incomplete monitor data, loss to follow-up, and participant withdraw
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
| 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.
|
|---|---|---|
|
Systolic Blood Pressure Over All Timepoints for 12 Months
Baseline
|
122.62 mmHG
Standard Error 2.83
|
120.60 mmHG
Standard Error 2.78
|
|
Systolic Blood Pressure Over All Timepoints for 12 Months
6-month
|
125.46 mmHG
Standard Error 2.96
|
123.79 mmHG
Standard Error 2.95
|
|
Systolic Blood Pressure Over All Timepoints for 12 Months
12-month
|
119.87 mmHG
Standard Error 4.15
|
118.56 mmHG
Standard Error 4.14
|
SECONDARY outcome
Timeframe: measured at baseline, 6 and 12 monthsPopulation: there were less participants with valid data at the 6 and 12 month timepoint due to incomplete monitor data, loss to follow-up, and participant withdraw
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
| 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.
|
|---|---|---|
|
Body Weight Over All Timepoints for 12 Months
Baseline
|
216.87 pounds (US)
Standard Error 6.08
|
207.41 pounds (US)
Standard Error 5.97
|
|
Body Weight Over All Timepoints for 12 Months
6-months
|
217.90 pounds (US)
Standard Error 6.22
|
205.65 pounds (US)
Standard Error 6.11
|
|
Body Weight Over All Timepoints for 12 Months
12-months
|
218.44 pounds (US)
Standard Error 6.63
|
207.83 pounds (US)
Standard Error 6.53
|
SECONDARY outcome
Timeframe: measured at baseline, 6 and 12 monthsPopulation: there were less participants with valid data at the 6 and 12 month timepoint due to incomplete monitor data, loss to follow-up, and participant withdraw
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
| 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.
|
|---|---|---|
|
Waist Circumference Over All Timepoints for 12 Months
Baseline
|
112.78 centimeters
Standard Error 2.62
|
108.24 centimeters
Standard Error 2.58
|
|
Waist Circumference Over All Timepoints for 12 Months
6-months
|
109.12 centimeters
Standard Error 2.25
|
108.48 centimeters
Standard Error 2.23
|
|
Waist Circumference Over All Timepoints for 12 Months
12-months
|
111.25 centimeters
Standard Error 2.46
|
110.01 centimeters
Standard Error 2.44
|
SECONDARY outcome
Timeframe: measured at baseline, 6 and 12 monthsPopulation: there were less participants with valid data at the 6 and 12 month timepoint due to incomplete monitor data, loss to follow-up, and participant withdraw
A fasting blood draw will be taken after 12-16 hours fast.
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.
|
|---|---|---|
|
Fasting Blood Glucose Over All Timepoints for 12 Months
Baseline
|
96.80 mg/dL
Standard Error 3.00
|
102.56 mg/dL
Standard Error 2.99
|
|
Fasting Blood Glucose Over All Timepoints for 12 Months
6-months
|
96.74 mg/dL
Standard Error 3.89
|
100.15 mg/dL
Standard Error 4.00
|
|
Fasting Blood Glucose Over All Timepoints for 12 Months
12-months
|
100.36 mg/dL
Standard Error 3.96
|
106.09 mg/dL
Standard Error 4.28
|
SECONDARY outcome
Timeframe: measured at baseline, 6 and 12 monthsPopulation: there were less participants with valid data at the 6 and 12 month timepoint due to incomplete monitor data, loss to follow-up, and participant withdraw
A fasting blood draw will be taken after 12-16 hours fast.
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.
|
|---|---|---|
|
HbA1c Over All Timepoints for 12 Months
Baseline
|
5.42 percentage
Standard Error 0.10
|
5.63 percentage
Standard Error 0.10
|
|
HbA1c Over All Timepoints for 12 Months
6-months
|
5.52 percentage
Standard Error 0.10
|
5.60 percentage
Standard Error 0.11
|
|
HbA1c Over All Timepoints for 12 Months
12-months
|
5.61 percentage
Standard Error 0.10
|
5.82 percentage
Standard Error 0.11
|
SECONDARY outcome
Timeframe: measured at baseline, 6 and 12 monthsPopulation: there were less participants with valid data at the 6 and 12 month timepoint due to incomplete monitor data, loss to follow-up, and participant withdraw
A fasting blood draw will be taken after 12-16 hours fast.
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.
|
|---|---|---|
|
LDL Cholesterol Over All Timepoints for 12 Months
Baseline
|
116.52 mg/dL
Standard Error 8.39
|
119.66 mg/dL
Standard Error 8.54
|
|
LDL Cholesterol Over All Timepoints for 12 Months
6-months
|
119.07 mg/dL
Standard Error 8.24
|
115.90 mg/dL
Standard Error 8.56
|
|
LDL Cholesterol Over All Timepoints for 12 Months
12-months
|
118.23 mg/dL
Standard Error 8.93
|
123.07 mg/dL
Standard Error 9.49
|
SECONDARY outcome
Timeframe: measured at baseline, 6 and 12 monthsPopulation: there were less participants with valid data at the 6 and 12 month timepoint due to incomplete monitor data, loss to follow-up, and participant withdraw
A fasting blood draw will be taken after 12-16 hours fast.
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.
|
|---|---|---|
|
HDL Cholesterol Over All Timepoints for 12 Months
Baseline
|
54.70 mg/dL
Standard Error 2.77
|
53.04 mg/dL
Standard Error 2.77
|
|
HDL Cholesterol Over All Timepoints for 12 Months
6-months
|
55.01 mg/dL
Standard Error 2.71
|
53.83 mg/dL
Standard Error 2.73
|
|
HDL Cholesterol Over All Timepoints for 12 Months
12-months
|
51.78 mg/dL
Standard Error 2.38
|
51.41 mg/dL
Standard Error 2.47
|
SECONDARY outcome
Timeframe: measured at baseline, 6 and 12 monthsPopulation: there were less participants with valid data at the 6 and 12 month timepoint due to incomplete monitor data, loss to follow-up, and participant withdraw
EuroQAL Visual Analogue Scale (EQ-VAS)-Self-reported perception of health on a 0 (lowest possible) to 100 (highest possible) scale.
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.
|
|---|---|---|
|
Perceived Health Score Over All Timepoints for 12 Months
Baseline
|
71.23 score on a scale
Standard Error 2.79
|
72.15 score on a scale
Standard Error 2.79
|
|
Perceived Health Score Over All Timepoints for 12 Months
6-months
|
68.05 score on a scale
Standard Error 3.22
|
72.28 score on a scale
Standard Error 3.24
|
|
Perceived Health Score Over All Timepoints for 12 Months
12-months
|
71.95 score on a scale
Standard Error 2.97
|
72.92 score on a scale
Standard Error 2.98
|
SECONDARY outcome
Timeframe: measured at baseline, 6 and 12 monthsPopulation: there were less participants with valid data at the 6 and 12 month timepoint due to incomplete monitor data, loss to follow-up, and participant withdraw
A fasting blood draw will be taken after 12-16 hours fast.
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.
|
|---|---|---|
|
Insulin Over All Timepoints for 12 Months
Baseline
|
14.27 IU
Standard Error 2.21
|
15.52 IU
Standard Error 2.28
|
|
Insulin Over All Timepoints for 12 Months
6-months
|
12.79 IU
Standard Error 1.70
|
14.47 IU
Standard Error 1.75
|
|
Insulin Over All Timepoints for 12 Months
12-months
|
15.95 IU
Standard Error 2.72
|
17.83 IU
Standard Error 3.17
|
SECONDARY outcome
Timeframe: measured at baseline, 6 and 12 monthsPopulation: there were less participants with valid data at the 6 and 12 month timepoint due to incomplete monitor data, loss to follow-up, and participant withdraw
A fasting blood draw will be taken after 12-16 hours fast.
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.
|
|---|---|---|
|
Triglycerides Over All Timepoints for 12 Months
Baseline
|
128.85 mg/dL
Standard Error 16.68
|
162.16 mg/dL
Standard Error 16.63
|
|
Triglycerides Over All Timepoints for 12 Months
6-months
|
139.81 mg/dL
Standard Error 17.22
|
146.89 mg/dL
Standard Error 17.33
|
|
Triglycerides Over All Timepoints for 12 Months
12-months
|
146.28 mg/dL
Standard Error 17.46
|
166.11 mg/dL
Standard Error 18.25
|
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place