Trial Outcomes & Findings for Targeting Physical Activity to Improve Cardiovascular Health in Type 2 Diabetes (NCT NCT02473926)
NCT ID: NCT02473926
Last Updated: 2023-08-21
Results Overview
ActiGraph accelerometer measures physical activity objectively as steps/week. These data are presented as the change from baseline values.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
55 participants
Primary outcome timeframe
Baseline, 4 Months
Results posted on
2023-08-21
Participant Flow
A total of 55 people were determined to be eligible for this study, however 5 of them withdrew prior to randomization. This explains the discrepancy between Protocol section (n=55) and Participant Flow Module (n=50).
Participant milestones
| Measure |
Physical Activity Program Intervention
The intervention seeks to increase physical activity and improve strength by addressing individual , behavioral, and social/environmental factors. Health promotion clinic staff will deliver counseling by phone on a bi-weekly basis - a clinic physician assistant will coordinate with the counselor during in-person clinic visits, teach participants to perform strengthening exercise, and assess for safety concerns associated with type 2 diabetes.
In addition to behavioral counseling targeting social cognitive theory constructs, counselors will assist participants in the intervention group to set specific goals for physical activity in a paper log and on an electronic FitBit activity tracking device.Health promotion clinic staff will encourage participants to advance goals towards meeting U.S. physical activity guidelines of 150 minutes/week of moderate intensity activity and 2-3 days/week of strength activities.
Physical Activity: Physical Activity Program Intervention
|
Usual Care Group
Participants in the usual care arm will receive three mailings (Intervention Questionnaires) during the intervention phase. Health promotion clinic staff will mail materials from the Center for Disease Control and Prevention website that address general health aging topics.
Questionnaires: Participants in the usual care arm will receive three mailings during the intervention phase.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
22
|
|
Overall Study
COMPLETED
|
25
|
22
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Targeting Physical Activity to Improve Cardiovascular Health in Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Physical Activity Program Intervention
n=28 Participants
The intervention seeks to increase physical activity and improve strength by addressing individual , behavioral, and social/environmental factors. Health promotion clinic staff will deliver counseling by phone on a bi-weekly basis - a clinic physician assistant will coordinate with the counselor during in-person clinic visits, teach participants to perform strengthening exercise, and assess for safety concerns associated with type 2 diabetes.
In addition to behavioral counseling targeting social cognitive theory constructs, counselors will assist participants in the intervention group to set specific goals for physical activity in a paper log and on an electronic FitBit activity tracking device.Health promotion clinic staff will encourage participants to advance goals towards meeting U.S. physical activity guidelines of 150 minutes/week of moderate intensity activity and 2-3 days/week of strength activities.
Physical Activity: Physical Activity Program Intervention
|
Usual Care Group
n=22 Participants
Participants in the usual care arm will receive three mailings (Intervention Questionnaires) during the intervention phase. Health promotion clinic staff will mail materials from the Center for Disease Control and Prevention website that address general health aging topics.
Questionnaires: Participants in the usual care arm will receive three mailings during the intervention phase.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.5 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
66.5 years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
66.5 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Alaskan Native/Native American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
22 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Weight (kg)
|
92.0 kilograms
STANDARD_DEVIATION 21.4 • n=5 Participants
|
90.6 kilograms
STANDARD_DEVIATION 21.7 • n=7 Participants
|
91.2 kilograms
STANDARD_DEVIATION 47.0 • n=5 Participants
|
|
Body Mass Index (kg/m^2)
|
32.8 kg/m^2
STANDARD_DEVIATION 6.0 • n=5 Participants
|
31.6 kg/m^2
STANDARD_DEVIATION 6.7 • n=7 Participants
|
32.1 kg/m^2
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
Hemoglobin A1c (%)
|
6.9 percent
STANDARD_DEVIATION 1.3 • n=5 Participants
|
6.7 percent
STANDARD_DEVIATION 0.8 • n=7 Participants
|
6.8 percent
STANDARD_DEVIATION 1.1 • n=5 Participants
|
|
Systolic Blood Pressure (mm/Hg)
|
128.1 mm/Hg
STANDARD_DEVIATION 9.4 • n=5 Participants
|
125.6 mm/Hg
STANDARD_DEVIATION 10.5 • n=7 Participants
|
127.0 mm/Hg
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Diastolic Blood Pressure (mm/Hg)
|
83.6 mm/Hg
STANDARD_DEVIATION 8.6 • n=5 Participants
|
80.0 mm/Hg
STANDARD_DEVIATION 8.1 • n=7 Participants
|
82.0 mm/Hg
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Baseline fitness level (VO2peak, ml/kg/min)
|
18.5 ml/kg/min
STANDARD_DEVIATION 4.7 • n=5 Participants
|
18.3 ml/kg/min
STANDARD_DEVIATION 3.0 • n=7 Participants
|
18.4 ml/kg/min
STANDARD_DEVIATION 4.4 • n=5 Participants
|
|
Depressive symptoms by Center for Epidemiologic Studies Depression Scale (CES-D)
|
10.3 points
STANDARD_DEVIATION 8.3 • n=5 Participants
|
10.2 points
STANDARD_DEVIATION 8.3 • n=7 Participants
|
10.2 points
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Endurance Confidence Survey
|
695.0 points
STANDARD_DEVIATION 372.7 • n=5 Participants
|
584.1 points
STANDARD_DEVIATION 288.9 • n=7 Participants
|
682.8 points
STANDARD_DEVIATION 345.8 • n=5 Participants
|
|
Confidence: Motivation to conduct physical activity(PA) amidst competing demands
|
41.2 points
STANDARD_DEVIATION 9.8 • n=5 Participants
|
43.8 points
STANDARD_DEVIATION 8.6 • n=7 Participants
|
41.7 points
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Confidence: Self-efficacy for physical activity in presence of diabetes
|
592.1 points
STANDARD_DEVIATION 158.6 • n=5 Participants
|
587.3 points
STANDARD_DEVIATION 183.2 • n=7 Participants
|
588.8 points
STANDARD_DEVIATION 153.2 • n=5 Participants
|
|
% participants with baseline functional impairment
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 MonthsActiGraph accelerometer measures physical activity objectively as steps/week. These data are presented as the change from baseline values.
Outcome measures
| Measure |
Physical Activity Program Intervention
n=25 Participants
The intervention seeks to increase physical activity and improve strength by addressing individual , behavioral, and social/environmental factors. Health promotion clinic staff will deliver counseling by phone on a bi-weekly basis - a clinic physician assistant will coordinate with the counselor during in-person clinic visits, teach participants to perform strengthening exercise, and assess for safety concerns associated with type 2 diabetes.
In addition to behavioral counseling targeting social cognitive theory constructs, counselors will assist participants in the intervention group to set specific goals for physical activity in a paper log and on an electronic FitBit activity tracking device.Health promotion clinic staff will encourage participants to advance goals towards meeting U.S. physical activity guidelines of 150 minutes/week of moderate intensity activity and 2-3 days/week of strength activities.
Physical Activity: Physical Activity Program Intervention
|
Usual Care Group
n=21 Participants
Participants in the usual care arm will receive three mailings (Intervention Questionnaires) during the intervention phase. Health promotion clinic staff will mail materials from the Center for Disease Control and Prevention website that address general health aging topics.
Questionnaires: Participants in the usual care arm will receive three mailings during the intervention phase.
|
|---|---|---|
|
Change From Baseline in Objective Physical Activity at 4 Months
|
3155 steps/week
Interval -2169.0 to 8478.0
|
1581 steps/week
Interval -5183.0 to 8344.0
|
SECONDARY outcome
Timeframe: Baseline, 4 MonthsMeasured via 400-meter rapid gait speed test. These data are presented as the change from baseline values, where decrease in numbers indicate a faster walking speed.
Outcome measures
| Measure |
Physical Activity Program Intervention
n=25 Participants
The intervention seeks to increase physical activity and improve strength by addressing individual , behavioral, and social/environmental factors. Health promotion clinic staff will deliver counseling by phone on a bi-weekly basis - a clinic physician assistant will coordinate with the counselor during in-person clinic visits, teach participants to perform strengthening exercise, and assess for safety concerns associated with type 2 diabetes.
In addition to behavioral counseling targeting social cognitive theory constructs, counselors will assist participants in the intervention group to set specific goals for physical activity in a paper log and on an electronic FitBit activity tracking device.Health promotion clinic staff will encourage participants to advance goals towards meeting U.S. physical activity guidelines of 150 minutes/week of moderate intensity activity and 2-3 days/week of strength activities.
Physical Activity: Physical Activity Program Intervention
|
Usual Care Group
n=22 Participants
Participants in the usual care arm will receive three mailings (Intervention Questionnaires) during the intervention phase. Health promotion clinic staff will mail materials from the Center for Disease Control and Prevention website that address general health aging topics.
Questionnaires: Participants in the usual care arm will receive three mailings during the intervention phase.
|
|---|---|---|
|
Change From Baseline in Physical Function at 4 Months
|
-23.4 seconds
Interval -46.5 to -0.3
|
7.3 seconds
Interval -17.6 to 32.3
|
SECONDARY outcome
Timeframe: Baseline, 4 MonthsMeasured via the Short Physical Performance Battery (SPPB), which evaluates balance, usual walking speed, and repeated chair rise. These data are presented as the change from baseline values where higher values indicate better physical function (scoring range 0-12).
Outcome measures
| Measure |
Physical Activity Program Intervention
n=25 Participants
The intervention seeks to increase physical activity and improve strength by addressing individual , behavioral, and social/environmental factors. Health promotion clinic staff will deliver counseling by phone on a bi-weekly basis - a clinic physician assistant will coordinate with the counselor during in-person clinic visits, teach participants to perform strengthening exercise, and assess for safety concerns associated with type 2 diabetes.
In addition to behavioral counseling targeting social cognitive theory constructs, counselors will assist participants in the intervention group to set specific goals for physical activity in a paper log and on an electronic FitBit activity tracking device.Health promotion clinic staff will encourage participants to advance goals towards meeting U.S. physical activity guidelines of 150 minutes/week of moderate intensity activity and 2-3 days/week of strength activities.
Physical Activity: Physical Activity Program Intervention
|
Usual Care Group
n=22 Participants
Participants in the usual care arm will receive three mailings (Intervention Questionnaires) during the intervention phase. Health promotion clinic staff will mail materials from the Center for Disease Control and Prevention website that address general health aging topics.
Questionnaires: Participants in the usual care arm will receive three mailings during the intervention phase.
|
|---|---|---|
|
Change From Baseline in Physical Function at 4 Months
|
0.9 units on a scale
Interval 0.1 to 1.8
|
-0.1 units on a scale
Interval -0.6 to 0.4
|
Adverse Events
Physical Activity Program Intervention
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Usual Care 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
| Measure |
Physical Activity Program Intervention
n=28 participants at risk
The intervention seeks to increase physical activity and improve strength by addressing individual , behavioral, and social/environmental factors. Health promotion clinic staff will deliver counseling by phone on a bi-weekly basis - a clinic physician assistant will coordinate with the counselor during in-person clinic visits, teach participants to perform strengthening exercise, and assess for safety concerns associated with type 2 diabetes.
In addition to behavioral counseling targeting social cognitive theory constructs, counselors will assist participants in the intervention group to set specific goals for physical activity in a paper log and on an electronic FitBit activity tracking device.Health promotion clinic staff will encourage participants to advance goals towards meeting U.S. physical activity guidelines of 150 minutes/week of moderate intensity activity and 2-3 days/week of strength activities.
Physical Activity: Physical Activity Program Intervention
|
Usual Care Group
n=22 participants at risk
Participants in the usual care arm will receive three mailings (Intervention Questionnaires) during the intervention phase. Health promotion clinic staff will mail materials from the Center for Disease Control and Prevention website that address general health aging topics.
Questionnaires: Participants in the usual care arm will receive three mailings during the intervention phase.
|
|---|---|---|
|
Psychiatric disorders
Unrelated Medical Issue
|
3.6%
1/28 • Number of events 1 • 6 months
|
0.00%
0/22 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Unrelated Medical Issue
|
3.6%
1/28 • Number of events 1 • 6 months
|
0.00%
0/22 • 6 months
|
Additional Information
Dr. Amy Huebschmann
University of Colorado - Anschutz Medical Campus
Phone: 3037242268
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place