Trial Outcomes & Findings for Impact of Structured Physical Activity Education Delivery in Patients With Type 2 Diabetes Mellitus (NCT NCT02093702)
NCT ID: NCT02093702
Last Updated: 2016-10-06
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
Baseline and 12 months
Results posted on
2016-10-06
Participant Flow
Participant milestones
| Measure |
Standard PA Education for People With T2DM (From a CDE)
Subjects in the control arm (n = 2) received the standard approach to PA education from a Canadian Certified Diabetes Educator (CDE).
|
Structured PA Education Program for People With T2DM
Subjects in the experimental arm (n = 3) participated in a structured PA education program for people with T2DM.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
|
Overall Study
COMPLETED
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Structured Physical Activity Education Delivery in Patients With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Standard PA Education for People With T2DM (From a CDE)
n=2 Participants
Subjects in the control arm (n = 2) received the standard approach to PA education from a Canadian Certified Diabetes Educator (CDE).
|
Structured PA Education Program for People With T2DM
n=3 Participants
Subjects in the experimental arm (n = 3) participated in a structured PA education program for people with T2DM.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsOutcome measures
| Measure |
Standard PA Education for People With T2DM (From a CDE)
n=2 Participants
Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
|
Structured PA Education Program for People With T2DM
n=3 Participants
Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
|
|---|---|---|
|
Mean Change in Hemoglobin A1c (HbA1c) Levels
|
0.001 mmol/mol
Interval 0.0007 to 0.0013
|
-0.007 mmol/mol
Interval -0.0073 to -0.0067
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsOutcome measures
| Measure |
Standard PA Education for People With T2DM (From a CDE)
n=2 Participants
Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
|
Structured PA Education Program for People With T2DM
n=3 Participants
Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
|
|---|---|---|
|
Mean Change in Systolic Blood Pressure
|
5.0 mm Hg
Interval 2.0 to 7.0
|
7 mm Hg
Interval 3.0 to 10.0
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsOutcome measures
| Measure |
Standard PA Education for People With T2DM (From a CDE)
n=2 Participants
Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
|
Structured PA Education Program for People With T2DM
n=3 Participants
Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
|
|---|---|---|
|
Mean Change in Waist Circumference
|
0.7 cm
Interval -1.5 to 3.7
|
-3.4 cm
Interval -4.8 to -2.0
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsOutcome measures
| Measure |
Standard PA Education for People With T2DM (From a CDE)
n=2 Participants
Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
|
Structured PA Education Program for People With T2DM
n=3 Participants
Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
|
|---|---|---|
|
Mean Change in Body Mass Index
|
0.6 kg/m^2
Interval -1.2 to 1.8
|
-2.0 kg/m^2
Interval -2.8 to -1.0
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsOutcome measures
| Measure |
Standard PA Education for People With T2DM (From a CDE)
n=2 Participants
Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
|
Structured PA Education Program for People With T2DM
n=3 Participants
Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
|
|---|---|---|
|
Mean Change in Serum Total Cholesterol
|
-0.75 mmol/L
Interval -0.87 to -0.62
|
-0.13 mmol/L
Interval -0.17 to -0.1
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsOutcome measures
| Measure |
Standard PA Education for People With T2DM (From a CDE)
n=2 Participants
Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
|
Structured PA Education Program for People With T2DM
n=3 Participants
Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
|
|---|---|---|
|
Mean Change in HDL-C
|
-0.03 mmol/L
Interval -0.05 to -0.01
|
0.08 mmol/L
Interval 0.06 to 0.09
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsOutcome measures
| Measure |
Standard PA Education for People With T2DM (From a CDE)
n=2 Participants
Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
|
Structured PA Education Program for People With T2DM
n=3 Participants
Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
|
|---|---|---|
|
Mean Change in LDL-C
|
-0.59 mmol/L
Interval -0.63 to -0.55
|
0.08 mmol/L
Interval 0.063 to 0.095
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsOutcome measures
| Measure |
Standard PA Education for People With T2DM (From a CDE)
n=2 Participants
Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
|
Structured PA Education Program for People With T2DM
n=3 Participants
Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
|
|---|---|---|
|
Mean Change in Triglycerides (TGs)
|
-0.28 mmol/L
Interval -0.46 to -0.1
|
-0.63 mmol/L
Interval -0.71 to -0.57
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsOutcome measures
| Measure |
Standard PA Education for People With T2DM (From a CDE)
n=2 Participants
Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
|
Structured PA Education Program for People With T2DM
n=3 Participants
Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
|
|---|---|---|
|
Mean Change in Total Cholesterol: HDL-C Ratio
|
-0.7 mmol/L:mmol/L
Interval -0.87 to -0.53
|
-0.4 mmol/L:mmol/L
Interval -0.5 to -0.3
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsOutcome measures
| Measure |
Standard PA Education for People With T2DM (From a CDE)
n=2 Participants
Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
|
Structured PA Education Program for People With T2DM
n=3 Participants
Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
|
|---|---|---|
|
Mean Change in Diastolic Blood Pressure
|
5 mm Hg
Interval 4.0 to 6.0
|
2 mm Hg
Interval -1.0 to 4.0
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsThe Canadian Diabetes Association's Clinical Practice Guidelines recommends at least 150 minutes per week of aerobic exercise.
Outcome measures
| Measure |
Standard PA Education for People With T2DM (From a CDE)
n=2 Participants
Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
|
Structured PA Education Program for People With T2DM
n=3 Participants
Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
|
|---|---|---|
|
Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Aerobic Exercise Recommendations
|
58 minutes/week
Interval 20.0 to 96.0
|
26 minutes/week
Interval 10.0 to 55.0
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsThe Canadian Diabetes Association's Clinical Practice Guidelines recommends at least 2 sessions per week of resistance exercise.
Outcome measures
| Measure |
Standard PA Education for People With T2DM (From a CDE)
n=2 Participants
Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
|
Structured PA Education Program for People With T2DM
n=3 Participants
Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
|
|---|---|---|
|
Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Resistance Exercise Recommendations
|
0 sessions/week
Interval -0.6 to 0.6
|
0.7 sessions/week
Interval 0.5 to 1.1
|
Adverse Events
Structured PA Education Program for People With T2DM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard PA Education for People With T2DM (From a CDE)
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
Dr. Andrew Wozniak
Barrie and Community Family Health Team
Phone: (705) 728-2618
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place