Impact of Structured Physical Activity Education Delivery... | NCT02093702

NCT02093702

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Unstructured Physical Activity and Exercise Education Delivery	Active Comparator	50 subjects will receive the standard approach to physical activity and exercise education from a Certified Diabetes Educator.	Behavioral: Unstructured Physical Activity and Exercise Education
Structured Physical Activity and Exercise Education Delivery	Experimental	50 subjects will receive physical activity and exercise education and behaviour counseling from a qualified Exercise Specialist (Registered Kinesiologist). These subjects will receive access to a community health and fitness centre as well as exercise instruction and on-going support and motivation from a YMCA Wellness Coach who focuses on establishing healthy behaviors towards the attainment of personal goals. Subjects will be requested to complete a lifestyle questionnaire at each appointment with their Wellness Coach. Subjects will receive a Physical Activity and Exercise Journal that will help them keep track of their weekly physical activity and exercise activities.	Behavioral: Physical activity and exercise education and behaviour counseling from a Registered Kinesiologist and a YMCA Wellness Coach

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Physical activity and exercise education and behaviour counseling from a Registered Kinesiologist and a YMCA Wellness Coach	Behavioral		Structured Physical Activity and Exercise Education Delivery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Change in Hemoglobin A1c (HbA1c) Levels		Baseline and 12 months
Mean Change in Systolic Blood Pressure		Baseline and 12 months
Mean Change in Waist Circumference		Baseline and 12 months
Mean Change in Body Mass Index		Baseline and 12 months
Mean Change in Serum Total Cholesterol		Baseline and 12 months
Mean Change in HDL-C		Baseline and 12 months
Mean Change in LDL-C		Baseline and 12 months
Mean Change in Triglycerides (TGs)		Baseline and 12 months
Mean Change in Total Cholesterol: HDL-C Ratio		Baseline and 12 months
Mean Change in Diastolic Blood Pressure		Baseline and 12 months

Secondary Outcomes

Measure	Description	Time Frame
Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Aerobic Exercise Recommendations	The Canadian Diabetes Association's Clinical Practice Guidelines recommends at least 150 minutes per week of aerobic exercise.	Baseline and 12 months
Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Resistance Exercise Recommendations

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Dr. Andrew Wozniak, MD, CCFP	Barrie and Community Family Health Team	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Barrie and Community Family Health Team Diabetes Program		Barrie	Ontario	L4M 6L2	Canada

References Module

Citations

PubMed Identifier	Type	Citation
	Background	J.R. Fowles, C. Shields, R.J.L. Murphy and P Dunbar. Developing Competency in Diabetes Education Volume 3: Physical Activity and Exercise Professional Resource Manual. The Canadian Diabetes Association. 2012. Toronto, Ontario. 110 pages.
24070961	Background	Canadian Diabetes Association Clinical Practice Guidelines Expert Committee; Booth G, Cheng AY. Canadian Diabetes Association 2013 clinical practice guidelines for the prevention and management of diabetes in Canada. Methods. Can J Diabetes. 2013 Apr;37 Suppl 1:S4-7. doi: 10.1016/j.jcjd.2013.01.010. Epub 2013 Mar 26. No abstract available.
17192512

Label	URL
YMCA Wellness Coaching	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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).
FG001	Structured PA Education Program for People With T2DM

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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).
BG001	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.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG0002 BG0013 BG0025

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	OG0000.001(0.0007 to 0.0013) OG001-0.007(-0.0073 to -0.0067)

Primary

Mean Change in Systolic Blood Pressure

Posted

Mean

Full Range

mm Hg

Baseline and 12 months

ID	Title	Description
OG000	Standard PA Education for People With T2DM (From a CDE)	Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
OG001	Structured PA Education Program for People With T2DM	Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.

Units	Counts
Participants	OG000

Primary

Mean Change in Waist Circumference

Posted

Mean

Full Range

Baseline and 12 months

ID	Title	Description
OG000	Standard PA Education for People With T2DM (From a CDE)	Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
OG001	Structured PA Education Program for People With T2DM	Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach. .

Units	Counts
Participants	OG000

Primary

Mean Change in Body Mass Index

Posted

Mean

Full Range

kg/m^2

Baseline and 12 months

ID	Title	Description
OG000	Standard PA Education for People With T2DM (From a CDE)	Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
OG001	Structured PA Education Program for People With T2DM	Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.

Units	Counts
Participants	OG000

Primary

Mean Change in Serum Total Cholesterol

Posted

Mean

Full Range

mmol/L

Baseline and 12 months

ID	Title	Description
OG000	Standard PA Education for People With T2DM (From a CDE)	Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
OG001	Structured PA Education Program for People With T2DM	Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.

Units	Counts
Participants	OG000

Primary

Mean Change in HDL-C

Posted

Mean

Full Range

mmol/L

Baseline and 12 months

ID	Title	Description
OG000	Standard PA Education for People With T2DM (From a CDE)	Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
OG001	Structured PA Education Program for People With T2DM	Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.

Units	Counts
Participants	OG000

Primary

Mean Change in LDL-C

Posted

Mean

Full Range

mmol/L

Baseline and 12 months

ID	Title	Description
OG000	Standard PA Education for People With T2DM (From a CDE)	Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
OG001	Structured PA Education Program for People With T2DM	Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.

Units	Counts
Participants	OG000

Primary

Mean Change in Triglycerides (TGs)

Posted

Mean

Full Range

mmol/L

Baseline and 12 months

ID	Title	Description
OG000	Standard PA Education for People With T2DM (From a CDE)	Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
OG001	Structured PA Education Program for People With T2DM	Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.

Units	Counts
Participants	OG000

Primary

Mean Change in Total Cholesterol: HDL-C Ratio

Posted

Mean

Full Range

mmol/L:mmol/L

Baseline and 12 months

ID	Title	Description
OG000	Standard PA Education for People With T2DM (From a CDE)	Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
OG001	Structured PA Education Program for People With T2DM	Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.

Units	Counts
Participants	OG000

Primary

Mean Change in Diastolic Blood Pressure

Posted

Mean

Full Range

mm Hg

Baseline and 12 months

ID	Title	Description
OG000	Standard PA Education for People With T2DM (From a CDE)	Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
OG001	Structured PA Education Program for People With T2DM	Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.

Units	Counts
Participants	OG000

Secondary

Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Aerobic Exercise Recommendations

The Canadian Diabetes Association's Clinical Practice Guidelines recommends at least 150 minutes per week of aerobic exercise.

Posted

Mean

Full Range

minutes/week

Baseline and 12 months

ID	Title	Description
OG000	Standard PA Education for People With T2DM (From a CDE)	Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
OG001	Structured PA Education Program for People With T2DM	Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.

Units	Counts
Participants	OG000

Secondary

Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Resistance Exercise Recommendations

The Canadian Diabetes Association's Clinical Practice Guidelines recommends at least 2 sessions per week of resistance exercise.

Posted

Mean

Full Range

sessions/week

Baseline and 12 months

ID	Title	Description
OG000	Standard PA Education for People With T2DM (From a CDE)	Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
OG001	Structured PA Education Program for People With T2DM	Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Structured PA Education Program for People With T2DM	Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.			0	0	0	0
EG001	Standard PA Education for People With T2DM (From a CDE)	Group of subjects receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).			0	0	0	0

ID	Term
D003924	Diabetes Mellitus, Type 2

ID	Term
D015444	Exercise

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena