Small Steps for Big Changes: A Lifestyle Program to Reduce the Risk of Developing Type 2 Diabetes

PreDiabetes Clinical Trial

Official title:

Small Steps for Big Changes: A Lifestyle Program to Reduce the Risk of Developing Type 2 Diabetes in the Community

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03096002
• Other study ID #: H16-02028
• Status: Recruiting
• Start date: June 12, 2017
• Est. completion date: April 2019

Study information

• Verified date: May 2018
• Source: University of British Columbia
• Contact: Mary E Jung, Ph.D.
• Phone: 250 807 9670
• Email: mary.jung[@]ubc.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to address whether inactive individuals with prediabetes who take part in the Small Steps for Big Changes program, which is a 3-week supervised exercise and lifestyle change program with brief counseling, will be more adherent to regular exercise one year after program completion compared to before they took part in the program.

Description:

The study is a one-group repeated measures design and the primary outcome is exercise adherence at 12 months post the 3-week supervised exercise program. There is no randomization of individuals to conditions. Exercise adherence will be measured using self-report physical activity (using the Godin leisure time exercise questionnaire) and a subsample will also wear tri-axial accelerometers to measure total time spent in moderate-to-vigorous physical activity assessed over 7 days. Secondary outcomes include physical fitness, haemoglobin A1C, quality of life, self-regulatory efficacy, anthropometrics, diet and exercise-related cognitive errors.

The 3-week lifestyle program includes six sessions with a lifestyle coach and exercise sessions performed at home. These sessions will focus on regular healthy lifestyle that includes walking (or exercise of any kind) at least three times per week and will highlight simple dietary strategies that are linked to reduced risk of T2D. The 3-week supervised exercise program includes brief exercise counseling sessions that teach participants self-regulatory skills to promote independence and long-term adherence to exercise and a healthy diet. At the conclusion of the three-week program, participants will be asked to continue exercising a minimum of three times per week for twelve months on their own.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• ability to speak and read English

• BMI between 25-40 kg/m2 (as measured by body mass and height self-reporting),

• blood pressure of <160/99 mm Hg assessed according to CHEP guidelines,

• not diagnosed with type 2 diabetes

• no prior history of cardiovascular disease

• not on hormone replacement therapy

• Cardiovascular medications (e.g., statins) will be allowed if the participant is on stable therapy (6 months on same dose).

Exclusion Criteria, if subjects:

• take glucose-lowering medications that have changed within the past 6 months;

• report any explicit contraindications to exercise (e.g., musculoskeletal injury, chest pain during exercise)

• report having had a heart attack or stroke in the past;

• report that they are pregnant or plan on becoming pregnant over the next 12 months;

• have uncontrolled major depression;

• have bone or joint problem (for example, back, knee, or hip) that could be made worse by a change in physical activity which a physician has not cleared them for to exercise;

• report that a physician has not cleared their participant for exercise.

Related Conditions & MeSH terms

• Glucose Intolerance
• PreDiabetes
• Prediabetic State

Intervention

Behavioral:
• Lifestyle change
The 3-week lifestyle change program will introduce participants to a regular healthy lifestyle including exercise and dietary changes for reducing sugar intake, reducing refined/processed carbohydrate intake, increasing vegetable consumption. The 3-week program will include six supervised exercise sessions and three exercise sessions performed independently (e.g., at home or outside of the lab). The supervised session will include brief behavioral counseling sessions that teach participants self-regulatory skills to promote independence and long-term adherence to exercising and dietary changes.

Locations

Country	Name	City	State
Canada	YMCA of Okanagan	Kelowna	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	blood pressure	mean arterial blood pressure assessed manually	before the program begins (week 0), after the program is completed (week 3), 24 weeks after completion of the program (week 27), and 52 weeks after completion of the program (week 55)
Other	weight	body weight assessed by objective scale	before the program begins (week 0), after the program is completed (week 3), 24 weeks after completion of the program (week 27), and 52 weeks after completion of the program (week 55)
Other	waist circumference	circumference of the waist assessed manually	before the program begins (week 0), after the program is completed (week 3), 24 weeks after completion of the program (week 27), and 52 weeks after completion of the program (week 55)
Other	reach	reach of the program as assessed by RE-AIM	before the program begins (week 0)
Other	dietary adherence	brief food frequency questionnaire	before the program begins (week 0), 24 weeks after completion of the program (week 27), and 52 weeks after completion of the program (week 55)
Primary	minutes of moderate to vigorous physical activity	objective measure of physical activity will be measured using tri-axial accelerometers in a subsample of ~100 participants	change from before participants begin the program to 52 weeks after they finish the program for 7 consecutive days
Primary	independent bouts of physical activity	self-reported measure of bouts of physical activity as assessed by the Godin Leisure Time Exercise Questionnaire	change from when participants begin the program to 52 weeks after they finish the program
Secondary	glucose control	haemoglobin A1C	change from when participants begin the program to 52 weeks after they finish the program (week 55)
Secondary	Aerobic fitness	six-minute walk test	before the program begins (week 0), after the program is completed (week 3), 24 weeks after completion of the program (week 27), and 52 weeks after completion of the program (week 55)
Secondary	Perceived health-related quality-of-life	SF-12 Health Survey (Ware, Kosinski, & Keller, 1995)	before the program begins (week 0), 24 weeks after completion of the program (week 27), and 52 weeks after completion of the program (week 55)
Secondary	Self-regulatory efficacy for physical activity and diet	questionnaire	before the program begins (week 0), after the program is completed (week 3), 4-weeks after the completion of the program (week 7), 24 weeks after completion of the program (week 27), and 52 weeks after completion of the program (week 55)
Secondary	minutes of moderate to vigorous physical activity	objective measure of physical activity will be measured using tri-axial accelerometers in a subsample of ~100 participants	24 weeks after program completion (week 27) for 7 consecutive days
Secondary	independent bouts of physical activity	self-reported measure of bouts of physical activity as assessed by the Godin Leisure Time Exercise Questionnaire	4- (week 7) and 24-weeks (week 27) after completion of the program