Clinical trial NCT03096002: Small Steps for Big Changes: A Lifestyle Program to Reduce the Risk of Developing Type 2 Diabetes
Official title: Small Steps for Big Changes: A Lifestyle Program to Reduce the Risk of Developing Type 2 Diabetes in the Community
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: PreDiabetes
Keywords: PreDiabetes, Lifestyle intervention, Exercise Behavior, Adherence
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2017-03-30
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We aim to recruit a community-based sample of adults living with prediabetes.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: minutes of moderate to vigorous physical activity
timeFrame: change from before participants begin the program to 52 weeks after they finish the program for 7 consecutive days
measure: independent bouts of physical activity
timeFrame: change from when participants begin the program to 52 weeks after they finish the program
Secondary outcomes:
measure: glucose control
timeFrame: change from when participants begin the program to 52 weeks after they finish the program (week 55)
measure: Aerobic fitness
timeFrame: 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)
measure: Perceived health-related quality-of-life
timeFrame: 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)
measure: Self-regulatory efficacy for physical activity and diet
timeFrame: 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)
measure: minutes of moderate to vigorous physical activity
timeFrame: 24 weeks after program completion (week 27) for 7 consecutive days
measure: independent bouts of physical activity
timeFrame: 4- (week 7) and 24-weeks (week 27) after completion of the program
Other outcomes:
measure: blood pressure
timeFrame: 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)
measure: weight
timeFrame: 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)
measure: waist circumference
timeFrame: 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)
measure: reach
timeFrame: before the program begins (week 0)
measure: dietary adherence
timeFrame: 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)
Locations:
city: Kelowna
country: Canada
facility: YMCA of Okanagan
state: British Columbia
Study officials:
References: