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

University of British Columbia

Status: Unknown

Conditions: PreDiabetes

Treatments: Behavioral: Lifestyle change

Study type: Observational

Funder types: Other

Identifiers

NCT03096002

H16-02028

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

500 participants in 1 patient group

Lifestyle change (one-treatment group)

Description:

The lifestyle change program is a 3-week program that will introduce participants to a regular healthy lifestyle that includes exercising at least three times per week and the program will highlight simple dietary strategies. There is no randomization to this program - all individuals enrolled will partake in the same program and will be followed up for 12 months after the program has concluded.

Treatment:

Behavioral: Lifestyle change