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

NCT ID: NCT03096002

Last Updated: 2018-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-12
• Study Completion Date: 2019-04-30

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.

Conditions

PreDiabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Lifestyle change (one-treatment group)

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.

Lifestyle change

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Mary Jung

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

YMCA of Okanagan

Kelowna, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Mary E Jung, Ph.D.

Role: CONTACT

mary.jung@ubc.ca

250 807 9670

Jonathan P Little

Role: CONTACT

jonathan.little@ubc.ca

250 807 9876

Facility Contacts

Mary E Jung, PhD

Role: primary

mary.jung@ubc.ca

250-807-8419

Other Identifiers

H16-02028

Identifier Type: -

Identifier Source: org_study_id