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

NCT03096002 | Unknown

• 1 other identifier: H16-02028
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

PreDiabetes

Keywords

PreDiabetes, Lifestyle intervention, Exercise Behavior, Adherence

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• glucose control

  change from when participants begin the program to 52 weeks after they finish the program (week 55)

• Aerobic fitness

  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)

• Perceived health-related quality-of-life

  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)

• Self-regulatory efficacy for physical activity and diet

  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)

• minutes of moderate to vigorous physical activity

  24 weeks after program completion (week 27) for 7 consecutive days

Other Outcomes (5)

• blood pressure

  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)

• weight

  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)

• waist circumference

  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)

Study Arms (1)

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.

Behavioral: Lifestyle change

Interventions

Lifestyle change 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.

Lifestyle change (one-treatment group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We aim to recruit a community-based sample of adults living with prediabetes.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

YMCA of Okanagan

Kelowna, British Columbia, V1X 2M9, Canada

RECRUITING

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Mary E Jung, Ph.D.

CONTACT

250 807 9670; mary.jung@ubc.ca

Jonathan P Little

CONTACT

250 807 9876; jonathan.little@ubc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: March 30, 2017
• Study Start: June 12, 2017
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: May 9, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)