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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03096002
Recruitment Status : Recruiting
First Posted : March 30, 2017
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
Mary Jung, University of British Columbia

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.

Condition or disease Intervention/treatment
PreDiabetes Behavioral: Lifestyle change

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Small Steps for Big Changes: A Lifestyle Program to Reduce the Risk of Developing Type 2 Diabetes in the Community
Actual Study Start Date : June 12, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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.




Primary Outcome Measures :
  1. minutes of moderate to vigorous physical activity [ Time Frame: change from before participants begin the program to 52 weeks after they finish the program for 7 consecutive days ]
    objective measure of physical activity will be measured using tri-axial accelerometers in a subsample of ~100 participants

  2. independent bouts of physical activity [ Time Frame: change from when participants begin the program to 52 weeks after they finish the program ]
    self-reported measure of bouts of physical activity as assessed by the Godin Leisure Time Exercise Questionnaire


Secondary Outcome Measures :
  1. glucose control [ Time Frame: change from when participants begin the program to 52 weeks after they finish the program (week 55) ]
    haemoglobin A1C

  2. Aerobic fitness [ Time Frame: 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) ]
    six-minute walk test

  3. Perceived health-related quality-of-life [ Time Frame: 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) ]
    SF-12 Health Survey (Ware, Kosinski, & Keller, 1995)

  4. Self-regulatory efficacy for physical activity and diet [ Time Frame: 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) ]
    questionnaire

  5. minutes of moderate to vigorous physical activity [ Time Frame: 24 weeks after program completion (week 27) for 7 consecutive days ]
    objective measure of physical activity will be measured using tri-axial accelerometers in a subsample of ~100 participants

  6. independent bouts of physical activity [ Time Frame: 4- (week 7) and 24-weeks (week 27) after completion of the program ]
    self-reported measure of bouts of physical activity as assessed by the Godin Leisure Time Exercise Questionnaire


Other Outcome Measures:
  1. blood pressure [ Time Frame: 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) ]
    mean arterial blood pressure assessed manually

  2. weight [ Time Frame: 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) ]
    body weight assessed by objective scale

  3. waist circumference [ Time Frame: 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) ]
    circumference of the waist assessed manually

  4. reach [ Time Frame: before the program begins (week 0) ]
    reach of the program as assessed by RE-AIM

  5. dietary adherence [ Time Frame: 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) ]
    brief food frequency questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We aim to recruit a community-based sample of adults living with prediabetes.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03096002


Contacts
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Contact: Mary E Jung, Ph.D. 250 807 9670 mary.jung@ubc.ca
Contact: Jonathan P Little 250 807 9876 jonathan.little@ubc.ca

Locations
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Canada, British Columbia
YMCA of Okanagan Recruiting
Kelowna, British Columbia, Canada, V1X 2M9
Contact: Mary E Jung, PhD    250-807-8419    mary.jung@ubc.ca   
Principal Investigator: Mary E Jung, PhD         
Sponsors and Collaborators
University of British Columbia

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Responsible Party: Mary Jung, Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03096002    
Other Study ID Numbers: H16-02028
First Posted: March 30, 2017    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mary Jung, University of British Columbia:
PreDiabetes, Lifestyle intervention, Exercise Behavior, Adherence
Additional relevant MeSH terms:
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Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia