PreDiabetesNCT03096002
Small Steps for Big Changes: A Lifestyle Program to Reduce the Risk of Developing Type 2 Diabetes
An observational study of PreDiabetes, run by University of British Columbia at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Lifestyle change
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- 12 Jun 2017to Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We aim to recruit a community-based sample of adults living with prediabetes.
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
YMCA of Okanagan
Kelowna, British Columbia, V1X 2M9
Mary E Jung, PhD, 250-807-8419, mary.jung@ubc.ca
Mary E Jung, PhD
About this study
Official title: Small Steps for Big Changes: A Lifestyle Program to Reduce the Risk of Developing Type 2 Diabetes in the Community
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.
Read the 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
- Being tested
- Lifestyle change
- Keywords
- PreDiabetes, Lifestyle intervention, Exercise Behavior, Adherence
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle changeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Lifestyle change |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: change from when participants begin the program to 52 weeks after they finish the program
Secondary outcomes (6)
glucose control
haemoglobin A1C
Measured: change from when participants begin the program to 52 weeks after they finish the program (week 55)
Aerobic fitness
six-minute walk test
Measured: 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
SF-12 Health Survey (Ware, Kosinski, \& Keller, 1995)
Measured: 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
questionnaire
Measured: 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
objective measure of physical activity will be measured using tri-axial accelerometers in a subsample of ~100 participants
Measured: 24 weeks after program completion (week 27) 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
Measured: 4- (week 7) and 24-weeks (week 27) after completion of the program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start12 Jun 2017
- Primary completionApr 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Jung, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096002
- Sponsor's protocol ID
- H16-02028
- Status last verified
- May 2018
- First submitted
- 15 Mar 2017
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Steps for Big Changes: A Lifestyle Program to Reduce the Risk of Developing Type 2 Diabetes in the Community
- ClinicalTrials.gov ID
- NCT03096002
- Acronym / sponsor ID
- H16-02028
- Conditions
- PreDiabetes
- Keywords
- PreDiabetes, Lifestyle intervention, Exercise Behavior, Adherence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 30 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle change (one-treatment group) | – | Behavioral: Lifestyle changeThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We aim to recruit a community-based sample of adults living with prediabetes.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle changeThe 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. | Behavioural | Lifestyle change (one-treatment group) |
Primary outcome
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
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
6 secondary outcomes
glucose control
Time frame: change from when participants begin the program to 52 weeks after they finish the program (week 55)
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)
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)
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)
minutes of moderate to vigorous physical activity
Time frame: 24 weeks after program completion (week 27) for 7 consecutive days
independent bouts of physical activity
Time frame: 4- (week 7) and 24-weeks (week 27) after completion of the program
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PreDiabetes, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mary E Jung, Ph.D. (250 807 9670, mary.jung@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2018.