Your session is about to expire
← Back to Search
Behavioral Intervention
Small Steps for Big Changes Program for Prediabetes (RFH Trial)
N/A
Waitlist Available
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults over the age of 18 and able to read and speak English
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 timepoints: (-3), 0-, 3-, 6-, 9-, 12-, 21-, and 24-months following diet and exercise intervention.
Awards & highlights
RFH Trial Summary
This trial seeks to evaluate changes in HbA1c, diet, weight and waist circumference in people with prediabetes who have taken part in a 6-week diet & exercise program (SSBC).
Who is the study for?
This trial is for adults over 18 at high risk of type 2 diabetes or living with prediabetes, having HbA1c levels between 5.7-6.4%. It's also open to those in remission from type 2 diabetes with HbA1c below 6.4% without medication for at least three months. Pregnant individuals and current type 2 diabetics with an HbA1c of 6.5% or higher are excluded.Check my eligibility
What is being tested?
The 'Small Steps for Big Changes' program focuses on diet and exercise changes over six weeks to see if it improves blood sugar control (HbA1c), weight, waist size, eating habits, and motives behind food choices in the short to long term after completing the program.See study design
What are the potential side effects?
Since this intervention involves lifestyle modifications rather than medications, typical drug side effects aren't expected; however participants may experience fatigue or muscle soreness due to new exercise routines.
RFH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 and can read and speak English.
RFH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 timepoints: (-3), 0-, 3-, 6-, 9-, 12-, 21-, and 24-months following diet and exercise intervention.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 timepoints: (-3), 0-, 3-, 6-, 9-, 12-, 21-, and 24-months following diet and exercise intervention.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
change in hemoglobin A1c% (HbA1c%)
Secondary outcome measures
change in caloric intake (kcal)
change in carbohydrate intake (grams)
change in fibre intake (grams)
+2 moreOther outcome measures
eating motives
RFH Trial Design
1Treatment groups
Experimental Treatment
Group I: SSBC participantsExperimental Treatment1 Intervention
Participants will attend a 6-week diet and exercise changes program (SSBC).
Find a Location
Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,415 Previous Clinical Trials
2,466,766 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My type 2 diabetes is in remission with an HbA1c below 6.4% without medication for over 3 months.I am over 18 and can read and speak English.You have a high risk of developing type 2 diabetes based on a specific questionnaire score.My HbA1c levels are between 5.7% and 6.4%, indicating prediabetes.I have type 2 diabetes with an HbA1c of 6.5% or higher.
Research Study Groups:
This trial has the following groups:- Group 1: SSBC participants
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open slots for enrollees in this clinical experiment?
"This trial, first posted on August 1st 2023 and last updated on July 24th of that same year, is not currently recruiting patients. However, there are 199 other trials with open enrolments at this time according to clinicaltrials.gov."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger