Small Steps for Big Changes - Recipe for Health
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of British Columbia
About this trial
The purpose of this study is to evaluate changes in HbA1c levels, diet, weight and waist circumference in Small Steps for Big Changes (SSBC) diabetes prevention program participants two year after program completion compared to before they took part in the program.
The main questions it aims to answer are:
1. Are changes in caloric, carbohydrate, and fibre intake associated with HbA1c levels after SSBC program completion in the short (3- and 6- months), medium (9- and 12- months) and long-term (21- and 24- months)? 2. Are changes in caloric, carbohydrate, and fibre intake associated with anthropometrics (weight and waist circumference) after program completion in the short (3- and 6- months), medium (9- and 12- months) and long-term (21- and 24- months)? 3. Are eating motives associated with dietary intake in individuals with prediabetes? 4. Does participation in SSBC result in changes to eating motives over time?
It is hypothesized that:
1. Dietary changes will be associated with HbA1c levels at 3-, 6-,12- and 24- months post-intervention. 2. Dietary changes will be associated with weight and waist circumference at 3-, 6-, and 12-months post-intervention. 3. Participants' eating motives are associated with their dietary intake. 4. Eating motives will change after partaking in SSBC and at 3-, 6-, 12- months post intervention.
A total number of 250 individuals with prediabetes will be recruited to take part in a 6-week diet and exercise changes program (SSBC). The program will be administered and facilitated by the community facility trainers at YMCA locations. Participants will be asked to visit Diabetes Prevention Research Group (DPRG) Lab in the University of British Columbia Okanagan Campus for Hba1c (primary outcome), anthropometric measurements and dietary assessment.
Eligibility criteria
Qualifiers
adults over the age of 18 and able to read and speak English
living with prediabetes: HbA1c% values between 5.7-6.4% (American Diabetes Association, 2012), or
individuals diagnosed with type 2 diabetes in remission, defined as achieving HbA1c of < 6.4% without any diabetes-related medications for a minimum of 3 months (Diabetes Canada Clinical Practice Guidelines, 2022), or
individuals at high risk of developing type 2 diabetes defined as an American Diabetes Association risk questionnaire score ≥ 5.
Disqualifiers
failure to obtain participant's signed declaration for the Get Active questionnaire
currently diagnosed with type 2 diabetes with an HbA1c of 6.5% or greater
pregnant
Trial design
Treatments tested in this trial
- Small Steps for Big Changes Program
Treatment groups
250 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov