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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Small Steps for Big Changes Program
BehavioralParticipants will be asked to attend six one on one sessions providing diet and exercise counselling each lasting 20-30 minutes over the course of six weeks. The nutrition counselling will introduce participants to a healthy dietary changes for reducing added sugar intake and refined/processed carbohydrate intake as well as increasing vegetable consumption. After counselling sessions, participants will complete their chosen form of aerobic exercise: 1) traditional continuous exercise that involves exercising at a constant pace for 20-30 minutes (moderate-intensity continuous training, MICT); or 2) interval exercise that involves alternating between 30 seconds and 1-minute of brisk exercise and 1-minute of easy exercise for \~15 min (high-intensity interval training, HIIT). Both exercise forms could be completed on treadmill, elliptical or stationary bike. In total, each session will last approximately one hour.
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: SSBC participantsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
change in hemoglobin A1c% (HbA1c%)
HbA1c% provides a measure of the average glucose concentration over the past three months.
Time frame
8 timepoints: (-3), 0-, 3-, 6-, 9-, 12-, 21-, and 24-months following diet and exercise intervention.Secondary outcomes
1
change in caloric intake (kcal)
It refers to the number of calories (energy content) consumed during a day.
Time frame
5 timepoints: at baseline (0), immediate post program (after session 6) and 3-,6- and 12- month follow ups2
change in carbohydrate intake (grams)
Carbohydrates are one of the three macronutrients in the human diet.
Time frame
5 timepoints: at baseline (0), immediate post program (after session 6) and 3-,6- and 12- month follow ups3
change in fibre intake (grams)
It refers to a group of substances in plant foods which cannot be completely broken down by human digestive enzymes.
Time frame
5 timepoints: at baseline (0), immediate post program (after session 6) and 3-,6- and 12- month follow ups4
change in weight (lbs)
Participants' mass or weight
Time frame
7 timepoints: at baseline (month 0), and 3-,6-,9-,12-, 21-and 24-month follow-upsOther outcomes
1
eating motives
reasons for eating (hungry, tired, bored, stressed, sad, social, eating time, other). A multiple question will be prompted to participants prior to every food intake through Keenoa food diet assessment tool.
Time frame
5 timepoints: at baseline (0), immediate post program (after session 6) and 3-,6- and 12- month follow upsSponsors and contacts
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Source ClinicalTrials.gov
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