Small Steps for Big Changes - Recipe for Health

NCT05962983 | Not Yet Recruiting

• 1 other identifier: H23-01062
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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. 3.Are eating motives associated with dietary intake in individuals with prediabetes?
4. 4.Does participation in SSBC result in changes to eating motives over time?
5. 5.Dietary changes will be associated with HbA1c levels at 3-, 6-,12- and 24- months post-intervention.
6. 6.Dietary changes will be associated with weight and waist circumference at 3-, 6-, and 12-months post-intervention.
7. 7.Participants' eating motives are associated with their dietary intake.
8. 8.Eating motives will change after partaking in SSBC and at 3-, 6-, 12- months post intervention.

Conditions

PreDiabetes; Prediabetic State

Keywords

dietary assessment; type 2 diabetes; diabetes prevention; behaviour change

Outcome Measures

Primary Outcomes (1)

• change in hemoglobin A1c% (HbA1c%)

  HbA1c% provides a measure of the average glucose concentration over the past three months.

  8 timepoints: (-3), 0-, 3-, 6-, 9-, 12-, 21-, and 24-months following diet and exercise intervention.

Secondary Outcomes (5)

• change in caloric intake (kcal)

  5 timepoints: at baseline (0), immediate post program (after session 6) and 3-,6- and 12- month follow ups

• change in carbohydrate intake (grams)

  5 timepoints: at baseline (0), immediate post program (after session 6) and 3-,6- and 12- month follow ups

• change in fibre intake (grams)

  5 timepoints: at baseline (0), immediate post program (after session 6) and 3-,6- and 12- month follow ups

• change in weight (lbs)

  7 timepoints: at baseline (month 0), and 3-,6-,9-,12-, 21-and 24-month follow-ups

• change in waist circumference (inches)

  7 timepoints: at baseline (month 0), and 3-,6-,9-,12-, 21-and 24-month follow-ups

Other Outcomes (1)

• eating motives

  5 timepoints: at baseline (0), immediate post program (after session 6) and 3-,6- and 12- month follow ups

Study Arms (1)

SSBC participants

EXPERIMENTAL

Participants will attend a 6-week diet and exercise changes program (SSBC).

Behavioral: Small Steps for Big Changes Program

Interventions

Small Steps for Big Changes Program BEHAVIORAL

Participants 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.

SSBC participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia

Kelowna, British Columbia, V1V 1V7, Canada

Location

MeSH Terms

Conditions

Prediabetic State; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Mary E Jung, PhD

CONTACT

(250) 807-9670; mary.jung@ubc.ca

Azize N Yildirim, MSc

CONTACT

(778) 363-8033; azize@student.ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study is a treatment-only repeated measures design.

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: July 27, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)