Small Steps for Big Changes - Recipe for Health

NCT05962983 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2023-07-27

No results posted yet for this study

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. 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.

Conditions

Interventions

BEHAVIORAL

Small Steps for Big Changes Program

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.

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2026-08-01
Completion
2026-08-01

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05962983 on ClinicalTrials.gov