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NCT05962983: RFH

Small Steps for Big Changes - Recipe for Health

Not yet recruiting NA Last updated 27 July 2023
What this trial tests

NA trial testing Small Steps for Big Changes Program in PreDiabetes in 250 participants. Not yet recruiting.

Timeline
1 August 2023
Primary endpoint
1 August 2026
1 August 2026

Quick facts

Lead sponsorUniversity of British Columbia
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeprevention
Enrollment250
Start date1 August 2023
Primary completion1 August 2026
Estimated completion1 August 2026
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

University of British Columbia

Who can join

18 and older, any sex, with PreDiabetes or Prediabetic State. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for PreDiabetes

Currently open trials in the same condition.

Other University of British Columbia trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05962983.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing