Recruiting

Therapeutic Nutrition

Sponsor:

University of British Columbia

Code:

NCT04616482

Conditions

Diet Modification

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Digital therapeutic carbohydrate restriction (TCR) program

Study Details

Brief summary:

Low-carbohydrate diets (less than approximately 130 grams per day) are emerging as an efficacious treatment option with several studies supporting weight loss and remission of type 2 diabetes. Many physicians are now implementing this strategy but the time it takes to educate patients on nutrition is a barrier. The research team is working with physicians to develop a solution whereby the nutrition education and intervention is delivered via mobile/online technology (i.e., an app). This study will test whether it is feasible and efficacious for physicians to recommend this app to their patients with obesity and type 2 diabetes to help them lose weight and improve their condition.

Conditions

Diet Modification

Study ID

NCT04616482

Start date

Sep 15, 2020

Status verified date

Oct, 2020

Completion date

Sep 30, 2021

Anticipated

Primary completion date

Sep 15, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Overweight or obese (BMI >25 kg/m2)
  • At risk for T2D as deemed by physician
  • Diagnosed with T2D
  • Able to read and speak English (in order to communicate with the technology platform/app
  • Over the age of 18

Exclusion Criteria:

  • Unable to read or speak English (due to the app being provided in English)
  • Unable to access a computer or mobile phone that has access to the internet.
  • Currently compliant with a very low carbohydrate ketogenic diet or very low calorie commercial weight loss program
  • Planning to change doctors in the next 12 months.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Digital therapeutic carbohydrate restriction (TCR) program

The intervention involves 12 weeks of online/app-based behaviour change coaching. Each week the participant focuses on a different aspect of healthy eating habits designed to cut sugar and refined carbohydrates while encouraging and providing resources for lower-carbohydrate food options. Education is done through short videos and information sheets. Participants set goals and complete worksheets/tasks based on their individual goals.

Interventions

Digital therapeutic carbohydrate restriction (TCR) program

A 12-week, personalized, online program to teach and coach patients about therapeutic carbohydrate restriction as for obesity and/or T2D (or risk of T2D). The program is intended to enhance the usual clinical care provided for patients.

Primary outcome measure

  • The percentage of eligible patients who receive prescriptions to access the online TCR program [ Time Frame: through study completion, an average of 9 months ]

Central Contacts and Locations

Central contacts

Jonathon Little, PhD

(250) 807-9876jonathan.little@ubc.ca

Tineke Dineen, MSc

403-470-9754tineke.dineen@ubc.ca

Locations

University of British Columbia Okanagan

Recruiting

Kelowna, British Columbia, Canada, V1V 3G1

Contacts

Jonathan Little, PhD

2508079876jonathan.little@ubc.ca

2508079876jonathan.little@ubc.ca

More Information

Sponsor

University of British Columbia

Last update posted

Nov 5, 2020

Last verified

Oct, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2020-11-05.