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Therapeutic Nutrition With Technology in Primary Care

University of British Columbia logo

University of British Columbia

Status

Unknown

Conditions

Diet Modification

Treatments

Behavioral: Digital therapeutic carbohydrate restriction (TCR) program

Study type

Observational

Funder types

Other

Identifiers

NCT04616482
H19-00316

Details and patient eligibility

About

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.

Full description

The study is a non-experimental feasibility study to explore the acceptability, practicality and demand for the use of a 12-week, personalized, online program to teach and coach patients about therapeutic carbohydrate restriction for individuals with obesity and/or at risk for type 2 diabetes/with type 2 diabetes. The program is intended to enhance the usual clinical care provided for patients with these conditions and will allow for physicians to monitor patient progress through the program. Both physician and patient perspectives will be explored.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Digital therapeutic carbohydrate restriction (TCR) program
Description:
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.
Treatment:
Behavioral: Digital therapeutic carbohydrate restriction (TCR) program

Trial contacts and locations

1

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Central trial contact

Jonathon Little, PhD; Tineke Dineen, MSc

Data sourced from clinicaltrials.gov

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