Therapeutic Nutrition With Technology in Primary Care

• Conditions: Diet Modification
• Interventions: Behavioral: Digital therapeutic carbohydrate restriction (TCR) program

• Registration Number: NCT04616482
• Lead Sponsor: University of British Columbia

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-09-15
• Status Verified: 2020-10
• Study First Submitted: 2020-10-08
• Study First Submitted QC: 2020-10-29
• Last Update Submitted: 2020-10-29
• Study First Posted: 2020-11-05
• Last Update Posted: 2020-11-05
• Primary Completion: 2021-09-15
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Digital therapeutic carbohydrate restriction (TCR) program	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.

Primary Outcome Measures

Name	Time	Method
The percentage of eligible patients who receive prescriptions to access the online TCR program	through study completion, an average of 9 months	Assessed through the number of voucher cards handed-out over physician documentation of eligible patient visits over the study period.

Secondary Outcome Measures

Name	Time	Method
Present descriptive characteristics of patients who get prescriptions to access the online TCR program	through study completion, an average of 9 months	Assessed through program intake collected through the online program (e.g. age, sex, weight, HbA1c, chronic condition, health goals)
The percentage of patients who receive a prescription for TCR program that sign up and start	through study completion, an average of 9 months	Assessed through the number of voucher cards redeemed on the online program over the number of voucher cards handed-out by physicians.
Program drop-out as assessed by the number of patients who sign up for and start the TCR program and the number of patients who complete the full program.	Pre-program (month 0) to post-program (6 months)	Assessed through the number of patients enrolled in the program and the number of patients who complete the program through program tracking.
Program impact assessed through changes in weight from pre-program to post-program.	Pre-program (month 0) to post-program (6 months)	For patients who complete the program, the change in weight from program sign-up to program completion.
Program impact assessed through change in HbA1c from pre-program to post-program.	Pre-program (month 0) to post-program (6 months)	For patients who complete the program, the change in HbA1c from program sign-up to program completion.
Program impact assessed through changes in medications from pre-program to post-program.	Pre-program (month 0) to post-program (6 months)	For patients who complete the program, the change in medications from program sign-up to program completion.

Trial Locations

Locations (1)

University of British Columbia Okanagan; 🇨🇦 Kelowna, British Columbia, Canada