Therapeutic Nutrition With Technology in Primary Care

Supporting and Enabling Physicians to Deliver Personalized Therapeutic Nutrition Using an Online Technology Platform

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.

Study Overview

• Status: Unknown
• Conditions: Diet Modification
• Intervention / Treatment: Behavioral: Digital therapeutic carbohydrate restriction (TCR) program

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1V 3G1
      • Recruiting
      • University of British Columbia Okanagan
      • Contact: Jonathan Little, PhD; Phone Number: 2508079876; Email: jonathan.little@ubc.ca
      • Contact: Phone Number: 2508079876; Email: jonathan.little@ubc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Individuals with obesity, at risk for type 2 diabetes or diagnosed with type 2 diabetes interested in therapeutic carbohydrate restriction for management of their condition.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative patient feedback on program acceptability	Qualitative semi-structured interviews with patients collecting program feedback on their experiences in the program, specifically asking about the acceptability of the program. Acceptability will be assessed through the audio-recorded responses to semi-structured interview questions, subsequently transcribed and coded using content analysis.	Post-program (6 months)
Qualitative patient feedback on program practicality	Qualitative semi-structured interviews with patients collecting program feedback on their experiences in the program, specifically asking about the practicality of the program. Practicality will be assessed through the audio-recorded responses to semi-structured interview questions, subsequently transcribed and coded using content analysis.	Post-program (6 months)
Qualitative patient feedback on program satisfaction	Qualitative semi-structured interviews with patients collecting program feedback on their experiences in the program, specifically asking about their satisfaction of the program. Satisfaction will be assessed through the audio-recorded responses to semi-structured interview questions, subsequently transcribed and coded using content analysis.	Post-program (6 months)
Qualitative physician feedback on program acceptability	Qualitative semi-structured interviews with physicians collecting feedback on their experiences in the program, specifically asking about the acceptability of the program within their daily physician practice. Acceptability will be assessed through the audio-recorded responses to semi-structured interview questions, subsequently transcribed and coded using content analysis.	through study completion, an average of 9 months
Qualitative physician feedback on program practicality	Qualitative semi-structured interviews with physicians collecting feedback on their experiences in the program, specifically asking about the practicality of the program within their daily physician practice. Practicality will be assessed through the audio-recorded responses to semi-structured interview questions, subsequently transcribed and coded using content analysis.	through study completion, an average of 9 months
Qualitative physician feedback on program satisfaction	Qualitative semi-structured interviews with physicians collecting feedback on their experiences in the program, specifically asking about the satisfaction of the program within their daily physician practice. Satisfaction will be assessed through the audio-recorded responses to semi-structured interview questions, subsequently transcribed and coded using content analysis.	through study completion, an average of 9 months
Characteristics of individuals who drop-out of program	Provide descriptive statistics (e.g. age, sex, weight, HbA1c, chronic condition, health goals) of individuals who drop-out after enrolling in the program and prior to program completion.	through study completion, an average of 9 months

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Jonathon Little, PhD, The University of British Columbia, Okanagan Campus

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Anticipated): September 15, 2021
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: October 8, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (Actual): November 5, 2020

Study Record Updates

• Last Update Posted (Actual): November 5, 2020
• Last Update Submitted That Met QC Criteria: October 29, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: H19-00316

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No