Therapeutic Nutrition With Technology in Primary Care

Diet Modification Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04616482
• Other study ID #: H19-00316
• Status: Recruiting
• Start date: September 15, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: October 2020
• Source: University of British Columbia
• Contact: Jonathon Little, PhD
• Phone: (250) 807-9876
• Email: jonathan.little[@]ubc.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 30, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diet Modification

Intervention

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.

Locations

Country	Name	City	State
Canada	University of British Columbia Okanagan	Kelowna	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)