Clinical trial NCT04616482: Therapeutic Nutrition With Technology in Primary Care
Official title: Supporting and Enabling Physicians to Deliver Personalized Therapeutic Nutrition Using an Online Technology Platform
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diet Modification
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The percentage of eligible patients who receive prescriptions to access the online TCR program
timeFrame: through study completion, an average of 9 months
Secondary outcomes:
measure: Present descriptive characteristics of patients who get prescriptions to access the online TCR program
timeFrame: through study completion, an average of 9 months
measure: The percentage of patients who receive a prescription for TCR program that sign up and start
timeFrame: through study completion, an average of 9 months
measure: 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.
timeFrame: Pre-program (month 0) to post-program (6 months)
measure: Program impact assessed through changes in weight from pre-program to post-program.
timeFrame: Pre-program (month 0) to post-program (6 months)
measure: Program impact assessed through change in HbA1c from pre-program to post-program.
timeFrame: Pre-program (month 0) to post-program (6 months)
measure: Program impact assessed through changes in medications from pre-program to post-program.
timeFrame: Pre-program (month 0) to post-program (6 months)
Other outcomes:
measure: Qualitative patient feedback on program acceptability
timeFrame: Post-program (6 months)
measure: Qualitative patient feedback on program practicality
timeFrame: Post-program (6 months)
measure: Qualitative patient feedback on program satisfaction
timeFrame: Post-program (6 months)
measure: Qualitative physician feedback on program acceptability
timeFrame: through study completion, an average of 9 months
measure: Qualitative physician feedback on program practicality
timeFrame: through study completion, an average of 9 months
measure: Qualitative physician feedback on program satisfaction
timeFrame: through study completion, an average of 9 months
measure: Characteristics of individuals who drop-out of program
timeFrame: through study completion, an average of 9 months
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia Okanagan
state: British Columbia
Study officials:
affiliation: The University of British Columbia, Okanagan Campus
name: Jonathon Little, PhD
role: PRINCIPAL_INVESTIGATOR
References: