Therapeutic Nutrition With Technology in Primary Care

NCT04616482 | Unknown

• 1 other identifier: H19-00316
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diet Modification

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Present descriptive characteristics of patients who get prescriptions to access the online TCR program

  through study completion, an average of 9 months

• The percentage of patients who receive a prescription for TCR program that sign up and start

  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.

  Pre-program (month 0) to post-program (6 months)

• Program impact assessed through changes in weight from pre-program to post-program.

  Pre-program (month 0) to post-program (6 months)

• Program impact assessed through change in HbA1c from pre-program to post-program.

  Pre-program (month 0) to post-program (6 months)

Other Outcomes (7)

• Qualitative patient feedback on program acceptability

  Post-program (6 months)

• Qualitative patient feedback on program practicality

  Post-program (6 months)

• Qualitative patient feedback on program satisfaction

  Post-program (6 months)

Study Arms (1)

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

Interventions

Digital therapeutic carbohydrate restriction (TCR) program BEHAVIORAL

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.

Digital therapeutic carbohydrate restriction (TCR) program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia Okanagan

Kelowna, British Columbia, V1V 3G1, Canada

RECRUITING

Study Officials

• Jonathon Little, PhD

  The University of British Columbia, Okanagan Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathon Little, PhD

CONTACT

(250) 807-9876; jonathan.little@ubc.ca

Tineke Dineen, MSc

CONTACT

403-470-9754; tineke.dineen@ubc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: November 5, 2020
• Study Start: September 15, 2020
• Primary Completion: September 15, 2021
• Study Completion: September 30, 2021
• Last Updated: November 5, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)