Therapeutic Nutrition With Technology in Primary Care

NCT ID: NCT04616482

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-15

Study Completion Date

2021-09-30

Brief Summary

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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

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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.

Conditions

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Diet Modification

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Digital therapeutic carbohydrate restriction (TCR) program

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Jonathan Little

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jonathon Little, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of British Columbia, Okanagan Campus

Locations

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University of British Columbia Okanagan

Kelowna, British Columbia, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Jonathon Little, PhD

Role: CONTACT

(250) 807-9876

Tineke Dineen, MSc

Role: CONTACT

403-470-9754

Facility Contacts

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Jonathan Little, PhD

Role: primary

2508079876

Role: backup

2508079876

Other Identifiers

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H19-00316

Identifier Type: -

Identifier Source: org_study_id