Therapeutic Nutrition With Technology in Primary Care

October 29, 2020 updated by: Jonathan Little, University of British Columbia

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1V 3G1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The percentage of eligible patients who receive prescriptions to access the online TCR program
Time Frame: through study completion, an average of 9 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Present descriptive characteristics of patients who get prescriptions to access the online TCR program
Time Frame: through study completion, an average of 9 months
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
Time Frame: through study completion, an average of 9 months
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.
Time Frame: Pre-program (month 0) to post-program (6 months)
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.
Time Frame: Pre-program (month 0) to post-program (6 months)
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.
Time Frame: Pre-program (month 0) to post-program (6 months)
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.
Time Frame: Pre-program (month 0) to post-program (6 months)
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Qualitative patient feedback on program acceptability
Time Frame: Post-program (6 months)
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
Time Frame: Post-program (6 months)
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
Time Frame: Post-program (6 months)
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
Time Frame: through study completion, an average of 9 months
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
Time Frame: through study completion, an average of 9 months
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
Time Frame: through study completion, an average of 9 months
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
Time Frame: through study completion, an average of 9 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of British Columbia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jonathon Little, PhD, The University of British Columbia, Okanagan Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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