Diet ModificationNCT04616482
Therapeutic Nutrition With Technology in Primary Care
An observational study of Diet Modification, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diet Modification
- What is being tested?
- Digital therapeutic carbohydrate restriction (TCR) program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 15 Sep 2020to 30 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of British Columbia Okanagan
Kelowna, British Columbia, V1V 3G1
Jonathan Little, PhD, 2508079876, jonathan.little@ubc.ca
2508079876, jonathan.little@ubc.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Diet Modification
- Being tested
- Digital therapeutic carbohydrate restriction (TCR) program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital therapeutic carbohydrate restriction (TCR) programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Digital therapeutic carbohydrate restriction (TCR) program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Assessed through program intake collected through the online program (e.g. age, sex, weight, HbA1c, chronic condition, health goals)
Measured: through study completion, an average of 9 months
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.
Measured: 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.
Assessed through the number of patients enrolled in the program and the number of patients who complete the program through program tracking.
Measured: Pre-program (month 0) to post-program (6 months)
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.
Measured: Pre-program (month 0) to post-program (6 months)
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.
Measured: Pre-program (month 0) to post-program (6 months)
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.
Measured: Pre-program (month 0) to post-program (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start15 Sep 2020
- Primary completion15 Sep 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet ModificationStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Little, University of British Columbia
- Investigators
- Jonathon Little, PhD, Principal investigator, The University of British Columbia, Okanagan Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616482
- Sponsor's protocol ID
- H19-00316
- Status last verified
- Oct 2020
- First submitted
- 8 Oct 2020
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting and Enabling Physicians to Deliver Personalized Therapeutic Nutrition Using an Online Technology Platform
- ClinicalTrials.gov ID
- NCT04616482
- Acronym / sponsor ID
- H19-00316
- Conditions
- Diet Modification
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 15 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 5 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital therapeutic carbohydrate restriction (TCR) program | – | Behavioral: Digital therapeutic carbohydrate restriction (TCR) programThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital therapeutic carbohydrate restriction (TCR) programA 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. | Behavioural | Digital therapeutic carbohydrate restriction (TCR) program |
Primary outcome
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.
6 secondary outcomes
Present descriptive characteristics of patients who get prescriptions to access the online TCR program
Time frame: 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
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)
Program impact assessed through changes in weight from pre-program to post-program.
Time frame: 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)
Program impact assessed through changes in medications from pre-program to post-program.
Time frame: Pre-program (month 0) to post-program (6 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathon Little, PhD principal investigator
The University of British Columbia, Okanagan Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diet Modification, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathon Little, PhD ((250) 807-9876, jonathan.little@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of eligible patients who receive prescriptions to access the online TCR program (time frame: through study completion, an average of 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.