TechnologyNCT04634851
Video Home Visits for Dietary Counselling
A study testing Virtual home visits in people with Technology and Diet Habit, run by University of California, San Francisco.
Trial summary
This pilot study aims to develop a protocol for home video informed dietary counseling with the goal of reducing overall sodium consumption among kidney stone formers. To accomplish this the investigators will: 1)Assess which data available on video visits are most informative to convey patient sodium consumption, and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Technology, Diet Habit
- What is being tested?
- Virtual home visits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2027to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients known to have a history of calcium-based kidney stone disease verified by stone analysis (stones containing calcium oxalate(CaOx) or calcium phosphate(CaP) on stone analysis), or patients with a diagnosis of kidney stone disease verified by imaging (computerized tomography, ultrasound, or plain film/x-ray) and a prior 24-hour urine results with elevated SS CaOx>8 or SS CaP>1.25.
- Patients 18 years or older.
- Patients with a smartphone, internet capable tablet, or video capable laptop.
- Patients with a household member with a smartphone, internet capable tablet, or video capable laptop.
Who cannot join
- Pregnant patients.
- Patients unable to produce a urine sample.
- Patients who have previous surgical reconstruction involving incorporation of bowel in the urinary tract.
- Patients with known sodium regulation abnormalities (adrenal tumors, pituitary tumors, glucocorticoid deficiency, hypothyroidism, syndrome of inappropriate antidiuretic hormone secretion, nephrotic syndrome, severe congestive heart failure, severe hepatic impairment, etc.).
- Patients on medications significantly affecting urinary sodium levels (lithium, amphotericin, vasopressin V2-receptor antagonists, lactulose, for example).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Optimizing Dietary Habits for Kidney Stone Formers Using Telehealth Directed Individualized Nutritional Counseling
This pilot study aims to develop a protocol for home video informed dietary counseling with the goal of reducing overall sodium consumption among kidney stone formers. To accomplish this the investigators will: 1)Assess which data available on video visits are most informative to convey patient sodium consumption, and 2) Administer virtual home visits with informed dietary counseling in our intervention arm and compare this to standard dietary counseling looking specifically at the outcome of 24-hour urine sodium excretion results over time. This study will benefit dramatically from the rapid growth of telehealth medical visits as a consequence of the SARS-CoV-2 pandemic, with the ultimate goal to improve and adapt patient dietary counseling for the prevention of kidney stone disease in the new and evolving era of telehealth.
Read the detailed description
Urolithiasis affects 1 in 11 Americans and is associated with annual health care expenditures of up to $4.5 billion. Fifty percent of stone risk can be attributed to diet and fluid intake. Modifications in sodium intake can dramatically reduce risk of kidney stone disease as determined by 24-hour urine results. Despite this understanding, dietary counseling is largely ineffective as kidney stone formers have difficulty adhering to low sodium diets. The precise reasons behind this are unknown, but it is hypothesized that socioeconomic factors such as low income and low education contribute to a lack of knowledge of, and access to, healthy alternatives to salty foods. The relationship between lithogenic diet consumption and stone disease requires a more in depth understanding of patients' home food environments, dietary habits, and perceived barriers to following a low-sodium diet. This understanding will help direct appropriate interventions to prevent recurrent stones.
Routine historic face-to-face clinic visits rapidly have been replaced with telehealth encounters with the SARS-CoV-2 pandemic. Such changes will likely remain the standard of care and will define the new "normal" for some time. This presents an opportunity to integrate robust information now available through the exponential growth of video visits with directed dietary counseling. Through video exchange with patients in their homes an abundance of previously untapped information is immediately available to healthcare providers. Smartphone video capabilities are available to most stone patients irrespective of their financial status. Images from telehealth video visits, including patient lifestyle, behaviors, resources, and home environment will give objective data as to types of food consumed regularly by patients and their capacity to prepare healthy foods at home.
The following specific aims are proposed: 1) Assess which data from video visits are most informative for identifying how to counsel patients to reduce patient sodium intake, and 2) Administer virtual home visit-informed individualized dietary counseling to stone formers and compare this to survey-informed dietary counseling. 24-hour urinary sodium results and patient dietary sodium knowledge and perceptions will be monitored over 6 months. This study will leverage the rapid growth of telehealth medical visits as a consequence of the SARS-CoV-2 pandemic to better understand and improve food consumption behavior of recurrent stone formers.
- Conditions
- Technology, Diet Habit
- Being tested
- Virtual home visits
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual home visitsBehavioural
These participants will have a tailored evaluation of dietary choices based on their home dietary environment (refrigerator, pantry, etc). This will be conducted over video exchange.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | These participants will get virtual home visits with the urologist and dietitian Receives: Behavioral: Virtual home visits |
| Control | No intervention | These participants will get standard urologist and dietitian counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary sodium
24hr urinary sodium, mean change in mmol/24hrs of excreted urinary sodium from baseline over 24 weeks (Three time points will be recorded: baseline, after 12 weeks, after 24 weeks. Outcome will be mean change from baseline. We will take the average of change from baseline at 12 weeks and change from baseline at 24 weeks)
Measured: baseline, 12 weeks, 24 weeks
Secondary outcomes (2)
Food Frequency Questionnaire (FFQ)
Change in response to NutritionQuest® block sodium screener Food Frequency Questionnaire (FFQ), (Three points will be recorded: baseline, after 12 weeks, after 24 weeks. Outcome will be change from baseline over time. We will look specifically for a reduction in self reported weekly consumption of high sodium foods including soups, pizza, hot dogs, lunch meets, table salt, cooking salt, etc. Results will be noted for change from baseline at 12 weeks and at 24 weeks)
Measured: baseline, 12 weeks, 24 weeks
Short Sodium Knowledge Survey (SKSS)
Change in response to Short Sodium Knowledge Survey (SKSS), (Three points will be recorded: baseline, after 12 weeks, after 24 weeks. Outcome will be change from baseline over time. We will look specifically for a an increased frequency in accurate identification of high sodium foods and accurate identification of dietary sodium intake recommendations. Results will be noted for change from baseline at 12 weeks and at 24 weeks)
Measured: baseline, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start1 Jul 2027 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TechnologyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot study comparing intervention (virtual dietary counselling) versus standard of care
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Bayne, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634851
- Sponsor's protocol ID
- UCSFUroVV
- Status last verified
- Jan 2026
- First submitted
- 12 Nov 2020
- Last updated
- 2 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will not share IPD
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Dietary Habits for Kidney Stone Formers Using Telehealth Directed Individualized Nutritional Counseling
- ClinicalTrials.gov ID
- NCT04634851
- Acronym / sponsor ID
- UCSFUroVV
- Conditions
- Technology, Diet Habit
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Jul 2027 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 18 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.
This pilot study aims to develop a protocol for home video informed dietary counseling with the goal of reducing overall sodium consumption among kidney stone formers. To accomplish this the investigators will: 1)Assess which data available on video visits are most informative to convey patient sodium consumption, and 2) Administer virtual home visits with informed dietary counseling in our intervention arm and compare this to standard dietary counseling looking specifically at the outcome of 24-hour urine sodium excretion results over time. This study will benefit dramatically from the rapid growth of telehealth medical visits as a consequence of the SARS-CoV-2 pandemic, with the ultimate goal to improve and adapt patient dietary counseling for the prevention of kidney stone disease in the new and evolving era of telehealth.
Detailed description
Urolithiasis affects 1 in 11 Americans and is associated with annual health care expenditures of up to $4.5 billion. Fifty percent of stone risk can be attributed to diet and fluid intake. Modifications in sodium intake can dramatically reduce risk of kidney stone disease as determined by 24-hour urine results. Despite this understanding, dietary counseling is largely ineffective as kidney stone formers have difficulty adhering to low sodium diets. The precise reasons behind this are unknown, but it is hypothesized that socioeconomic factors such as low income and low education contribute to a lack of knowledge of, and access to, healthy alternatives to salty foods. The relationship between lithogenic diet consumption and stone disease requires a more in depth understanding of patients' home food environments, dietary habits, and perceived barriers to following a low-sodium diet. This understanding will help direct appropriate interventions to prevent recurrent stones.
Routine historic face-to-face clinic visits rapidly have been replaced with telehealth encounters with the SARS-CoV-2 pandemic. Such changes will likely remain the standard of care and will define the new "normal" for some time. This presents an opportunity to integrate robust information now available through the exponential growth of video visits with directed dietary counseling. Through video exchange with patients in their homes an abundance of previously untapped information is immediately available to healthcare providers. Smartphone video capabilities are available to most stone patients irrespective of their financial status. Images from telehealth video visits, including patient lifestyle, behaviors, resources, and home environment will give objective data as to types of food consumed regularly by patients and their capacity to prepare healthy foods at home.
The following specific aims are proposed: 1) Assess which data from video visits are most informative for identifying how to counsel patients to reduce patient sodium intake, and 2) Administer virtual home visit-informed individualized dietary counseling to stone formers and compare this to survey-informed dietary counseling. 24-hour urinary sodium results and patient dietary sodium knowledge and perceptions will be monitored over 6 months. This study will leverage the rapid growth of telehealth medical visits as a consequence of the SARS-CoV-2 pandemic to better understand and improve food consumption behavior of recurrent stone formers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot study comparing intervention (virtual dietary counselling) versus standard of care
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Virtual home visitsThese participants will get virtual home visits with the urologist and dietitian |
| Control | No intervention | –These participants will get standard urologist and dietitian counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients known to have a history of calcium-based kidney stone disease verified by stone analysis (stones containing calcium oxalate(CaOx) or calcium phosphate(CaP) on stone analysis), or patients with a diagnosis of kidney stone disease verified by imaging (computerized tomography, ultrasound, or plain film/x-ray) and a prior 24-hour urine results with elevated SS CaOx>8 or SS CaP>1.25.
- Patients 18 years or older.
- Patients with a smartphone, internet capable tablet, or video capable laptop.
- Patients with a household member with a smartphone, internet capable tablet, or video capable laptop.
Key exclusion criteria (5 listed)
- Pregnant patients.
- Patients unable to produce a urine sample.
- Patients who have previous surgical reconstruction involving incorporation of bowel in the urinary tract.
- Patients with known sodium regulation abnormalities (adrenal tumors, pituitary tumors, glucocorticoid deficiency, hypothyroidism, syndrome of inappropriate antidiuretic hormone secretion, nephrotic syndrome, severe congestive heart failure, severe hepatic impairment, etc.).
- Patients on medications significantly affecting urinary sodium levels (lithium, amphotericin, vasopressin V2-receptor antagonists, lactulose, for example).
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 |
|---|---|---|
| Virtual home visitsThese participants will have a tailored evaluation of dietary choices based on their home dietary environment (refrigerator, pantry, etc). This will be conducted over video exchange. | Behavioural | Intervention |
Primary outcome
Urinary sodium
Time frame: baseline, 12 weeks, 24 weeks
24hr urinary sodium, mean change in mmol/24hrs of excreted urinary sodium from baseline over 24 weeks (Three time points will be recorded: baseline, after 12 weeks, after 24 weeks. Outcome will be mean change from baseline. We will take the average of change from baseline at 12 weeks and change from baseline at 24 weeks)
2 secondary outcomes
Food Frequency Questionnaire (FFQ)
Time frame: baseline, 12 weeks, 24 weeks
Short Sodium Knowledge Survey (SKSS)
Time frame: baseline, 12 weeks, 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: No. The investigators will not share IPD
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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.
David Bayne, MD, MPH principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
A study testing Virtual home visits in people with Technology and Diet Habit, run by University of California, San Francisco.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Bayne, MD, MPH (4153532200, david.bayne@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary sodium (time frame: baseline, 12 weeks, 24 weeks). 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 2 Feb 2026.