Video Home Visits for Dietary Counselling

NCT04634851 | Not Yet Recruiting

• 1 other identifier: UCSFUroVV
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Technology; Diet Habit

Outcome Measures

Primary Outcomes (1)

• 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)

  baseline, 12 weeks, 24 weeks

Secondary Outcomes (2)

• Food Frequency Questionnaire (FFQ)

  baseline, 12 weeks, 24 weeks

• Short Sodium Knowledge Survey (SKSS)

  baseline, 12 weeks, 24 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

These participants will get virtual home visits with the urologist and dietitian

Behavioral: Virtual home visits

Control

NO INTERVENTION

These participants will get standard urologist and dietitian counseling

Interventions

Virtual home visits BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of California, San Francisco: lead

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Officials

• David Bayne, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Bayne, MD, MPH

CONTACT

4153532200; david.bayne@ucsf.edu

Marshall Stoller, MD

CONTACT

4153532200; marshall.stoller@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot study comparing intervention (virtual dietary counselling) versus standard of care

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 18, 2020
• Study Start (Estimated): July 1, 2027
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share