NCT03099343

Brief Summary

The proposed study will determine the effectiveness of a mobile application location-based tailored notification message system in helping hypertensive patients reduce dietary sodium intake and feel more confident in following a low sodium diet.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

September 21, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2019

Completed
Last Updated

June 5, 2019

Status Verified

June 1, 2019

Enrollment Period

1.6 years

First QC Date

March 28, 2017

Last Update Submit

June 4, 2019

Conditions

Hypertension

Keywords

sodiumsaltdiettailored messagingmobile application

Outcome Measures

Primary Outcomes (2)

  • 24-hour urinary sodium excretion

    Change from baseline in 24-hour urinary sodium excretion at week 8

    Baseline, Week 8

  • Self-care Confidence in Following a Low-sodium Diet Scale (SCFLDS)

    Change from baseline in Self-care Confidence in Following a Low-sodium Diet Scale (SCFLDS) at week 8. It assesses the participants' confidence in the ability to select and prepare low-sodium foods. The self-reported tool consists of 7 items with 4 response options per item. The score range is 1-4 (1=Not confident, 2=Somewhat confident, 3=Very confident, 4=Extremely confident) then added for each question. Possible scores range from 7 to 28 and the higher the score indicates greater confidence.

    Baseline, Week 8

Other Outcomes (2)

  • Change from baseline in blood pressure

    Baseline, week 8

  • Estimated dietary sodium intake

    Baseline, week 8

Study Arms (2)

Location-based Tailored Messaging

EXPERIMENTAL

Participants receive location-based tailored messaging via a mobile application throughout the 8-week research study.

Behavioral: Location-based Tailored Messaging

Control Group

NO INTERVENTION

Participants follow their usual eating pattern and will not have access to the application throughout the 8-week research study.

Interventions

Location-based Tailored MessagingBEHAVIORAL

The mobile application works by providing tailored messages targeted to participant locations that can help individuals to choose lower sodium foods.

Location-based Tailored Messaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 18 years of age
  • Hypertension
  • Use of anti-hypertensive therapy for at least 3 months, with stable anti-hypertensive therapy (medication type and dose) for at least 2 weeks
  • Daily sodium intake of \>2,000 mg with sodium to kcal ratio \> 1, estimated via Food Frequency Questionnaire
  • Ownership and use of an Apple iPhone

You may not qualify if:

  • Chronic Kidney Disease
  • Heart Failure
  • Systolic Blood Pressure \>180 mm Hg
  • Diastolic Blood Pressure \>110 mm Hg
  • Use of a loop diuretic or corticosteroid
  • Insulin dependent diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michigan Medicine, University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (3)

  • Alhashimi L, Cordwin DJ, Dandu C, Hummel SL, Dorsch MP. Patient self-assessment of urine dipsticks to estimate sodium intake in patients with hypertension. Clin Nutr ESPEN. 2022 Oct;51:295-300. doi: 10.1016/j.clnesp.2022.08.011. Epub 2022 Aug 12.

    PMID: 36184219DERIVED

  • Dorsch MP, Cornellier ML, Poggi AD, Bilgen F, Chen P, Wu C, An LC, Hummel SL. Effects of a Novel Contextual Just-In-Time Mobile App Intervention (LowSalt4Life) on Sodium Intake in Adults With Hypertension: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Aug 10;8(8):e16696. doi: 10.2196/16696.

    PMID: 32663139DERIVED

  • Dorsch MP, An LC, Hummel SL. A Novel Just-in-Time Contextual Mobile App Intervention to Reduce Sodium Intake in Hypertension: Protocol and Rationale for a Randomized Controlled Trial (LowSalt4Life Trial). JMIR Res Protoc. 2018 Dec 7;7(12):e11282. doi: 10.2196/11282.

    PMID: 30530462DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Scott L Hummel, MD, MS

    University of Michigan

    PRINCIPAL INVESTIGATOR

  • Michael P Dorsch, PharmD, MS

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD MS Assistant Professor Internal Medicine Cardiology

Study Record Dates

First Submitted

March 28, 2017

First Posted

April 4, 2017

Study Start

September 21, 2017

Primary Completion

April 26, 2019

Study Completion

April 26, 2019

Last Updated

June 5, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)