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Behavioral Intervention
Soft Commitment Device for High Blood Pressure (iFAST Trial)
N/A
Waitlist Available
Led By Alexander Fanaroff, MD, MHS
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 1-18
Awards & highlights
iFAST Trial Summary
This study is evaluating whether a commitment device can help people with hypertension and obesity to follow a time-restricted eating plan.
Eligible Conditions
- High Blood Pressure
- Obesity
iFAST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 1-18
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 1-18
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence to the Intermittent Fasting Regimen, Captured Via Daily Text Message, Over 18 Weeks, Expressed in Days Per Week
Secondary outcome measures
Adherence to the IF Regimen, Captured Via Daily Text Message, Over 12 Weeks, Expressed in Days Per Week
Other outcome measures
Exploratory analyses will compare change in blood pressure in patients that were adherent to IF ≥ 4 days per week vs. < 4 days per week
Exploratory analyses will compare change in weight in patients that were adherent to IF ≥ 4 days per week vs. < 4 days per week
iFAST Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Soft Commitment DeviceExperimental Treatment1 Intervention
Patients randomized to the commitment device arm will be asked to visit the Way to Health platform. There, they will identify a support person, a family or friend who they speak to frequently and who is invested in their health. They will then complete a series of questions intended to create implementation intentions. Specifically, they will pick a time for their fast to begin each 24-hour period and a time for their fast to end. They will also develop strategies to deal with hunger arising during a fast period. After this process, they will sign a contract pledging to adhere to the 16:8 time-restricted feeding dietary pattern, and acknowledging that their support person will receive a copy of the contract and weekly updates about their adherence to the regimen.
Group II: Attention ControlActive Control1 Intervention
Patients will be instructed via text message and email to fast at least 16 hours per day every day. For the next 18 weeks, they will receive a daily text message via the Way to Health platform asking if they fasted for at least 16 hours over the past 24 hours. If they fail to respond, reminder text messages will be sent. Once per week, they will receive a text message asking them to weigh themselves and check their blood pressure, and reply with the results via text message
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Soft Commitment Device
2021
N/A
~40
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,880,051 Total Patients Enrolled
Alexander Fanaroff, MD, MHSPrincipal InvestigatorUniversity of Pennsylvania
5 Previous Clinical Trials
4,399 Total Patients Enrolled
Mitesh Patel, MD, MBA, MSPrincipal InvestigatorUniversity of Pennsylvania
14 Previous Clinical Trials
134,428 Total Patients Enrolled
Frequently Asked Questions
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