N/A N=37 Randomized Double-blind Health Services Research

Intermittent Fasting Adherence and Self Tracking

Hypertension · Obesity

Bottom Line

View on ClinicalTrials.gov: NCT04836312 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2023

Primary outcome: Primary: Adherence to the Intermittent Fasting Regimen, Captured Via Daily Text Message, Over 18 Weeks, Expressed in Days Per Week — 4.7; 5.4 days per week

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Soft Commitment Device (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Pennsylvania
Primary completion: Aug 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Adherence to the Intermittent Fasting Regimen, Captured Via Daily Text Message, Over 18 Weeks, Expressed in Days Per Week	4.7; 5.4	—
SECONDARY Adherence to the IF Regimen, Captured Via Daily Text Message, Over 12 Weeks, Expressed in Days Per Week	5.0; 5.7	—

Summary

This pilot study will randomize 34 patients with hypertension and obesity to either time-restricted feeding alone or a commitment device to encourage time-restricted feeding, including a commitment pledge, involvement of a supportive partner, setting of implementation intentions, and multiple daily reminder text messages. The intervention will last 12 weeks, followed by a 6-week follow-up period. The primary outcome is adherence to the IF regimen, captured via daily text message, over 18 weeks

Eligibility Criteria

Inclusion Criteria

Age 18 or older
Body mass index > 30 kg/m2
Systolic blood pressure > 150 mmHg
Owns a smartphone or tablet operating the iOS or Android operating system

Exclusion Criteria

Unable or unwilling to provide informed consent, including but not limited to cognitive or language barriers (reading or comprehension)
Type 1 diabetes
Use of insulin or insulin secretagogues (sulfonylureas, metaglinides)
Use of medications that require food intake
Ongoing use of pharmacologic therapy for weight loss
Self-reported eating disorder
Other medical condition that could be harmed by intermittent fasting as judged by study physician
Anticipated life expectancy less than 6 months
Any other reason why it is not feasible to complete the entire 6-month study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04836312). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.