Intermittent Fasting Adherence and Self Tracking

NCT04836312 | Completed Results

• 1 other identifier: 844153
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hypertension; Obesity

Outcome Measures

Primary Outcomes (1)

• Adherence to the Intermittent Fasting Regimen, Captured Via Daily Text Message, Over 18 Weeks, Expressed in Days Per Week

  Adherence to the IF regimen, captured via daily text message, over 18 weeks, expressed in days per week. This will measure adherence to the IF regimen throughout the 12 week intervention period and the 6 week follow-up period.

  Weeks 1-18

Secondary Outcomes (1)

• Adherence to the IF Regimen, Captured Via Daily Text Message, Over 12 Weeks, Expressed in Days Per Week

  Weeks 1-12

Study Arms (2)

Attention Control

NO 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

Soft Commitment Device

EXPERIMENTAL

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.

Behavioral: Soft Commitment Device

Interventions

Soft Commitment Device BEHAVIORAL

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.

Soft Commitment Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Fanaroff AC, Coratti S, Halaby R, Sanghavi M, O'Quinn RP, Krishnan S, Glassberg H, Bajaj A, Adusumalli S, Chokshi N, Patel MS. Feasibility and outcomes from using a commitment device and text message reminders to increase adherence to time-restricted eating: A randomized trial. Am Heart J. 2023 Apr;258:85-95. doi: 10.1016/j.ahj.2022.12.010. Epub 2023 Jan 11.

  PMID: 36640862 RESULT

MeSH Terms

Conditions

Hypertension; Obesity

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Alexander Fanaroff, MD
• Organization: University of Pennsylvania

alexander.fanaroff@pennmedicine.upenn.edu

215-615-7674

Study Officials

• Mitesh Patel, MD, MBA, MS

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Alexander Fanaroff, MD, MHS

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: April 8, 2021
• Study Start: July 12, 2021
• Primary Completion: August 28, 2022
• Study Completion: August 28, 2022
• Last Updated: December 1, 2023
• Results First Posted: December 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)