A Soft Commitment Device to Encourage Intermittent Fasting in Patients With the Metabolic Syndrome
Phase: NA
Conditions: Hypertension, Obesity
Sponsor: University of Pennsylvania

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IFAST 
Intermittent Fasting Adherence and Self-Tracking 
 
 
 
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October 19, 2021 
 
 

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1. 
Background 
1.1.  
Non-Pharmacologic Interventions to Improve Blood Pressure Control 
Despite the wide availability of multiple classes of antihypertensive agents, compelling data that 
blood pressure (BP) lowering reduces mortality and cardiovascular events, and decades of public 
health campaigns, half of American adults with hypertension do not achieve adequate BP 
control.1–3 Randomized controlled trials of interventions to improve BP control in patients with 
hypertension have largely focused on home blood pressure monitoring, nurse- or pharmacist-lead 
education and medication titration, and/or financial incentives. Though many of these 
interventions improve short-term blood pressure control,4–10 they are cost-additive to health 
systems,11 post-intervention data is mixed,12,13 and none have been widely implemented. 
Though consensus guidelines recommend dietary changes to improve hypertension control, with 
a particular recommendation in favor of the DASH (Dietary Approaches to Stop Hypertension) 
diet,14,15 very few U.S. patients adhere to this complex dietary pattern.16,17 The DASH diet 
reduced systolic BP (SBP) by 11 mmHg in randomized controlled trials in which participants 
were provided with food,18,19 and 4 mmHg in a study testing a 6-month, 18-visit intensive 
lifestyle intervention intended to promote the DASH diet;20 however, BP control was not 
sustained 12 months after the end of the intensive intervention.21  
1.2. 
Effect of Intermittent Fasting on Metabolic Parameters 
In contrast to the DASH diet, intermittent fasting (IF) is a dietary pattern that emphasizes 
temporal restriction of caloric intake rather than restricting the number of calories and/or 
changing the types of foods eaten.22 The simplest and most popular variation of IF involves 
restricting caloric intake to an 8-hour period each day, and consuming no calories for the other 
16 hours (so-called 16:8 time-restricted feeding).23 In animal studies, IF has been shown to 
activate cellular pathways with potential disease-modifying benefits in a number of conditions.22 
In small human studies, IF is associated with a reduction in SBP by 5-10 mmHg, LDL 
cholesterol by ~8 mg/dl, and weight by ~ 3 kg, though none of the studies of a time-restricted 
feeding regimen included concurrent controls.23–29 Some patients report that IF is easier to 
initiate and maintain than other dietary patterns, though this has not been tested empirically.30 
1.3. 
Commitment Devices to Promote Healthy Behaviors    
Commitment devices are centered in theoretical research that posits a planner-doer framework, 
wherein an individual can be conceptualized as dual sub-selves: The planner, who cares about 
long-term well-being; and the doer, who cares only for the present and prioritizes immediate 
payoffs.31 Conflict between the motivations and priorities of the planner and the doer sub-selves 
results in failure to follow-through with a plan when the moment to act arrives.32 Commitment 
devices are mechanisms by which the planner sub-self constrains the actions of their future doer 
sub-self by making certain choices more costly.33 Hard commitments impose a financial penalty 
for failing to follow through on the commitment, and soft commitments impose a psychological 
penalty. Hard commitments have been shown to change health behaviors, as in a study where 
smokers forfeited money deposited in a savings account if they failed to quit smoking after 6 
months.34 However, monetary losses may not be attractive to many people, and effective soft 
commitment devices may be more appealing.33 

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Pre-clinical research suggests that both intra- and interpersonal commitments might be useful 
components of a soft commitment device. Intrapersonal commitments have also been framed as 
implementation intentions, or specific plans as to where, how, and/or when an action will be 
taken.35 In small experiments, smokers who set a quit date were more likely to quit, and college 
students who set a date and time to visit a vaccination clinic were more likely to receive their 
vaccination.36,37 Interpersonal commitments leverage social networks, so that the penalty 
involves letting down a support partner.38 Involvement of social networks has been used to 
increase physical activity and improve control of weight and blood glucose in patients with 
obesity and diabetes.39–42 Social networks have been used explicitly within the context of 
commitment devices to encourage deposits in a savings account in a study of Chilean micro-
entrepreneurs who either attended or did not attend a weekly peer support group meeting.43 
Weight loss studies encouraging participants to exercise and change their eating behavior have 
employed commitment devices,44 including some that leveraged the involvement of family 
members or friends of the participant,45,46 with mixed results.  
1.4  
Rationale for the IFAST Study 
The IF dietary pattern, though not inspired by behavioral economic concepts, is structured to take 
advantage of them and thus may be particularly amenable to a robust commitment device 
intervention. Changing one’s eating patterns to a complex new diet is a cognitively intense 
process that requires active consideration of complex information multiple times per day, leading 
to cognitive overload and impaired decision-making.47–49 By contrast, IF, especially time-
restricted feeding, is cognitively very simple. This simplicity may help participants avoid 
cognitive overload, initiate the dietary pattern and adhere over the long term. 
This study seeks to test how a robust soft commitment device, incorporating both intra- and 
interpersonal commitments, affects uptake and adherence to an intermittent fasting dietary 
pattern, as compared with control, in patients with obesity and hypertension  
2. Study Objectives 
The objectives of this study are the following: 
1. To determine the effect of a robust soft commitment device, incorporating both intra- and 
interpersonal commitments, on uptake and adherence to an intermittent fasting dietary 
pattern, as compared with control, in patients with hypertension and obesity 
2. To determine the effect of the intervention promoting intermittent fasting on blood 
pressure and weight in patients with hypertension and obesity 
 
3. 
Study Design 
3.1.  
General Overview 
The IFAST study is a two-arm randomized controlled trial aimed at evaluating whether a soft 
commitment device increases uptake and adherence to an intermittent fasting dietary pattern 
compared with control in patients with hypertension and obesity. The study will randomize 34 
patients with hypertension and obesity to a 12-week intervention employing a commitment 
pledge, involvement of a supportive partner, setting of implementation intentions, and multiple 
daily reminder text messages or to an attention control involving daily text messages alone. 

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Following the intervention, there will be a 6-week follow-up period (see study protocol figure 
below). 
 
  
 
The study will be conducted using Way to Health, a research information technology platform at 
the University of Pennsylvania used previously for behavioral interventions. 
 
After institutional review board (IRB) approval of the study, patients who meet the eligibility 
criteria will be approached in select cardiology clinics and invited to participate. Those who 
qualify and express interest will provide informed consent to the study procedures via the Way to 
Health platform. All patients will receive a blood pressure cuff and scale, which will be used to 
measure blood pressure and weight weekly. Within the Way to Health platform, patients will be 
randomized to the intervention or control arms. All other management decisions are completely 
at the discretion of the care providers. Data capture will include: 
 Baseline case report form (for each patient) collecting clinical information abstracted 
from the medical record 
 Baseline survey collected via the Way to Health platform including psychometric 
questions, dietary patterns, and experiences with weight loss and dieting 
 Daily adherence to an intermittent fasting dietary pattern collected via self-report 
from text messages 
 Weekly weight and blood pressure measurement collected via self-report from text 
messages  
 

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3.2.  
Site 
IFAST will enroll patients from cardiology clinics at the Hospital of the University of 
Pennsylvania and/or via email. 
 
3.3.  
Patient Selection Criteria 
3.3.1.  Inclusion Criteria 
Patients are eligible to be included in the study if they are ≥ 18 years of age and meet all of the 
following criteria: 
1. Body mass index > 30 kg/m2 
2. Systolic blood pressure > 140 mmHg 
3. Owns a smartphone or tablet operating the iOS or Android operating system 
 
3.3.2.  Exclusion Criteria 
Patients are excluded if they meet any of the following criteria: 
1. Unable or unwilling to provide informed consent, including but not limited to cognitive 
or language barriers (reading or comprehension) 
2. Type 1 diabetes 
3. Use of insulin or insulin secretagogues (sulfonylureas, metaglinides) 
4. Use of medications that require food intake 
5. Ongoing use of pharmacologic therapy for weight loss 
6. Self-reported eating disorder 
7. Other medical condition that could be harmed by intermittent fasting as judged by study 
physician 
8. Anticipated life expectancy less than 6 months 
9. Any other reason why it is not feasible to complete the entire 6-month study 
 
4.  
Study Procedures 
4.1. 
Screening and Informed Consent 
Patients with body mass index > 30 kg/m2 and SBP > 140 mmHg will be identified in select 
cardiology clinics and invited to participate. Interested participants will be instructed to visit the 
Way to Health platform online to register. They will also provide a contact number and email 
address, and will receive a reminder email and a phone call from a study coordinator for 
assistance with registration.  
 
In addition, a data pull of potentially eligible participants will be performed during the study 
preparation phase. Once the research team obtains this eligibility list, the order of participants on 
the list will be randomized and then split into batches of 1000. The initial recruitment list will 
consist of 500 potentially eligible participants, which will help to ensure all the enrollment 
mechanisms are in place and working well. Three weeks after the initial recruitment 
emails/letters are sent, a second batch will be sent. Every 2-3 weeks thereafter, a new batch will 
be sent out until the randomization target is met. Interested participants will be provided with 
instructions to visit the Way to Health online platform to register for the study. 
 
On the Way to Health platform, participants will learn more about the study, create an account, 
provide informed consent, and complete baseline study surveys. Study coordinators will be 
available to assist patients with this process, as necessary.  

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We will follow an IRB-approved approach taken by many studies using the Way to Health 
platform to obtaining informed consent. Upon reaching the portal, potential participants will be 
asked to create an account and will then be informed of the details of the study, including its 
objectives, duration, requirements, and financial payments.  The Way to Health portal will then 
take interested participants through an online informed consent. The consent document will be 
divided into sections and potential participants will have to click a button to advance through 
each section. This is to help ensure that participants read the consent form thoroughly by 
breaking down the form into manageable blocks of text. Each section will have a button allowing 
the user to contact a researcher via email or by telephone if they have questions about the 
consent form. Successive screens will explain the voluntary nature of the study, the risks and 
benefits of participation, alternatives to participation, and that participants can withdraw from the 
study at any time. On the final consent screen, potential participants who click a clearly 
delineated button stating that they agree to participate in the study will be considered to have 
consented to enroll. Participants will be provided with details regarding how to contact the 
research team via email or phone at any time if they subsequently wish to withdraw from the 
study. This contact information will remain easily accessible via the participants’ individual Way 
to Health web portal dashboards throughout the study.   
Support partners will provide verbal informed consent via telephone for their name, email 
address, and phone number to be stored in the study database. 
Once participants have completed the informed consent process, they will be mailed a scale and 
blood pressure cuff. 
4.2. 
Baseline Questionnaire and Intermittent Fasting Education 
After providing informed consent, participants will complete an online questionnaire. The 
baseline surveys will ask about dietary patterns and experiences with weight loss and dieting. 
Patients will also complete the Grit Scale and the MOS Social Support survey to obtain a 
psychometric profile relevant for persistence with a dietary intervention. They will also complete 
the 2005 Healthy Eating Index scale to assess pre-intervention diet quality. 
Following completion of the baseline questionnaire, participants will receive education about 
intermittent fasting, including its definition, potential health benefits, and expectations about the 
experience.  
4.3. 
Randomization 
Once patients have received their scale and blood pressure cuff, they will be prompted by 
automated text message from the Way to Health platform to obtain a baseline weight and blood 
pressure. Once they provide baseline measurements and baseline questionnaires have been 
completed, they will be randomly assigned via the Way to Health platform to attention control or 
the soft commitment device using 1:1 allocation. Randomization will be stratified based on BMI 
(≤ and > 40 kg/m2) and systolic blood pressure (≤ and > 160 mmHg) and will use blocks of 6 to 
ensure equal allocation over time. 
4.4. 
Study Arms 
4.4.1 Attention control 
These patients will be instructed via text message and email to fast at least 16 hours per day 
every day. For the next 16 weeks, they will receive a daily text message via the Way to Health 

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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 
 
4.4.1.  Soft commitment device 
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. 
 
For the next 12 weeks, participants in this arm will receive reminder text messages two times 
daily via Way to Health: Once at the start of their fast period and once during the meal that they 
skip during the fast period. Each week, participants and their support partner will also receive a 
text message noting how many days in the previous week they successfully fasted for at least 16 
hours. After the 12 week intervention, these text messages will stop, but for the entire 18-week 
period, participants in this arm will receive the same text messages as the attention control arm: 
A daily text message asking if they fasted for at least 16 hours over the previous 24 hours, and a 
weekly text message asking for weight and blood pressure results. 
 
4.5.  
End-of-Study Questionnaire Completion 
At the end of the 16-week study period, patients will be alerted by the Way to Health platform to 
return to the website to complete an end-of-study questionnaire regarding their experience with 
IF.  
 
5. 
Statistical Methods 
5.1 
Primary and secondary outcome measures 
The study’s primary outcome measure is adherence to the IF regimen, captured via daily text 
message, over 18 weeks, expressed in days per week.  
 
Secondary outcome measures will include:  
1) Adherence to the IF regimen over 12 weeks 
2) Change in systolic blood pressure from baseline to 12 weeks and 18 weeks 
3) Change in weight from baseline to 12 weeks and 18 weeks 
Exploratory analyses will compare change in blood pressure and weight in patients that were 
adherent to IF ≥ 4 days per week vs. < 4 days per week 
 
5.2.  
Sample Size  
With 34 patients (17 per arm), we will have 90% power to detect a 1 day per week difference in 
adherence to IF, assuming a standard deviation in days fasted per week < 1.24 The study will 

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have ~ 50% power to detect a 10 mmHg change in systolic and diastolic blood pressure 
(assuming a standard deviation of 15 mmHg) and a 3 kg weight loss (assuming a standard 
deviation of 5 kg). 
 
5.3.  
Data Analyses 
Data for all patients who received at least 1 text message asking if they fasted the day prior, 
whether or not they completed all protocol requirements, will be included for analysis. Patient 
demographics, risk profiles, clinical characteristics, and baseline questionnaire results will be 
reported. All analyses will be performed using a modified intention-to-treat, excluding only 
patients who did not receive at least 1 text message asking if they fasted the day prior. Data can 
be missing for any day if the participant did not report adherence with daily fasting. For the main 
analysis, we will assume that days for which patients did not report adherence with daily fasting 
were non-adherent days. The primary analysis will compare days fasted per week between 
attention control and commitment device arms using a t test.  Secondary analyses compare 
change from baseline in blood pressure and weight between arms using mixed effects regression 
models. Exploratory analyses will compare change from baseline in blood pressure and weight in 
patients who reported fasting ≥ 4 days/week versus those who reported fasting < 4 days/week 
using mixed effects regression models.  
 
6.  
Human Research Protection 
6.1  
Data confidentiality  
Paper-based records will be kept in a secure location and only be accessible to personnel 
involved in the study. Computer-based files will only be made available to personnel involved in 
the study through the use of access privileges and passwords. Wherever feasible, identifiers will 
be removed from study-related information. Precautions are in place to ensure the data are secure 
by using passwords and encryption, because the research involves web-based surveys.  
 
6.2  
Subject confidentiality  
Research material will be obtained from participant surveys and wearable devices. All 
participants will provide informed consent for access to these materials. The data to be collected 
include data on participant characteristics and behaviors, daily adherence to an IF dietary pattern, 
and weekly weight and blood pressure measurements. Research material that is obtained will be 
used for research purposes only. The same procedure used for the analysis of automated data 
sources to ensure protection of patient information will be used for the survey data, in that 
patient identifiers will be used only for linkage purposes or to contact patients. The study 
identification number, and not other identifying information, will be used on all data collection 
instruments. All study staff will be reminded to appreciate the confidential nature of the data 
collected and contained in these databases. The Penn Medicine Academic Computing Services 
(PMACS) will be the hub for the hardware and database infrastructure that will support the 
project and is where the Way to Health web portal is based. The PMACS is a joint effort of the 
University of Pennsylvania's Abramson Cancer Center, the Cardiovascular Institute, the 
Department of Pathology, and the Leonard Davis Institute. The PMACS provides a secure 
computing environment for a large volume of highly sensitive data, including clinical, genetic, 
socioeconomic, and financial information. Among the IT projects currently managed by PMACS 
are: (1) the capture and organization of complex, longitudinal clinical data via web and clinical 

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applications portals from cancer patients enrolled in clinical trials; (2) the integration of genetic 
array databases and clinical data obtained from patients with cardiovascular disease; (3) 
computational biology and cytometry database management and analyses; (4) economic and 
health policy research using Medicare claims from over 40 million Medicare beneficiaries. 
PMACS requires all users of data or applications on PMACS servers to complete a PMACS-
hosted cybersecurity awareness course annually, which stresses federal data security policies 
under data use agreements with the university. The curriculum includes Health Insurance 
Portability and Accountability Act (HIPAA) training and covers secure data transfer, passwords, 
computer security habits and knowledge of what constitutes misuse or inappropriate use of the 
server. We will implement multiple, redundant protective measures to guarantee the privacy and 
security of the participant data. All investigators and research staff with direct access to the 
identifiable data will be required to undergo annual responsible conduct of research, 
cybersecurity, and HIPAA certification in accordance with University of Pennsylvania 334 
regulations. Data will be stored, managed, and analyzed on a secure, encrypted server behind the 
University of Pennsylvania Health System (UPHS) firewall. This server was created for projects 
conducted by the Penn Medicine Nudge Unit related to physician and patient behavior at UPHS. 
All study personnel that will use this data are listed on the IRB application and have completed 
training in HIPAA standards and the CITI human subjects research. Data access will be 
password protected. Whenever possible, data will be deidentified for analysis.  
 
6.3  
Subject privacy  
Interested participants will be directed to the Way to Health portal where they will be asked to 
enter data related to eligibility and their demographic characteristics. Enrollment will include a 
description of the voluntary nature of participation, the study procedures, risks and potential 
benefits in detail. The enrollment procedure will provide the opportunity for potential 
participants to ask questions and review the consent form information prior to making a decision 
to participate. Participants will be told that they do not have to answer any questions if they do 
not wish and can drop out of the study at any time, without affecting their medical care or the 
cost of their care. They will be told that they may or may not benefit directly from the study and 
that all information will be kept strictly confidential, except as required by law. Subjects will 
have access to a copy of the consent document. All efforts will be made by study staff to ensure 
subject privacy.  
 
6.4  
Data disclosure  
The following entities, besides the members of the research team, may receive protected health 
information (PHI) for this research study: Twilio, Inc., the company which processes some 359 
study-related messages. Twilio will store patients' phone numbers on their secure computers. 
Qualtrics, Inc., the company which processes most study-related surveys. Qualtrics will house 
de-identified answers to these surveys on their secure servers. The Office of Human Research 
Protections at the University of Pennsylvania -Federal and state agencies (for example, the 
Department of Health and Human Services, the National Institutes of Health, and/or the Office 
364 for Human Research Protections), or other domestic or foreign government bodies if 
required by 365 law and/or necessary for oversight purposes.  
 
6.5  
Data safety and monitoring  

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The Principal Investigator will be responsible for monitoring the study. All participants will be 
given anticipatory guidance on when to seek medical attention. In addition, participants will be 
asked to report to the study team any injuries or medical care that they feel resulted from 
participation in the study. They can either call the study team or send an email. The research 
coordinator will call the participant to collect information regarding the issue and then the PI will 
review and determine whether it is ok to proceed, further investigation is needed, or the 
participant should stop the study. For this study there will be no stopping rules or endpoints and 
thus no planned interim analyses.  
 
6.6  
Risk/benefit  
6.6.1  Potential study risks  
Both arms will be instructed to pursue an IF dietary pattern, which has been shown to be 
generally safe across multiple studies. Potential adverse effects of IF include irritability, hunger, 
difficulty with concentration, development of an eating disorder, disrupted sleep, dehydration 
and dizziness, and feelings of guilt and increased stress. There is a theoretical risk of 
hypoglycemia and pancreatitis. At the start of the study, patients will be given information on 
risks of IF and guidance on when to seek medical attention. They will also be encouraged to 
consume plenty of fluids during their daily fasting period. Patients on insulin or insulin 
secretagogues will be excluded from participation, limiting the risk of iatrogenic hypoglycemia, 
but patients with diabetes mellitus will be asked about episodes of hypoglycemia via weekly text 
messages, and all patients will be asked about hospitalizations and emergency room visits via 
weekly text messages. 
 
Another potential risk of this study is a breach of participant confidentiality. We will minimize 
this risk by using secure data methods as described previously. Names and addresses will be 
stored in encrypted databases. These data will be viewable only by the respective participants, 
the study coordinator(s) and the project manager(s). All other members of the research team will 
be able to view only participant ID numbers. Even the study arms will be identified by code 
letters until both the statistician and PI agree that analysis is complete.  
 
6.6.2  Potential study benefits  
Through participation in this study, each participant will have the potential to engage in an IF 
dietary pattern. In small studies, IF has been associated with weight loss and improvement in 
cardiometabolic parameters, including blood pressure and lipids. If this approach to encouraging 
IF is effective, it could have tremendous benefits for society if adopted on a wide scale to help 
individuals. It is expected that other people will gain knowledge from this study and that 
participation could help understand how to effectively motivate individuals to change behavior. 
Participants may also receive no benefit from their participation in the study.  
 
6.6.3  Risk/benefit assessment  
Anticipated risks of this study should be minimal and the risk/benefit ratio is very favorable. To 
minimize the chance for serious and unexpected adverse events, study participants will be 
screened through exclusion criteria for any health conditions that may be exacerbated by 
participating in this study. We have previously outlined the procedures that will be used to 
prevent a breach of participant data. 
 

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