Trial Outcomes & Findings for Intermittent Fasting Adherence and Self Tracking (NCT NCT04836312)
NCT ID: NCT04836312
Last Updated: 2023-12-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
37 participants
Primary outcome timeframe
Weeks 1-18
Results posted on
2023-12-01
Participant Flow
Participant milestones
| Measure |
Attention Control
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
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.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
17
|
|
Overall Study
COMPLETED
|
20
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intermittent Fasting Adherence and Self Tracking
Baseline characteristics by cohort
| Measure |
Attention Control
n=20 Participants
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
n=17 Participants
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.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
60.1 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
60 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
17 participants
n=7 Participants
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 1-18Adherence 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.
Outcome measures
| Measure |
Attention Control
n=20 Participants
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
n=17 Participants
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.
|
|---|---|---|
|
Adherence to the Intermittent Fasting Regimen, Captured Via Daily Text Message, Over 18 Weeks, Expressed in Days Per Week
|
4.7 days per week
Standard Deviation 1.9
|
5.4 days per week
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Weeks 1-12Adherence to the IF regimen, captured via daily text message, over 12 weeks, expressed in days per week. This will measure adherence to the IF regimen for the 12 week intervention period only.
Outcome measures
| Measure |
Attention Control
n=20 Participants
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
n=17 Participants
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.
|
|---|---|---|
|
Adherence to the IF Regimen, Captured Via Daily Text Message, Over 12 Weeks, Expressed in Days Per Week
|
5.0 days per week
Standard Deviation 1.8
|
5.7 days per week
Standard Deviation 1.6
|
Adverse Events
Attention Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Soft Commitment Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place