At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Soft Commitment Device to Encourage Intermittent Fasting in Patients With the Metabolic Syndrome
In Brief
A clinical study evaluating Soft Commitment Device for Hypertension and Obesity. Completed, enrolled 37 participants across 1 site.
Detailed 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
Study Details
Timeline
Interventions
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.