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NCT03739151 · ClinicalTrials.gov registry record · NA
Passive Sensing Technology for Lapse Measurement
A NA study, sponsored by The Miriam Hospital.
- Completed
- Registry status
- NA
- Development phase
- 32
- Enrollment target
NCT03739151 is a NA study that has completed, run by The Miriam Hospital. The registered enrollment target is 32 participants.
The verdict
NCT03739151, a NA study, has completed, sponsored by The Miriam Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 32 participants
- Enrollment target
Study Summary
Behavioral obesity treatment (BOT) produces clinically significant weight loss and health benefits for many individuals with overweight/obesity and cardiovascular disease (CVD). Yet, about half of patients fall short of expected outcomes and most experience gradual weight regain, thus negating the benefits over time. Lapses (i.e., self-reported eating instances that deviate from the BOT prescribed diet) could explain poor outcomes, but the behavior is understudied because it is difficult to assess in-lab and via self-report. The investigators therefore propose to study lapses using a multimethod approach with the following tools: ecological momentary assessment (EMA; repeated sampling method via mobile device), a wrist-worn device that automatically detects eating behavior and various eating characteristics (frequency, rate, and duration of eating episodes), and 24-hour dietary recalls. The investigators will recruit participants (n=40) with overweight/obesity and one additional CVD risk factor to enroll in a 12-week BOT program and an additional 12-week period of weight loss maintenance. Participants will complete a biweekly 7-day EMA protocol to self-report on eating behavior, including the occurrence of dietary lapse. Participants will continuously wear the wrist-worn ActiGraph Link to characterize eating behavior. Lastly, participants will complete 24-hour dietary recalls via structured interview (split between days with and without lapses) at 6-week intervals to measure the composition of all food and beverages consumed. This study aims to 1) identifying characteristics of lapse behavior by measuring passively-sensed timing, duration, frequency, and rate of eating amongst known lapse episodes, 2) test the association between dietary lapse frequency and weight change, and 3) estimate nutrition composition of dietary lapses. The study approach is consistent with priorities of NHLBI to optimize clinical research and diagnostic strategies to improve CVD and related
Interventions
- BEHAVIORAL Behavioral Obesity Treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2018-10-24 |
| Est. Completion | 2020-09-15 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03739151
The ClinicalTrials.gov registry entry for NCT03739151 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Miriam Hospital, which has 136 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Behavioral Obesity Treatment is the first listed.
NCT03739151 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03739151 about?
NCT03739151 is a clinical study titled "Passive Sensing Technology for Lapse Measurement". Behavioral obesity treatment (BOT) produces clinically significant weight loss and health benefits for many individuals with overweight/obesity and cardiovascular disease (CVD). Yet, about half of patients fall short of expected outcomes and most experience gradual weight regain, thus negating the b...
What is the current status of trial NCT03739151?
This trial is currently completed. It is a NA study. The enrollment target is 32 participants. The study started on 2018-10-24. Estimated completion is 2020-09-15.
What interventions are being tested in trial NCT03739151?
The interventions under investigation include: Behavioral Obesity Treatment (BEHAVIORAL).
Who is sponsoring clinical trial NCT03739151?
This trial is sponsored by The Miriam Hospital, which has 136 total clinical trials registered on ClinicalTrials.gov.
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