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NCT05562427 · ClinicalTrials.gov registry record · NA

Program for Fully Understanding Eating and Lifestyle Change (FUEL)

A NA study of Obesity, sponsored by The Miriam Hospital.

Recruiting
Registry status
NA
Development phase
150
Enrollment target
1
Study location

NCT05562427 is a NA study of Obesity that is actively recruiting participants, run by The Miriam Hospital. The registered enrollment target is 150 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05562427, a NA study of Obesity, is actively recruiting participants, sponsored by The Miriam Hospital.

RECRUITING
Registry status
NA
Development phase
150 participants
Enrollment target
1
Study location

Study Summary

This project seeks to better understand dietary lapses (instances of nonadherence to dietary goals), a major cause of poor outcomes during behavioral obesity treatment (BOT). Investigators propose to conduct multimodal real-time assessment of behavioral, psychosocial, and contextual characteristics to uncover lapse phenotypes (i.e., meaningful clusters of lapse behaviors, such as lapsing via overeating vs. lapsing via eating an off-plan food). Using wearable sensors and a smartphone-based assessment platform, this research will identify latent characteristics underlying different phenotypes of dietary lapses reported by individuals who are participating in an online BOT. This study will also evaluate how these emerging lapse phenotypes vary over time, between individuals, and within individuals. Such information will ultimately help the field understand how best to reduce lapses in future treatments (e.g., how much to personalize future interventions for lapse vs. generalizability of lapse phenotypes across individuals). Therefore, this study has three goals. First, investigators aim to establish lapse phenotypes by identifying clusters of behavioral, psychosocial, contextual and individual-level factors (e.g., sex, race) that differentiate lapse behaviors during weight loss and maintenance. Second, the investigators aim to test the association of lapse phenotypes with energy intake and weight change during weight loss and maintenance to determine which lapse phenotypes have the greatest impact on BOT outcomes (e.g. personal, environmental, and behavioral factors). Lastly, investigators aim to evaluate individual variability in the occurrence of lapse phenotypes during weight loss and maintenance to determine the generalizability of lapse phenotypes across individuals. Participants will be recruited through various methods including advertisements in local media, targeted online advertising, advertisements in medical and minority communities, and direct mailers. Al

Conditions Studied

Interventions

  • BEHAVIORAL Gold-Standard Online Behavioral Obesity Treatment

Study Locations (1)

Rhode Island

  • Weight Control and Diabetes Research Center - Providence

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2022-10-31
Est. Completion 2027-04-30
Phase NA

Sponsor

The Miriam Hospital

136 total trials

What the Registry Record Tells You About NCT05562427

The ClinicalTrials.gov registry entry for NCT05562427 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (82% lower). The listed sponsor is The Miriam Hospital, which has 136 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Obesity appearing as the primary indexed condition, and to 1 intervention - of which Gold-Standard Online Behavioral Obesity Treatment is the first listed.

NCT05562427 reports 1 study location spanning 1 distinct geographic area - top geographies include Rhode Island.

Frequently Asked Questions

What is clinical trial NCT05562427 about?

NCT05562427 is a clinical study titled "Program for Fully Understanding Eating and Lifestyle Change (FUEL)". This project seeks to better understand dietary lapses (instances of nonadherence to dietary goals), a major cause of poor outcomes during behavioral obesity treatment (BOT). Investigators propose to conduct multimodal real-time assessment of behavioral, psychosocial, and contextual characteristics ...

What is the current status of trial NCT05562427?

This trial is currently recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2022-10-31. Estimated completion is 2027-04-30.

What conditions does trial NCT05562427 study?

This clinical trial studies the following conditions: Obesity.

What interventions are being tested in trial NCT05562427?

The interventions under investigation include: Gold-Standard Online Behavioral Obesity Treatment (BEHAVIORAL).

Who is sponsoring clinical trial NCT05562427?

This trial is sponsored by The Miriam Hospital, which has 136 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05562427 being conducted?

This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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