Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-04 @ 9:03 PM
Study NCT ID:
NCT04190069
Status:
WITHDRAWN
Last Update Posted:
2020-06-25
First Post:
2019-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Behavioral Interventions on Weight Loss and Weight Maintenance
Sponsor:
University of Pittsburgh
Organization:
Study Overview
Official Title:
Effects of Behavioral Interventions on Weight Loss and Weight Maintenance
Status:
WITHDRAWN
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
IRB recommended change to registry study or quality improvement project status
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of the study is to examine the extent to which diet/lifestyle change programs with a multidisciplinary team (consisting of a dietician, physician and behaviorist/health coach) that develop healthy behaviors before creating a calorie deficit for weight loss will result in greater weight loss and a longer duration of weight maintenance. It intends to compare the extent of weight loss and weight maintenance in participants who will undergo calorie restriction without prior behavioral interventions to participants that will undergo behavioral interventions prior to starting calorie restriction.
Detailed Description:
OPTIFAST is a medically supervised weight loss and weight management program that involves a complete meal replacement followed by a gradual introduction of foods after dietary education. The resources offered through this program are through a physician, registered dietitian and behaviorist, including a psychologist.
UPMC Prescription for Wellness is an innovative physician/provider prescribed coaching and feedback program that improves patient engagement and outcomes in healthy behaviors; self-care of chronic disease and condition management; and shared decision-making. The resources available through this program are offered via a telephonic health coach, online or through a digital intervention based on the participant's convenience.
The objective of the study is to examine the extent to which diet/lifestyle change programs with a multidisciplinary team (consisting of a dietician, physician and behaviorist/health coach) that develop healthy behaviors before creating a calorie deficit for weight loss will result in greater weight loss and a longer duration of weight maintenance. It intends to compare the extent of weight loss and weight maintenance in participants who will undergo calorie restriction without prior behavioral interventions to participants that will undergo behavioral interventions prior to starting calorie restriction.
Behavioral interventions will first be provided by UPMC Prescription for Wellness prior to starting OPTIFAST. Calorie restriction will be during the OPTIFAST Program. The participants will be actively recruited by the study team at the Center for Diabetes and Metabolism (CDE) at the Falk Clinic in Oakland, Pittsburgh.
UPMC Prescription for Wellness is an innovative physician/provider prescribed coaching and feedback program that improves patient engagement and outcomes in healthy behaviors; self-care of chronic disease and condition management; and shared decision-making. The resources available through this program are offered via a telephonic health coach, online or through a digital intervention based on the participant's convenience.
The objective of the study is to examine the extent to which diet/lifestyle change programs with a multidisciplinary team (consisting of a dietician, physician and behaviorist/health coach) that develop healthy behaviors before creating a calorie deficit for weight loss will result in greater weight loss and a longer duration of weight maintenance. It intends to compare the extent of weight loss and weight maintenance in participants who will undergo calorie restriction without prior behavioral interventions to participants that will undergo behavioral interventions prior to starting calorie restriction.
Behavioral interventions will first be provided by UPMC Prescription for Wellness prior to starting OPTIFAST. Calorie restriction will be during the OPTIFAST Program. The participants will be actively recruited by the study team at the Center for Diabetes and Metabolism (CDE) at the Falk Clinic in Oakland, Pittsburgh.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: