Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-26 @ 4:38 PM
Study NCT ID:
NCT04225234
Status:
TERMINATED
Last Update Posted:
2024-09-05
First Post:
2020-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sustaining the Reach of a Scalable Weight Loss Intervention Through Financial Incentives
Sponsor:
University of Nebraska
Organization:
Study Overview
Official Title:
Sustaining the Reach of a Scalable Weight Loss Intervention Through Financial Incentives: an Exploratory Randomized Controlled Trial
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to the COVID-19 pandemic
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study seeks to assess how different incentive strategies may reduce the initial attrition gap when implementing weight management in a primary care clinic predominantly serving African American patients. This will be done through an innovative research-practice partnership involving primary care, research expertise, and a small business. Participants will be randomly assigned to one of four financial incentive conditions respectively tied to: weight loss, weigh-ins, weigh-ins and weight-loss, and incentive choice. Participants will be followed for 3 and 6 months to assess program reach, sustaining the reach after initial weigh-in, and weight loss outcomes based on records on participant enrollment and subsequent weigh-ins automatically collected through a kiosk at the clinic.
Detailed Description:
The proposed study "Sustaining the Reach of a Scalable Weight Loss Intervention through Financial Incentives: an Exploratory Randomized Trial" seeks to assess how the use of different incentive strategies may reduce the initial attrition gap when implementing weight management in a primary care clinic predominantly serving African American patients through an innovative research-practice partnership involving primary care, research expertise, and a small business.
The sample will include approximately 200 persons ages 19+ from Nebraska Medicine or the greater Omaha community. The inclusion criteria are (1) age 19+ years; (2) are obese (BMI \>=30) or overweight (BMI \>=25 yet smaller than 30); (3) have internet access. Following the completion of an automated informed consent embedded within the program registration using a kiosk placed at the Fontenelle Clinic, we plan to conduct a 4-arm, pragmatic randomized controlled trial (RCT) that will randomly assign overweight/obese patients at the Nebraska Medicine Fontenelle clinic to one of four financial incentive conditions respectively tied to: weight loss, weigh-ins, weigh-ins and weight-loss, and incentive choice, following the completion of an automated informed consent embedded within the program registration and initial weigh-in. Participants will be followed for 3 and 6 months to assess program reach, sustaining the reach after initial weigh-in, and weight loss outcomes based on records on participant enrollment and subsequent weigh-ins automatically collected through a kiosk placed at the Fontenelle clinic.
The sample will include approximately 200 persons ages 19+ from Nebraska Medicine or the greater Omaha community. The inclusion criteria are (1) age 19+ years; (2) are obese (BMI \>=30) or overweight (BMI \>=25 yet smaller than 30); (3) have internet access. Following the completion of an automated informed consent embedded within the program registration using a kiosk placed at the Fontenelle Clinic, we plan to conduct a 4-arm, pragmatic randomized controlled trial (RCT) that will randomly assign overweight/obese patients at the Nebraska Medicine Fontenelle clinic to one of four financial incentive conditions respectively tied to: weight loss, weigh-ins, weigh-ins and weight-loss, and incentive choice, following the completion of an automated informed consent embedded within the program registration and initial weigh-in. Participants will be followed for 3 and 6 months to assess program reach, sustaining the reach after initial weigh-in, and weight loss outcomes based on records on participant enrollment and subsequent weigh-ins automatically collected through a kiosk placed at the Fontenelle clinic.
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?: