Sustaining the Reach of a Scalable Weight Loss Intervention Through Financial Incentives

Not Applicable

Terminated

• Conditions: Overweight and Obesity

• Registration Number: NCT04225234
• Lead Sponsor: University of Nebraska

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.

Study Timeline

• Study Start: 2019-08-20
• Study First Submitted: 2020-01-08
• Study First Submitted QC: 2020-01-08
• Study First Posted: 2020-01-13
• Primary Completion: 2020-03-31
• Study Completion: 2021-08-31
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-25
• Last Update Posted: 2023-08-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

• Overweight or obese participants who are of 19 years or older and have internet access

Exclusion Criteria

• Not meeting the inclusion criteria.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sustaining the reach	3, 6, and 12 months	Percentage of participants returning to weigh-in 3, 6, and 12 months after initial program registration

Secondary Outcome Measures

Name	Time	Method
Clinical meaningful weight loss	3, 6, and 12 months	Percentage of participants achieving clinically significant weight loss (percentage of patients who lost \>3% or \>5% of their initial bodyweight)
Weight loss	3, 6, and 12 months	weight loss achieved at 3, 6 and 12 months

Trial Locations

Locations (1)

Nebraska Medicine Fontenelle clinic; 🇺🇸 Omaha, Nebraska, United States