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

NCT ID: NCT04225234

Last Updated: 2024-09-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-20
• Study Completion Date: 2021-08-31

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.

Conditions

Overweight and Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Weight loss incentive

Participants will receive incentive rewards based on WEIGHT LOSS outcomes.

Group Type: ACTIVE_COMPARATOR

Financial incentives

Intervention Type: OTHER

Depending on their level of participation or weight loss outcomes, participants will have the opportunity to receive between $60-$120 (over 12 months), on average, regardless of program assignment.

Regardless of which incentive program that participants are randomized to, they will receive the incentaHEALTH weight loss program intervention. incentaHEALTH is an technology-supported multi-component coaching intervention for weight loss includes a website, objective weight assessment using HIPAA-compliant kiosks, daily social cognitive theory-based email and text message support, and online access to health coaches. The intervention encourages increased intake of fruit, vegetables, lean protein, and complex carbohydrates while monitoring portion sizes.

Weigh-in incentive

Participants will receive incentive rewards based on WEIGH-INs frequency

Group Type: EXPERIMENTAL

Financial incentives

Intervention Type: OTHER

Depending on their level of participation or weight loss outcomes, participants will have the opportunity to receive between $60-$120 (over 12 months), on average, regardless of program assignment.

Regardless of which incentive program that participants are randomized to, they will receive the incentaHEALTH weight loss program intervention. incentaHEALTH is an technology-supported multi-component coaching intervention for weight loss includes a website, objective weight assessment using HIPAA-compliant kiosks, daily social cognitive theory-based email and text message support, and online access to health coaches. The intervention encourages increased intake of fruit, vegetables, lean protein, and complex carbohydrates while monitoring portion sizes.

Combination incentive

Participants will receive half of the incentive from WEIGHT LOSS and WEIGH-INs

Group Type: EXPERIMENTAL

Financial incentives

Intervention Type: OTHER

Depending on their level of participation or weight loss outcomes, participants will have the opportunity to receive between $60-$120 (over 12 months), on average, regardless of program assignment.

Regardless of which incentive program that participants are randomized to, they will receive the incentaHEALTH weight loss program intervention. incentaHEALTH is an technology-supported multi-component coaching intervention for weight loss includes a website, objective weight assessment using HIPAA-compliant kiosks, daily social cognitive theory-based email and text message support, and online access to health coaches. The intervention encourages increased intake of fruit, vegetables, lean protein, and complex carbohydrates while monitoring portion sizes.

Choice option incentive

Participants will choose one out of the three incentive programs (Weight-loss, Weigh-ins, and Combination).

Group Type: EXPERIMENTAL

Financial incentives

Intervention Type: OTHER

Depending on their level of participation or weight loss outcomes, participants will have the opportunity to receive between $60-$120 (over 12 months), on average, regardless of program assignment.

Regardless of which incentive program that participants are randomized to, they will receive the incentaHEALTH weight loss program intervention. incentaHEALTH is an technology-supported multi-component coaching intervention for weight loss includes a website, objective weight assessment using HIPAA-compliant kiosks, daily social cognitive theory-based email and text message support, and online access to health coaches. The intervention encourages increased intake of fruit, vegetables, lean protein, and complex carbohydrates while monitoring portion sizes.

Interventions

Financial incentives

Depending on their level of participation or weight loss outcomes, participants will have the opportunity to receive between $60-$120 (over 12 months), on average, regardless of program assignment.

Regardless of which incentive program that participants are randomized to, they will receive the incentaHEALTH weight loss program intervention. incentaHEALTH is an technology-supported multi-component coaching intervention for weight loss includes a website, objective weight assessment using HIPAA-compliant kiosks, daily social cognitive theory-based email and text message support, and online access to health coaches. The intervention encourages increased intake of fruit, vegetables, lean protein, and complex carbohydrates while monitoring portion sizes.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tzeyu Michaud, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

Nebraska Medicine Fontenelle clinic

Omaha, Nebraska, United States

Countries

United States

References

Michaud TL, Estabrooks PA, You W, McGuire TJ, Almeida F, Karls K, Love K, King K, Hill J, Reed J, Porter G, Su D. Sustaining the reach of a scalable weight loss intervention through financial incentives- a pragmatic, feasibility, online randomized trial protocol. Contemp Clin Trials. 2020 Nov;98:106142. doi: 10.1016/j.cct.2020.106142. Epub 2020 Sep 10.

Reference Type: DERIVED

PMID: 32920241 (View on PubMed)

Other Identifiers

0211-19-EP

Identifier Type: -

Identifier Source: org_study_id