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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Sustaining the Reach of a Scalable Weight Loss Intervention Through Financial Incentives: an Exploratory Randomized Controlled Trial

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Other: Financial incentives


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overweight or obese participants who are of 19 years or older and have internet access Exclusion Criteria: Not meeting the inclusion criteria.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Our proposed project would be most appropriately be categorized as a partial factorial with choice model, because our study design includes 2 intervention each alone (weight loss and weigh-in), and in combination (weight loss + weigh-in), and choice. No control group is included.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Weight loss incentive<br>Participants will receive incentive rewards based on WEIGHT LOSS outcomes. | Other: Financial incentives<br>* 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.<br>|
| Experimental: Weigh-in incentive<br>Participants will receive incentive rewards based on WEIGH-INs frequency | Other: Financial incentives<br>* 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.<br>|
| Experimental: Combination incentive<br>Participants will receive half of the incentive from WEIGHT LOSS and WEIGH-INs | Other: Financial incentives<br>* 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.<br>|
| Experimental: Choice option incentive<br>Participants will choose one out of the three incentive programs (Weight-loss, Weigh-ins, and Combination). | Other: Financial incentives<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustaining the reach | Percentage of participants returning to weigh-in 3, 6, and 12 months after initial program registration | 3, 6, and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | weight loss achieved at 3, 6 and 12 months | 3, 6, and 12 months | 
| Clinical meaningful weight loss | Percentage of participants achieving clinically significant weight loss (percentage of patients who lost >3% or >5% of their initial bodyweight) | 3, 6, and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Financial incentive, Behavioral economics, Attrition, Reach, Participation, Retention, Weight loss