Clinical trial NCT04225234: Sustaining the Reach of a Scalable Weight Loss Intervention Through Financial Incentives
Official title: Sustaining the Reach of a Scalable Weight Loss Intervention Through Financial Incentives: an Exploratory Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Financial incentive
Behavioral economics
Attrition
Reach
Participation
Retention
Weight loss
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 119
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Not meeting the inclusion criteria.

Primary outcomes:
measure: Sustaining the reach
timeFrame: 3, 6, and 12 months
Secondary outcomes:
measure: Weight loss
timeFrame: 3, 6, and 12 months
measure: Clinical meaningful weight loss
timeFrame: 3, 6, and 12 months
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Nebraska Medicine Fontenelle clinic
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Tzeyu Michaud, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.