NCT04225234

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

September 5, 2024

Status Verified

August 1, 2024

Enrollment Period

7 months

First QC Date

January 8, 2020

Last Update Submit

August 30, 2024

Conditions

Overweight and Obesity

Keywords

Financial incentiveBehavioral economicsAttritionReachParticipationRetentionWeight loss

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Weight loss

    3, 6, and 12 months

  • Clinical meaningful weight loss

    3, 6, and 12 months

Study Arms (4)

Weight loss incentive

ACTIVE COMPARATOR

Participants will receive incentive rewards based on WEIGHT LOSS outcomes.

Other: Financial incentives

Weigh-in incentive

EXPERIMENTAL

Participants will receive incentive rewards based on WEIGH-INs frequency

Other: Financial incentives

Combination incentive

EXPERIMENTAL

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

Other: Financial incentives

Choice option incentive

EXPERIMENTAL

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

Other: Financial incentives

Interventions

Financial incentivesOTHER

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 incentiveCombination incentiveWeigh-in incentiveWeight loss incentive

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nebraska Medicine Fontenelle clinic

Omaha, Nebraska, 68104, United States

Location

Related Publications (1)

  • 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.

    PMID: 32920241DERIVED

MeSH Terms

Conditions

OverweightObesityTooth WearWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsTooth DiseasesStomatognathic DiseasesBody Weight Changes

Study Officials

  • Tzeyu Michaud, PhD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2020

First Posted

January 13, 2020

Study Start

August 20, 2019

Primary Completion

March 31, 2020

Study Completion

August 31, 2021

Last Updated

September 5, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)