Overweight and ObesityNCT04225234
Sustaining the Reach of a Scalable Weight Loss Intervention Through Financial Incentives
A study testing Financial incentives in people with Overweight and Obesity, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Financial incentives
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2019to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Overweight or obese participants who are of 19 years or older and have internet access
Who cannot join
- Not meeting the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nebraska Medicine Fontenelle clinic
Omaha, Nebraska, 68104
About this study
Official title: Sustaining the Reach of a Scalable Weight Loss Intervention Through Financial Incentives: an Exploratory Randomized Controlled Trial
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.
Read the 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
- Being tested
- Financial incentives
- Keywords
- Financial incentive, Behavioral economics, Attrition, Reach, Participation, Retention, Weight loss
- Medical subject headings
- Overweight, Obesity, Tooth Wear, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Weight loss incentive | Active comparator | Participants will receive incentive rewards based on WEIGHT LOSS outcomes. Receives: Other: Financial incentives |
| Weigh-in incentive | Experimental | Participants will receive incentive rewards based on WEIGH-INs frequency Receives: Other: Financial incentives |
| Combination incentive | Experimental | Participants will receive half of the incentive from WEIGHT LOSS and WEIGH-INs Receives: Other: Financial incentives |
| Choice option incentive | Experimental | Participants will choose one out of the three incentive programs (Weight-loss, Weigh-ins, and Combination). Receives: Other: Financial incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustaining the reach
Percentage of participants returning to weigh-in 3, 6, and 12 months after initial program registration
Measured: 3, 6, and 12 months
Secondary outcomes (2)
Weight loss
weight loss achieved at 3, 6 and 12 months
Measured: 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)
Measured: 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start20 Aug 2019
- Primary completion31 Mar 2020
- Study completion31 Aug 2021
Why it stopped: Due to the COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tzeyu Michaud, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225234
- Sponsor's protocol ID
- 0211-19-EP
- Status last verified
- Aug 2024
- First submitted
- 8 Jan 2020
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32920241
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustaining the Reach of a Scalable Weight Loss Intervention Through Financial Incentives: an Exploratory Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04225234
- Acronym / sponsor ID
- 0211-19-EP
- Conditions
- Overweight and Obesity
- Keywords
- Financial incentive, Behavioral economics, Attrition, Reach, Participation, Retention, Weight loss
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the COVID-19 pandemic
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Weight loss incentive | Active comparator | Other: Financial incentivesParticipants will receive incentive rewards based on WEIGHT LOSS outcomes. |
| Weigh-in incentive | Experimental | Other: Financial incentivesParticipants will receive incentive rewards based on WEIGH-INs frequency |
| Combination incentive | Experimental | Other: Financial incentivesParticipants will receive half of the incentive from WEIGHT LOSS and WEIGH-INs |
| Choice option incentive | Experimental | Other: Financial incentivesParticipants will choose one out of the three incentive programs (Weight-loss, Weigh-ins, and Combination). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Overweight or obese participants who are of 19 years or older and have internet access
Key exclusion criteria (1 listed)
- Not meeting the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Financial incentivesDepending 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. | Other | Choice option incentive, Combination incentive, Weigh-in incentive, Weight loss incentive |
Primary outcome
Sustaining the reach
Time frame: 3, 6, and 12 months
Percentage of participants returning to weigh-in 3, 6, and 12 months after initial program registration
2 secondary outcomes
Weight loss
Time frame: 3, 6, and 12 months
Clinical meaningful weight loss
Time frame: 3, 6, and 12 months
Results and safety
The study was stopped early (reason given: Due to the COVID-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Derived from this study: PubMed 32920241Michaud 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tzeyu Michaud, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial incentives in people with Overweight and Obesity, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to the COVID-19 pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustaining the reach (time frame: 3, 6, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04225234, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.