ObesityRISENCT04353258
Research Intervention to Support Healthy Eating and Exercise
A study testing Behavioral Economics intervention (BE mHealth) and Standard mHealth intervention (mHealth) in people with Obesity, run by University of Connecticut at 1 site in United States.
Trial summary
The primary aim of this study is to test the efficacy of a behavioral economics intervention for weight loss in adults from economically disadvantaged backgrounds. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- Behavioral Economics intervention (BE mHealth) and Standard mHealth intervention (mHealth)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2021to 17 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18-75
- BMI between 25-55kg/m2
- All sexes
- All racial/ethnic groups
- Low SES and/or report qualifying for federal, state or local benefits
- Have a smartphone and willing to use for research purposes
Who cannot join
- <18-75>years of age
- Report being unable to walk 2 blocks without stopping
- Are currently participating in weight loss treatment, have a history of bariatric surgery, or lost ≥5% in the past 6-months
- Are pregnant or plan to become pregnant within 1 year
- Report a heart condition, chest pain during periods of rest or activity, or loss of consciousness on the Physical Activity Readiness Questionnaire
- Report a medical condition that could jeopardize their safety in a weight control program with diet and exercise guidelines
Show all 10Show fewer
- Have diabetes and are on insulin
- Report a medical condition that could jeopardize their safety in a weight loss program with diet and exercise guidelines
- Report conditions that, in the judgment of the PI, would render them unlikely to follow the protocol (e.g., relocation, dementia, unable to read and write in English)
- Report unable to read and write English
Trial locations and contacts
1 site in 1 country.
United States1 site
UConn Weight Management Research Lab
Hartford, Connecticut, 06103
About this study
Official title: Using Behavioral Economic Strategies to Address Obesity in Economically Disadvantaged Adults
The primary aim of this study is to test the efficacy of a behavioral economics intervention for weight loss in adults from economically disadvantaged backgrounds.
- Conditions
- Obesity
- Being tested
- Behavioral Economics intervention (BE mHealth), Standard mHealth intervention (mHealth)
- Keywords
- weight loss, low income, behavioral economics, contingency management, episodic future thinking, mHealth
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Economics intervention (BE mHealth)Behavioural
Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth) that includes behavioral economics components.
Standard mHealth intervention (mHealth)Behavioural
Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth).
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Economics intervention (BE mHealth) | Experimental | Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth) that includes behavioral economics components. Receives: Behavioral: Behavioral Economics intervention (BE mHealth) |
| Standard mHealth intervention (mHealth) | Active comparator | Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth). Receives: Behavioral: Standard mHealth intervention (mHealth) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Weight change measured on a digital scale to the nearest 0.1-kilogram
Measured: Baseline, 2 month, 6 month, 12 month, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start7 Sep 2021
- Primary completion17 Dec 2024
- Study completion17 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tricia Leahey, University of Connecticut
- Investigators
- Tricia Leahey, PhD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04353258
- Sponsor's protocol ID
- H19-141
- Other IDs
- 1R01DK118957
- Acronym
- RISE
- Status last verified
- Jul 2025
- First submitted
- 16 Apr 2020
- Last updated
- 9 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Behavioral Economic Strategies to Address Obesity in Economically Disadvantaged Adults
- ClinicalTrials.gov ID
- NCT04353258
- Acronym / sponsor ID
- RISE / H19-141
- Conditions
- Obesity
- Keywords
- weight loss, low income, behavioral economics, contingency management, episodic future thinking, mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 17 Dec 2024 (actual)
- Study completion
- 17 Dec 2024 (actual)
- First posted
- 20 Apr 2020 (actual)
- Results
- Posted 9 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this study is to test the efficacy of a behavioral economics intervention for weight loss in adults from economically disadvantaged backgrounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Economics intervention (BE mHealth) | Experimental | Behavioral: Behavioral Economics intervention (BE mHealth)Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth) that includes behavioral economics components. |
| Standard mHealth intervention (mHealth) | Active comparator | Behavioral: Standard mHealth intervention (mHealth)Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18-75
- BMI between 25-55kg/m2
- All sexes
- All racial/ethnic groups
- Low SES and/or report qualifying for federal, state or local benefits
Key exclusion criteria (10 listed)
- <18-75>years of age
- Report being unable to walk 2 blocks without stopping
- Are currently participating in weight loss treatment, have a history of bariatric surgery, or lost ≥5% in the past 6-months
- Are pregnant or plan to become pregnant within 1 year
- Report a heart condition, chest pain during periods of rest or activity, or loss of consciousness on the Physical Activity Readiness Questionnaire
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 |
|---|---|---|
| Behavioral Economics intervention (BE mHealth)Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth) that includes behavioral economics components. | Behavioural | Behavioral Economics intervention (BE mHealth) |
| Standard mHealth intervention (mHealth)Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth). | Behavioural | Standard mHealth intervention (mHealth) |
Primary outcome
Weight
Time frame: Baseline, 2 month, 6 month, 12 month, 18 months
Weight change measured on a digital scale to the nearest 0.1-kilogram
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Obesity
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.
Tricia Leahey, PhD principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Economics intervention (BE mHealth) and Standard mHealth intervention (mHealth) in people with Obesity, run by University of Connecticut 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 6 inclusion and 10 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: finished, as of the sponsor's last update on 9 Jan 2026. 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?
Yes. Results are posted in the registry (first posted 9 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Weight (time frame: Baseline, 2 month, 6 month, 12 month, 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2026.