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CompletedNCT04353258RISEUpdated Jan 9, 2026Results posted

Research Intervention to Support Healthy Eating and Exercise

An interventional study of Behavioral Economics intervention (BE mHealth) and Standard mHealth intervention (mHealth) in Obesity, sponsored by University of Connecticut. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-09.

Sponsored by University of Connecticut · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
195
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity

Keywords

  • weight loss, low income, behavioral economics, contingency management, episodic future thinking, mHealth
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 195 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University of Connecticut is the lead sponsor of 133 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • \<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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
195 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Behavioral Economics intervention (BE mHealth)

  • Active comparator
    Standard mHealth intervention (mHealth)

    Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth).

    Behavioral: Standard mHealth intervention (mHealth)

Interventions

  • BehavioralBehavioral 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.

  • BehavioralStandard mHealth intervention (mHealth)

    Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth).

06

What researchers measure

Primary outcomes

  1. Weight

    Weight change measured on a digital scale to the nearest 0.1-kilogram

    Time frame: Baseline, 2 month, 6 month, 12 month, 18 months

07

Results

Posted Jan 9, 2026

Participant flow

Participant flow — Overall Study
MilestoneBehavioral Economics Intervention (BE mHealth)Standard mHealth Intervention (mHealth)
Started9798
Completed8385
Not completed1413

Outcome measures

PrimaryWeight

Weight change measured on a digital scale to the nearest 0.1-kilogram

Time frame:
Baseline, 2 month, 6 month, 12 month, 18 months
Reported as:
Mean · kg
Weight
kgBehavioral Economics Intervention (BE mHealth)Standard mHealth Intervention (mHealth)
Baseline98.2 ± 24.593.5 ± 19.1
2 month95.3 ± 23.991.6 ± 19.5
6 month93.9 ± 23.690.2 ± 20.5
12 month94.9 ± 24.989.3 ± 21.0
18 month94.1 ± 24.790.9 ± 20.7

Adverse events

Collected over Adverse event data were collected over 12 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Behavioral Economics Intervention (BE mHealth)0/97 (0%)3/97 (3.1%)7/97 (7.2%)
Standard mHealth Intervention (mHealth)0/98 (0%)6/98 (6.1%)5/98 (5.1%)
Most frequent serious events
Most frequent serious events
EventBehavioral Economics Intervention (BE mHealth)Standard mHealth Intervention (mHealth)
HospitalizationRespiratory, thoracic and mediastinal disorders2/970/98
HospitalizationCardiac disorders0/972/98
HospitalizationGastrointestinal disorders0/972/98
HospitalizationNervous system disorders1/971/98
HospitalizationMusculoskeletal and connective tissue disorders0/971/98
Most frequent other events
Most frequent other events
EventBehavioral Economics Intervention (BE mHealth)Standard mHealth Intervention (mHealth)
Break/Bad SprainMusculoskeletal and connective tissue disorders1/973/98
COVID - long/severeRespiratory, thoracic and mediastinal disorders2/972/98
Gall BladderGastrointestinal disorders2/970/98
PneumoniaRespiratory, thoracic and mediastinal disorders1/970/98
Back issuesMusculoskeletal and connective tissue disorders1/970/98

Baseline characteristics

Age, Continuous
Age, Continuous(years)Behavioral Economics Intervention (BE mHealth)Standard mHealth Intervention (mHealth)Total
Mean37.6 ± 12.842.0 ± 16.939.7 ± 15.1
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Behavioral Economics Intervention (BE mHealth)Standard mHealth Intervention (mHealth)Total
Gender — Female8484168
Gender — Male131326
Gender — Non-binary011
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Behavioral Economics Intervention (BE mHealth)Standard mHealth Intervention (mHealth)Total
Hispanic or Latino7177148
Not Hispanic or Latino252146
Unknown or Not Reported101
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Behavioral Economics Intervention (BE mHealth)Standard mHealth Intervention (mHealth)Total
American Indian or Alaska Native213
Asian7310
Native Hawaiian or Other Pacific Islander101
Black or African American333770
White364783
More than one race10616
Unknown or Not Reported8412
Body Mass Index (BMI; kg/m2)
Body Mass Index (BMI; kg/m2)(kg/m2)Behavioral Economics Intervention (BE mHealth)Standard mHealth Intervention (mHealth)Total
Mean35.7 ± 7.134.7 ± 6.535.2 ± 6.8
08

Study locations

1 site
  • UConn Weight Management Research Lab
    Hartford, Connecticut 06103, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Dec 17, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04353258
Lead sponsor
University of Connecticut
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Tricia Leahey (Associate Professor, University of Connecticut) — Principal investigator
First posted
Apr 20, 2020
Start date
Sep 7, 2021
Primary completion
Dec 17, 2024
Completion
Dec 17, 2024
Results posted
Jan 9, 2026
Last update
Jan 9, 2026

Study contacts

Tricia Leahey, PhD
principal investigator · University of Connecticut

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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