NCT04353258

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
195

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 16, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 20, 2020

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 7, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2024

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 9, 2026

Completed
Last Updated

January 9, 2026

Status Verified

July 1, 2025

Enrollment Period

3.3 years

First QC Date

April 16, 2020

Results QC Date

December 17, 2025

Last Update Submit

December 17, 2025

Conditions

Obesity

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Weight

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

    Baseline, 2 month, 6 month, 12 month, 18 months

Study Arms (2)

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.

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).

Behavioral: Standard mHealth intervention (mHealth)

Interventions

Standard mHealth intervention (mHealth)BEHAVIORAL

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

Standard mHealth intervention (mHealth)
Behavioral Economics intervention (BE mHealth)BEHAVIORAL

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

Behavioral Economics intervention (BE mHealth)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \<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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UConn Weight Management Research Lab

Hartford, Connecticut, 06103, United States

Location

MeSH Terms

Conditions

ObesityWeight Loss

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Results Point of Contact

Title
Principal Investigator
Organization
University of Connecticut
tricia.leahey@uconn.edu
8604862834

Study Officials

  • Tricia Leahey, PhD

    University of Connecticut

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 16, 2020

First Posted

April 20, 2020

Study Start

September 7, 2021

Primary Completion

December 17, 2024

Study Completion

December 17, 2024

Last Updated

January 9, 2026

Results First Posted

January 9, 2026

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)