Research Intervention to Support Healthy Eating and Exercise

NCT ID: NCT04353258

Last Updated: 2026-01-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

195 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-07

Study Completion Date

2024-12-17

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Behavioral Economics intervention (BE mHealth)

Intervention Type BEHAVIORAL

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)

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

Group Type ACTIVE_COMPARATOR

Standard mHealth intervention (mHealth)

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Standard mHealth intervention (mHealth)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* \<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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Connecticut

OTHER

Sponsor Role lead

Responsible Party

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Tricia Leahey

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tricia Leahey, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Connecticut

Locations

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UConn Weight Management Research Lab

Hartford, Connecticut, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1R01DK118957

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H19-141

Identifier Type: -

Identifier Source: org_study_id

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