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Research Intervention to Support Healthy Eating and Exercise (RISE)

Primary Purpose

Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Economics intervention (BE mHealth)
Standard mHealth intervention (mHealth)
Sponsored by
University of Connecticut
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring weight loss, low income, behavioral economics, contingency management, episodic future thinking, mHealth

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UConn Weight Management Research LabRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Behavioral Economics intervention (BE mHealth)

Standard mHealth intervention (mHealth)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 16, 2020
Last Updated
October 31, 2022
Sponsor
University of Connecticut
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT04353258
Brief Title
Research Intervention to Support Healthy Eating and Exercise
Acronym
RISE
Official Title
Using Behavioral Economic Strategies to Address Obesity in Economically Disadvantaged Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 7, 2021 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Connecticut
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
weight loss, low income, behavioral economics, contingency management, episodic future thinking, mHealth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
192 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Economics intervention (BE mHealth)
Arm Type
Experimental
Arm Description
Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth) that includes behavioral economics components.
Arm Title
Standard mHealth intervention (mHealth)
Arm Type
Active Comparator
Arm Description
Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth).
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Economics intervention (BE mHealth)
Intervention Description
Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth) that includes behavioral economics components.
Intervention Type
Behavioral
Intervention Name(s)
Standard mHealth intervention (mHealth)
Intervention Description
Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth).
Primary Outcome Measure Information:
Title
Weight
Description
Weight change measured on a digital scale to the nearest 0.1-kilogram
Time Frame
Baseline, 2 month, 6 month, 12 month, 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Denise F Pierre, BS
Phone
860-380-1284
Email
denise.pierre@uconn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tricia Leahey, PhD
Organizational Affiliation
University of Connecticut
Official's Role
Principal Investigator
Facility Information:
Facility Name
UConn Weight Management Research Lab
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise F Pierre, BS
Email
denise.pierre@uconn.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Research Intervention to Support Healthy Eating and Exercise

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