Research Intervention to Support Healthy Eating and Exercise

Obesity Clinical Trial

— RISE  

Official title:

Using Behavioral Economic Strategies to Address Obesity in Economically Disadvantaged Adults

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04353258
• Other study ID #: H19-141
• Secondary ID: 1R01DK118957
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 7, 2021
• Est. completion date: September 2025

Study information

• Verified date: November 2023
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 192
• Est. completion date: September 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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

Locations

Country	Name	City	State
United States	UConn Weight Management Research Lab	Hartford	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
University of Connecticut	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	Weight change measured on a digital scale to the nearest 0.1-kilogram	Baseline, 2 month, 6 month, 12 month, 18 months