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ShapeUp Empower Study

Primary Purpose

Obesity, Overweight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight Loss Apps
ShapeUp Empower
Financial Incentives for Engagement
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-70 years
  • Body mass index (BMI) between 25 and 45 kg/m2
  • English speaking
  • Have access to the Internet via a computer and smartphone compatible with Empower and Commercial Apps, and basic knowledge of how to use this technology.
  • Agree to sharing of data entered in the Empower and Commercial Apps intervention systems.
  • Agree to ShapeUp's privacy policy and user agreement.

Exclusion Criteria:

  • Report health problems that make weight loss or unsupervised exercise unsafe or unreasonable
  • Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire
  • Are currently pregnant or breastfeeding, or intend to become pregnant in the next 12 months
  • Are planning to move outside of the greater Providence area within the next 12 months
  • Report any cognitive or physical limitations that preclude use of a personal computer
  • Have participated in a study conducted by the WCDRC in the past 2 years
  • Have followed a commercial weight-loss program within the previous 6 months or who are currently following a commercial weight loss program
  • Weight loss of ≥ 5% of initial body weight in the last 6 months
  • History of clinically diagnosed eating disorder excluding Binge Eating Disorder.
  • Previous surgical procedure for weight loss
  • Currently taking weight loss medication\
  • Treatment of cancer within the last 6 months
  • Have any medical or psychological condition, or life situation, that would make participation in a weight loss program inadvisable in the opinion of the principal investigator.

Sites / Locations

  • Weight Control and Diabetes Resarch Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Apps Only

ShapeUp Empower

ShapeUp Empower + Incentives

Arm Description

Outcomes

Primary Outcome Measures

Body Weight (kg)

Secondary Outcome Measures

Full Information

First Posted
August 3, 2015
Last Updated
August 24, 2016
Sponsor
The Miriam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02518217
Brief Title
ShapeUp Empower Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Miriam Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This randomized controlled trial will evaluate patterns of use and health outcomes of the ShapeUp Empower online program with and without financial incentives for program engagement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apps Only
Arm Type
Active Comparator
Arm Title
ShapeUp Empower
Arm Type
Experimental
Arm Title
ShapeUp Empower + Incentives
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Weight Loss Apps
Intervention Description
Provision of commercially available smartphone applications for healthy eating, physical activity, and weight loss.
Intervention Type
Behavioral
Intervention Name(s)
ShapeUp Empower
Intervention Description
Online intervention with training in behavioral strategies for healthy eating, physical activity, and weight loss. Includes periodic feedback on weight loss progress and engagement with the intervention platform.
Intervention Type
Behavioral
Intervention Name(s)
Financial Incentives for Engagement
Intervention Description
Financial incentives for completing tasks such as viewing instructional information and reporting self-monitored body weights via the study website.
Primary Outcome Measure Information:
Title
Body Weight (kg)
Time Frame
6 months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-70 years Body mass index (BMI) between 25 and 45 kg/m2 English speaking Have access to the Internet via a computer and smartphone compatible with Empower and Commercial Apps, and basic knowledge of how to use this technology. Agree to sharing of data entered in the Empower and Commercial Apps intervention systems. Agree to ShapeUp's privacy policy and user agreement. Exclusion Criteria: Report health problems that make weight loss or unsupervised exercise unsafe or unreasonable Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire Are currently pregnant or breastfeeding, or intend to become pregnant in the next 12 months Are planning to move outside of the greater Providence area within the next 12 months Report any cognitive or physical limitations that preclude use of a personal computer Have participated in a study conducted by the WCDRC in the past 2 years Have followed a commercial weight-loss program within the previous 6 months or who are currently following a commercial weight loss program Weight loss of ≥ 5% of initial body weight in the last 6 months History of clinically diagnosed eating disorder excluding Binge Eating Disorder. Previous surgical procedure for weight loss Currently taking weight loss medication\ Treatment of cancer within the last 6 months Have any medical or psychological condition, or life situation, that would make participation in a weight loss program inadvisable in the opinion of the principal investigator.
Facility Information:
Facility Name
Weight Control and Diabetes Resarch Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Learn more about this trial

ShapeUp Empower Study

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