ShapeUp Empower Study

August 24, 2016 updated by: Rena R. Wing, The Miriam Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Weight Control and Diabetes Resarch Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Apps Only
Behavioral: Weight Loss Apps
Provision of commercially available smartphone applications for healthy eating, physical activity, and weight loss.
Experimental: ShapeUp Empower
Behavioral: Weight Loss Apps
Provision of commercially available smartphone applications for healthy eating, physical activity, and weight loss.
Behavioral: ShapeUp Empower
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.
Experimental: ShapeUp Empower + Incentives
Behavioral: Weight Loss Apps
Provision of commercially available smartphone applications for healthy eating, physical activity, and weight loss.
Behavioral: ShapeUp Empower
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.
Behavioral: Financial Incentives for Engagement
Financial incentives for completing tasks such as viewing instructional information and reporting self-monitored body weights via the study website.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body Weight (kg)
Time Frame: 6 months after randomization
6 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Miriam Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

August 3, 2015

First Submitted That Met QC Criteria

August 4, 2015

First Posted (Estimate)

August 7, 2015

Study Record Updates

Last Update Posted (Estimate)

August 25, 2016

Last Update Submitted That Met QC Criteria

August 24, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShapeUpEmpower2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Weight Loss Apps

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe