ShapeUp Empower Study | NCT02518217

Studies
ShapeUp Empower Study

NCT02518217

Sponsor

The Miriam Hospital

Status

Completed

Last Update Posted

Aug 25, 2016Estimated

Enrollment

130Actual

Phase

Not Applicable

Conditions

Obesity
Overweight

Interventions

Weight Loss Apps
ShapeUp Empower
Financial Incentives for Engagement

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2015

Primary Completion Date

Jul 2016Actual

Completion Date

Jul 2016Actual

First Submitted Date

Aug 3, 2015

First Submission Date that Met QC Criteria

Aug 4, 2015

First Posted Date

Aug 7, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2016

Last Update Posted Date

Aug 25, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Apps Only	Active Comparator	Behavioral: Weight Loss Apps
ShapeUp Empower	Experimental	Behavioral: Weight Loss Apps Behavioral: ShapeUp Empower
ShapeUp Empower + Incentives	Experimental	Behavioral: Weight Loss Apps Behavioral: ShapeUp Empower Behavioral: Financial Incentives for Engagement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Weight Loss Apps	Behavioral	Provision of commercially available smartphone applications for healthy eating, physical activity, and weight loss.	Apps Only ShapeUp Empower

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

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

ID	Term
D009765	Obesity
D050177	Overweight