NCT02518217

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 25, 2016

Status Verified

August 1, 2016

Enrollment Period

7 months

First QC Date

August 3, 2015

Last Update Submit

August 24, 2016

Conditions

ObesityOverweight

Outcome Measures

Primary Outcomes (1)

  • Body Weight (kg)

    6 months after randomization

Study Arms (3)

Apps Only

ACTIVE COMPARATOR
Behavioral: Weight Loss Apps

ShapeUp Empower

EXPERIMENTAL
Behavioral: Weight Loss AppsBehavioral: ShapeUp Empower

ShapeUp Empower + Incentives

EXPERIMENTAL
Behavioral: Weight Loss AppsBehavioral: ShapeUp EmpowerBehavioral: Financial Incentives for Engagement

Interventions

Weight Loss AppsBEHAVIORAL

Provision of commercially available smartphone applications for healthy eating, physical activity, and weight loss.

Apps OnlyShapeUp EmpowerShapeUp Empower + Incentives
ShapeUp EmpowerBEHAVIORAL

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.

ShapeUp EmpowerShapeUp Empower + Incentives
Financial Incentives for EngagementBEHAVIORAL

Financial incentives for completing tasks such as viewing instructional information and reporting self-monitored body weights via the study website.

ShapeUp Empower + Incentives

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weight Control and Diabetes Resarch Center

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Director of the Weight Control and Diabetes Research Center

Study Record Dates

First Submitted

August 3, 2015

First Posted

August 7, 2015

Study Start

December 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 25, 2016

Record last verified: 2016-08

Locations

US(1)