ObesityNCT02518217
ShapeUp Empower Study
A study testing Weight Loss Apps, ShapeUp Empower and Financial Incentives for Engagement in people with Obesity and Overweight, run by The Miriam Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Weight Loss Apps, ShapeUp Empower and Financial Incentives for Engagement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weight Control and Diabetes Resarch Center
Providence, Rhode Island, 02903
About this study
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.
- Conditions
- Obesity, Overweight
- Being tested
- Weight Loss Apps, ShapeUp Empower, Financial Incentives for Engagement
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight Loss AppsBehavioural
Provision of commercially available smartphone applications for healthy eating, physical activity, and weight loss.
ShapeUp EmpowerBehavioural
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.
Financial Incentives for EngagementBehavioural
Financial incentives for completing tasks such as viewing instructional information and reporting self-monitored body weights via the study website.
| Study group | Role | What they receive |
|---|---|---|
| Apps Only | Active comparator | Not described Receives: Behavioral: Weight Loss Apps |
| ShapeUp Empower | Experimental | Not described Receives: Behavioral: Weight Loss Apps; Behavioral: ShapeUp Empower |
| ShapeUp Empower + Incentives | Experimental | Not described Receives: Behavioral: Weight Loss Apps; Behavioral: ShapeUp Empower; Behavioral: Financial Incentives for Engagement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight (kg)
Measured: 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startDec 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rena R. Wing, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518217
- Sponsor's protocol ID
- ShapeUpEmpower2015
- Status last verified
- Aug 2016
- First submitted
- 3 Aug 2015
- Last updated
- 25 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ShapeUp Empower Study
- ClinicalTrials.gov ID
- NCT02518217
- Acronym / sponsor ID
- ShapeUpEmpower2015
- Conditions
- Obesity, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 7 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight Loss AppsProvision of commercially available smartphone applications for healthy eating, physical activity, and weight loss. | Behavioural | Apps Only, ShapeUp Empower, ShapeUp Empower + Incentives |
| ShapeUp EmpowerOnline 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. | Behavioural | ShapeUp Empower, ShapeUp Empower + Incentives |
| Financial Incentives for EngagementFinancial incentives for completing tasks such as viewing instructional information and reporting self-monitored body weights via the study website. | Behavioural | ShapeUp Empower + Incentives |
Primary outcome
Body Weight (kg)
Time frame: 6 months after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2016.
Related trials for Obesity
Active, not recruitingPhase 2
Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment
Electric Stimulation Therapy, Obesity
Enrolling by invitationObservational study
Bariatric Surgery Registry
Obesity, Morbid
Recruiting
Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments
Obesity
Active, not recruiting
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
COPD Exacerbation, Oxygen Toxicity
Active, not recruiting
A Multidisciplinary Weight Loss Program at AUB-MC
Obesity, Weight Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight Loss Apps, ShapeUp Empower and Financial Incentives for Engagement in people with Obesity and Overweight, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight (kg) (time frame: 6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2016; AzTrials last refreshed its copy on 6 Nov 2026.