ShapeUp Empower Study

Study Overview
=================
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.

Conditions
-----------------
Obesity, Overweight

Intervention / Treatment
-----------------
* Behavioral: Weight Loss Apps
* Behavioral: ShapeUp Empower
* Behavioral: Financial Incentives for Engagement


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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