Noom Health for Weight Management

Study Overview
=================
Brief Summary
-----------------
The goals of the study are to use the Noom mobile app to help individuals with weight loss and weight loss maintenance. This project will test the comparative efficacy of Noom Health vs. Noom Digital Health for weight loss, quality of life, psychosocial functioning, and self-reported health status. It is expected that use of Noom Health will show post-intervention success relative to Noom Digital Health as well as long-term success with weight loss maintenance. Data is expected to show that participants who are older, have less support, have more health conditions, and with more psychosocial problems will benefit more from Noom Health. It is also expected that confidence in the ability to lose weight will produce more successful results in Noom Health vs. Noom Digital Health.

Detailed Description
-----------------
A total of 600 subjects will be enrolled in a randomized-controlled trial comparing the Noom app (Noom Health) to a digital control (Noom Digital Health) with 6 months of intervention and 6 months active maintenance in both groups. Measures will include demographics, psychosocial measures, height/weight, waist circumference, weight loss history/practices, health care practices/utilization, and quality of life. Participants will complete informed consent and interviews via a HIPAA-compliant videoconference (Zoom) and other questionnaires via a REDCap interface. All participants will complete screening/baseline procedures to determine eligibility and initial information. Subsequently, they will be randomized to one of the groups for a 6-month intervention and 6- month maintenance period (12 months total). In Noom Health, participants will be encouraged to use the app multiple times per day to log eating episodes, physical activity and weight. Coaches will also interact with participants directly through the app. In Noom Digital Health, participants will use a simplified version to log eating episodes and weight. Both conditions will receive the same weight loss advice content. During the intervention, participants will complete monthly satisfaction surveys. Additionally, follow-up measures will be conducted at 7 time points (Screening/Baseline, 1 month, 4 months, 6 months, 12 months, 18 months, 24 months, and 30 months).

Official Title
-----------------
Noom Health for Weight Management

Conditions
-----------------
Weight Loss, Obesity

Intervention / Treatment
-----------------
* Behavioral: Noom Health
* Behavioral: Noom Digital Health


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must be interested in the Noom app BMI > 27 kg/m2 Ages of 18 and 60 at entry to the study Speak English Exclusion Criteria: Contraindication to smartphone use (e.g., seizures from prior smartphone use, do not own a smartphone) Acute suicide risk Pregnant or planning to become pregnant during the study Current Noom use

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized to one of two conditions in a parallel design including a 12-month intervention. Participants will be openly-enrolled over the course of 12-months until the recruitment goal of 600, 300 in each group, is reached.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Noom Health<br> | Behavioral: Noom Health<br>* In Noom Health, participants will be encouraged to use the Noom app multiple times a day to log eating episodes, physical activity and weight. They will also have the ability to interact with coaches to receive advice and feedback specific to weight loss.<br>|
| Active Comparator: Noom Digital Health<br> | Behavioral: Noom Digital Health<br>* In Noom Digital Health, participants will use a simplified version to log eating episodes and weight. Both conditions will receive the same weight loss advice content.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weight from Baseline to 6 Months | Weight at 6 months as compared to baseline. Weight will be documented using staff-led Zoom calls and taken with the participant's home scale. | Baseline and 6 Months | 
| Change in Weight from Baseline to 30 Months | Weight at 30 months as compared to baseline. Weight will be documented using staff-led Zoom calls and taken with the participant's home scale. | Baseline and 30 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Caloric Intake using the Automated Self-Administered Recall System (ASA24) from Baseline to 30 months | Caloric intake at 30 months as compared to baseline. Caloric intake will be measured using the ASA24 dietary recall system. | Baseline and 30 Months | 
| Change in Dietary Behavior using the Eating Disorder Examination Questionnaire (EDE-Q) from Baseline to 30 Months | EDE-Q global score at 30 months as compared to baseline. Dietary restraint, eating, shape, and weight concerns are measured with the EDE-Q. These subscales are summed and then divided by the total number of subscales (4) to create a global score. Scores range from 0 to 52 with higher scores indicating higher severity. | Baseline and 30 Months | 
| Change in Physical Activity using the International Physical Activity Questionnaire (IPAQ) from Baseline to 30 Months | Physical activity at 30 months as compared to baseline. The IPAQ includes 27 items and determines a MET value for time spent in an average week completing different levels of activity including vigorous or moderate physical activity, walking, and sitting. One MET is the energy spent sitting at rest. | Baseline and 30 Months | 
| Change in Depression using the Depression Anxiety Stress Scales (DASS) from Baseline to 30 Months | Depression subscale score at 30 months as compared to baseline. DASS is a 42-item self-report scale of negative emotional states with subscales of depression, anxiety, and stress. Each subscale is scored 0-42, with total score from 0-126. Higher scores indicate more severe psychological distress. | Baseline and 30 Months | 
| Change in Anxiety using the Depression Anxiety Stress Scales (DASS) from Baseline to 30 Months | Anxiety subscale score at 30 months as compared to baseline. DASSis a 42-item self-report scale of negative emotional states with subscales of depression, anxiety, and stress. Each subscale is scored 0-42, with total score from 0-126. Higher scores indicate more severe psychological distress. | Baseline and 30 Months | 
| Change in Stress using the Depression Anxiety Stress Scales (DASS) from Baseline to 30 Months | Stress subscale score at 30 months as compared to baseline. DASS a 42-item self-report scale of negative emotional states with subscales of depression, anxiety, and stress. Each subscale is scored 0-42, with total score from 0-126. Higher scores indicate more severe psychological distress. | Baseline and 30 Months | 
| Change in Sleep Impairment using the PROMIS Sleep Related Impairment Survey from Baseline to 30 Months | Sleep impairment at 30 months as compared to baseline. The PROMIS Sleep Related Impairment v.1.0 is a 16-item self-report measure of perceived functioning during waking hours in relation to tiredness and trouble sleeping. A raw score is calculated by summing all individual items and is translated into a T-score with standard error (SE). A T-score of 50 indicates normal impairment compared to the general population, scores above 50 indicate more impairment. | Baseline and 30 Months | 
| Change in Physical Composite Score (PCS) using the Short-Form-36 (SF-36) from Baseline to 30 Months | PCS at 30 months as compared to baseline. The SF-36 is a 36-item self-report health-related quality of life assessment of physical functioning, limitations, energy, emotional well-being, social functioning, pain and general health. Scores range from 17.2- 66.7 with lower scores indicating worse quality of life related to physical health. | Baseline and 30 Months | 
| Change in Mental Composite Score (MCS) using the Short-Form-36 (SF-36) from Baseline to 30 Months | MCS at 30 months as compared to baseline. The SF-36 is a 36-item self-report health-related quality of life assessment of physical functioning, limitations, energy, emotional well-being, social functioning, pain and general health. Scores range from 12.7-64.2 with lower scores indicating worse quality of life related to mental health. | Baseline and 30 Months | 
| Change in Self-Efficacy for Healthy Eating using the Diet Self-Efficacy Scale (DIET-SE) from Baseline to 6 Months | Self-efficacy at 6 months as compared to baseline. The DIET-SE is an 11-item self-report assessment of healthy eating with scales specific to temptations, social/internal factors, and negative emotional related to resistance. The score ranges from 0 - 40 with higher scores indicating more self-efficacy. | Baseline and 6 Months | 
| Change in Self-Efficacy for Healthy Eating using the Diet Self-Efficacy Scale (DIET-SE) from Baseline to 30 Months | Self-efficacy at 30 months as compared to baseline. The DIET-SE is an 11-item self-report assessment of healthy eating with scales specific to temptations, social/internal factors, and negative emotional related to resistance. The score ranges from 0 - 40 with higher scores indicating more self-efficacy. | Baseline and 30 Months | 
| Adherence to intervention measured using a percentage of the total number of available app features used from Baseline to 6 Months | The percent of available features on the app, expected verses completed at 6 months as compared to baseline. | Baseline and 6 Months | 
| 12-Month Completion Status | Attrition at 12 months as compared to number randomized at baseline documented using completion status | Baseline and 12 Months | 
| Percent of Successful Technological Fixes | App compatibility will be examined by calculating the percent of successful technological fixes at 12 months as compared to baseline. The type of technological problems encountered by participants while using the app and any fixes needed will be categorized. | Baseline and 12 Months | 
| Change in CDC NCHS National Health Interview Survey | Changes in health status from baseline to 30-months as measured by questions from the CDC NCHS National Health Interview Survey. Using an adapted version of the CDC NCHS National Health Interview Survey, the survey includes 4 questions about healthcare utilization. Items identify type of healthcare sought and frequency. The frequency of provider visits will be calculated to determine healthcare utilization. A frequency score of zero indicates no healthcare utilized. There is no upper limit for the frequency. | Baseline and 30 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Weight Loss, Mobile App, Digital Health, Weight Loss Maintenance, Weight Loss Suppression, Obesity