Obesity, Weight Loss
Conditions
Keywords
Weight Loss, Mobile App, Digital Health, Weight Loss Maintenance, Weight Loss Suppression, Obesity
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).
Interventions
BEHAVIORALNoom Health
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.
BEHAVIORALNoom Digital Health
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.
Sponsors
Noom Inc.
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight From Baseline | Baseline, 6 months and 30 Months | Weight at 6 months and 30 months as compared to baseline. Weight will be documented using staff-led Zoom calls and taken with the participant's home scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Dietary Behavior Using the Eating Disorder Examination Questionnaire (EDE-Q) From Baseline to 30 Months | Baseline and 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. |
| Change in Physical Activity Using the International Physical Activity Questionnaire (IPAQ) From Baseline to 30 Months | Baseline and 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. |
| Change in Depression Using the Depression Anxiety Stress Scales (DASS) From Baseline to 30 Months | Baseline and 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. |
| Change in Anxiety Using the Depression Anxiety Stress Scales (DASS) From Baseline to 30 Months | Baseline and 30 Months | Anxiety 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. |
| Change in Stress Using the Depression Anxiety Stress Scales (DASS) From Baseline to 30 Months | Baseline and 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. |
| Change in Sleep Impairment Using the PROMIS Sleep Related Impairment Survey From Baseline to 30 Months | Baseline and 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. |
| Change in Caloric Intake Using the Automated Self-Administered Recall System (ASA24) From Baseline to 30 Months | Baseline and 30 Months | Caloric intake at 30 months as compared to baseline. Caloric intake will be measured using the ASA24 dietary recall system. |
| Change in Mental Composite Score (MCS) Using the Short-Form-36 (SF-36) From Baseline to 30 Months | Baseline and 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. |
| Change in Self-Efficacy for Healthy Eating Using the Diet Self-Efficacy Scale (DIET-SE) From Baseline to 30 Months | Baseline and 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. |
| Adherence to Intervention Measured Using a Percentage of the Total Number of Available App Features Used at 6 Months | 6 Months | The percent of available features on the app, expected verses completed at 6 months |
| Number of Participants With 12-Month Completion Status | 12 Months | Attrition at 12 months as compared to number randomized at baseline documented using completion status |
| Percent of Successful Technological Fixes | Baseline and 12 Months | 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. |
| Change in CDC NCHS National Health Interview Survey | Baseline and 30 Months | 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. |
| Change in Physical Composite Score (PCS) Using the Short-Form-36 (SF-36) From Baseline to 30 Months | Baseline and 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Noom Health In Noom Health, participants 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. | 302 |
| Noom Digital Health In Noom Digital Health, participants used a simplified version to log eating episodes and weight. Both conditions will receive the same weight loss advice content. | 298 |
| Total | 600 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 84 | 67 |
| Overall Study | Pregnancy | 1 | 3 |
| Overall Study | Withdrawal by Subject | 27 | 35 |
Baseline characteristics
| Characteristic | Total | Noom Digital Health | Noom Health |
|---|---|---|---|
| 24-hr Caloric Intake | 2152.7 calories STANDARD_DEVIATION 933 | 2118.2 calories STANDARD_DEVIATION 908.1 | 2186.6 calories STANDARD_DEVIATION 957.3 |
| Age, Continuous | 42 years STANDARD_DEVIATION 10 | 42 years STANDARD_DEVIATION 9 | 41 years STANDARD_DEVIATION 9 |
| CDC NCHS National Health Interview Survey | 1.7 visits/months STANDARD_DEVIATION 3.1 | 1.7 visits/months STANDARD_DEVIATION 3.6 | 1.8 visits/months STANDARD_DEVIATION 2.4 |
| EDEQ Global | 2.5 units on a scale STANDARD_DEVIATION 1 | 2.6 units on a scale STANDARD_DEVIATION 1 | 2.5 units on a scale STANDARD_DEVIATION 0.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 48 Participants | 24 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 551 Participants | 274 Participants | 277 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Metabolic Equivalents (METS) Value measured by IPAQ | 2288.8 METS Value STANDARD_DEVIATION 1607.5 | 2249.0 METS Value STANDARD_DEVIATION 1577.6 | 2328.1 METS Value STANDARD_DEVIATION 1638.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 16 Participants | 9 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 33 Participants | 18 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 29 Participants | 15 Participants | 14 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) White | 509 Participants | 249 Participants | 260 Participants |
| Self-Efficacy for Healthy Eating using the Diet Self-Efficacy Scale (DIET-SE) | 16.4 units on a scale STANDARD_DEVIATION 9.6 | 16.4 units on a scale STANDARD_DEVIATION 9.5 | 16.3 units on a scale STANDARD_DEVIATION 9.6 |
| Sex: Female, Male Female | 497 Participants | 246 Participants | 251 Participants |
| Sex: Female, Male Male | 103 Participants | 52 Participants | 51 Participants |
| Short Form 36 (SF-36) Mental Composite | 53.3 units on a scale STANDARD_DEVIATION 7.4 | 53.1 units on a scale STANDARD_DEVIATION 7.5 | 53.4 units on a scale STANDARD_DEVIATION 7.2 |
| Short Form 36 (SF-36) Physical Composite | 42.7 units on a scale STANDARD_DEVIATION 10.3 | 42.3 units on a scale STANDARD_DEVIATION 1.03 | 43.1 units on a scale STANDARD_DEVIATION 10.2 |
| Sleep Impairment using the PROMIS Sleep Related Impairment Survey Sleep impairment | 36.6 t-score STANDARD_DEVIATION 11.8 | 37.5 t-score STANDARD_DEVIATION 11.8 | 35.7 t-score STANDARD_DEVIATION 11.7 |
| The Depression Anxiety Stress Scales (DASS) Anxiety | 3.0 units on a scale STANDARD_DEVIATION 3.8 | 3.1 units on a scale STANDARD_DEVIATION 3.8 | 2.8 units on a scale STANDARD_DEVIATION 3.9 |
| The Depression Anxiety Stress Scales (DASS) Depression | 4.7 units on a scale STANDARD_DEVIATION 5.6 | 5.0 units on a scale STANDARD_DEVIATION 5.9 | 4.5 units on a scale STANDARD_DEVIATION 5.4 |
| The Depression Anxiety Stress Scales (DASS) Stress | 8.2 units on a scale STANDARD_DEVIATION 7.1 | 8.6 units on a scale STANDARD_DEVIATION 7.4 | 7.8 units on a scale STANDARD_DEVIATION 6.8 |
| Weight | 210.9 pounds STANDARD_DEVIATION 43.4 | 211.7 pounds STANDARD_DEVIATION 44.7 | 210.1 pounds STANDARD_DEVIATION 42.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 302 | 0 / 298 |
| other Total, other adverse events | 43 / 302 | 42 / 298 |
| serious Total, serious adverse events | 1 / 302 | 2 / 298 |
Outcome results
Primary
Change in Weight From Baseline
Weight at 6 months and 30 months as compared to baseline. Weight will be documented using staff-led Zoom calls and taken with the participant's home scale.
Time frame: Baseline, 6 months and 30 Months
Population: Results available for participants who had study visit and provided data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Noom Health | Change in Weight From Baseline | Baseline | 210.1 lbs | Standard Deviation 42.1 |
| Noom Health | Change in Weight From Baseline | 6 months | 199.4 lbs | Standard Deviation 41.4 |
| Noom Health | Change in Weight From Baseline | 30 months | 197.2 lbs | Standard Deviation 43.1 |
| Noom Digital Health | Change in Weight From Baseline | Baseline | 211.7 lbs | Standard Deviation 44.7 |
| Noom Digital Health | Change in Weight From Baseline | 6 months | 204.6 lbs | Standard Deviation 45.8 |
| Noom Digital Health | Change in Weight From Baseline | 30 months | 201.6 lbs | Standard Deviation 43.6 |
Secondary
Adherence to Intervention Measured Using a Percentage of the Total Number of Available App Features Used at 6 Months
The percent of available features on the app, expected verses completed at 6 months
Time frame: 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Noom Health | Adherence to Intervention Measured Using a Percentage of the Total Number of Available App Features Used at 6 Months | 38.4 percentage of available features on app | Standard Deviation 24.2 |
| Noom Digital Health | Adherence to Intervention Measured Using a Percentage of the Total Number of Available App Features Used at 6 Months | 17.9 percentage of available features on app | Standard Deviation 15.2 |
Secondary
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. 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.
Time frame: Baseline and 30 Months
Population: Results available for participants who had study visit and provided data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Noom Health | Change in Anxiety Using the Depression Anxiety Stress Scales (DASS) From Baseline to 30 Months | Baseline | 2.8 score on a scale | Standard Deviation 3.9 |
| Noom Health | Change in Anxiety Using the Depression Anxiety Stress Scales (DASS) From Baseline to 30 Months | 30 months | 2.4 score on a scale | Standard Deviation 4.8 |
| Noom Digital Health | Change in Anxiety Using the Depression Anxiety Stress Scales (DASS) From Baseline to 30 Months | Baseline | 3.1 score on a scale | Standard Deviation 3.8 |
| Noom Digital Health | Change in Anxiety Using the Depression Anxiety Stress Scales (DASS) From Baseline to 30 Months | 30 months | 2.7 score on a scale | Standard Deviation 4.4 |
Secondary
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.
Time frame: Baseline and 30 Months
Population: Results available for participants who had study visit and provided data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Noom Health | Change in Caloric Intake Using the Automated Self-Administered Recall System (ASA24) From Baseline to 30 Months | Baseline | 2186.6 calories | Standard Deviation 957.3 |
| Noom Health | Change in Caloric Intake Using the Automated Self-Administered Recall System (ASA24) From Baseline to 30 Months | 30 months | 1681.7 calories | Standard Deviation 906.9 |
| Noom Digital Health | Change in Caloric Intake Using the Automated Self-Administered Recall System (ASA24) From Baseline to 30 Months | Baseline | 2118.2 calories | Standard Deviation 908.1 |
| Noom Digital Health | Change in Caloric Intake Using the Automated Self-Administered Recall System (ASA24) From Baseline to 30 Months | 30 months | 1578.5 calories | Standard Deviation 784.8 |
Secondary
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.
Time frame: Baseline and 30 Months
Population: Results available for participants who had study visit and provided data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Noom Health | Change in CDC NCHS National Health Interview Survey | Baseline | 1.8 visits/months | Standard Deviation 2.4 |
| Noom Health | Change in CDC NCHS National Health Interview Survey | 30 months | 1.9 visits/months | Standard Deviation 3 |
| Noom Digital Health | Change in CDC NCHS National Health Interview Survey | Baseline | 1.7 visits/months | Standard Deviation 3.6 |
| Noom Digital Health | Change in CDC NCHS National Health Interview Survey | 30 months | 1.8 visits/months | Standard Deviation 3 |
Secondary
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.
Time frame: Baseline and 30 Months
Population: Results available for participants who had study visit and provided data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Noom Health | Change in Depression Using the Depression Anxiety Stress Scales (DASS) From Baseline to 30 Months | Baseline | 4.5 score on a scale | Standard Deviation 5.4 |
| Noom Health | Change in Depression Using the Depression Anxiety Stress Scales (DASS) From Baseline to 30 Months | 30 months | 3.9 score on a scale | Standard Deviation 7.2 |
| Noom Digital Health | Change in Depression Using the Depression Anxiety Stress Scales (DASS) From Baseline to 30 Months | Baseline | 5.0 score on a scale | Standard Deviation 5.9 |
| Noom Digital Health | Change in Depression Using the Depression Anxiety Stress Scales (DASS) From Baseline to 30 Months | 30 months | 4.4 score on a scale | Standard Deviation 6.8 |
Secondary
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.
Time frame: Baseline and 30 Months
Population: Results available for participants who had study visit and provided data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Noom Health | Change in Dietary Behavior Using the Eating Disorder Examination Questionnaire (EDE-Q) From Baseline to 30 Months | Baseline | 2.5 score on a scale | Standard Deviation 0.9 |
| Noom Health | Change in Dietary Behavior Using the Eating Disorder Examination Questionnaire (EDE-Q) From Baseline to 30 Months | 30 months | 1.7 score on a scale | Standard Deviation 1.1 |
| Noom Digital Health | Change in Dietary Behavior Using the Eating Disorder Examination Questionnaire (EDE-Q) From Baseline to 30 Months | Baseline | 2.6 score on a scale | Standard Deviation 1 |
| Noom Digital Health | Change in Dietary Behavior Using the Eating Disorder Examination Questionnaire (EDE-Q) From Baseline to 30 Months | 30 months | 1.8 score on a scale | Standard Deviation 1.2 |
Secondary
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.
Time frame: Baseline and 30 Months
Population: Results available for participants who had study visit and provided data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Noom Health | Change in Mental Composite Score (MCS) Using the Short-Form-36 (SF-36) From Baseline to 30 Months | Baseline | 53.4 score on a scale | Standard Deviation 7.2 |
| Noom Health | Change in Mental Composite Score (MCS) Using the Short-Form-36 (SF-36) From Baseline to 30 Months | 30 months | 53.5 score on a scale | Standard Deviation 7.6 |
| Noom Digital Health | Change in Mental Composite Score (MCS) Using the Short-Form-36 (SF-36) From Baseline to 30 Months | Baseline | 53.1 score on a scale | Standard Deviation 7.5 |
| Noom Digital Health | Change in Mental Composite Score (MCS) Using the Short-Form-36 (SF-36) From Baseline to 30 Months | 30 months | 54.9 score on a scale | Standard Deviation 7.4 |
Secondary
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.
Time frame: Baseline and 30 Months
Population: Results available for participants who had study visit and provided data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Noom Health | Change in Physical Activity Using the International Physical Activity Questionnaire (IPAQ) From Baseline to 30 Months | Baseline | 2328.1 Met Value | Standard Deviation 1638.2 |
| Noom Health | Change in Physical Activity Using the International Physical Activity Questionnaire (IPAQ) From Baseline to 30 Months | 30 months | 1919.6 Met Value | Standard Deviation 1463 |
| Noom Digital Health | Change in Physical Activity Using the International Physical Activity Questionnaire (IPAQ) From Baseline to 30 Months | Baseline | 2249.0 Met Value | Standard Deviation 1577.6 |
| Noom Digital Health | Change in Physical Activity Using the International Physical Activity Questionnaire (IPAQ) From Baseline to 30 Months | 30 months | 1973.9 Met Value | Standard Deviation 1748.8 |
Secondary
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.
Time frame: Baseline and 30 Months
Population: Results available for participants who had study visit and provided data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Noom Health | Change in Physical Composite Score (PCS) Using the Short-Form-36 (SF-36) From Baseline to 30 Months | Baseline | 43.1 score on a scale | Standard Deviation 10.2 |
| Noom Health | Change in Physical Composite Score (PCS) Using the Short-Form-36 (SF-36) From Baseline to 30 Months | 30 months | 45.9 score on a scale | Standard Deviation 10.1 |
| Noom Digital Health | Change in Physical Composite Score (PCS) Using the Short-Form-36 (SF-36) From Baseline to 30 Months | Baseline | 42.3 score on a scale | Standard Deviation 10.3 |
| Noom Digital Health | Change in Physical Composite Score (PCS) Using the Short-Form-36 (SF-36) From Baseline to 30 Months | 30 months | 44.8 score on a scale | Standard Deviation 11.4 |
Secondary
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.
Time frame: Baseline and 30 Months
Population: Results available for participants who had study visit and provided data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Noom Health | Change in Self-Efficacy for Healthy Eating Using the Diet Self-Efficacy Scale (DIET-SE) From Baseline to 30 Months | Baseline | 16.3 score on a scale | Standard Deviation 9.6 |
| Noom Health | Change in Self-Efficacy for Healthy Eating Using the Diet Self-Efficacy Scale (DIET-SE) From Baseline to 30 Months | 30 months | 23.0 score on a scale | Standard Deviation 11.4 |
| Noom Digital Health | Change in Self-Efficacy for Healthy Eating Using the Diet Self-Efficacy Scale (DIET-SE) From Baseline to 30 Months | Baseline | 16.4 score on a scale | Standard Deviation 9.5 |
| Noom Digital Health | Change in Self-Efficacy for Healthy Eating Using the Diet Self-Efficacy Scale (DIET-SE) From Baseline to 30 Months | 30 months | 21.7 score on a scale | Standard Deviation 12.9 |
Secondary
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.
Time frame: Baseline and 30 Months
Population: Results available for participants who had study visit and provided data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Noom Health | Change in Sleep Impairment Using the PROMIS Sleep Related Impairment Survey From Baseline to 30 Months | 30 months | 31.6 t-score | Standard Deviation 11.6 |
| Noom Health | Change in Sleep Impairment Using the PROMIS Sleep Related Impairment Survey From Baseline to 30 Months | Baseline | 35.7 t-score | Standard Deviation 11.7 |
| Noom Digital Health | Change in Sleep Impairment Using the PROMIS Sleep Related Impairment Survey From Baseline to 30 Months | 30 months | 33.9 t-score | Standard Deviation 12.4 |
| Noom Digital Health | Change in Sleep Impairment Using the PROMIS Sleep Related Impairment Survey From Baseline to 30 Months | Baseline | 37.5 t-score | Standard Deviation 11.8 |
Secondary
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.
Time frame: Baseline and 30 Months
Population: Results available for participants who had study visit and provided data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Noom Health | Change in Stress Using the Depression Anxiety Stress Scales (DASS) From Baseline to 30 Months | Baseline | 7.8 score on a scale | Standard Deviation 6.8 |
| Noom Health | Change in Stress Using the Depression Anxiety Stress Scales (DASS) From Baseline to 30 Months | 30 months | 5.4 score on a scale | Standard Deviation 7.3 |
| Noom Digital Health | Change in Stress Using the Depression Anxiety Stress Scales (DASS) From Baseline to 30 Months | Baseline | 8.6 score on a scale | Standard Deviation 7.4 |
| Noom Digital Health | Change in Stress Using the Depression Anxiety Stress Scales (DASS) From Baseline to 30 Months | 30 months | 6.7 score on a scale | Standard Deviation 8.3 |
Secondary
Number of Participants With 12-Month Completion Status
Attrition at 12 months as compared to number randomized at baseline documented using completion status
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Noom Health | Number of Participants With 12-Month Completion Status | 220 Participants |
| Noom Digital Health | Number of Participants With 12-Month Completion Status | 222 Participants |
Secondary
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.
Time frame: Baseline and 12 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Noom Health | Percent of Successful Technological Fixes | 86 percent of successful tech fixes |
| Noom Digital Health | Percent of Successful Technological Fixes | 81 percent of successful tech fixes |