Clinical trial NCT04797169: Noom Health for Weight Management
Official title: Noom Health for Weight Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Obesity
Keywords: Weight Loss
Mobile App
Digital Health
Weight Loss Maintenance
Weight Loss Suppression
Obesity
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Noom Inc.
First posted: 2021-03-15
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change in Weight from Baseline to 6 Months
timeFrame: Baseline and 6 Months
measure: Change in Weight from Baseline to 30 Months
timeFrame: Baseline and 30 Months
Secondary outcomes:
measure: Change in Caloric Intake using the Automated Self-Administered Recall System (ASA24) from Baseline to 30 months
timeFrame: Baseline and 30 Months
measure: Change in Dietary Behavior using the Eating Disorder Examination Questionnaire (EDE-Q) from Baseline to 30 Months
timeFrame: Baseline and 30 Months
measure: Change in Physical Activity using the International Physical Activity Questionnaire (IPAQ) from Baseline to 30 Months
timeFrame: Baseline and 30 Months
measure: Change in Depression using the Depression Anxiety Stress Scales (DASS) from Baseline to 30 Months
timeFrame: Baseline and 30 Months
measure: Change in Anxiety using the Depression Anxiety Stress Scales (DASS) from Baseline to 30 Months
timeFrame: Baseline and 30 Months
measure: Change in Stress using the Depression Anxiety Stress Scales (DASS) from Baseline to 30 Months
timeFrame: Baseline and 30 Months
measure: Change in Sleep Impairment using the PROMIS Sleep Related Impairment Survey from Baseline to 30 Months
timeFrame: Baseline and 30 Months
measure: Change in Physical Composite Score (PCS) using the Short-Form-36 (SF-36) from Baseline to 30 Months
timeFrame: Baseline and 30 Months
measure: Change in Mental Composite Score (MCS) using the Short-Form-36 (SF-36) from Baseline to 30 Months
timeFrame: Baseline and 30 Months
measure: Change in Self-Efficacy for Healthy Eating using the Diet Self-Efficacy Scale (DIET-SE) from Baseline to 6 Months
timeFrame: Baseline and 6 Months
measure: Change in Self-Efficacy for Healthy Eating using the Diet Self-Efficacy Scale (DIET-SE) from Baseline to 30 Months
timeFrame: Baseline and 30 Months
measure: Adherence to intervention measured using a percentage of the total number of available app features used from Baseline to 6 Months
timeFrame: Baseline and 6 Months
measure: 12-Month Completion Status
timeFrame: Baseline and 12 Months
measure: Percent of Successful Technological Fixes
timeFrame: Baseline and 12 Months
measure: Change in CDC NCHS National Health Interview Survey
timeFrame: Baseline and 30 Months
Other outcomes:
Locations:
city: New York
country: United States
facility: Department of Psychiatry, Eating and Weight Disorders Program
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Thomas Hildebrandt, PsyD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sysko R, Bibeau J, Boyar A, Costello K, Michaelides A, Mitchell ES, Susanin A, Hildebrandt T. A 2.5-Year Weight Management Program Using Noom Health: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Aug 12;11(8):e37541. doi: 10.2196/37541.