Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04797169
Status:
COMPLETED
Last Update Posted:
2023-08-03
First Post:
2021-03-10
Brief Title:
Noom Health for Weight Management
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Noom Health for Weight Management
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 heightweight waist circumference weight loss historypractices health care practicesutilization 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 screeningbaseline 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 ScreeningBaseline 1 month 4 months 6 months 12 months 18 months 24 months and 30 months
Participants will complete informed consent and interviews via a HIPAA-compliant videoconference Zoom and other questionnaires via a REDCap interface All participants will complete screeningbaseline 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 ScreeningBaseline 1 month 4 months 6 months 12 months 18 months 24 months and 30 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None