Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04586647
Status:
COMPLETED
Last Update Posted:
2022-10-06
First Post:
2020-10-07
Brief Title:
Attitudes Toward Food During a Weight Loss Intervention
Sponsor:
Noom Inc
Organization:
Noom Inc
Study Overview
Official Title:
Investigation of Healthy Eating Habits and Attitudes Toward Food During a Weight Loss Intervention
Status:
COMPLETED
Status Verified Date:
2022-10
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 purpose of this study is to evaluate whether the Noom Healthy Weight Program a digital behavior change weight loss intervention creates a positive relationship with food compared to a waitlist control group
Detailed Description:
This is a prospective randomized controlled pilot study evaluating relationships towards food in overweight and obese Noom Healthy Weight participants
Participants will be randomly assigned to one of two conditions intervention waitlist control In the intervention condition participants will have immediate access to the full Noom program after consenting to Nooms Research Policy which states the collection of in app user data for research purposes In the waitlist control condition participants will be informed that they are on a waiting list and will be provided access to the full Noom program after 4 months after consenting to Nooms Research Policy
Noom will have access to participants username and email address Before the start of the program participants in both conditions will be emailed a survey containing the validated questionnaires mentioned below The survey will also ask for demographic information such as race ethnicity and socioeconomic status Survey responses will be linked to weight data by email address but all data will be de-identified prior to analysis The same survey without demographic questions will be sent to participants again at program end 4 months
The intervention consists of a curriculum provided through daily articles that users are encouraged to read logging features for weight meals and physical activity in-app groups and a virtual coach who will communicate with participants via in-app messaging During the first week of the study participants will be introduced to the program the Noom app and their coach
Coaches will use a secure dashboard to monitor patient progress which is used to increase engagement and motivation Participants are encouraged to log their weight and physical activity on a weekly basis and meals daily
The primary outcome of this study is to assess self-reported eating behaviors via the Three Factor Eating Questionnaire following a 4 month weight loss intervention Noom Healthy Weight program
Secondary outcomes assessing disordered eating habits and mindfulness will be measured via the Disordered Eating Attitude Questionnaire and the Mindful Eating Scale Mean weight loss differences between groups will also be measured
Participants will be randomly assigned to one of two conditions intervention waitlist control In the intervention condition participants will have immediate access to the full Noom program after consenting to Nooms Research Policy which states the collection of in app user data for research purposes In the waitlist control condition participants will be informed that they are on a waiting list and will be provided access to the full Noom program after 4 months after consenting to Nooms Research Policy
Noom will have access to participants username and email address Before the start of the program participants in both conditions will be emailed a survey containing the validated questionnaires mentioned below The survey will also ask for demographic information such as race ethnicity and socioeconomic status Survey responses will be linked to weight data by email address but all data will be de-identified prior to analysis The same survey without demographic questions will be sent to participants again at program end 4 months
The intervention consists of a curriculum provided through daily articles that users are encouraged to read logging features for weight meals and physical activity in-app groups and a virtual coach who will communicate with participants via in-app messaging During the first week of the study participants will be introduced to the program the Noom app and their coach
Coaches will use a secure dashboard to monitor patient progress which is used to increase engagement and motivation Participants are encouraged to log their weight and physical activity on a weekly basis and meals daily
The primary outcome of this study is to assess self-reported eating behaviors via the Three Factor Eating Questionnaire following a 4 month weight loss intervention Noom Healthy Weight program
Secondary outcomes assessing disordered eating habits and mindfulness will be measured via the Disordered Eating Attitude Questionnaire and the Mindful Eating Scale Mean weight loss differences between groups will also be measured
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