search
Back to results

Attitudes Toward Food During a Weight Loss Intervention

Primary Purpose

Obesity, Weight Loss, Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Noom Healthy Weight; mobile behavior change program for weight loss.
Sponsored by
Noom Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Able to understand and provide informed consent
  • 18 years and older
  • Self-report of good health
  • Not diagnosed with an eating disorder
  • Overweight or obesity (BMI ≥ 25)
  • Able to meet our criteria of adherence to the program (at least 1 engagement per week on
  • one of the following: logged exercise, logged meals, steps, weigh-ins, coach messages, read articles, and days with at least one weigh-in.) For females
  • Not 6 months postpartum
  • Not planning to become pregnant in the next 5 months.

Exclusion Criteria:

  • Inability or unwillingness of a participant to give written informed consent
  • Currently pregnant or 6 months postpartum
  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the quality of the data
  • E.g., eating disorders

Sites / Locations

  • Noom, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Noom Health Weight Program

Wait List Control

Arm Description

Outcomes

Primary Outcome Measures

Self-reported eating behaviors via the Three Factor Eating Questionnaire
The primary outcome of this study is to assess self-reported eating behaviors via the Three Factor Eating Questionnaire following a weight loss intervention This assessment is designed to measure 3 dimensions of human eating behavior: cognitive restraint of eating (Factor I - 20 items), disinhibition (Factor II - 16 items), and hunger (Factor III - 15 items). The minimum score for factors I-II-III is therefore 0-0-0, and maximum possible score is 20-16-15. Part I includes items 1-36 and are rated either 1-True or 0-False. Part II includes items 37-51 and is rated on a 4-point scale with the exception of item 50, which is rated on a 6-point scale. Higher scores reflective of higher restraint,

Secondary Outcome Measures

Self reported disordered eating habits via the Disordered Eating Attitude Questionnaire
A 25-item questionnaire that assesses the individual's eating attitudes.
Self reported mindful eating habits via the Mindful Eating Scale
self-report scale to measure mindfulness with respect to eating behaviors

Full Information

First Posted
October 7, 2020
Last Updated
October 5, 2022
Sponsor
Noom Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04586647
Brief Title
Attitudes Toward Food During a Weight Loss Intervention
Official Title
Investigation of Healthy Eating Habits and Attitudes Toward Food During a Weight Loss Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 4, 2020 (Actual)
Primary Completion Date
August 15, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Noom Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 Noom's 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 Noom's 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss, Overweight and Obesity, Overweight or Obesity, Eating Behavior, Food Habits, Eating Disorder Symptom

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Noom Health Weight Program
Arm Type
Experimental
Arm Title
Wait List Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Noom Healthy Weight; mobile behavior change program for weight loss.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-reported eating behaviors via the Three Factor Eating Questionnaire
Description
The primary outcome of this study is to assess self-reported eating behaviors via the Three Factor Eating Questionnaire following a weight loss intervention This assessment is designed to measure 3 dimensions of human eating behavior: cognitive restraint of eating (Factor I - 20 items), disinhibition (Factor II - 16 items), and hunger (Factor III - 15 items). The minimum score for factors I-II-III is therefore 0-0-0, and maximum possible score is 20-16-15. Part I includes items 1-36 and are rated either 1-True or 0-False. Part II includes items 37-51 and is rated on a 4-point scale with the exception of item 50, which is rated on a 6-point scale. Higher scores reflective of higher restraint,
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Self reported disordered eating habits via the Disordered Eating Attitude Questionnaire
Description
A 25-item questionnaire that assesses the individual's eating attitudes.
Time Frame
4 months
Title
Self reported mindful eating habits via the Mindful Eating Scale
Description
self-report scale to measure mindfulness with respect to eating behaviors
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Able to understand and provide informed consent 18 years and older Self-report of good health Not diagnosed with an eating disorder Overweight or obesity (BMI ≥ 25) Able to meet our criteria of adherence to the program (at least 1 engagement per week on one of the following: logged exercise, logged meals, steps, weigh-ins, coach messages, read articles, and days with at least one weigh-in.) For females Not 6 months postpartum Not planning to become pregnant in the next 5 months. Exclusion Criteria: Inability or unwillingness of a participant to give written informed consent Currently pregnant or 6 months postpartum Presence of a condition or abnormality that in the opinion of the Investigator would compromise the quality of the data E.g., eating disorders
Facility Information:
Facility Name
Noom, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Attitudes Toward Food During a Weight Loss Intervention

We'll reach out to this number within 24 hrs