Attitudes Toward Food During a Weight Loss Intervention

Sponsor
Noom Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04586647
Collaborator
(none)
160
Enrollment
1
Location
2
Arms
9.8
Actual Duration (Months)
16.3
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Noom Healthy Weight; mobile behavior change program for weight loss.
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Investigation of Healthy Eating Habits and Attitudes Toward Food During a Weight Loss Intervention
Actual Study Start Date :
Nov 4, 2020
Actual Primary Completion Date :
Aug 15, 2021
Actual Study Completion Date :
Aug 30, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: Noom Health Weight Program

Behavioral: Noom Healthy Weight; mobile behavior change program for weight loss.
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.

No Intervention: Wait List Control

Outcome Measures

Primary Outcome Measures

  1. Self-reported eating behaviors via the Three Factor Eating Questionnaire [4 months]

    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

  1. Self reported disordered eating habits via the Disordered Eating Attitude Questionnaire [4 months]

    A 25-item questionnaire that assesses the individual's eating attitudes.

  2. Self reported mindful eating habits via the Mindful Eating Scale [4 months]

    self-report scale to measure mindfulness with respect to eating behaviors

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Noom, Inc.New YorkNew YorkUnited States10001

Sponsors and Collaborators

  • Noom Inc.

Investigators

  • Principal Investigator: Siobhan Mitchell, PhD, Noom Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Noom Inc.
ClinicalTrials.gov Identifier:
NCT04586647
Other Study ID Numbers:
  • 00046455
First Posted:
Oct 14, 2020
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2021