CClinicalTrials.gg
CompletedNCT04645108Updated Oct 7, 2022

Coached or Non-Coached Weight Loss Intervention

An interventional study of Noom Healthy Weight; mobile behavior change program for weight loss with 1:1 coaching and Noom Healthy Weight; mobile behavior change program for weight loss in Obesity, Behavior, Health and Behavior, Eating, sponsored by Noom Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-07.

Sponsored by Noom Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
246
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

To evaluate the effect of one-on-one coaching in the Noom Healthy Weight Program, a digital behavior change, weight loss intervention, compared to the same program with no coaching, as well as influential factors.

02

Conditions studied

  • Obesity
  • Behavior, Health
  • Behavior, Eating
  • Weight Loss
  • Overweight and Obesity
  • Self Efficacy
03

In context

Obesity

6,297 studies on the registry are indexed under Obesity; 1,693 are open to participants now.

This study's enrollment of 246 is above the median of 78 across 4,879 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Noom Inc. is the lead sponsor of 12 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Able to understand and provide informed consent
  • 18-65 years old
  • Self-report of good health (physical and mental)
  • Not diagnosed with diabetes
  • Overweight or obesity (BMI ≥ 27)
  • 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

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., evidence of an eating disorder, major chronic condition
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
246 participants (actual)

Study arms

  • Experimental
    Coached

    Behavioral: Noom Healthy Weight; mobile behavior change program for weight loss with 1:1 coaching

  • Active comparator
    No Coach

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

Interventions

  • BehavioralNoom Healthy Weight; mobile behavior change program for weight loss with 1:1 coaching

    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.

  • BehavioralNoom 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. During the first week of the study, participants will be introduced to the program, and the Noom app.

06

What researchers measure

Primary outcomes

  1. Weight

    Self reported

    Time frame: 4 months

  2. Self reported in app engagement measures

    self reported and automatically logged

    Time frame: 4 months

Secondary outcomes

  1. Quality of Life Via SF-12

    Self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure

    Time frame: 4 months

  2. Eating Behavior via the Dutch Eating Behavior Questionnaire

    The Dutch Eating Behavior Questionnaire (DEBQ) assesses the structure of an individual's eating behavior. the DEBQ contains separate scales for emotional, external, and restrained eating behavior.

    Time frame: 4 months

  3. Resilience via Devereux Adult Resilience Survey

    Provides insights into personal strengths

    Time frame: 4 months

  4. Self Efficacy via General Self-Efficacy Scale

    The scale was created to assess a general sense of perceived self-efficacy with the aim in mind to predict coping with daily hassles as well as adaptation after experiencing all kinds of stressful life events.

    Time frame: 4 months

  5. Linguistic Features via Linguistic Inquiry Word Count (LIWC)

    LIWC-derived linguistic analysis of emotional tone taken from from expressively written text following a writing task prompt

    Time frame: 16 weeks

07

Study locations

1 site
  • Noom, Inc
    New York, New York 10001, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04645108
Lead sponsor
Noom Inc.
Responsible party
Sponsor
First posted
Nov 27, 2020
Start date
Nov 20, 2020
Primary completion
Jun 10, 2021
Completion
Jun 10, 2021
Last update
Oct 7, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion