Coached or Non-Coached Weight Loss Intervention

Sponsor
Noom Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04645108
Collaborator
(none)
250
Enrollment
1
Location
2
Arms
16.3
Anticipated Duration (Months)
15.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Noom Healthy Weight; mobile behavior change program for weight loss with 1:1 coaching
  • Behavioral: Noom Healthy Weight; mobile behavior change program for weight loss
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Randomized, Parallel Trial of Overweight Men and Women Using a Coached or Non-Coached Weight Loss Intervention
Actual Study Start Date :
Nov 20, 2020
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Mar 30, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Coached

Behavioral: Noom 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.

Active Comparator: No Coach

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

Outcome Measures

Primary Outcome Measures

  1. Weight [4 months]

    Self reported

  2. Self reported in app engagement measures [4 months]

    self reported and automatically logged

Secondary Outcome Measures

  1. Quality of Life Via SF-12 [4 months]

    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

  2. Eating Behavior via the Dutch Eating Behavior Questionnaire [4 months]

    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.

  3. Resilience via Devereux Adult Resilience Survey [4 months]

    Provides insights into personal strengths

  4. Self Efficacy via General Self-Efficacy Scale [4 months]

    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.

  5. Linguistic Features via Linguistic Inquiry Word Count (LIWC) [16 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
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:
  • 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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Noom, IncNew YorkNew YorkUnited States10001

Sponsors and Collaborators

  • Noom Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Noom Inc.
ClinicalTrials.gov Identifier:
NCT04645108
Other Study ID Numbers:
  • 00046922
First Posted:
Nov 27, 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