NCT04645108

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
246

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2020

Completed
23 days until next milestone

Study Start

First participant enrolled

November 20, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 27, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2021

Completed
Last Updated

October 7, 2022

Status Verified

October 1, 2022

Enrollment Period

7 months

First QC Date

October 28, 2020

Last Update Submit

October 5, 2022

Conditions

ObesityBehavior, HealthBehavior, EatingWeight LossOverweight and ObesitySelf Efficacy

Outcome Measures

Primary Outcomes (2)

  • Weight

    Self reported

    4 months

  • Self reported in app engagement measures

    self reported and automatically logged

    4 months

Secondary Outcomes (5)

  • Quality of Life Via SF-12

    4 months

  • Eating Behavior via the Dutch Eating Behavior Questionnaire

    4 months

  • Resilience via Devereux Adult Resilience Survey

    4 months

  • Self Efficacy via General Self-Efficacy Scale

    4 months

  • Linguistic Features via Linguistic Inquiry Word Count (LIWC)

    16 weeks

Study Arms (2)

Coached

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

No Coach

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

Interventions

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

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.

Coached
Noom Healthy Weight; mobile behavior change program for weight lossBEHAVIORAL

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.

No Coach

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to understand and provide informed consent
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Noom, Inc

New York, New York, 10001, United States

Location

MeSH Terms

Conditions

ObesityHealth BehaviorFeeding BehaviorWeight LossOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorBehavior, AnimalBody Weight Changes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2020

First Posted

November 27, 2020

Study Start

November 20, 2020

Primary Completion

June 10, 2021

Study Completion

June 10, 2021

Last Updated

October 7, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)