Improving Quality of Life in Men and Women With Overweight or Obesity

NCT ID: NCT04871295

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

370 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-15

Study Completion Date

2022-02-15

Brief Summary

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The purpose of this study is to evaluate the effect of the Noom Healthy Weight Program, a digital behavior change weight loss intervention, on quality of life as measured both by self-report and objective measures, compared to a waitlist control condition.

Detailed Description

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Conditions

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Obesity Overweight and Obesity Quality of Life Health Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Wait List

Group Type NO_INTERVENTION

No interventions assigned to this group

Noom Healthy Weight

Group Type EXPERIMENTAL

Noom Healthy Weight

Intervention Type BEHAVIORAL

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.

Interventions

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Noom Healthy Weight

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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 ≥ 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 within the 6 months postpartum time frame
* Not planning to become pregnant in the next 5 months.

Exclusion Criteria

* Inability or unwillingness of a participant to give written informed consent
* Currently taking medication which affects sleep or heart rate (e.g., (i) central nervous system stimulants, (ii) respiratory medications, (iii) antihistamines, (iv) central acting hormones (e.g. corticosteroids, thyroid), (v) high-dose anticholinergics, (vi) and cannot be using the maximum recommended dose for antihypertensive medications or use of multiple antihypertensive medications)
* Current diagnosed mental health condition (except mild anxious or depressive symptoms)
* Current diagnosed sleep disorder or condition not related to obesity (e.g., narcolepsy)
* Currently pregnant or ≤ 6 months postpartum
* Currently participating in shift work and/or have travelled between time zones in the last month
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Noom Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Noom

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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00048812

Identifier Type: -

Identifier Source: org_study_id

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