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ObesityNCT04871295

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

A study testing Noom Healthy Weight in people with Obesity and Overweight and Obesity, run by Noom Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Overweight and Obesity, Quality of Life
What is being tested?
Noom Healthy Weight
Could I receive a placebo?
No, everyone receives an active treatment
How many people
370 participants
Where
1 siteUnited States
Study dates
15 Apr 2021to 15 Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.)
Show all 9Show fewer
  • For females
  • Not within the 6 months postpartum time frame
  • Not planning to become pregnant in the next 5 months.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Noom

    New York, New York, 10001

Other trials in United States

About this study

Official title: Randomized, Controlled Trial of a Weight Loss Intervention in Improving Quality of Life in Men and Women With Overweight or Obesity

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.

Being tested
Noom Healthy Weight
Medical subject headings
Obesity, Overweight, Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Noom Healthy WeightBehavioural

    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.

Study groups in NCT04871295
Study groupRoleWhat they receive
Wait ListNo interventionNot described
Noom Healthy WeightExperimentalNot described
Receives: Behavioral: Noom Healthy Weight

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight

    Self Reported

    Measured: 4 months

  2. In app engagement measures

    Self reported and automatically recorded

    Measured: 4 months

  3. Stress

    Measured via heart rate variability; Data will be collected with a wearable tracking device (Oura Ring). Heart rate variability (HRV) measures the specific changes in time (or variability) between successive heart beats. The time between beats is measured in milliseconds (ms) and is called an "R-R interval" or "inter-beat interval (IBI).

    Measured: 4 months

Secondary outcomes (8)

  1. Self Reported Perceived Stress

    Perceived Stress Scale (PSS) Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress

    Measured: 4 months

  2. Sleep Quality

    Pittsburgh Sleep Quality Index (PSQI); The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range of 0-21 points, "0" indicating no difficulty and "21" indicating severe difficulties in all areas.

    Measured: 4 months

  3. Sleep Impact

    Adult Sickle Cell Quality of Life Measurement (ASCQ-Me); 5 point rating scale ranging from never - always.

    Measured: 4 months

  4. Sleep Score

    Measured via a wearable health tracking device (Oura Ring). Sleep score consists of: Total sleep time, time in bed, sleep efficiency, and resting heart rate.

    Measured: 4 months

  5. Appetite and food craving

    Food Cravings Questionnaire-State; he Food Cravings Questionnaire-State (FCQ-S) measures the intensity of momentary food craving. The questionnaire has 15 items and response categories range from 1 = strongly disagree to 5 = strongly agree

    Measured: 4 months

  6. Reward-related eating

    Reward based eating scale (RED-9); A validated, 9-item index that captures reward-based eating drive as a single factor

    Measured: 4 months

  7. Perceived physical and mental health over time

    Reported via the Health-related quality of life (HRQoL) survey; A multi-dimensional concept that includes domains related to physical, mental, emotional, and social functioning. It goes beyond direct measures of population health, life expectancy, and causes of death, and focuses on the impact health status has on quality of life.

    85 = Very good quality of life. 70 = Good quality of life. 57.5 = Moderately good quality of life.

    Measured: 4 months

  8. Depression and anxiety

    Depression Anxiety Stress Scales (DASS); The DASS is a 42-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress.

    Scoring:

    Normal

    Depression: 0-9

    Anxiety: 0-7

    Stress: 0-14

    Mild

    Depression: 10-13

    Anxiety: 8-9

    Stress: 15-18

    Moderate

    Depression: 14-20

    Anxiety: 10-14

    Stress: 19-25

    Severe

    Depression: 21-27

    Anxiety: 15-19

    Stress: 26-33

    Extremely severe

    Depression: 28+

    Anxiety: 20+

    Stress: 34+

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2021
  2. Study start15 Apr 2021
  3. Primary completion15 Feb 2022
  4. Study completion15 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
370 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04871295
Sponsor's protocol ID
00048812
Status last verified
Nov 2023
First submitted
6 Apr 2021
Last updated
18 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Noom Healthy Weight in people with Obesity and Overweight and Obesity, run by Noom Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04871295.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.

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