- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04871295
Improving Quality of Life in Men and Women With Overweight or Obesity
Randomized, Controlled Trial of a Weight Loss Intervention in Improving Quality of Life in Men and Women With Overweight or Obesity
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10001
- Noom
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Wait List
|
|
Experimental: 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight
Time Frame: 4 months
|
Self Reported
|
4 months
|
In app engagement measures
Time Frame: 4 months
|
Self reported and automatically recorded
|
4 months
|
Stress
Time Frame: 4 months
|
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).
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self Reported Perceived Stress
Time Frame: 4 months
|
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
|
4 months
|
Sleep Quality
Time Frame: 4 months
|
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.
|
4 months
|
Sleep Impact
Time Frame: 4 months
|
Adult Sickle Cell Quality of Life Measurement (ASCQ-Me); 5 point rating scale ranging from never - always.
|
4 months
|
Sleep Score
Time Frame: 4 months
|
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.
|
4 months
|
Appetite and food craving
Time Frame: 4 months
|
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
|
4 months
|
Reward-related eating
Time Frame: 4 months
|
Reward based eating scale (RED-9); A validated, 9-item index that captures reward-based eating drive as a single factor
|
4 months
|
Perceived physical and mental health over time
Time Frame: 4 months
|
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. |
4 months
|
Depression and anxiety
Time Frame: 4 months
|
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+ |
4 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
COVID status
Time Frame: 4 months
|
COVID health questionnaire
|
4 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00048812
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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