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

• ClinicalTrials.gov Identifier: NCT04871295
• Recruitment Status: Active, not recruiting
• First Posted: May 4, 2021
• Last Update Posted: November 18, 2021
• Sponsor: Noom Inc.
• Information provided by (Responsible Party): Noom Inc.

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Obesity; Overweight and Obesity; Quality of Life; Health Behavior	Behavioral: Noom Healthy Weight	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 370 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized, Controlled Trial of a Weight Loss Intervention in Improving Quality of Life in Men and Women With Overweight or Obesity
• Actual Study Start Date: April 15, 2021
• Estimated Primary Completion Date: February 15, 2022
• Estimated Study Completion Date: March 1, 2022

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Wait List
Experimental: Noom Healthy Weight	Behavioral: 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.

Outcome Measures

Primary Outcome Measures :

1. Weight [ Time Frame: 4 months ]
   Self Reported
2. In app engagement measures [ Time Frame: 4 months ]
   Self reported and automatically recorded
3. 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).

Secondary Outcome Measures :

1. 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
2. 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.
3. Sleep Impact [ Time Frame: 4 months ]
   Adult Sickle Cell Quality of Life Measurement (ASCQ-Me); 5 point rating scale ranging from never - always.
4. 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.
5. 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
6. 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
7. 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.

8. 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+

Other Outcome Measures:

1. COVID status [ Time Frame: 4 months ]
   COVID health questionnaire

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, New York

Noom

New York, New York, United States, 10001

Sponsors and Collaborators

Noom Inc.

More Information

• Responsible Party: Noom Inc.
• ClinicalTrials.gov Identifier: NCT04871295
• Other Study ID Numbers: 00048812
• First Posted: May 4, 2021
• Last Update Posted: November 18, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• 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:

Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight