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

Primary Purpose

Obesity, Overweight and Obesity, Quality of Life

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Noom Healthy Weight
Sponsored by
Noom Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Noom

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Wait List

Noom Healthy Weight

Arm Description

Outcomes

Primary Outcome Measures

Weight
Self Reported
In app engagement measures
Self reported and automatically recorded
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).

Secondary Outcome Measures

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
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.
Sleep Impact
Adult Sickle Cell Quality of Life Measurement (ASCQ-Me); 5 point rating scale ranging from never - always.
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.
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
Reward-related eating
Reward based eating scale (RED-9); A validated, 9-item index that captures reward-based eating drive as a single factor
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.
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+

Full Information

First Posted
April 6, 2021
Last Updated
March 29, 2023
Sponsor
Noom Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04871295
Brief Title
Improving Quality of Life in Men and Women With Overweight or Obesity
Official Title
Randomized, Controlled Trial of a Weight Loss Intervention in Improving Quality of Life in Men and Women With Overweight or Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
February 15, 2022 (Actual)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Noom Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight and Obesity, Quality of Life, Health Behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
370 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wait List
Arm Type
No Intervention
Arm Title
Noom Healthy Weight
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Noom Healthy Weight
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight
Description
Self Reported
Time Frame
4 months
Title
In app engagement measures
Description
Self reported and automatically recorded
Time Frame
4 months
Title
Stress
Description
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).
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Self Reported Perceived Stress
Description
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
Time Frame
4 months
Title
Sleep Quality
Description
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.
Time Frame
4 months
Title
Sleep Impact
Description
Adult Sickle Cell Quality of Life Measurement (ASCQ-Me); 5 point rating scale ranging from never - always.
Time Frame
4 months
Title
Sleep Score
Description
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.
Time Frame
4 months
Title
Appetite and food craving
Description
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
Time Frame
4 months
Title
Reward-related eating
Description
Reward based eating scale (RED-9); A validated, 9-item index that captures reward-based eating drive as a single factor
Time Frame
4 months
Title
Perceived physical and mental health over time
Description
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.
Time Frame
4 months
Title
Depression and anxiety
Description
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+
Time Frame
4 months
Other Pre-specified Outcome Measures:
Title
COVID status
Description
COVID health questionnaire
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Noom
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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