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

Not Applicable

Completed

• Conditions: Health Behavior; Obesity; Overweight and Obesity; Quality of Life
• Interventions: Behavioral: Noom Healthy Weight

• Registration Number: NCT04871295
• Lead Sponsor: Noom Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-06
• Study Start: 2021-04-15
• Study First Submitted QC: 2021-04-30
• Study First Posted: 2021-05-04
• Primary Completion: 2022-02-15
• Study Completion: 2022-02-15
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 370

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Noom Healthy Weight	Noom Healthy Weight	-

Primary Outcome Measures

Name	Time	Method
In app engagement measures	4 months	Self reported and automatically recorded
Weight	4 months	Self Reported
Stress	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

Name	Time	Method
Self Reported Perceived Stress	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
Sleep Quality	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.
Sleep Impact	4 months	Adult Sickle Cell Quality of Life Measurement (ASCQ-Me); 5 point rating scale ranging from never - always.
Sleep Score	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.
Appetite and food craving	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
Reward-related eating	4 months	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	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.
Depression and anxiety	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+

Trial Locations

Locations (1)

Noom; 🇺🇸 New York, New York, United States