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

NCT04871295 | Completed

• 1 other identifier: 00048812
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Overweight and Obesity; Quality of Life; Health Behavior

Outcome Measures

Primary Outcomes (3)

• Weight

  Self Reported

  4 months

• In app engagement measures

  Self reported and automatically recorded

  4 months

• 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).

  4 months

Secondary Outcomes (8)

• Self Reported Perceived Stress

  4 months

• Sleep Quality

  4 months

• Sleep Impact

  4 months

• Sleep Score

  4 months

• Appetite and food craving

  4 months

Other Outcomes (1)

• COVID status

  4 months

Study Arms (2)

Wait List

NO INTERVENTION

Noom Healthy Weight

EXPERIMENTAL

Behavioral: Noom Healthy Weight

Interventions

Noom Healthy Weight BEHAVIORAL

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.

Noom Healthy Weight

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and provide informed consent
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Noom Inc.: lead

Study Sites (1)

Noom

New York, New York, 10001, United States

Location

MeSH Terms

Conditions

Obesity; Overweight; Health Behavior

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: May 4, 2021
• Study Start: April 15, 2021
• Primary Completion: February 15, 2022
• Study Completion: February 15, 2022
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)