Status:
COMPLETED
Improving Quality of Life in Men and Women With Overweight or Obesity
Lead Sponsor:
Noom Inc.
Conditions:
Obesity
Overweight and Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
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 objec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2022
Estimated Enrollment :
370 Patients enrolled
Trial Details
Trial ID
NCT04871295
Start Date
April 15 2021
End Date
February 15 2022
Last Update
November 18 2023
Active Locations (1)
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1
Noom
New York, New York, United States, 10001