Clinical trial NCT04871295: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight and Obesity
Quality of Life
Health Behavior
Lead sponsor: Noom Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-04
Enrollment: 370
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Weight
timeFrame: 4 months
measure: In app engagement measures
timeFrame: 4 months
measure: Stress
timeFrame: 4 months
Secondary outcomes:
measure: Self Reported Perceived Stress
timeFrame: 4 months
measure: Sleep Quality
timeFrame: 4 months
measure: Sleep Impact
timeFrame: 4 months
measure: Sleep Score
timeFrame: 4 months
measure: Appetite and food craving
timeFrame: 4 months
measure: Reward-related eating
timeFrame: 4 months
measure: Perceived physical and mental health over time
timeFrame: 4 months
measure: Depression and anxiety
timeFrame: 4 months
Other outcomes:
measure: COVID status
timeFrame: 4 months
Locations:
city: New York
country: United States
facility: Noom
state: New York
Study officials:
References: