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

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Noom

Status

Completed

Conditions

Quality of Life
Overweight and Obesity
Obesity
Health Behavior

Treatments

Behavioral: Noom Healthy Weight

Study type

Interventional

Funder types

Industry

Identifiers

NCT04871295
00048812

Details and patient eligibility

About

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.

Enrollment

370 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

370 participants in 2 patient groups

Wait List
No Intervention group
Noom Healthy Weight
Experimental group
Treatment:
Behavioral: Noom Healthy Weight

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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