Longitudinal Effects of a Commercial Digital Weight Management Program on Weight Loss
Completed · Not applicable
Conditions studied: Obesity, Weight Loss
In brief
This randomized controlled trial (RCT) will test how well a fully remote weight management program (Noom Weight) helps adults with overweight or obesity (BMI 25-45) achieve weight loss in both the short-term (16 weeks) and the long-term (68 weeks), compared to an educational program). Participants will be randomly assigned to use the 16-week Noom Weight program or receive weekly emails with weight loss-related tips and information. Weight will be measured at baseline, 16, 29, 42, and 68 weeks. Changes in physical activity, eating disorder risk, and body appreciation will also be assessed.
Key facts
- Study ID
- NCT06666842
- Run by
- Noom Inc.
- People needed
- 412
- Starts
- 2022-06-01
- Expected to finish
- 2023-12-01
- Last updated by the study team
- 2024-10-31
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18 to 75 years old
- Self-reported body mass index (BMI) of 25-45
- Proficient in English
- Live in the United States
- Have access to an iOS smartphone or tablet and were willing to use applications daily
- Willing to abstain from engaging in other weight loss programs for 16 weeks
- Willing to discontinue any current over-the-counter (OTC) supplements not recommended/prescribed by a physician (except for multivitamins or other vitamin supplements)
- Have a goal of losing weight
- Complete a decisional balance exercise based on the work of Goldberg and Kiernan (2005). During this exercise, participants reviewed the nature, design, and importance of this study and were prompted to consider the pros and cons of participation. The purpose of this exercise was to ensure that participants fully understood and were willing to participate in the study, as well as to increase study retention.
You may not qualify if…
- Weight loss of ≥ 5 kg within the past 6 months
- History of heart problems (e.g., angina, bypass surgery, myocardial infarction, etc.) within the past 6 months
- Major surgery interfering with consuming a regular diet and performing physical activity within the past 6 months
- Hospitalized for psychiatric problems within the past 12 months
- Paid subscription to Noom within the past 12 months
- Concurrent enrollment in other weight management programs or clinical trials that may interfere
- Living with another study participant
- Ever been diagnosed with an eating disorder
- Diagnosis of conditions indicative of weight loss difficulties or unsupervised exercise as being unsafe or unreasonable (e.g., orthopedic limitations, heart problems)
- History of chronic/inflammatory gastrointestinal disorder, with the expectation of irritable bowel syndrome
- Diagnosis of diabetes
- Previous surgical procedure for weight loss
- Presence of implanted cardiac defibrillator or pacemaker
- Current, recent, or planned pregnancy in the next 12 months
- Cancer within past 5 years
- Current cancer treatment
- Untreated thyroid disease or changes (type or dose) in thyroid medication in the last 6 months
- Prescription medication with known effects on appetite or weight (e.g., oral steroids, weight loss medications such as Qsymia, Contrave, etc.) with the exception of a stable dose of selective serotonin reuptake inhibitors (SSRIs) for 6 months
Where it is running
- Noom Inc. — New York, New York, United States
Full record on ClinicalTrials.gov
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