Sign in

NCT06666842Completed

Longitudinal Effects of a Commercial Digital Weight Management Program on Weight Loss

Longitudinal Effects of a Digital WM Program on Weight Loss: a Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 31 Oct 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
412 (actual)
First submitted
29 Oct 2024
Start date
1 Jun 2022
Primary completion date
1 Dec 2022
Lead sponsor
Noom Inc.
Diseases
Obesity
NCT number
NCT06666842

What you commit to

  • Study type: Interventional
  • Participants enrolled: 412
  • From 1 Jun 2022 to the primary completion date, 1 Dec 2022
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Major surgery interfering with consuming a regular diet and performing physical activity within the past 6 months
  • Concurrent enrollment in other weight management programs or clinical trials that may interfere
  • Previous surgical procedure for weight loss
  • 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

Other illness

  • History of heart problems (e.g., angina, bypass surgery, myocardial infarction, etc.) within the past 6 months
  • Hospitalized for psychiatric problems within the past 12 months
  • 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
  • Presence of implanted cardiac defibrillator or pacemaker
  • Cancer within past 5 years
  • Current cancer treatment
  • Untreated thyroid disease or changes (type or dose) in thyroid medication in the last 6 months

Other

  • Weight loss of ≥ 5 kg within the past 6 months
  • Paid subscription to Noom within the past 12 months
  • Living with another study participant
  • Current, recent, or planned pregnancy in the next 12 months

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Noom Inc.
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.