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

Noom

Status

Completed

Conditions

Weight Loss

Obesity

Treatments

Behavioral: Noom Weight

Behavioral: Educational Control

Study type

Interventional

Funder types

Industry

Identifiers

NCT06666842

00064357

Details and patient eligibility

About

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.

Full description

The proposed study seeks to rigorously evaluate and compare the effectiveness of a fully remote digital weight management program (Noom Weight) to an educational control.

Potential participants will be recruited via social media advertisements, which include a brief study description, eligibility criteria, and a link to a web-based screening questionnaire to assess eligibility and interest. If deemed eligible, participants will be invited to complete informed consent and baseline questionnaires. Study staff will then use a random number generator to allocate participants randomly to the Noom Weight program or the educational control. All participants will receive a cellular-connected digital scale (Body Trace), which will be linked to participant IDs and synced to record weigh-ins automatically.

During the initial 16 weeks, Noom Weight participants will be invited to engage with the mobile-based app, which focuses on weight loss and management via behavioral change, and provides features such as self-monitoring, psychoeducational articles, one-on-one coaching from health experts, and group support. Educational control participants will receive 16 weekly weight loss-related educational emails based on the United States Department of Agriculture (USDA) Dietary Guidelines.

After completing the program at 16 weeks, participants will be asked to complete an online questionnaire assessing weight, physical activity, eating disorder risk, and body appreciation. Additional data collection will occur via online questionnaires at 29, 42, and 68 weeks.

Enrollment

412 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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