Clinical trial NCT06666842: Longitudinal Effects of a Commercial Digital Weight Management Program on Weight Loss
Official title: Longitudinal Effects of a Digital WM Program on Weight Loss: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Weight Loss
Keywords: Obesity
Weight Loss
Weight Maintenance
Digital Health
Mobile App
Lead sponsor: Noom Inc.
Sponsor class: INDUSTRY
First posted: 2024-10-31
Enrollment: 412
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to one of two conditions in a parallel design with assessments occurring before randomization (Baseline) and at 16, 29, 42, and 68 weeks.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent weight change at Week 16
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Percent weight change at Week 29
timeFrame: Baseline, Week 29
measure: Percent weight change at Week 42
timeFrame: Baseline, Week 42
measure: Percent weight change at Week 68
timeFrame: Baseline, Week 68
measure: Physical activity change at Week 68
timeFrame: Baseline, Week 68
measure: Changes in eating disorder risk at Week 68
timeFrame: Baseline, Week 68
measure: Changes in body appreciation at Week 68
timeFrame: Baseline, Week 68
Other outcomes:
Locations:
city: New York
country: United States
facility: Noom Inc.
state: New York
Study officials:
References: