Longitudinal Effects of a Commercial Digital Weight Management Program on Weight Loss
NCT ID: NCT06666842
Last Updated: 2024-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
412 participants
INTERVENTIONAL
2022-06-01
2023-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Noom Weight
Participate in a 16-week fully remote digital weight management program focusing on weight loss and management via behavioral change
Noom Weight
Participants assigned to Noom Weight will be provided access to the app-based program for 16 weeks. This program offers access to self-monitoring features, psychoeducational articles, one-on-one coaching from health experts, and group support. The app includes a robust database of foods, allowing users to track their energy intake. Self-monitoring via the app enables users to review and monitor behavior and weight change patterns. Daily articles review principles of behavior change, nutrition, exercise, etc.
Educational Control
Receive 16 weekly weight loss-related educational emails based on the United States Department of Agriculture (USDA) Dietary Guidelines
Educational Control
Participants assigned to the educational control will receive 16 brief (5-10 minute read) weekly newsletters outlining information on developing and maintaining a healthy diet and lifestyle adapted from the 2015-2020 Department of Health and Human Services (HHS) and Department of Agriculture (USDA) Dietary Guidelines for Americans. Newsletters include detailed information on topics such as nutrition fundamentals (e.g., calorie limits; healthy eating), food groups and dietary guidelines (e.g., importance of vegetables, fruits, and grains), and tips for habit change (e.g., reducing added sugar and saturated fats). Each week includes prompts for individuals to try new strategies (e.g., make a conscious decision about everything you eat; try to eat at your calorie budget).
Interventions
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Noom Weight
Participants assigned to Noom Weight will be provided access to the app-based program for 16 weeks. This program offers access to self-monitoring features, psychoeducational articles, one-on-one coaching from health experts, and group support. The app includes a robust database of foods, allowing users to track their energy intake. Self-monitoring via the app enables users to review and monitor behavior and weight change patterns. Daily articles review principles of behavior change, nutrition, exercise, etc.
Educational Control
Participants assigned to the educational control will receive 16 brief (5-10 minute read) weekly newsletters outlining information on developing and maintaining a healthy diet and lifestyle adapted from the 2015-2020 Department of Health and Human Services (HHS) and Department of Agriculture (USDA) Dietary Guidelines for Americans. Newsletters include detailed information on topics such as nutrition fundamentals (e.g., calorie limits; healthy eating), food groups and dietary guidelines (e.g., importance of vegetables, fruits, and grains), and tips for habit change (e.g., reducing added sugar and saturated fats). Each week includes prompts for individuals to try new strategies (e.g., make a conscious decision about everything you eat; try to eat at your calorie budget).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Noom Inc.
INDUSTRY
Responsible Party
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Locations
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Noom Inc.
New York, New York, United States
Countries
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Other Identifiers
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00064357
Identifier Type: -
Identifier Source: org_study_id
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