NCT06666842

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 412 (actual)
• Sponsor: Noom Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity
• Weight Loss

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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).

Timeline

• Start date: 2022-06-01
• Primary completion: 2022-12-01
• Completion: 2023-12-01
• First posted: 2024-10-31
• Last updated: 2024-10-31

Locations

1 site across 1 country: United States