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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Noom Weight | Experimental | Participate in a 16-week fully remote digital weight management program focusing on weight loss and management via behavioral change |
|
| Educational Control | Active Comparator | Receive 16 weekly weight loss-related educational emails based on the United States Department of Agriculture (USDA) Dietary Guidelines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Noom Weight | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent weight change at Week 16 | Body weight will be measured using self-report and cellular-connected digital scales (Body Trace). The digital scale is linked to participant IDs and synced to record weigh-ins automatically. If a participant does not report a weight or the reported weight appears to be erroneous, then the raw scale data will be used. | Baseline, Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent weight change at Week 29 | Body weight will be measured using self-report and cellular-connected digital scales (Body Trace). The digital scale is linked to participant IDs and synced to record weigh-ins automatically. If a participant does not report a weight or the reported weight appears to be erroneous, then the raw scale data will be used. | Baseline, Week 29 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Noom Inc. | New York | New York | 10001 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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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.
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| Educational Control | Behavioral | 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). |
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| Percent weight change at Week 42 | Body weight will be measured using self-report and cellular-connected digital scales (Body Trace). The digital scale is linked to participant IDs and synced to record weigh-ins automatically. If a participant does not report a weight or the reported weight appears to be erroneous, then the raw scale data will be used. | Baseline, Week 42 |
| Percent weight change at Week 68 | Body weight will be measured using self-report and cellular-connected digital scales (Body Trace). The digital scale is linked to participant IDs and synced to record weigh-ins automatically. If a participant does not report a weight or the reported weight appears to be erroneous, then the raw scale data will be used. | Baseline, Week 68 |
| Physical activity change at Week 68 | Physical activity will be measured by the 7-item short International Physical Activity Questionnaire (IPAQ), which evaluates minutes of walking, moderate-intensity activities, and vigorous-intensity activities in the last seven days. Higher scores indicate more minutes engaging in each category. | Baseline, Week 68 |
| Changes in eating disorder risk at Week 68 | Eating disorder risk will be measured by the 28-item Eating Disorder Risk Questionnaire (EDE-Q), which evaluates the range, frequency, and severity of behaviors associated with a diagnosis of an eating disorder in the last four weeks using a seven-point Likert scale (1 = No Days; 2 = 1-5 Days; 3 = 6-12 Days; 4 = 13-15 Days; 5 = 16-22 Days; 6 = 23-27 Days; 7 = Every Day). Higher scores indicate greater eating disorder risk, with a global score of 4 or higher indicating a high risk of a clinical eating disorder. | Baseline, Week 68 |
| Changes in body appreciation at Week 68 | Body appreciation will be measured by the 10-item Body Appreciation Scale-2 (BAS), which evaluates acceptance, respect, and positive attitudes toward one's body using a five-point Likert scale (1 = Never; 2 = Seldom; 3 = Sometimes; 4 = Often; 5 = Always). Higher scores indicate greater body appreciation. | Baseline, Week 68 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |