ObesityNCT06666842
Longitudinal Effects of a Commercial Digital Weight Management Program on Weight Loss
A study testing Noom Weight in people with Obesity and Weight Loss, run by Noom Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity, Weight Loss
- What is being tested?
- Noom Weight
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 412 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Effects of a Digital WM Program on Weight Loss: a Randomized Controlled Trial
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.
Read the 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
- Being tested
- Noom Weight, Educational Control
- Keywords
- Obesity, Weight Loss, Weight Maintenance, Digital Health, Mobile App
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noom WeightBehavioural
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 ControlBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Noom Weight | Experimental | Participate in a 16-week fully remote digital weight management program focusing on weight loss and management via behavioral change Receives: Behavioral: Noom Weight |
| Educational Control | Active comparator | Receive 16 weekly weight loss-related educational emails based on the United States Department of Agriculture (USDA) Dietary Guidelines Receives: Behavioral: Educational Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 16
Secondary outcomes (6)
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.
Measured: Baseline, Week 29
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 68
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start1 Jun 2022
- Primary completion1 Dec 2022
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 412 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noom Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666842
- Sponsor's protocol ID
- 00064357
- Status last verified
- Oct 2024
- First submitted
- 29 Oct 2024
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Effects of a Digital WM Program on Weight Loss: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06666842
- Acronym / sponsor ID
- 00064357
- Conditions
- Obesity, Weight Loss
- Keywords
- Obesity, Weight Loss, Weight Maintenance, Digital Health, Mobile App
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 412 participants (actual)
- Lead sponsor
- Noom Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Noom Weight | Experimental | Behavioral: Noom WeightParticipate in a 16-week fully remote digital weight management program focusing on weight loss and management via behavioral change |
| Educational Control | Active comparator | Behavioral: Educational ControlReceive 16 weekly weight loss-related educational emails based on the United States Department of Agriculture (USDA) Dietary Guidelines |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Noom WeightParticipants 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. | Behavioural | Noom Weight |
| Educational ControlParticipants 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). | Behavioural | Educational Control |
Primary outcome
Percent weight change at Week 16
Time frame: Baseline, 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.
6 secondary outcomes
Percent weight change at Week 29
Time frame: Baseline, Week 29
Percent weight change at Week 42
Time frame: Baseline, Week 42
Percent weight change at Week 68
Time frame: Baseline, Week 68
Physical activity change at Week 68
Time frame: Baseline, Week 68
Changes in eating disorder risk at Week 68
Time frame: Baseline, Week 68
Changes in body appreciation at Week 68
Time frame: Baseline, Week 68
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noom Weight in people with Obesity and Weight Loss, run by Noom Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent weight change at Week 16 (time frame: Baseline, Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.