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Weight LossNCT04302389

Single Arm Trial of a Multi-component Commercial Digital Weight Loss Program

A study testing myWW App, Virtual Workshops, and Private Facebook Group in people with Weight Loss, run by University of Connecticut at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of the proposed research project is to evaluate the acceptability and efficacy of an online multicomponent commercial weight loss program and to understand the relationship between program engagement and weight loss and health outcomes. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Weight Loss
What is being tested?
myWW App, Virtual Workshops, and Private Facebook Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
153 participants
Where
1 siteUnited States
Study dates
10 Feb 2021to 1 Nov 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 18-75 years old.
  • BMI 25-45 kg/m2.
  • Has Wi-Fi connectivity at home
  • Able to participate in the study in English.
  • Self-reported desire to lose weight.
  • Willing to follow recommendations required by study protocol.
  • Willing to include demographic information (e.g., ethnicity, income and education)
  • Lives in the United States

Who cannot join

  • Pregnant, lactating, or plans to become pregnant during study period.
  • Bipolar disorder, substance abuse, psychosis, bulimia, binge eating disorder, or severe depression.
  • Had bariatric surgery or plans to have any surgery during the study
  • Unable to make dietary changes or increase physical activity.
  • Unable to walk ¼ mile unaided without stopping
  • Smoker or use nicotine vape daily.
Show all 24Show fewer
  • Participants that are currently, or within the last 6 months, trying to lose weight via a structured weight-loss program (e.g., at a medical center, university, commercial programs)
  • Participants who were a member of WW within the past 12 months.
  • Participants who are involved in any other research studies at this time.
  • Weight loss of ≥ 5 kg in the previous 6 months.
  • Reported health problems that make weight loss or unsupervised exercise unsafe or unreasonable (e.g., chronic pain, orthopedic limitations, heart problems).
  • Untreated thyroid disease or any changes (type or dose) in thyroid medication in last 6 months.
  • Taking any prescription medication with known effects on appetite or weight (e.g., oral steroids, weight loss medications such as Qysmia, Contrave, etc.) with the exception of subjects on a stable dose of SSRIs for 6 months.
  • Chronic/inflammatory gastrointestinal disorders (irritable bowel syndrome is acceptable).
  • History of heart problems (e.g., angina, bypass surgery, myocardial infarction, etc.) within previous 6 months.
  • Diagnosis of type 1 or type 2 diabetes.
  • Major surgery within the previous 6 months.
  • Presence of implanted cardiac defibrillator or pacemaker.
  • History of cancer within past 5 years or current treatment for cancer (completely resected basal or squamous cell carcinoma acceptable if treatment completed more than 6 months prior to enrollment).
  • Meets criteria for severe depression on the PHQ-9 (score of >20) or endorsement of "Thoughts that you would be better off dead, or of hurting yourself in some way".
  • Hospitalization for psychiatric disorders during the past 12 months.
  • Not willing to sign an NDA; or indicated they do not want to agree to NDA's terms.
  • Unable to attend any virtual workshop meeting times.
  • Does not have an iPhone.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Connecticut

    Storrs, Connecticut, 06269

Other trials in United States

About this study

The goal of the proposed research project is to evaluate the acceptability and efficacy of an online multicomponent commercial weight loss program and to understand the relationship between program engagement and weight loss and health outcomes.

Read the detailed description

Technology is changing the opportunities to deliver behavioral weight loss programs and providing a way to extend their reach to wider audiences. Commercial programs that were once completely delivered via in person meetings at brick-and-mortar businesses are now expanding to virtual programs. WW (formerly known as Weight Watchers) is an industry leader and one of few commercial programs that has significant evidence for efficacy on weight loss. Their program currently includes a mobile app - that helps people follow the WW Program, rewards for consistent tracking and achieving milestones, an online community to connect with other users, and a 24/7 text chat with coaches.

Previous research by the investigators and others reveals that greater engagement in an online group-based weight loss program is associated with greater weight loss. We have found that an online group coaching program paired with a calorie tracking mobile app is effective at producing weight loss. WW is testing a new comprehensive program that involves an updated program paired with virtual workshops that offer actionable behavior change techniques for members, led by a trained WW coach. They have agreed to fund us to perform a one-arm trial of their new comprehensive program that includes a holistic approach to healthy lifestyle (activity, diet, and mindset). Findings will inform the continued development of this program. Our aims are as follows: 1) To examine the preliminary outcomes and acceptability of a multicomponent online commercial weight loss program that includes a mobile app, incentives for tracking, weekly virtual workshops, and an online community. Preliminary outcome is defined as weight change from baseline to 3 and 6-months. Secondary preliminary outcomes include changes in diet quality, physical activity, quality of life, sleep quality, and food cravings from baseline to 6 months. Acceptability of each program component and the overall program will be evaluated at 6 months. 2) To examine whether greater app use, greater engagement in the online community, and engagement with a higher number of peers (in the online community) predict greater weight loss at 3- and 6-months. 3) To examine the associations between total use of program components (and each individual program component) and change in weight. We hypothesize that greater use of program components (individually and total) will predict greater weight loss.

Conditions
Weight Loss
Being tested
myWW App, Virtual Workshops, and Private Facebook Group
Medical subject headings
Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • myWW App, Virtual Workshops, and Private Facebook GroupBehavioural

    The 6-month intervention includes the use of WW's mobile app, weekly virtual workshops, and a private online community. Participants are given a personalized food plan based on expert healthy eating guidelines and the latest nutritional science, an activity plan designed to promote regular physical activity and techniques to help shift members towards a helpful mindset for lasting change all within the WW app. Participants will attend weekly virtual workshops led by an expert WW Coach. The coach will help with goal setting, overcoming setbacks, and follow-up on progress toward goals each week. Participants will be encouraged to participate in a private Facebook group that gives participants an opportunity to receive motivational support from each other. Participants can post about their journey through photos, videos, and comments.

Study groups in NCT04302389
Study groupRoleWhat they receive
Lifestyle Modification ProgramExperimentalThis 6-month intervention includes the use of three components: WW's mobile app, virtual workshops, and a private online community. The WW Program involves: self-monitoring of weight, dietary intake, and physical activity; making dietary changes; increasing physical activity; shifting to a more helpful mindset; and learning behavioral strategies to manage these goals. Each week, participants will set goals and weigh-in with a coach via virtual workshop. Participants will be encouraged to use the app and private online community daily and attend weekly virtual workshops. The weekly virtual workshop led by a trained WW Coach features a behavior change technique and enables the participant to practice it to support their goals. These are actionable techniques and strategies that are grounded in scientific research.
Receives: Behavioral: myWW App, Virtual Workshops, and Private Facebook Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent of Days Diet Tracking Feature Was Used in App

    Percent of days participants used the diet tracking feature in the WW app during the intervention to track their daily food intake. A day of use will be defined as a day where participants tracked any food item in the WW app.

    Measured: 6 months

  2. Intervention Acceptability

    Percent of participants who agree or strongly agree that the program made them feel healthier.

    Measured: 6 months

  3. Percent Change in Weight From Baseline to 3 Months

    Weight was measured using a smart scale at baseline and at the three month assessment.

    Measured: Baseline to 3-months

  4. Weight Change in Pounds From Baseline to 6 Months

    Weight will be measured using a smart scale at all assessments. Weight change will be calculated as weight at 6 months in pounds minus baseline weight in pounds. Lower values mean more weight loss.

    Measured: Baseline to 6-months

  5. Number of Days Physical Activity Tracking Feature Was Used in App

    Number of days participants used the physical activity feature in the WW app during the intervention. A day of use will be defined as any day in which any physical activity was logged. Total days possible = 168 days.

    Measured: 6 months

  6. Number of Weekly Virtual Workshops Attended

    Number of weekly workshops attended by participants during the program. During the 6-month intervention, there were a total of 24 weekly workshops.

    Measured: 6 months

  7. Number of Weekly Check Ins Attended

    Number of weekly check ins completed by participants during the program. During the 6-month intervention, there were 24 opportunities for weekly check ins. Higher numbers mean more weekly check ins were completed.

    Measured: 6 months

  8. Number of Weeks Participants Engaged in the Private, Online Community

    All posts, comments, and reactions made in the Facebook group were captured using Grytics for Facebook each of the 24 weeks of the intervention. Participants were considered engaged with the intervention by making at least one post, one comment, and/or one reaction (e.g., like) during the intervention week. Values could range from 0 to 24 weeks with higher numbers indicating more frequent engagement in the intervention.

    Measured: 6 months

  9. Weight Change in Pounds From Baseline to 3 Months

    Weight will be assessed via digital scales provided to participants. Weight change will be calculated by subtracting weight in pounds at 3 months from baseline weight. Lower values indicate greater weight loss in pounds.

    Measured: 3 months

  10. Percent Weight Change From Baseline to 6 Months

    Weight is assessed via digital scales provided to participants. Percent weight change will be calculated by subtracting 6 month weight in pounds from baseline weight in pounds, dividing by baseline weight in pounds, and then multiplying this number by 100. Lower values indicated greater weight loss.

    Measured: 6 months

Secondary outcomes (11)
  1. Change in Fruit Intake Score

    At baseline and 6 months, participants completed the National Health Interview Survey Five-Factor Screener, which contains 19 items that assess the consumption frequency (measured on a scale ranging from 0=never to 5=≥5 times per day) of different food groups, including fruit intake. 1 assessed fruit intake. Change in fruit intake score was calculated by subtracting 6 month values from baseline values. Higher change scores indicate greater increases in fruit intake.

    Measured: Baseline to 6-months

  2. Change in Physical Activity

    Changes in physical activity will be measured from baseline to 6-months using the Global Physical Activity Questionnaire (GPAQ). The GPAQ has questions assessing activity at work, travel to and from places, and recreational activities. The number of minutes spent on each activity is assigned a METs value to determine level of energy expenditure. The higher the METs value the higher the activity level.

    Measured: Baseline to 6-months

  3. Changes in Quality of Life

    Changes in weight related quality of life will be measured from baseline to 6-months using the Impact of Weight on Quality of Life-Lite. This is a 31-item measure assessing physical function (11 items), self-esteem (7 items), sexual life (4 items), public distress (5 items), and work (4 items). Scores range from 0-100, with 100 representing the best quality of life. Change was calculated by subtracting 6 month scores from baseline scores. Higher values indicate greater increases in quality of life.

    Measured: Baseline to 6-months

  4. Changes in Sleep Quality

    Changes in sleep quality will be measured from baseline to 6-months using the Pittsburgh Sleep Quality Index. This measure contains 10 items to assess sleep quality with a score possible score of 0 - 21. Lower scores represent better the sleep quality (< 5 is associated with good sleep quality; > 5 is associated with poor sleep quality. Change in sleep quality was calculated by subtracting 6 month scores from baseline scores. Lower values indicate improvements in sleep quality.

    Measured: Baseline to 6-months

  5. Changes in Food Cravings

    Changes in food cravings will be measured from baseline to 6-months using the Food Craving Inventory. This inventory includes 28 foods that are scored based on level of craving ranging in answers from 1 (Never) to 5 (Always) for each. A mean is calculated across the 28 items. Scores then would range from a minimum of 1 to a maximum of 5. Higher scores indicate more frequent cravings. Change was calculated by subtracting 6 month scores from baseline scores. Higher scores indicate greater increases in food cravings.

    Measured: Baseline to 6-months

  6. Changes in Hunger

    Changes in hunger will be measured from baseline to 6-months using the Hunger VAS (Visual Analogue Scale). This one-question measure asks "How hungry did you feel over the past week" and is composed of a slider with words anchored at each end describing the extremes (Not at all hungry, Extremely hungry). Participants rated their hunger over the past week using a slider on a visual analog scale ranging from 0=not at all hungry to 100=extremely hungry. Change in hunger was then calculated by subtracting the hunger score at 6 months from the hunger score at baseline. Higher values indicate increases in hunger over time and lower values indicate decreases in hunger over time.

    Measured: Baseline to 6-months

  7. Changes in Positive Behavioral Automaticity

    Changes in behavioral automaticity will be measured using the Self-Report Behavioral Automaticity Index (SRBAI). This 4-item measure assesses whether Behavior X is something... "I do automatically", "I do without having to consciously remember", "I do without thinking", and "I start doing before I realize I'm doing it". Items are scored using a 7-point Likert scale ranging from strongly disagree to strongly agree. A mean score was calculated for each behavior. Then, mean scores were calculated for the 7 healthy behaviors to produce a positive behavioral automaticity score which could range from 1 to 7. Change in positive behavioral automaticity was then calculated by subtracting the 6 month value from the baseline value. Higher scores indicate greater behavioral automaticity for healthy behaviors.

    Measured: Baseline to 6-months

  8. Changes in Self-Compassion

    Changes in self-compassion will be measured using the Self-Compassion Scale. This is a 26-item measure of self-compassion that consists of six subscales: self-kindness, self-judgement, common humanity, isolation, mindfulness, and over-identified. Items were rated a scale ranging from 1=almost never to 5=almost always. Subscales are computed by calculating the mean of subscale item responses. A total self-compassion score can be obtained by reverse scoring the negative subscale items (self-judgement, isolation, and over-identification) and computing a grand mean of all six subscale means. The total possible scores range from 1-5. Then to calculate change in self-compassion, we subtracted the 6 month value from the baseline value. Higher scores mean greater increases in self-compassion over time.

    Measured: Baseline to 6-months

  9. Change in Well-being

    Changes in well-being will be measured using the WHO-5 Well Being Index (0-100 score where higher scores mean greater well-being). Change in well-being was then calculated by subtracting the 6 month score from the baseline score. Higher values indicate increases in well-being over time.

    Measured: Baseline to 6-months

  10. Change in Vegetable Intake Score

    At baseline and 6 months, participants completed the National Health Interview Survey Five-Factor Screener, which contains 19 items that assess the consumption frequency (measured on a scale ranging from 0=never to 5=≥5 times per day) of different food groups, including fruits and vegetables. 1 assessed vegetable intake. Change in vegetable intake score was calculated by subtracting 6 month values from baseline values. Higher change scores indicate greater increases in vegetable intake.

    Measured: baseline to 6 months

  11. Change in Salad Intake Score

    At baseline and 6 months, participants completed the National Health Interview Survey Five-Factor Screener, which contains 19 items that assess the consumption frequency (measured on a scale ranging from 0=never to 5=≥5 times per day) of different food groups, including fruits and vegetables. 1 assessed salad intake. Change in salad intake score was calculated by subtracting 6 month values from baseline values. Higher change scores indicate greater increases in salad intake.

    Measured: baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2020
  2. Study start10 Feb 2021
  3. Primary completion1 Nov 2021
  4. Study completion1 Nov 2021

Resources

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
Not applicable
Intervention model
Single group
Model description
This project includes a one-arm trial to evaluate WW's new lifestyle modification program.
Masking
None (open label)
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04302389
Sponsor's protocol ID
H20-0030
Status last verified
Jul 2025
First submitted
6 Mar 2020
Last updated
7 Aug 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Xu R, Bannor R, Cardel MI, Foster GD, Pagoto S. How much food tracking during a digital weight-management program is enough to produce clinically significant weight loss? Obesity (Silver Spring). 2023 Jul;31(7):1779-1786. doi: 10.1002/oby.23795. Epub 2023 Jun 4.

    PubMed 37271576

Questions about this trial

What is this clinical trial studying?

A study testing myWW App, Virtual Workshops, and Private Facebook Group in people with Weight Loss, run by University of Connecticut 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 8 inclusion and 24 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 7 Aug 2025. 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?

Yes. Results are posted in the registry (first posted 7 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 of Days Diet Tracking Feature Was Used in App (time frame: 6 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04302389, which also lists 1 linked publication.

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 7 Aug 2025.

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