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

NCT04302389 | Completed Results

• 1 other identifier: H20-0030
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (10)

• 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.

  6 months

• Intervention Acceptability

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

  6 months

• Percent Change in Weight From Baseline to 3 Months

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

  Baseline to 3-months

• 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.

  Baseline to 6-months

• 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.

  6 months

• 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.

  6 months

• 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.

  6 months

• 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.

  6 months

• 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.

  3 months

• 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.

  6 months

Secondary Outcomes (11)

• Change in Fruit Intake Score

  Baseline to 6-months

• Change in Physical Activity

  Baseline to 6-months

• Changes in Quality of Life

  Baseline to 6-months

• Changes in Sleep Quality

  Baseline to 6-months

• Changes in Food Cravings

  Baseline to 6-months

Study Arms (1)

Lifestyle Modification Program

EXPERIMENTAL

This 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.

Behavioral: myWW App, Virtual Workshops, and Private Facebook Group

Interventions

myWW App, Virtual Workshops, and Private Facebook Group BEHAVIORAL

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.

Lifestyle Modification Program

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Connecticut: lead
• WW International Inc: collaborator

Study Sites (1)

University of Connecticut

Storrs, Connecticut, 06269, United States

Location

Related Publications (1)

• 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.

  PMID: 37271576 DERIVED

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Sherry Pagoto
• Organization: University of Connecticut

sherry.pagoto@uconn.edu

860-486-8979

Study Officials

• Sherry Pagoto, PhD

  University of Connecticut

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This project includes a one-arm trial to evaluate WW's new lifestyle modification program.

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 10, 2020
• Study Start: February 10, 2021
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: August 7, 2025
• Results First Posted: August 7, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)