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

NCT ID: NCT04302389

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-10
• Study Completion Date: 2021-11-01

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lifestyle Modification Program

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.

Group Type: EXPERIMENTAL

myWW App, Virtual Workshops, and Private Facebook Group

Intervention Type: 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.

Interventions

myWW App, Virtual Workshops, and Private Facebook Group

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. 18-75 years old.

2. BMI 25-45 kg/m2.

3. Has Wi-Fi connectivity at home

4. Able to participate in the study in English.

5. Self-reported desire to lose weight.

6. Willing to follow recommendations required by study protocol.

7. Willing to include demographic information (e.g., ethnicity, income and education)

8. Lives in the United States

Exclusion Criteria

1. Pregnant, lactating, or plans to become pregnant during study period.

2. Bipolar disorder, substance abuse, psychosis, bulimia, binge eating disorder, or severe depression.

3. Had bariatric surgery or plans to have any surgery during the study

4. Unable to make dietary changes or increase physical activity.

5. Unable to walk ¼ mile unaided without stopping

6. Smoker or use nicotine vape daily.

7. 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)

8. Participants who were a member of WW within the past 12 months.

9. Participants who are involved in any other research studies at this time.

10. Weight loss of ≥ 5 kg in the previous 6 months.

11. Reported health problems that make weight loss or unsupervised exercise unsafe or unreasonable (e.g., chronic pain, orthopedic limitations, heart problems).

12. Untreated thyroid disease or any changes (type or dose) in thyroid medication in last 6 months.

13. 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.

14. Chronic/inflammatory gastrointestinal disorders (irritable bowel syndrome is acceptable).

15. History of heart problems (e.g., angina, bypass surgery, myocardial infarction, etc.) within previous 6 months.

16. Diagnosis of type 1 or type 2 diabetes.

17. Major surgery within the previous 6 months.

18. Presence of implanted cardiac defibrillator or pacemaker.

19. 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).

20. 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".

21. Hospitalization for psychiatric disorders during the past 12 months.

22. Not willing to sign an NDA; or indicated they do not want to agree to NDA's terms.

23. Unable to attend any virtual workshop meeting times.

24. Does not have an iPhone.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

WW International Inc

INDUSTRY

Sponsor Role: collaborator

University of Connecticut

OTHER

Sponsor Role: lead

Responsible Party

Sherry Pagoto

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sherry Pagoto, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Connecticut

Locations

University of Connecticut

Storrs, Connecticut, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37271576 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

H20-0030

Identifier Type: -

Identifier Source: org_study_id