Clinical trial NCT04302389: Single Arm Trial of a Multi-component Commercial Digital Weight Loss Program
Official title: Single Arm Trial of a Multi-component Commercial Digital Weight Loss Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Weight Loss
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: WW International Inc
First posted: 2020-03-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This project includes a one-arm trial to evaluate WW's new lifestyle modification program.
Primary purpose: TREATMENT

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.

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 indivated 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.

Primary outcomes:
measure: Intervention Use
timeFrame: 6 months
measure: Intervention acceptability
timeFrame: 6 months
measure: Change in Weight
timeFrame: Baseline to 3-months
measure: Change in Weight
timeFrame: Baseline to 6-months
Secondary outcomes:
measure: Change in Diet
timeFrame: Baseline to 6-months
measure: Change in Physical Activity
timeFrame: Baseline to 6-months
measure: Changes in Quality of Life
timeFrame: Baseline to 6-months
measure: Changes in Sleep Quality
timeFrame: Baseline to 6-months
measure: Changes in Food Cravings
timeFrame: Baseline to 6-months
measure: Changes in Hunger
timeFrame: Baseline to 6-months
measure: Changes in Behavioral Automaticity
timeFrame: Baseline to 6-months
measure: Changes in Self-Compassion
timeFrame: Baseline to 6-months
measure: Change in Well-being
timeFrame: Baseline to 6-months
Other outcomes:
Locations:
city: Storrs
country: United States
facility: University of Connecticut
state: Connecticut
Study officials:
affiliation: University of Connecticut
name: Sherry Pagoto, PhD
role: PRINCIPAL_INVESTIGATOR
References: