Status:
COMPLETED
Single Arm Trial of a Multi-component Commercial Digital Weight Loss Program
Lead Sponsor:
University of Connecticut
Collaborating Sponsors:
WW International Inc
Conditions:
Weight Loss
Eligibility:
All Genders
18-75 years
Phase:
NA
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 en...
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 delivere...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
February 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2021
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT04302389
Start Date
February 10 2021
End Date
November 1 2021
Last Update
August 7 2025
Active Locations (1)
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1
University of Connecticut
Storrs, Connecticut, United States, 06269