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

Completed · Not applicable

Conditions studied: Weight Loss

In brief

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.

Key facts

Study ID

NCT04302389

Run by

University of Connecticut

People needed

153

Starts

2021-02-10

Expected to finish

2021-11-01

Last updated by the study team

2025-08-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

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.
• 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.

Where it is running

• University of Connecticut — Storrs, Connecticut, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.