Evaluation of a Commercial Program on Weight Loss and Health Outcomes

Completed · Early Phase 1

Conditions studied: Obesity, Weight Loss

In brief

To examine weight loss and acceptability of a modified WW program. This study is designed to detect differences in weight loss at the end of 24 weeks of intervention.

Key facts

Study ID

NCT03928483

Run by

Medical University of South Carolina

People needed

143

Starts

2019-03-18

Expected to finish

2019-11-07

Last updated by the study team

2019-12-11

Who can join

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

You may qualify if…

• Ages 18-75 years
• Body Mass Index (BMI) of 25 to 43
• Self-reported desire to lose weight
• Willing to discontinue any current over-the-counter (OTC) supplements not recommended/prescribed by physician, with the exception of multivitamins or other vitamin supplement
• Willing to follow recommendations required by study protocol
• Willing to include demographic information (e.g., ethnicity, income and education)
• Use of a personal iPhone on a daily basis
• Basic app skills
• Reliable home Wi-Fi access
• Ability to commit to attending up to 27 study visits in approximately 26 weeks

You may not qualify if…

• Participants that are currently, or within the last 6 months, trying to lose weight by following guidelines (e.g., self-initiated programs) or 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 (also, cannot join other research studies while in this study, over the next 6 months).
• Pregnant, nursing, or planning on becoming pregnant over the next 9 months.
• Weight loss of ≥ 5 kg in the previous 6 months.
• History of clinically diagnosed eating disorder.
• Reported health problems that make weight loss or unsupervised exercise unsafe or unreasonable (e.g., 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
• Diuretic use, unless taken on a regular, daily basis for hypertension and on a stable dose for at least 30 days
• 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.
• Resting systolic blood pressure >160 mmHg or resting diastolic blood pressure >100 mmHg
• Diagnosis of type 1 or type 2 diabetes
• Previous surgical procedure for weight loss.
• 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).
• Hospitalization for psychiatric disorders during the past 12 months
• Self-reported alcohol use > 7/week standard drinks for females and > 14/week for males or meets DSM-5 criteria for mild or greater, Alcohol Use Disorder
• Planning to relocate in the next 9 months

Where it is running

• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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