Evaluation of a Commercial Program on Weight Loss and Health Outcomes 2

This is an interventional treatment trial for Weight Loss Read More

Inclusion Criteria:

• Male or female ages 18-75 years. Set "soft quotas" on the number of male and female participants. The desire is to have an 80% female/20% male split.
• Willing to enroll in the Weight Watchers Program
• With or without previous Weight Watchers experience Set maximum quota on the number of participants with previous Weight Watchers experience at 65%.
• Self-reported height/weight resulting in a Body Mass Index (BMI) of 25 to 43 (will re-screen at facility).
• Self report that he/she feels the need 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

  1. iPhone must have iOS 8.0 or later
  2. Must have at least 600 MB of available storage to accommodate the size of the app
• The willingness and ability to navigate and use applications on their iPhone on a daily basis (minimum training will be provided)
• Reliable home Wi-Fi access

• Ability to commit to attending up to 27 study visits in approximately 26 weeks:

  1. Ability to commit (to best of their ability) to attending weekly meetings, 30-60 minutes in duration, on the same day and at the same time each week for 24 consecutive weeks.
  2. Ability to commit to up to 3 additional study visits at Weeks 0, 12 and 24, with each visit being 60-90 minutes in duration to complete assessments (height, weight, questionnaires, physical measures).

Exclusion Criteria:

• Currently, or within the last 6 months, trying to lose weight by following guidelines (e.g., self-initiated programs such as 5-2, or Atkins) or a structured weight-loss program (e.g., at a medical center, university, commercial programs)
• A member of Weight Watchers within the past 12 months.
• Involved in any other related research studies and self-report agreeing to not enroll in other studies that may affect weight or health outcomes over the next 12 months.
• Pregnant or 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 Selective Serotonin Reuptake Inhibitors (SSRIs) for 6 months
• Diuretic use for hypertension over 1.5mg per day
• Chronic/inflammatory gastrointestinal disorders (irritable bowel syndrome 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 problems during the past 12 months.
• Consuming more than 14 alcoholic drinks per week or not more than 3 drinks per day.
• Planning to relocate in the next 9 months.