Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT02585193
Eligibility Criteria:
Inclusion Criteria:
* Male or female over age 18. Set "soft quotas" on the number of male and female participants - The desire is to have a 90% female / 10% male split.
* With or without previous Weight Watchers experience. Set 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 27 to 43 kg/m2 (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).
* Willing to participate in consumer surveys and focus groups as a part of the intervention.
* Use of a personal smartphone on a daily basis. For Android devices, must be version 4.4 (code: KitKat) or 5.0 (codename: Lollipop). For iPhones, must be iOS6 and above. Cannot accommodate Blackberry devices.
* The willingness and ability to navigate and use applications on their smartphone on a daily basis (minimum training will be provided).
* Reliable home WiFi access
* Ability to commit to attending up to 27 study visits in approximately 26 weeks:
* Ability to commit (to best of their ability) to attending weekly meetings, 30-60 minutes in duration, at the same day and time each week for 24 consecutive weeks (daytime and evening options will be available).
* Ability to commit to up to 3 additional study visits at Weeks 0, 12, and 24, each approximately 90 minutes in duration, to complete assessments (height, weight, questionnaires, physical measures).
Exclusion Criteria:
* Participants that are currently following a commercial weight-loss program.
* Participants that have been involved in a related market research program within the last 6 months.
* Pregnant or nursing, or planning on becoming pregnant over the next 9 months.
* Recent weight loss of ≥ 5 kg in the previous 3 months.
* History of clinically diagnosed eating disorder.
* Orthopedic limitations preventing participation in regular physical activity.
* Untreated thyroid disease or \> 1 change in dose or type of thyroid medication over previous 6 months.
* Taking any prescription medication with known effects on appetite or weight.
\*With the exception of subjects on a stable dose of SSRIs (Selective Serotonin Re-uptake Inhibitors) for 6 months.
* Taking oral steroids.
* Chronic/inflammatory gastrointestinal disorders (irritable bowel syndrome acceptable).
* Previous surgical procedure for weight loss.
* Major surgery within the previous 3 months.
* History of heart problems (e.g., angina, bypass surgery, MI, etc) within previous 3 months.
* Presence of implanted cardiac defibrillator or pacemaker.
* Uncontrolled hypertension self-reported BP \> 160/100mmHg)
* Diuretic use for hypertension over 1.5mg per day
* Diagnosis of type 1 or type 2 diabetes
* History of presence of cancer (completely respected basal or squamous cell carcinoma acceptable if treatment completed more than 6 months prior to enrollment).
* Consuming more than 14 alcoholic drinks per week or not more than 3 drinks per day.
* Planning to relocate in the next 9 months
* Any orthopedic limitation preventing participation in regular physical activity.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02585193
Study Brief:
Protocol Section:
NCT02585193