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 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
NCT ID:
NCT03571893
Eligibility Criteria:
Inclusion Criteria:
* Male or female ages 18-75 years
* With or without previous WW experience
* Self-reported height/weight resulting in a Body Mass Index (BMI) of 25 to 45 (will be confirmed at the Baseline Assessment visit).
* 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 be randomized to one of two groups and follow recommendations according to study protocol.
* Willing to include demographic information (e.g., ethnicity, income and education).
* Use of a personal smartphone (iOS 9.0 or Android 4.1)
* The willingness and ability to download, navigate and use applications on their smartphone on a daily basis (minimum training will be provided)
* Ability to commit to attending study assessment visits at 0, 3 and 12 months
* Residing within 30 miles of a study assessment location
* Read, write and speak English
Exclusion Criteria:
* Participants that were a member of Weight Watchers within the past 12 months.
* Unwilling to refrain from using Weight Watchers if assigned to the DIY group.
* Participants that are involved in any other research studies at this time (also, cannot join other research studies while in this study, over the next 12 months) that would interfere with their ability to adhere to the protocol (i.e., attend assessment visits, attend WW meetings).
* Given birth past six months, currently pregnant, or planning on becoming pregnant over the next 12 months.
* Weight loss of ≥ 5 kg in the previous 6 months (and kept \> 5 kg off).
* Ever been diagnosed with an eating disorder (anorexia nervosa, bulimia).
* 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 Qsymia, Contrave, etc.) with the exception of subjects on a stable dose of Selective serotonin reuptake inhibitors (SSRIs) for 6 months
* Currently have chronic/inflammatory gastrointestinal disorder (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 (confirmed at baseline visit)
* Currently have type 1 or type 2 diabetes
* Ever had surgical procedure for weight loss.
* Major surgery within the previous 6 months that would interfere with consuming a regular diet and performing physical activity such as walking.
* 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
* Planning to relocate in the next 12 months
* Another member of the household is participating in this research study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03571893
Study Brief:
Protocol Section:
NCT03571893