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 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT04487158
Eligibility Criteria:
Inclusion Criteria:
* Female between the ages of 25 to 75
* BMI between 30 and 45
* Not currently participating in any other weight management programs
* Self-reports wanting to lose weight
* Willing to follow recommendations in the study protocol and attend weekly group intervention for 12 weeks and a 3-month follow-up group (one in-person group per month and one phone call per month)
* Ability to attend 4 assessment appointments over the course of the study period (at baseline, 3-months, 6-months, 12-months).
* Willing to be randomized into any of the two study arms and willing to adhere to guidelines and recommendations associated with the study arm they are randomized into
Exclusion Criteria:
* Cannot commit to weekly group times. Participants must be available for at least one group time of each intervention arm in order to be eligible to participate.
* Participated in a weight loss intervention in the past six months
* Participants who are pregnant (or less than 6 months post partum) or planning to become pregnant in the next 12 months
* Weight loss of \> 5kg (\~11 lb) in the previous 6 months
* History of, or current, clinically diagnosed eating disorder or exhibiting clinical symptoms of an eating disorder but undiagnosed (EDE-Q ≥ 4.0 unless clinical judgement indicates otherwise)
* Reported health problems that make weight loss or unsupervised exercise unsafe or unreasonable (as measured by the PAR-Q+) where a doctor's note is not provided
* Resting systolic blood pressure \>160 mmHg or resting diastolic blood pressure \>100 mmHg
* If any of the following medical conditions are present: Insulin dependent diabetes; Previous surgical procedure for weight loss; Major surgery within the previous 6 months; A history of heart problems (e.g., angina, bypass surgery, myocardial infarction) within the previous 6 months; Implanted cardiac defibrillator or pacemaker; Currently (or within the past 5 years) being treated for cancer; Inflammatory Bowel Disease (i.e., chronic inflammatory gastrointestinal disease such as Crohn's Disease or Ulcerative Colitis); Chronic Pain (e.g., fibromyalgia) that would prevent the participant from engaging in physical activity
* The participant is currently experiencing elevated symptoms of depression
* The participant is planning to move within the study period
* The participant consumes more than 14 alcoholic drinks per week or more than 3 drinks per day
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
25 Years
Maximum Age:
75 Years
Study:
NCT04487158
Study Brief:
Protocol Section:
NCT04487158