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:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT01155050
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 yrs old
* BMI ≥ 25 kg/m2 and waist circumference \> 40 inches (men)/ 35 inches (women)
* Weight ≤ 500lbs
* At least one of the following:
* Fasting blood sugar \> 100 mg/dL at any point and/or taking medications for diabetes And/Or
* Resting blood pressure \> 130/90 mm Hg at any point and/or taking medications for hypertension
* Not involved in regular physical activity or weight loss management programs
* Capable of being physically active
* Physically able to use in-home equipment (or presence of a household member who can assist the subject in equipment use)
* Currently-working conventional telephone line at primary residence
* Grounded electrical power supply at primary residence
* Have been in LSU HCSD system for 6 months and anticipate remaining in the LSU HCSD patient population for the next 6 months
Exclusion Criteria:
* A history of drug abuse in the last year, or excess alcohol consumption (40g/day)6
* Currently dieting or engaging in any activity with the goal of losing weight
* Significant weight loss or weight gain in the past year (\> 50 lbs) or current use of weight loss medications
* History of gastrointestinal bypass or other bariatric surgery in the last 3 years
* Diagnosis of congestive heart failure
* Under treatment for end-stage renal disease or end-stage liver disease
* History of major organ transplant
* History of cancers requiring treatment in the past 5 years with anything but excellent prognosis
* Current diagnosis of schizophrenia, bipolar disorder, or other psychotic disorders
* Pregnant or plan on becoming pregnant in the next 12 months.
* Lack support from health care provider or family members.
* Current member of household participating in study
* Factors that may limit adherence to intervention or affect conduct of the trial.
* Unable or unwilling to communicate with staff, to provide written informed consent, or accept the randomized assignment.
* Any other condition, which, in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01155050
Study Brief:
Protocol Section:
NCT01155050