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 @ 3:17 PM
Ignite Modification Date:
2025-12-24 @ 3:17 PM
NCT ID:
NCT01587092
Eligibility Criteria:
Inclusion Criteria:
* Males or females
* BMI ≥ 25 kg/m2
* Willing to give informed consent
* Willing to accept randomization to group assignment and willing to follow the protocol for the group to which they have been assigned
* Willing to maintain fulltime employment at the company for the next 6 months
* Willing to receive frequent contacts and communication from study staff over the next 6 months
Exclusion Criteria:
* Current participation in other Pennington Biomedical research studies
* BMI \< 25 kg/m2
* Type 1 diabetes
* Average step count of ≥ 7,500 steps/day
* Self-reporting exercising \> 20 minutes on 3 or more days/wk, within the past 6 months
* Unable to walk 45 minutes continuously without taking a rest
* Unable to walk without the use of an assistive device, such as a cane or walker
* Have had a cardiovascular event (stroke or heart attack) in the past 6 months
* Have a pacemaker or any other internal electrical medical device
* Have been diagnosed with Schizophrenia or bipolar disorder
* Have any condition that would limit participation in a physical activity program
* Women who are pregnant, have been pregnant in the last 6 months, or are breastfeeding
* Actively participating in a weight loss program
* Plan to move out of the study area within the next 6 months or plan to be away from work for more than 4 weeks in the next 6 months
* Have another member of household participating in the study
* Have any condition, which, in the opinion of the investigator would impede competence or compliance or possibly hinder completion of the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01587092
Study Brief:
Protocol Section:
NCT01587092