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 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT06377020
Eligibility Criteria:
Inclusion Criteria:
* Adult men and women aged 18-75 years
* BMI 27-45 kg/m2
* Prediabetes (HbA1c 5.7-6.4%)
* Currently living in rural Eastern Colorado
* Have a primary care physician (or are willing to establish care with a primary care physician prior to study enrollment) to address medical issues which may arise during screening or study procedures/interventions.
* Participants will require sufficient internet connectivity and technological ability to connect to a videoconferencing platform OR they must be willing to travel to their primary care clinic or other location in order to connect to the videoconferencing platform.
* Capable and willing to give informed consent, understand exclusion criteria, attend the PACT2 program sessions, and complete outcome measures.
Exclusion Criteria:
* Type 1 or type 2 diabetes
* Self-reported significant uncontrolled medical condition (uncontrolled or untreated cardiovascular, pulmonary, renal or gastrointestinal disease; untreated hyper-or hypothyroidism; active untreated cancer)
* Uncontrolled hypertension, defined as diastolic blood pressure \>100 mmHG, systolic blood pressure \>160 mmHG as measured in duplicate at the screening visit after 5 minutes of rest in a seated position.
* Plans to relocate in the next 7 months
* Currently participating in or planning to participate in any formal weight loss, dietary modification, or physical activity/exercise programs or clinical trials.
* Current severe depression. Score \> 16 on Center for Epidemiologic Studies Depression Scale (CES-D) questionnaire will require further assessment by the Study MD to determine if it is appropriate for the subject to participate in the study.
* History of other significant psychiatric illness (e.g., psychosis, schizophrenia, mania, bipolar disorder) which in the opinion of the Study MD would interfere with ability to adhere to the dietary intervention.
* History of clinically diagnosed eating disorders including anorexia nervosa, bulimia, binge eating disorder. Score \>20 on the EATS-26 or pattern of response on the QEWP-5 suggestive of possible binge eating disorder or bulimia will require further assessment by the Study MD to determine if it is appropriate for the subject to participate in the study.
* Regular use of prescription or over-the-counter medications known to significantly impact appetite, weight, sleep, or energy metabolism (e.g., appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic antidepressants)
* Regular use of obesity pharmacotherapeutic agents within the last 6 months.
* Weight change \>5 kg in past 3 months
* Women who are pregnant, lactating, or planning pregnancy in the next 6 months
* Current alcohol or substance abuse
* Individuals who are already participating in a weight loss program or who already follow one of the dietary strategies offered will also be excluded
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06377020
Study Brief:
Protocol Section:
NCT06377020