A program to help people with prediabetes choose their diet for weight loss
Effects of Allowing Choice of Dietary Regimen Within a Lifestyle Intervention Among Adults With Prediabetes Living in Rural Communities: Pilot and Feasibility Study
This study tests a new online program that helps people with prediabetes in rural areas choose their own diets for weight loss to see if it works better than regular diet plans.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT06377020 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate a virtual group-based intensive lifestyle intervention (ILI) program called PACT2, which allows individuals with prediabetes to select from various dietary strategies for weight loss. The program is designed to improve adherence to dietary changes by considering individual preferences, particularly for adults living in rural communities. Participants will engage in a 16-week program that focuses on sustainable weight loss and improved glycemic outcomes, with the hypothesis that this personalized approach will yield better results than standard dietary interventions. The study will also assess the feasibility of delivering this program remotely to enhance accessibility for those with limited medical care options.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-75 with a BMI between 27-45 and diagnosed with prediabetes, living in rural Eastern Colorado.
Not a fit: Patients with type 1 or type 2 diabetes or those with significant uncontrolled medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could lead to better weight loss outcomes and reduced risk of developing type 2 diabetes for individuals with prediabetes.
How similar studies have performed: Other studies have shown success with personalized dietary interventions for weight loss, making this approach promising yet still innovative in its specific application to prediabetes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aurora, Colorado
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Elizabeth Thomas, MD — University of Colorado School of Medicine
- Study coordinator: Elizabeth Thomas, MD
- Email: elizabeth.thomas@cuanschutz.edu
- Phone: 3037249083
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.