NCT06377020Completed
Prevention and Choice for Type 2
Effects of Allowing Choice of Dietary Regimen Within a Lifestyle Intervention Among Adults With Prediabetes Living in Rural Communities: Pilot and Feasibility Study
Source: ClinicalTrials.gov · Last updated 8 Aug 2025
Brief summary (registry, in English)
People living with prediabetes are advised to lose weight to prevent development of type 2 diabetes by participating in intensive lifestyle interventions (ILI's), such as PreventT2. The PreventT2 program focuses on a low-calorie diet for weight loss. However, many people find it difficult to stick to a low-calorie diet over the long-term. The identification of novel, effective and individualized dietary strategies to produce long-term weight loss is critically important in diabetes prevention. An ILI based on PreventT2 which considers individual preferences, allowing participants to choose among a variety of diets, may result in greater adherence to the diet than a standard PreventT2 intervention. ILIs also need to be available to individuals in a wide range of communities, including Americans living in rural communities, who experience higher rates of obesity and chronic disease, yet have less access to medical care, including programs for diabetes prevention. The investigators plan to develop and carry out a 16-week pilot and feasibility study of a group-based ILI program based on PreventT2 plus choice of dietary strategy (Prevention and Choice for Type2 , PACT2) delivered via videoconference to adults with prediabetes living in rural communities. Successful completion of this project will result in the refinement of an ILI that incorporates personal preferences and is tailored to individuals at high risk for type 2 diabetes living in rural areas where access to such interventions is limited.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 19 Mar 2024
- Start date
- 10 Apr 2024
- Primary completion date
- 27 Sept 2024
- Lead sponsor
- University of Colorado, Denver
- NCT number
- NCT06377020
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 10 Apr 2024 to the primary completion date, 27 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- 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.
- 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.
Other
- 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.
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Anschutz Medical Campus Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.