Prevention and Choice for Type 2

NCT06377020 | Completed

• 1 other identifier: 23-2490
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PreDiabetes

Outcome Measures

Primary Outcomes (1)

• Body weight

  Body weight

  Baseline and 16 weeks

Secondary Outcomes (6)

• Blood pressure

  Baseline and 16 weeks

• Physical activity

  Baseline and 16 weeks

• Energy intake

  Baseline and 16 weeks

• HbA1c

  Baseline and 16 weeks

• 24 hr glucose levels

  Baseline and 16 weeks

Study Arms (1)

PACT2

EXPERIMENTAL

All participants will join a 16-week diabetes prevention program based on the PreventT2 curriculum. We have worked with stakeholders within the communities in rural Eastern Colorado to develop and refine the curriculum to offer 3 dietary strategies (daily caloric restriction, time restricted eating, and low carb diet) among which participants can choose.

Behavioral: PACT2

Interventions

PACT2 BEHAVIORAL

Behavioral lifestyle intervention

PACT2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• American Diabetes Association: collaborator
• High Plains Research Network: collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Elizabeth Thomas, MD

  University of Colorado School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single group pilot and feasibility study

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 22, 2024
• Study Start: April 10, 2024
• Primary Completion: September 27, 2024
• Study Completion: May 20, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)