Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT06377020
Status:
COMPLETED
Last Update Posted:
2025-08-08
First Post:
2024-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevention and Choice for Type 2
Sponsor:
University of Colorado, Denver
Organization:
Study Overview
Official Title:
Effects of Allowing Choice of Dietary Regimen Within a Lifestyle Intervention Among Adults With Prediabetes Living in Rural Communities: Pilot and Feasibility Study
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PACT2
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.
Detailed Description:
Individuals with prediabetes are advised to lose weight to prevent progression to type 2 diabetes through engagement in intensive lifestyle interventions (ILI's), such as PreventT2, focusing on daily caloric restriction (DCR). However, long-term adherence to DCR is low; thus, identification of novel, effective and individualized dietary strategies to produce sustained weight loss and improvement in glycemic outcomes is critically important in diabetes prevention. An ILI based on PreventT2 which considers individual preferences, allowing participants to choose among a variety of dietary strategies, may result in greater engagement and adherence than a standard PreventT2 intervention. ILIs also need to be scalable and deliverable to individuals in a wide range of communities, including Americans living in rural communities, who experience higher rates of obesity and all-cause mortality, yet have significantly less access to medical care, including ILI programs for diabetes prevention. The investigators propose a 16-week pilot and feasibility study of a virtual group-based ILI program based on PreventT2 plus choice of dietary weight loss strategy (Prevention and Choice for Type 2, PACT2) delivered to adults with prediabetes living in rural communities. The overall hypothesis of the study is that PACT2 will result in increased dietary adherence and greater weight loss as compared to a standard DCR-based PreventT2 intervention in rural adults with pre-diabetes. The specific aims of this study are to: 1) Engage stakeholders at multiple levels to guide the design of the PreventT2 + Choice intervention in adults with prediabetes living in rural communities; and 2) Assess the feasibility and acceptability of PreventT2 + Choice intervention.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: