PreDiabetes
Conditions
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.
Interventions
BEHAVIORALPACT2
Behavioral lifestyle intervention
Sponsors
American Diabetes Association
High Plains Research Network
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a single group pilot and feasibility study
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | Baseline and 16 weeks | Body weight |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical activity | Baseline and 16 weeks | Physical activity measured with activPal device |
| Energy intake | Baseline and 16 weeks | energy intake measured with written food diaries |
| Blood pressure | Baseline and 16 weeks | systolic and diastolic blood pressure |
| 24 hr glucose levels | Baseline and 16 weeks | 24 hr glucose levels measured with continuous glucose monitor |
| Dietary adherence | 0-16 weeks | self-reported dietary adherence measured with questionnaires |
| HbA1c | Baseline and 16 weeks | HbA1c |
Countries
United States
Outcome results
None listed