PreDiabetesPACT2NCT06377020
Prevention and Choice for Type 2
A study testing PACT2 in people with PreDiabetes, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes
- What is being tested?
- PACT2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2024to 20 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
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
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.
Read the 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.
- Conditions
- PreDiabetes
- Being tested
- PACT2
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PACT2Behavioural
Behavioral lifestyle intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: PACT2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Body weight
Measured: Baseline and 16 weeks
Secondary outcomes (6)
Blood pressure
systolic and diastolic blood pressure
Measured: Baseline and 16 weeks
Physical activity
Physical activity measured with activPal device
Measured: Baseline and 16 weeks
Energy intake
energy intake measured with written food diaries
Measured: Baseline and 16 weeks
HbA1c
HbA1c
Measured: Baseline and 16 weeks
24 hr glucose levels
24 hr glucose levels measured with continuous glucose monitor
Measured: Baseline and 16 weeks
Dietary adherence
self-reported dietary adherence measured with questionnaires
Measured: 0-16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start10 Apr 2024
- Primary completion27 Sep 2024
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single group pilot and feasibility study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association, High Plains Research Network
- Responsible party
- Sponsor
- Investigators
- Elizabeth Thomas, MD, Principal investigator, University of Colorado School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377020
- Sponsor's protocol ID
- 23-2490
- Acronym
- PACT2
- Status last verified
- Aug 2025
- First submitted
- 19 Mar 2024
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06377020
- Acronym / sponsor ID
- PACT2 / 23-2490
- Conditions
- PreDiabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- American Diabetes Association, High Plains Research Network
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 27 Sep 2024 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single group pilot and feasibility study
| Arm | Type | Receives |
|---|---|---|
| PACT2 | Experimental | Behavioral: PACT2All 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PACT2Behavioral lifestyle intervention | Behavioural | PACT2 |
Primary outcome
Body weight
Time frame: Baseline and 16 weeks
Body weight
6 secondary outcomes
Blood pressure
Time frame: Baseline and 16 weeks
Physical activity
Time frame: Baseline and 16 weeks
Energy intake
Time frame: Baseline and 16 weeks
HbA1c
Time frame: Baseline and 16 weeks
24 hr glucose levels
Time frame: Baseline and 16 weeks
Dietary adherence
Time frame: 0-16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Thomas, MD principal investigator
University of Colorado School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PACT2 in people with PreDiabetes, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: Baseline and 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.