Is NCT06482944 recruiting in Nashville, TN?

Yes, NCT06482944 is currently recruiting participants at its Nashville, TN location. This prediabetes clinical trial is actively enrolling qualified participants.

How do I join the prediabetes clinical trial in Nashville?

To join this clinical trial in Nashville, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Nashville clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

PreDiabetes Clinical Trial in Nashville, TN

About This PreDiabetes Study in Nashville

This study will address the following aims: Aim 1 (primary): Conduct a pilot RCT to evaluate the feasibility, acceptability, enrollment, and retention rates of adult-child pairs after a 12-week family-centered, non-calorie restricted whole foods diet. Feasibility: ≥80% participant retention and completion of study outcome measures. Acceptability: ≥75 adult diet satisfaction via survey report and/or perceived diet satisfaction via focus groups. Aim 2: Conduct a pilot RCT to evaluate the preliminary effectiveness of a non-calorie restricted whole foods diet on adult HbA1c at 12 weeks and adult/child diet quality during the 12-week intervention. Aim 2a: Evaluate intervention effects on HbA1c measures in adults with prediabetes. Hypothesis 2a: Adults randomized to the treatment group will have lower HbA1c measures at 12 weeks than those in the control group. Aim 2b: Evaluate intervention effects on the diet quality (via the 2020 HEI) of adults and children. Hypothesis 2b: Adults and children randomized to the treatment group will have a higher diet quality score during the 12-week intervention period compared to adults and children in the control group. Aim 3: Conduct family focus groups to understand how SDOH and individual/family needs and preferences may be perceived barriers or facilitators of diet adherence.

Sponsor: Vanderbilt University

Who Can Participate

Inclusion Criteria

For this study, eligible adults will be those that:

are 25 to 59 years of age at time of initial screen and identify as a parent to at least one child or adolescent 6-18 years;

have a body mass index of between ≥23kg/m2 to \<40kg/m2;

have prediabetes (based on American Diabetes Association criteria of either fasting plasma glucose of ≥100 mg/dL, HgbA1c 5.7-6.4%, or 2-hour plasma glucose during 75-g oral glucose tolerance test \[OGTT\] 140 mg/dL to 199 mg/dL) with recent lab values reported within the prior 6-12 months and confirmed by an HbA1c A1cNow+ collected prior to enrollment (\*see comment below);

have no special dietary restrictions or food allergies that would prohibit consumption of a variety of foods/beverages;

are English speaking;

reside in Greater Nashville Tennessee and willing to come to Vanderbilt campus and Vanderbilt University Medical Center for required study visits;

are without medical conditions that would limit participation in a diet-related study (e.g., tube feeding, dysphagia, severe food allergy causing anaphylaxis);

are able to participate in a 12-week dietary program that requires home preparation/cooking for meals and snacks; For this study, eligible offspring will be those that:

Are 6-18 years at time of initial screen;

Have an index parent with prediabetes that is actively enrolled in the program;

have body mass index ≥5th percentile for age and gender on standardized CDC growth curves;

have no special dietary restrictions or food allergies that would prohibit consumption of a variety of foods/beverages;

have parental commitment to participate in a 12-week research study

are English speaking;

reside in the Greater Nashville Tennessee area and live at home with their index parent during the duration of 12- week study;

are without medical conditions that would limit participation in a diet-related study (e.g., tube feeding, dysphagia, severe food allergy causing anaphylaxis);

are able to participate in a 12-week dietary program that includes at least dinner and snacks provided during after-school hours;

Exclusion Criteria

Adult exclusion criteria include:

Adults who's HbA1c test is outside of the HbA1c range during screening\

(see details related to screening results)

adults outside the specified age range of \<25 years or \>59 years;

adults whose body mass index is \<23kg/m2 or those with a body mass index ≥40kg/m2 as that degree of morbid obesity represents a different phenotype where dietary behavioral intervention alone may not be sufficient to achieve weight loss);

receiving care by a healthcare provider (i.e., MD, NP, PA) for a complicated diagnosis of prediabetes that requires routine glycemic monitoring or frequent healthcare visits for management/treatment;

adults actively participating in any type of weight loss program (dietary or physical activity)

adults with a prior history of type 2 diabetes;

adults who are not English speaking or have limited English-language proficiency;

adults with special dietary restrictions, food allergies, or medical conditions that prohibit participation in a diet-related study;

adults with serious mental or neurologic illness that impairs the ability to consent/participate;

women who are pregnant or nursing due to increased metabolic state requiring greater energy requirements;

adults currently taking medications to treat diabetes or to promote weight loss;

adults living outside Greater Nashville Tennessee or who are unwilling to travel to Vanderbilt for study visits;

adults who do not otherwise meet the eligibility criteria listed in sections above as determined by pre-screen; Offspring (child\[ren\] and adolescent\[s\]) exclusion criteria include:

children/adolescents outside the specified age range of \<6 years or \>18 years;

children/adolescents whose body mass index is \<5th percentile for age and gender on standardized CDC growth curves;

children/adolescents who do not have an eligible index parent participating in the study;

children who do not have parental commitment to participate consistently for 12-weeks

children/adolescents who are not English speaking or have limited English-language proficiency;

children/adolescents with special dietary restrictions, food allergies, or medical conditions that prohibit participation in a diet-related study;

children/adolescents who display dissenting behaviors during baseline data collection;

children/adolescents actively participating in any type of weight loss program (medical or lifestyle);

children/adolescents who do not otherwise meet the eligibility criteria listed in sections above as determined by pre-screen;

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Nashville?

Yes, this clinical trial (NCT06482944) has an active research site in Nashville, TN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

PreDiabetes Treatment Options in Nashville, TN

If you're searching for prediabetes treatment options in Nashville, TN, this clinical trial (NCT06482944) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Nashville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced prediabetes specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all prediabetes clinical trials near you to find additional studies recruiting in your area.

PreDiabetes Clinical Trial in Nashville, TN

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