Is NCT06464497 recruiting in Nashville, TN?

Yes, NCT06464497 is currently recruiting participants at its Nashville, TN location. This obesity, childhood clinical trial is actively enrolling qualified participants.

How do I join the obesity, childhood 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.

Obesity, Childhood Clinical Trial in Nashville, TN

About This Obesity, Childhood Study in Nashville

This study will address the following aims: Aim 1: Conduct an 8-week pilot RCT to examine the effects of a whole foods diet intervention on body adiposity in adolescents with obesity. Aim 1a (Primary): Evaluate intervention effectiveness on total fat mass following the 8-week intervention. Hypothesis 1a: Adolescents randomized to the whole foods intervention will have lower total fat mass (kg) at the 8-week follow-up than those in the control group. Aim 1b: Evaluate intervention effectiveness on anthropometric changes following the 8-week intervention. Hypothesis 1b: Adolescents randomized to the whole foods intervention will have lower weight, BMI-z scores and/or waist circumference at the 8-week follow-up than those in the control group. Secondary Aims: Aim 2: Conduct an 8-week pilot RCT to examine the effects of a whole foods diet intervention on diet quality in adolescent and parent pairs during the study period. Hypothesis 2: Adolescents and parents randomized to the whole foods intervention will have higher diet quality scores at the 8-week follow-up than those in the control group. Aim 3: Conduct post-intervention family focus groups to identify how individual/family needs and preferences and social determinants of health (SDOH) may be perceived barriers and/or facilitators of diet adherence to a whole foods diet pattern.

Sponsor: Vanderbilt University

Who Can Participate

Inclusion Criteria

For this study, eligible adolescents will be those that:

10-18 years of age at time of initial screening;

living at home full-time with the enrolled parent or caregiver (≥80% in primary residence);

obesity defined as a body mass index (BMI) greater than or equal to 95th percentile for age and gender based on standardized CDC growth curves;

reside within greater Middle Tennessee area and has enrolled parent/caregiver willing to drive to Vanderbilt University and Vanderbilt University Medical Center for study visits;

are without medical conditions that would limit participation in a diet-related study (e.g., tube feeding, dysphagia, severe food allergy to 3 or more food groups causing anaphylaxis);

are willing and able to participate in an 8-week diet study that encourages preparing and eating healthy foods and snacks for 8 weeks with parental or caregiver support;

have parental or caregiver commitment to participate in the research study; For this study, eligible adult parents or caregivers will be those that:

adult parent or primary legal caregiver (greater than or equal to 25 years of age) of an enrolled adolescent;

live with the adolescent full-time (≥80% in primary residence);

have 1 or more metabolic risk factor(s) and/or metabolic condition(s) (e.g., overweight/obesity, hypertension, hypercholesterolemia or dyslipidemia, hyperglycemia \[elevated fasting blood glucose ≥100 mg/dL\] and/or prediabetes, history of gestational diabetes, polycystic ovarian syndrome, type 2 diabetes, non-alcoholic fatty liver disease);

reside within greater Middle Tennessee area and are willing to drive to Vanderbilt University and Vanderbilt University Medical Center for study visits;

are without medical conditions that would limit participation in a diet-related study (e.g., tube feeding, dysphagia, severe food allergy to 3 or more food groups);

are able to participate in a study program that encourages preparing and eating healthy foods and snacks for 8 weeks with most preparation/cooking of meals/snacks at home;

Exclusion Criteria

Adolescent exclusion criteria include:

Outside of the specified age range;

not living in the home of the enrolled parent or caregiver full time (≥80% in primary residence);

BMI less than 95th percentile for age and gender;

pregnant or lactating;

no eligible enrolled parent or caregiver or lack of parental/caregiver commitment to participate in study;

food allergy to 3 or more food groups; dietary restrictions or medical condition that prohibits participation in a diet study;

use of medications that cause weight loss or diabetes medications;

active participation in a weight loss or intense lifestyle modification program;

limited English-language proficiency;

participants unwilling or unable to give informed consent, accept random assignment, attend dietary counseling sessions, adhere to treatment prescription, or complete study measures;

adolescents who display dissenting behaviors during baseline data collection;

adolescents who do not otherwise meet the eligibility criteria listed in sections above as determined by pre-screen; Adult Parent or Caregiver exclusion criteria include:

not parent/ or legal caregiver;

not living in a household full-time with enrolled adolescent (less than 80% time spent away from primary residence);

lack of metabolic condition(s) per inclusion criteria;

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

limited English-language proficiency;

participants unwilling or unable to give informed consent, accept random assignment, attend dietary counseling sessions, adhere to treatment prescription, or complete study measures;

parent or caregivers 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 (NCT06464497) 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.

Obesity, Childhood Treatment Options in Nashville, TN

If you're searching for obesity, childhood treatment options in Nashville, TN, this clinical trial (NCT06464497) 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 obesity, childhood 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 obesity, childhood clinical trials near you to find additional studies recruiting in your area.

Obesity, Childhood Clinical Trial in Nashville, TN

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