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New treatment option for Obesity, Childhood
Official title Whole Foods for Teens: A Pilot Dietary Intervention to Reduce Body Adiposity in Adolescents With Obesity
ClinicalTrials.gov ID: NCT06464497
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 and older
You may be able to join if
- 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...
You likely can't join if
- 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;
See the full eligibility criteria
Who can join
- 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...
- 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;
What rules you out
- 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;
The study team makes the final eligibility decision.
Where it's taking place
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.