Whole Foods for Teens: A Pilot Dietary Intervention to Reduce Body Adiposity in Adolescents With Obesity

Inclusion Criteria: For this study, eligible adolescents will be those that: 1. 10-18 years of age at time of initial screening; 2. living at home full-time with the enrolled parent or caregiver (≥80% in primary residence); 3. 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; 4. 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; 5. 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); 6. 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; 7. have parental or caregiver commitment to participate in the research study; For this study, eligible adult parents or caregivers will be those that: 1. adult parent or primary legal caregiver (greater than or equal to 25 years of age) of an enrolled adolescent; 2. live with the adolescent full-time (≥80% in primary residence); 3. 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); 4. reside within greater Middle Tennessee area and are willing to drive to Vanderbilt University and Vanderbilt University Medical Center for study visits; 5. 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); 6. 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: 1. Outside of the specified age range; 2. not living in the home of the enrolled parent or caregiver full time (≥80% in primary residence); 3. BMI less than 95th percentile for age and gender; 4. pregnant or lactating; 5. no eligible enrolled parent or caregiver or lack of parental/caregiver commitment to participate in study; 6. food allergy to 3 or more food groups; dietary restrictions or medical condition that prohibits participation in a diet study; 7. use of medications that cause weight loss or diabetes medications; 8. active participation in a weight loss or intense lifestyle modification program; 9. limited English-language proficiency; 10. participants unwilling or unable to give informed consent, accept random assignment, attend dietary counseling sessions, adhere to treatment prescription, or complete study measures; 11. adolescents who display dissenting behaviors during baseline data collection; 12. 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: 1. not parent/ or legal caregiver; 2. not living in a household full-time with enrolled adolescent (less than 80% time spent away from primary residence); 3. lack of metabolic condition(s) per inclusion criteria; 4. special dietary restrictions, food allergies, or medical conditions that prohibit participation in a diet-related study; 5. limited English-language proficiency; 6. participants unwilling or unable to give informed consent, accept random assignment, attend dietary counseling sessions, adhere to treatment prescription, or complete study measures; 7. parent or caregivers who do not otherwise meet the eligibility criteria listed in sections above as determined by pre-screen;

Reproduced word-for-word from the public registry record — the study team can answer questions about it.