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:
• 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;