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

Launched by VANDERBILT UNIVERSITY · Jun 12, 2024

Keywords

ClinConnect Summary

This clinical trial, called "Whole Foods for Teens," is exploring how a diet focused on whole foods can help reduce body fat in adolescents with obesity. The study will last for 8 weeks and involves adolescents aged 10 to 18 who have a high body mass index (BMI), meaning they are heavier than most kids their age. To participate, teens must live at home with a parent or caregiver who is willing to support them in making healthy food choices. Both the teen and their parent will be involved in the study, which will help improve their overall diet quality.

Participants will be divided into two groups: one group will follow the whole foods diet while the other will continue with their usual eating habits. Throughout the study, the researchers will measure changes in body fat and weight to see how effective the diet is. Families will also have the chance to share their experiences and any challenges they faced with sticking to the diet. This trial is currently looking for participants from the Middle Tennessee area, and it aims to help families learn how to eat healthier together.

Gender

ALL

Eligibility criteria

• 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;