Dietary intervention using whole foods to reduce obesity in teens

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

This study is trying a whole foods diet for teens with obesity to see if it helps them lose weight and improve their health over 8 weeks.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 10 Years and up
• Sex: All
• Sponsor: Vanderbilt University (Academic / other)
• Locations: 1 site (Nashville, Tennessee)
• Trial ID: NCT06464497 on ClinicalTrials.gov

What this trial studies

This pilot intervention focuses on adolescents aged 10-18 with obesity, implementing an 8-week randomized controlled trial (RCT) to assess the effects of a whole foods diet on body fat and overall health. The study aims to evaluate changes in total fat mass, weight, BMI-z scores, and waist circumference, while also improving diet quality for both adolescents and their parents. By involving families in the dietary changes, the study seeks to address social determinants of health and enhance adherence to healthier eating patterns.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 10-18 with obesity, living at home with a parent or caregiver who can support their participation.

Not a fit: Patients with severe food allergies, medical conditions limiting diet participation, or those not living with a supportive caregiver may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could lead to significant reductions in body fat and improvements in metabolic health for adolescents with obesity.

How similar studies have performed: Previous studies have shown promise in dietary interventions focusing on whole foods, but this specific approach targeting family involvement is relatively novel.

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;

Where this trial is running

Nashville, Tennessee

• Vanderbilt University School of Nursing — Nashville, Tennessee, United States (Recruiting)

Study contacts

• Principal investigator: Nadia M Sneed, PhD, MSN — Vanderbilt University
• Study coordinator: Nadia M Sneed, PhD, MSN

Conditions Obesity, Childhood; Diet, Healthy; Body Weight Changes