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

Recruiting now · Not applicable

Conditions studied: Obesity, Childhood, Diet, Healthy, Body Weight Changes

In brief

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. Hypothesis 1a: Adolescents randomized to the whole foods intervention will have lower total fat mass (kg) at the 8-week follow-up than those in the control group. Aim 1b: Evaluate intervention effectiveness on anthropometric changes following the 8-week intervention. Hypothesis 1b: Adolescents randomized to the whole foods intervention will have lower weight, BMI-z scores and/or waist circumference at the 8-week follow-up than those in the control group. Secondary Aims: Aim 2: Conduct an 8-week pilot RCT to examine the effects of a whole foods diet intervention on diet quality in adolescent and parent pairs during the study period. Hypothesis 2: Adolescents and parents randomized to the whole foods intervention will have higher diet quality scores at the 8-week follow-up than those in the control group. Aim 3: Conduct post-intervention family focus groups to identify how individual/family needs and preferences and social determinants of health (SDOH) may be perceived barriers and/or facilitators of diet adherence to a whole foods diet pattern.

Key facts

Study ID: NCT06464497
Run by: Vanderbilt University
People needed: 60
Starts: 2025-03-24
Expected to finish: 2027-04-30
Last updated by the study team: 2026-03-23

Who can join

Age: 10 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 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;

You may not qualify 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;
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;

Where it is running

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

Full record on ClinicalTrials.gov

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