NCT06464497Recruiting
Whole Foods for Teens: A Pilot Dietary Intervention to Reduce Body Adiposity in Adolescents With Obesity
Source: ClinicalTrials.gov · Last updated 23 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 12 Jun 2024
- Start date
- 24 Mar 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Vanderbilt University
- Diseases
- Obesity
- NCT number
- NCT06464497
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 24 Mar 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
- lack of metabolic condition(s) per inclusion criteria;
- special dietary restrictions, food allergies, or medical conditions that prohibit participation in a diet-related study;
Age
- Outside of the specified age range;
- BMI less than 95th percentile for age and gender;
Other
- Adolescent exclusion criteria include:
- not living in the home of the enrolled parent or caregiver full time (≥80% in primary residence);
- pregnant or lactating;
- no eligible enrolled parent or caregiver or lack of parental/caregiver commitment to participate in study;
- 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);
- 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;
Who the study is looking for
- 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;
Age in the registry: 10 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University School of Nursing Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.