Actively Recruiting
Whole Foods for Teens: A Pilot Dietary Intervention to Reduce Body Adiposity in Adolescents With Obesity
Led by Vanderbilt University · Updated on 2026-03-23
60
Participants Needed
1
Research Sites
109 weeks
Total Duration
On this page
Sponsors
V
Vanderbilt University
Lead Sponsor
V
Vanderbilt University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Whole Foods for Teens: A Pilot Dietary Intervention to Reduce Body Adiposity in Adolescents With Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adolescents aged 10 to 18 years at initial screening
- Living at home full-time with enrolled parent or caregiver (80% or more in primary residence)
- Obesity defined as BMI at or above the 95th percentile for age and gender based on CDC growth curves
- Reside in greater Middle Tennessee area with parent/caregiver willing to drive to study visits
- No medical conditions limiting participation in a diet-related study (e.g., tube feeding, dysphagia, severe allergy to 3 or more food groups causing anaphylaxis)
- Willing and able to participate in 8-week diet study with parental or caregiver support
- Parental or caregiver commitment to participate in the research study
- Adult parent or primary legal caregiver aged 25 years or older of enrolled adolescent
- Living with adolescent full-time (80% or more in primary residence)
- Have one or more metabolic risk factors or conditions (e.g., overweight/obesity, hypertension, hypercholesterolemia, hyperglycemia, prediabetes, history of gestational diabetes, polycystic ovarian syndrome, type 2 diabetes, non-alcoholic fatty liver disease)
- Reside in greater Middle Tennessee area and willing to drive to study visits
- No medical conditions limiting participation in a diet-related study
- Able to participate in a program encouraging preparing and eating healthy foods and snacks for 8 weeks with home meal preparation
You will not qualify if you...
- Adolescents outside the 10 to 18 years age range
- Adolescents not living full-time with enrolled parent or caregiver (less than 80% in primary residence)
- Adolescents with BMI below 95th percentile for age and gender
- Pregnant or lactating adolescents
- No eligible enrolled parent or caregiver or lack of parental/caregiver commitment
- Adolescents with food allergy to 3 or more food groups or medical conditions prohibiting diet study participation
- Use of medications that cause weight loss or diabetes medications
- Active participation in weight loss or intense lifestyle modification programs
- Limited English-language proficiency
- Participants unwilling or unable to give informed consent, accept random assignment, attend counseling, adhere to treatment, or complete measures
- Adolescents displaying dissenting behaviors during baseline data collection
- Adult parents or caregivers not legal caregivers
- Adult parents or caregivers not living full-time with enrolled adolescent
- Adult parents or caregivers lacking metabolic conditions per inclusion
- Adult parents or caregivers with special dietary restrictions, food allergies, or medical conditions prohibiting diet study participation
- Adult parents or caregivers with limited English-language proficiency
- Adult parents or caregivers unwilling or unable to give informed consent, accept random assignment, attend counseling, adhere to treatment, or complete measures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Vanderbilt University School of Nursing
Nashville, Tennessee, United States, 37240
Actively Recruiting
Research Team
N
Nadia M Sneed, PhD, MSN
CONTACT
D
Daien Sanchez, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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