Whole Foods for Teens: A Pilot Dietary Intervention to Reduce Body Adiposity in Adolescents With Obesity
Eligible age
10+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Vanderbilt University
You may qualify if…
- ✓ 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;
You may not qualify if…
- ✕ 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;
Where it's recruiting
Nashville
Source: ClinicalTrials.gov · NCT06464497 · last updated 2026-03-23