No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
10 and older
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
60 (estimated)
Sponsor
Vanderbilt University · Other
Who this trial is looking for
This trial is looking for adolescents aged 10 to 18 who are struggling with obesity. Participants will follow a whole foods diet for 8 weeks while receiving family support.
Are You a Good Fit for This Trial?
You may be able to join if
I am 10 to 18 years old.
I live at home full-time with my parent or caregiver.
I have obesity based on my BMI.
I live in the greater Middle Tennessee area.
I do not have medical conditions that limit my diet.
I can participate in an 8-week diet study with my family's help.
My parent or caregiver is committed to participating.
You may not be able to join if
I am outside of the specified age range.
I do not live with my enrolled parent or caregiver full-time.
My BMI is less than the 95th percentile for my age and gender.
I am pregnant or breastfeeding.
I have food allergies to 3 or more food groups.
I am taking medications that cause weight loss.
I am currently in a weight loss program.
I have behaviors that do not align with study participation.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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) …
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.
Trial Locations
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Status
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 95t…
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;
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