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Whole foods diet for teens: a new hope against obesity?

NCT ID NCT06464497

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tests whether an 8-week whole foods diet (based on MyPlate, no calorie counting) can reduce body fat in 60 adolescents aged 10-18 with obesity. Participants will be randomly assigned to the diet or a control group. The study also looks at changes in diet quality for both teens and their parents. It is a small, early-stage trial to see if this approach is worth studying further.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Whole foods diet (MyPlate-based, no calorie restriction)
What this could lead to
If it works, this could point toward a simple, sustainable dietary approach to help teens with obesity reduce body fat and improve diet quality.
What could go wrong
This is a small, early pilot study (60 participants) with no blinding, so results may not be generalizable. Adherence to the diet may be challenging, and the 8-week duration is too short to assess long-term effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

Body Weight Changes obesity disorder Pediatric Obesity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Vanderbilt University School of Nursing

    RECRUITING

    Nashville, Tennessee, 37240, United States

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