← Back to Search

Behavioral Intervention

Whole Foods Diet for Childhood Obesity

N/A

Waitlist Available

Led By Nadia M Sneed, PhD, MSN

Research Sponsored by Vanderbilt University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adolescents aged 10-18 years at initial screening

Adolescents 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)

Must not have

Adolescents using medications that cause weight loss or diabetes medications

Adolescents outside of the specified age range

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 8-weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the effects of a whole foods diet on body fat in obese adolescents. The primary goal is to see if the intervention reduces total fat mass and improves body measurements like weight and waist

Who is the study for?

This trial is for teens with obesity. It's an 8-week study testing if a whole foods diet can reduce body fat and improve measurements like weight, BMI-z scores, and waist size. Teens participating will be compared to a control group not following this diet.

What is being tested?

The intervention being tested is the Whole Foods MyPlate Group diet. The study aims to see if following this specific dietary plan leads to lower body fat and better health markers in obese adolescents after 8 weeks.

What are the potential side effects?

Since the intervention involves dietary changes to whole foods, side effects may include initial digestive adjustments such as bloating or changes in bowel habits as the body adapts to healthier eating patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 10 and 18 years old.

Select...

I am a teenager with no severe food allergies or conditions that prevent eating normally.

Select...

I am a teenager and live mostly with my parent or caregiver.

Select...

My BMI is in the top 5% for my age and gender.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am a teenager taking medication for weight loss or diabetes.

Select...

I am not within the specified age range for adolescents.

Select...

I am currently pregnant or breastfeeding.

Select...

I am a teenager without a parent or caregiver able to join the study with me.

Select...

My BMI is below the 95th percentile for my age and gender.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 8-weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 8-weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 8-weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in adolescent body composition

Secondary study objectives

Change in Adult Body Mass Index (BMI)

Change in adolescent Body Mass Index (BMI) Z Scores

Change in adolescent Body Mass Index (BMI) percentiles

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Whole Foods MyPlate GroupExperimental Treatment1 Intervention

Adolescents and adults randomized to the "intervention group" will receive a MyPlate Plan to support daily food group and macronutrient goals that align with the whole foods diet per caloric needs. The 8-week intervention will consist of rotating menus (per above) and bi-weekly groceries of mostly fruits and vegetables delivered to family's homes that align with the study menus to support adherence.

Group II: Whole Foods Counseling GroupActive Control1 Intervention

Participants randomized to the "usual care" group will receive a MyPlate Plan that follows a conventional Dietary Guidelines for Americans (DGA) diet which is considered a healthy diet pattern for adolescents with obesity. This diet intervention will encourage the consumption of a whole foods "dietary patterns" such as a wide variety of fruits, vegetables, proteins, seafood, dairy and whole grains. Physical activity will be encouraged per MyPlate guidelines and will be reported on the MyPlate plan daily. At the end of each week, study personnel and/or the study RDN will follow up with the participants to review the food checklists. At this time personnel will address diet-related questions and provide guidance on diet adherence.

0 / 9Eligibility criteria met