30 Participants Needed

Whole Foods Diet for Childhood Obesity

NM
DS
Overseen ByDaien Sanchez, MA
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Vanderbilt University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how an 8-week whole foods diet affects body fat and weight in adolescents with obesity. Researchers are testing whether a diet focused on whole foods like fruits and vegetables can lower fat mass and improve overall diet quality for both adolescents and their parents. The study involves two groups: one follows a whole foods diet plan with support and groceries provided (the Whole Foods MyPlate Group), and the other follows standard dietary guidelines. Adolescents living with obesity (BMI at or above the 95th percentile) and their parents with certain metabolic risks are encouraged to participate, provided they live near Middle Tennessee and are willing to meet the study requirements. As an unphased trial, this study offers families a unique opportunity to contribute to important research on diet and health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes adolescents using medications that cause weight loss or diabetes medications.

What prior data suggests that this whole foods diet intervention is safe for adolescents with obesity?

Research shows that a whole foods diet, like the one tested in this study, is generally easy for people to follow. Studies have found that adhering to a MyPlate plan, which includes fruits, vegetables, proteins, dairy, and whole grains, usually doesn't cause significant side effects. Health experts already recommend this type of diet for managing weight and improving overall health.

Since this study is in the "Not Applicable" phase, the focus is on understanding the diet's effects and safety. Researchers are still closely examining its safety in people, but similar diets have been safely used in other situations. Overall, the diet is expected to be safe, with no major problems reported in past studies.12345

Why are researchers excited about this trial?

Researchers are excited about the Whole Foods MyPlate treatment for childhood obesity because it emphasizes a diet rich in whole foods, tailored to individual caloric needs with personalized meal plans. Unlike traditional approaches that may not provide structured food guidance, this treatment offers rotating menus and bi-weekly grocery deliveries of fruits and vegetables directly to participants' homes, enhancing adherence and accessibility. This hands-on strategy, combined with regular dietary counseling, aims to make healthy eating more practical and sustainable for families, potentially leading to more effective long-term weight management for adolescents.

What evidence suggests that a whole foods diet is effective for childhood obesity?

Research has shown that planned dietary changes can help reduce body fat in teenagers with obesity. This trial will compare two approaches: the Whole Foods MyPlate Group and the Whole Foods Counseling Group. Participants in the Whole Foods MyPlate Group will receive a MyPlate Plan with rotating menus and bi-weekly groceries, primarily fruits and vegetables, to support adherence to a whole foods diet. Meanwhile, the Whole Foods Counseling Group will follow a conventional Dietary Guidelines for Americans diet, with guidance and support from study personnel. Studies have found that eating mostly whole foods, like fruits and vegetables, can improve diet quality and lead to better health. For example, children who help with cooking and possess good cooking skills are more likely to eat healthier. This approach emphasizes eating more nutritious foods, which may help lower body fat and improve BMI (Body Mass Index) scores. Overall, a whole foods diet may support weight loss and better health for teenagers dealing with obesity.12678

Who Is on the Research Team?

NM

Nadia M Sneed, PhD, MSN

Principal Investigator

Vanderbilt University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a parent or caregiver aged 25 or older.
Adolescents residing within greater Middle Tennessee area with enrolled parent/caregiver willing to drive to Vanderbilt University and Vanderbilt University Medical Center for study visits
Adult parents or caregivers residing within greater Middle Tennessee area and willing to drive to Vanderbilt University and Vanderbilt University Medical Center for study visits
See 9 more

Exclusion Criteria

Adult parents or caregivers with special dietary restrictions, food allergies, or medical conditions that prohibit participation in a diet-related study
I am currently pregnant or breastfeeding.
Adolescents with food allergy to 3 or more food groups, dietary restrictions, or medical condition that prohibits participation in a diet study
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a whole foods diet intervention with bi-weekly food delivery and dietetic support for 8 weeks

8 weeks
Bi-weekly food delivery and dietetic support

Follow-up

Participants are monitored for changes in body composition and diet quality after the intervention

4 weeks

Post-intervention focus groups

Conduct family focus groups to identify barriers and facilitators of diet adherence

What Are the Treatments Tested in This Trial?

Interventions

  • Whole Foods MyPlate Group
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Whole Foods MyPlate GroupExperimental Treatment1 Intervention
Group II: Whole Foods Counseling GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University

Lead Sponsor

Trials
714
Recruited
6,143,000+

Vanderbilt University Medical Center

Collaborator

Trials
922
Recruited
939,000+

Published Research Related to This Trial

A systematic review of 125 studies found that various dietary interventions can effectively reduce body mass index (BMI) in children and adolescents with obesity, with very-low energy diets showing the greatest effectiveness, resulting in an average BMI reduction of -4.40 kg/mยฒ.
In contrast, dietary interventions without a specified energy target were ineffective, leading to a slight increase in BMI (+0.17 kg/mยฒ), highlighting the importance of clear energy targets in obesity treatment for children.
Targeted dietary approaches for the management of obesity and severe obesity in children and adolescents: A systematic review and meta-analysis.Southcombe, F., Lin, F., Krstic, S., et al.[2023]
The Best Food for Families, Infants, and Toddlers (Best Food FITS) initiative successfully partnered with 17 local restaurants in San Marcos, Texas, to improve children's access to healthier menu options by removing sugary drinks and increasing fruits and vegetables.
This community-based intervention demonstrates that modifying restaurant menus can effectively influence children's eating habits and can be replicated in other communities with minimal funding for promotional support.
Improving children's menus in community restaurants: best food for families, infants, and toddlers (Best Food FITS) intervention, South Central Texas, 2010-2014.Crixell, SH., Friedman, B., Fisher, DT., et al.[2022]
Obesity in children has become a major public health issue, with one in four children in the U.S. being overweight and a significant risk of remaining overweight into adulthood, highlighting the need for effective prevention strategies.
Changes in children's eating patterns, such as increased restaurant meals and larger portion sizes, contribute to rising obesity rates, suggesting that promoting healthier lifestyles is crucial for preventing obesity and its associated health risks.
Eating patterns, dietary quality and obesity.Nicklas, TA., Baranowski, T., Cullen, KW., et al.[2022]

Citations

Whole Foods for Teens: A Pilot Dietary Intervention to ...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 ...
Fill โ€œhalf your child's plate with fruits and vegetablesโ€Children who helped choose and prepare meals more frequently and had greater cooking skills had 7% (CI: 1.01 โ€“ 1.14) and 22% (CI: 1.06 โ€“ 1.41) higher odds of ...
Whole Foods Diet for Childhood ObesityWhat data supports the effectiveness of the Whole Foods MyPlate Group treatment for childhood obesity? Research shows that structured dietary interventions ...
Whole Foods for Teens: A Pilot Dietary Intervention to Reduce ...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 ...
The Kids Obesity Prevention Program: Cluster ...The primary outcome was the gain in knowledge about important lifestyle factors with the focus on nutrition, especially the DED-P. The secondary ...
Comparative effectiveness trial comparing MyPlate to calorie ...MyPlate is simpler, focusing on only four food groups on the plate and dairy on the side, showing fruits and vegetables as occupying twice the ...
The Effectiveness of Educational Tools on Finding Solutions to ...Social marketing campaigns have been used in the efforts to prevent and mitigate childhood obesity. For example, MyPlate has been a common approach to educate ...
Prevention of Pediatric Overweight and Obesity: Position ...From 2017 to 2018, the rate of pediatric obesity in the United States was 19.3%. Rates were 13.4% among 2- to 5-year-olds, 20.3% among 6- to 11-year-olds, and ...
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