Whole Foods for Teens: A Pilot Dietary Intervention to Reduce Body Adiposity in Adolescents With Obesity

Summary

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.

Conditions

• Obesity, Childhood
• Diet, Healthy
• Body Weight Changes

Interventions

BEHAVIORAL

Whole Foods MyPlate Group

Families will receive 4-weeks of rotating menus that have been designed as a part of our preliminary work and will be adapted to support adherence with the adolescent in mind (e.g., school lunch options, on-the-go snacks). Menus and diet recommendations will align with the current macronutrient nutritional goals outlined by the 2020-2025 DGA for age-sex groups. Participants will be encouraged to eat ad libitum (i.e., as desired until full) without calorie restrictions. MyPlate will be used by participants to implement the diet. During the study, adolescents and adults in 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center

  collaborator OTHER

• Vanderbilt University

  lead OTHER

Principal Investigators

• Nadia M Sneed, PhD, MSN · Vanderbilt University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

10 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-24

Primary Completion

2026-12-31

Completion

2027-04-30

Countries

• United States

Study Locations