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

NCT06464497 | Recruiting DMC

• 1 other identifier: 240866
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in adolescent body composition

  Body adiposity will be measured using DXA at the VUIIS with a Hologic Horizon series W scanner (Marlborough, MA). Total body fat mass (primary outcome), trunk fat mass, lean body mass (LBM) in kg, and total body %fat will be recorded.

  Baseline to 8-weeks

Secondary Outcomes (6)

• Changes in adolescent and adult diet quality

  Baseline to 8-weeks

• Change in Adult Body Mass Index (BMI)

  Baseline to 8-weeks

• Change in adolescent Body Mass Index (BMI) percentiles

  Baseline to 8-weeks

• Change in adolescent Body Mass Index (BMI) Z Scores

  Baseline to 8-weeks

• Change in adolescent and adult Waist Measurements

  Baseline to 8-weeks

Study Arms (2)

Whole Foods Counseling Group

NO 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.

Whole Foods MyPlate Group

EXPERIMENTAL

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.

Behavioral: Whole Foods MyPlate Group

Interventions

Whole Foods MyPlate Group BEHAVIORAL

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.

Whole Foods MyPlate Group

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• For this study, eligible adolescents will be those that:
• years of age at time of initial screening;
• living at home full-time with the enrolled parent or caregiver (≥80% in primary residence);
• 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;
• 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;
• 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);
• 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;
• have parental or caregiver commitment to participate in the research study;
• For this study, eligible adult parents or caregivers will be those that:
• adult parent or primary legal caregiver (greater than or equal to 25 years of age) of an enrolled adolescent;
• live with the adolescent full-time (≥80% in primary residence);
• 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);
• reside within greater Middle Tennessee area and are willing to drive to Vanderbilt University and Vanderbilt University Medical Center for study visits;
• 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);
• 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;

You may not qualify if:

• Outside of the specified age range;
• not living in the home of the enrolled parent or caregiver full time (≥80% in primary residence);
• BMI less than 95th percentile for age and gender;
• pregnant or lactating;
• no eligible enrolled parent or caregiver or lack of parental/caregiver commitment to participate in study;
• food allergy to 3 or more food groups; dietary restrictions or medical condition that prohibits participation in a diet study;
• use of medications that cause weight loss or diabetes medications;
• active participation in a weight loss or intense lifestyle modification program;
• limited English-language proficiency;
• participants unwilling or unable to give informed consent, accept random assignment, attend dietary counseling sessions, adhere to treatment prescription, or complete study measures;
• adolescents who display dissenting behaviors during baseline data collection;
• adolescents who do not otherwise meet the eligibility criteria listed in sections above as determined by pre-screen;
• not parent/ or legal caregiver;
• not living in a household full-time with enrolled adolescent (less than 80% time spent away from primary residence);
• special dietary restrictions, food allergies, or medical conditions that prohibit participation in a diet-related study;

Sponsors & Collaborators

• Vanderbilt University: lead
• Vanderbilt University Medical Center: collaborator

Study Sites (1)

Vanderbilt University School of Nursing

Nashville, Tennessee, 37240, United States

RECRUITING

Related Links

• Study website

MeSH Terms

Conditions

Pediatric Obesity; Body Weight Changes

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nadia M Sneed, PhD, MSN

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadia M Sneed, PhD, MSN

CONTACT

615-343-1542; nadia.sneed@vanderbilt.edu

Daien Sanchez, MA

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 18, 2024
• Study Start: March 24, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

US (1)