RECRUITING

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

Conditions

Obesity, Childhood Diet, Healthy Body Weight Changes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-24

Study Completion:2026-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06464497

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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; 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;	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; 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;

Inclusion Criteria

Exclusion Criteria

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;
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;

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;
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;

Contacts and Locations

Study Contact

Nadia M Sneed, PhD, MSN

CONTACT

615-343-1542

nadia.sneed@vanderbilt.edu

Daien Sanchez, MA

CONTACT

Principal Investigator

Nadia M Sneed, PhD, MSN

PRINCIPAL_INVESTIGATOR

Vanderbilt University

Study Locations (Sites)

Vanderbilt University School of Nursing

Nashville, Tennessee, 37240

United States

Collaborators and Investigators

Sponsor: Vanderbilt University

Nadia M Sneed, PhD, MSN, PRINCIPAL_INVESTIGATOR, Vanderbilt University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-24

Study Completion Date2026-06-30

Study Record Updates

Study Start Date2025-03-24

Study Completion Date2026-06-30

Terms related to this study

Additional Relevant MeSH Terms

Obesity, Childhood
Diet, Healthy
Body Weight Changes