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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Healthy Volunteers: f
View:

⁃ For this study, eligible adolescents will be those that:

• 10-18 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;

Locations
United States
Tennessee
Vanderbilt University School of Nursing
RECRUITING
Nashville
Contact Information
Primary
Nadia M Sneed, PhD, MSN
nadia.sneed@vanderbilt.edu
615-343-1542
Backup
Daien Sanchez, MA
Time Frame
Start Date: 2025-03-24
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 30
Treatments
No_intervention: Whole Foods Counseling Group
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.
Experimental: Whole Foods MyPlate Group
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.
Related Therapeutic Areas
Sponsors
Collaborators: Vanderbilt University Medical Center
Leads: Vanderbilt University

This content was sourced from clinicaltrials.gov