Whole Foods for Teens: A Pilot Dietary Intervention to Reduce Body Adiposity in Adolescents With Obesity
NCT Number: NCT06464497
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obesity, Childhood|Diet, Healthy|Body Weight Changes
Interventions: BEHAVIORAL: Whole Foods MyPlate Group
Sponsor: Vanderbilt University
Collaborators: Vanderbilt University Medical Center
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2025-06-30
Locations: Vanderbilt University School of Nursing, Nashville, Tennessee, 37240, United States

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.

Primary Outcome Measures: 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 Outcome Measures: Changes in adolescent and adult diet quality, The 2020 Healthy Eating Index (HEI) will be used to estimate adolescent and adult diet quality scores during the study. Scores will be calculated from 3-day food diaries imputed into NDSR software. The HEI uses a scoring system of 0-100 to determine how well an individual's diet (ages ≥2 years) aligns with major DGA recommendations with a higher diet quality score indicating a healthier diet. Dietary information from 3-day food diaries will be used to estimate the baseline diet quality score., Baseline to 8-weeks|Change in Adult Body Mass Index (BMI), Body mass index (BMI) is a person's weight in kilograms divided by the square of height in meters. BMI is interpreted using standard weight status categories. These categories are the same for men and women of all body types and ages. Below 18.5 : Underweight; 18.5 - 24.9: Normal or Healthy Weight; 25.0 - 29.9: Overweight; 30.0 and Above: Obese., Baseline to 8-weeks|Change in adolescent Body Mass Index (BMI) percentiles, Body mass index (BMI) is a person's weight in kilograms divided by the square of height in meters. BMI is interpreted using standard weight status categories. The CDC BMI-for-age charts for children above 2 years will be used to calculate BMI percentiles., Baseline to 8-weeks|Change in adolescent Body Mass Index (BMI) Z Scores, Body mass index (BMI) is a person's weight in kilograms divided by the square of height in meters. BMI is interpreted using standard weight status categories. The CDC BMI-for-age charts for children above 2 years will be used to calculate BMI z-scores., Baseline to 8-weeks|Change in adolescent and adult Waist Measurements, Waist circumference will be measured in centimeters., Baseline to 8-weeks|Diet adherence in adolescents and adults, ≥80% compliance with the diet will be considered "adherent" and will be estimated qualitatively from food diaries. The dietitian will review food checklists/diaries to assess adherence and to modify diets or support compliance., Baseline to 8-weeks