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

ConditionsObesity, ChildhoodDiet, HealthyBody Weight Changes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10+
SponsorVanderbilt University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Whole Foods Counseling GroupNo intervention 0 interventions
Group B: Whole Foods MyPlate GroupExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Baseline to 8-weeks

Secondary outcomes

1

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.

Time frame
Baseline to 8-weeks
2

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.

Time frame
Baseline to 8-weeks
3

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.

Time frame
Baseline to 8-weeks
4

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.

Time frame
Baseline to 8-weeks

Other outcomes

Sponsors and contacts

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Vanderbilt University

Lead sponsor

Vanderbilt University Medical Center

Collaborator

Source ClinicalTrials.gov
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