Whole Foods for Teens: A Pilot Dietary Intervention to Reduce Body Adiposity in Adolescents With Obesity
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
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
Treatments tested in this trial
- Whole Foods MyPlate Group
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Vanderbilt University
Lead sponsor
Vanderbilt University Medical Center
Collaborator
Source ClinicalTrials.gov