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| Name | Class |
|---|---|
| Vanderbilt University Medical Center | OTHER |
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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.
For adolescents with obesity, a healthy diet pattern is recommended as a first-line non-pharmacological treatment. Yet, despite decades of research, there is inconclusive evidence from randomized clinical trials (RCT) to support an optimal dietary pattern to treat adolescent obesity. While observational data has linked poor-quality diet patterns high in calories, fat, and refined carbohydrates to greater body adiposity in adolescents, some research suggests that dietary patterns that emphasize high-quality whole foods (e.g. Mediterranean, low-glycemic load) not only improve diet quality but can also effectively reduce body adiposity and improve metabolic outcomes (e.g., insulin resistance) without the need for calorie restrictions. However, for adolescents with obesity, adherence to a healthy diet pattern requires the involvement of the whole family, with the potential to improve diet quality and reduce body adiposity and its associated metabolic complications. Unfortunately, weaknesses of past studies include 1) a failure to intervene upon diet quality at the family level to modify adolescent dietary behaviors, and 2) a lack of consideration for how individual/family needs and social determinants of health (SDOH) impact diet adoption. To address these gaps, we will test a novel 8-week pilot RCT of a non-calorie-restricted whole foods diet adapted from the 2020-2025 Dietary Guidelines for Americans that offers a simple, customizable MyPlate Plan approach (i.e., 5 daily food group goals) focused on individual, family, cultural, and budgetary preferences. We will recruit 30 eligible adolescent (10-18 years) and parent (≥25 years) pairs to test the diet's effects on 1) adolescent body adiposity measured with dual-energy x-ray absorptiometry (DXA) to measure fat mass and anthropometry to measure weight, BMI, and waist circumference (Aim 1) and 2) adolescent and parent diet quality scores measured from dietary recalls using the 2020 Healthy Eating Index during the intervention (Aim 2). Post-intervention family focus groups will be conducted to understand how individual/family needs and preferences and SDOH may be perceived barriers or facilitators of diet adherence in families (Aim 3). Feasibility, acceptability, enrollment, retention, and diet satisfaction data will be generated to establish successful benchmarks to support future studies. Participants randomized to the intervention will receive bi- weekly food delivery, menus, and dietetic support for 8 weeks. Participants randomized to the usual care group will receive dietetic counseling on MyPlate. The successful completion of this study will result in the generation of quantitative and qualitative data to support a future R01 that will test the long-term effectiveness of a whole foods diet on obesity and metabolic outcomes, and diet sustainability in adolescents with obesity and their families.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole Foods Counseling Group | No Intervention | 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. | |
| Whole Foods MyPlate Group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
For this study, eligible adolescents will be those that:
For this study, eligible adult parents or caregivers will be those that:
Exclusion Criteria:
Adolescent exclusion criteria include:
Adult Parent or Caregiver exclusion criteria include:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nadia M Sneed, PhD, MSN | Contact | 615-343-1542 | nadia.sneed@vanderbilt.edu | |
| Daien Sanchez, MA | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Nadia M Sneed, PhD, MSN | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University School of Nursing | Recruiting | Nashville | Tennessee | 37240 | United States |
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| Label | URL |
|---|---|
| Study website | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form: Child Informed Consent (10-12 years) | Nov 2, 2025 | Mar 16, 2026 | ICF_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Child Informed Assent (18 Year Old) | Nov 2, 2025 | Mar 16, 2026 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Adult Informed Consent | Nov 2, 2025 | Mar 16, 2026 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Child Informed Consent 13-17 Years | Nov 2, 2025 | Mar 16, 2026 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D001836 | Body Weight Changes |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| 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 |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |