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NCT06464497Toboroz

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

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. márc. 23.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter)
Toboroz
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
60 (tervezett)
Első benyújtás
2024. jún. 12.
Kezdés
2025. márc. 24.
Elsődleges befejezés
2026. dec. 31.
Fő szponzor
Vanderbilt University
Betegségek
Elhízás
NCT-szám
NCT06464497

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 60
  • 2025. márc. 24. és az elsődleges befejezés (2026. dec. 31.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Más betegség

  • food allergy to 3 or more food groups; dietary restrictions or medical condition that prohibits participation in a diet study;
  • use of medications that cause weight loss or diabetes medications;
  • lack of metabolic condition(s) per inclusion criteria;
  • special dietary restrictions, food allergies, or medical conditions that prohibit participation in a diet-related study;

Életkor

  • Outside of the specified age range;
  • BMI less than 95th percentile for age and gender;

Egyéb

  • Adolescent exclusion criteria include:
  • not living in the home of the enrolled parent or caregiver full time (≥80% in primary residence);
  • pregnant or lactating;
  • no eligible enrolled parent or caregiver or lack of parental/caregiver commitment to participate in study;
  • active participation in a weight loss or intense lifestyle modification program;
  • limited English-language proficiency;
  • participants unwilling or unable to give informed consent, accept random assignment, attend dietary counseling sessions, adhere to treatment prescription, or complete study measures;
  • adolescents who display dissenting behaviors during baseline data collection;
  • adolescents who do not otherwise meet the eligibility criteria listed in sections above as determined by pre-screen;
    • Adult Parent or Caregiver exclusion criteria include:
  • not parent/ or legal caregiver;
  • not living in a household full-time with enrolled adolescent (less than 80% time spent away from primary residence);
  • limited English-language proficiency;
  • participants unwilling or unable to give informed consent, accept random assignment, attend dietary counseling sessions, adhere to treatment prescription, or complete study measures;
  • parent or caregivers who do not otherwise meet the eligibility criteria listed in sections above as determined by pre-screen;

Kiket keres a vizsgálat

  • 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;

Életkor a regiszterben: 10 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

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HelyszínVárosOrszágHelyszín állapota
Vanderbilt University School of NursingNashvilleEgyesült ÁllamokToboroz

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