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Набор по приглашению NCT07341841

Assessing Obesity Related Risk Factors in Adult Population: A Genetic and Behavioral Study

Без фазы С лечением Obesity Prevention

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Diet and exercise, Lifestyle Intervention, Exercise.
Кому может быть актуально
Состояния в реестре: Obesity Prevention. Базовые параметры: 18 лет — 70 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Assessing Obesity Related Risk Factors in Burke, Columbia, Richmond (BCR) Adult Population: A Genetic and Behavioral Study

Обзор

This study aims to explore the association between Melanocortin-4 Receptor (MC4R) polymorphisms, eating habits, and social determinants of health in a heterogeneous adult population in Georgia, USA.

Подробное описание

The study has three aims.

Aim 1: Genotyping and Participant Stratification To assess the genetic variation of the MC4R gene in the Burke-Columbia-Richmond (BCR) population using Targeted DNA sequencing technology and stratify participants into genotype-based intervention groups (e.g., risk vs. non-risk variants). We anticipate seeing differences in MC4R gene polymorphisms within the BCR residents.

Aim 2: Genotype-Informed Lifestyle Intervention To evaluate the effects of an 8-week personalized dietary and physical activity intervention and association with the frequency distribution of the MC4R variants in the BCR using modified Diet History Questionnaire II (DHQ II) and bicycle ergometer, respectively. In addition, the association between body composition and the subject's age group will be measured using BOD POD instrument. We expect to find associations between food intake and the MC4R variants within the residents of the BCR area. We also expect to see the difference between age groups and the MC4R variant based on body composition.

Primary outcome: change in body composition, primarily body fat percentage Secondary outcomes: changes in dietary patterns, physical activity, and BMI

Aim 3: Socioeconomic and environmental factors To assess whether socio-economic status and environmental inequalities influence diet quality and obesity status of the BCR residents. Data will be collected through a structured questionnaire and secondary sources, such as the U.S. Census Bureau. We expect to find differences in the obesity profiles in the BCR adult population due to socio-economic and environmental inequalities. We hypothesize that the MC4R variants, socio-economic, and environmental inequalities are correlated with eating habits and obesity status within BCR residents.

Вмешательства

  • Поведенческое Diet and exercise
    Diet intervention: Participants will be randomly divided into a control group (n=50) and a training group (n=50) using the simplest method of assigning participants to different treatment groups: a coin toss. They will be surveyed using the modified DHII questionnaire to assess their caloric intake. The baseline calorie intake will be evaluated during the first visit. Participants will be instructed to reduce their portion sizes by half of what they typically consume. The commitment of participa
  • Поведенческое Lifestyle Intervention
    8-week personalized diet using a personalized low-calorie diet based on the caloric intake baseline using modified Diet History Questionnaire II (DHQ II)
  • Поведенческое Exercise
    8-week personalized physical activity- subjects will be doing 30-minute exercise three times a week using a bicycle ergometer

Первичные конечные точки

  • Diet and exercise [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

Adults 18-70 years old are included in the study.

Target populations are 4 groups:

  • Group 1 - overweight (not obese), if BMI is 25.0-29.9 Kg/m2;
  • Group 2 - Class 1 (lower-risk) obesity, if BMI is 30.0-34.9 Kg/m2;
  • Group 3 - Class 2 (moderate-risk) obesity, if BMI is 35-39.9 Kg/m2 and
  • Group 4 - Class 3 (high-risk) obesity, if BMI is equal or greater than 40 Kg/m2.

Males and females will participate in the study.

Критерии исключения

Children younger than 18 years old and adults over 70 are excluded from the study. Non-English speakers and individuals with impaired decision-making capacity to consent are excluded from the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Скрининг

Центры проведения

США · 1 центр
  • Augusta University — Augusta

Идентификаторы

NCT: NCT07341841 · SPH

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗