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Идёт набор NCT07695675

Community Dining, Walking, and Glucose in Older Adults

Без фазы С лечением Prediabetes

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: Subsidized Community Dining, Home Eating.
Кому может быть актуально
Состояния в реестре: Prediabetes. Базовые параметры: 60 лет — 79 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
Китай
Следующий шаг
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Официальное название

Subsidized Community Dining as Social Welfare Infrastructure for Healthy Aging: A Randomized Crossover Field Study of Postmeal Walking and Glycemic Profiles in Older Adults

Обзор

This study will examine whether eating lunch and dinner at a subsidized community dining site affects postmeal walking and blood glucose patterns in older adults. Participants will be community-dwelling adults aged 60 to 79 years who are eligible for a local elderly meal subsidy and have prediabetes or elevated blood glucose risk. Each participant will complete two 6-day meal conditions in random order. In one condition, participants will eat lunch and dinner at home. In the other condition, participants will eat lunch and dinner at a subsidized community dining site. Participants will wear a continuous glucose monitor and an activity tracker so the study team can measure postmeal glucose levels, daily glucose patterns, and steps after meals. The study will compare community dining with home eating to determine whether community dining increases postmeal walking, improves postmeal glucose responses, and affects loneliness and meal experience.

Подробное описание

Subsidized community dining programs are designed to improve access to affordable meals for older adults, but they may also influence daily movement, social interaction, and metabolic health. Eating at a community dining site may encourage older adults to leave home, walk before or after meals, and interact with others in a shared meal environment.

This study will evaluate subsidized community dining as a real-world meal setting rather than as a prescribed exercise or dietary treatment. Participants will complete both study conditions: home eating and community dining. During the community dining condition, participants will eat lunch and dinner at a subsidized community dining site. During the home-eating condition, participants will eat lunch and dinner at home using meals designed to approximate the energy and macronutrient composition of the community dining meals.

The study will use continuous glucose monitoring and wearable activity tracking to measure postmeal glucose responses, daily glucose profiles, and postmeal steps under free-living conditions. No walking target will be prescribed. After each lunch and dinner, participants will be free to walk, sit, rest, remain at the dining site, or return home according to their usual preference.

The study will also assess loneliness and meal-condition experience to explore whether the dining setting affects social and experiential aspects of eating. Findings may help determine whether subsidized community dining can function not only as food assistance, but also as community-based infrastructure that supports healthy aging.

Вмешательства

  • Поведенческое Subsidized Community Dining
    Participants will eat lunch and dinner at a subsidized community dining site for 6 days. No walking target or exercise prescription will be given. After each meal, participants will be free to walk, sit, rest, remain at the dining site, or return home according to their usual preference.
  • Поведенческое Home Eating
    Participants will eat lunch and dinner at home for 6 days using a standardized Chinese meal rotation designed to approximate the energy and macronutrient composition of the community dining meals.

Первичные конечные точки

  • Meal-Level 0- to 90-Minute Postprandial Glucose Incremental Area Under the Curve [Срок оценки: Study Days 2-13; fixed premeal baseline window through 90 minutes after completion of each lunch and dinner during the 12-day randomized meal-condition period.]
Вторичные конечные точки (9)
  • Meal-Level 0- to 90-Minute Postmeal Step Count [Срок оценки: Study Days 2-13; from meal completion through 90 minutes after completion of each lunch and dinner during the 12-day randomized meal-condition period.]
  • Meal-Level Peak Postprandial Glucose [Срок оценки: Study Days 2-13; from meal completion through 90 minutes after completion of each lunch and dinner during the 12-day randomized meal-condition period.]
  • Meal-Level Time to Peak Postprandial Glucose [Срок оценки: Study Days 2-13; from meal completion through 90 minutes after completion of each lunch and dinner during the 12-day randomized meal-condition period.]
  • Daily 24-Hour Mean Glucose [Срок оценки: Study Days 2-13; over each 24-hour analytic day during the 12-day randomized meal-condition period.]
  • Daily Time Above Range [Срок оценки: Study Days 2-13; over each 24-hour analytic day during the 12-day randomized meal-condition period.]
  • Daily Combined Postmeal Steps [Срок оценки: Study Days 2-13; summed across the lunch and dinner 90-minute postmeal windows on each 24-hour analytic day during the 12-day randomized meal-condition period.]
  • Total Daily Steps [Срок оценки: Study Days 2-13; over each 24-hour analytic day during the 12-day randomized meal-condition period.]
  • End-of-Condition Loneliness Score [Срок оценки: Baseline and end of each 6-day meal condition during the 12-day randomized meal-condition period.]
  • End-of-Condition Meal-Condition Experience and Satisfaction Score [Срок оценки: End of each 6-day meal condition during the 12-day randomized meal-condition period.]

Критерии участия

Критерии включения

  • Community-dwelling adults aged 60 to 79 years
  • Eligible for the local elderly meal subsidy
  • Prediabetes or elevated glycemic risk, defined as HbA1c 5.7% to 6.4% or fasting plasma glucose 100 to 125 mg/dL
  • Able to consume meals orally
  • Able to walk independently without a walking aid
  • Able to attend the community dining site safely
  • Able and willing to wear a continuous glucose monitor and activity tracker
  • Able and willing to follow the home-meal plan and study procedures
  • Able to provide written informed consent

Критерии исключения

  • HbA1c ≥6.5% or fasting plasma glucose ≥126 mg/dL
  • Diagnosed diabetes
  • Use of insulin or glucose-lowering medication
  • Severe cognitive impairment
  • Acute illness or recent hospitalization
  • Severe gastrointestinal disease affecting usual food intake or gastric emptying
  • Severe renal, hepatic, cardiovascular, or neurologic disease that would make participation unsafe
  • Skin conditions preventing continuous glucose monitor use
  • Food allergy or dietary restrictions incompatible with the standardized meal plan

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

Китай · 1 центр
  • Community Elderly Meal-Assistance Site — Чанша

Идентификаторы

NCT: NCT07695675 · HNU-2026-410

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗