Идёт набор NCT07009288

A Study of Time-Restricted Eating in Childhood Cancer Survivors

Без фазы С лечением Childhood Cancer Survivors

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: Children's Oncology Group Heart Health Link, Monthly weights, Fasting, Calls.
Кому может быть актуально: Состояния в реестре: Childhood Cancer Survivors. Базовые параметры: от 18 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: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Decreasing Cardiometabolic Risk in Childhood Cancer Survivors: The STRENGTH (Survivors Engaged in Time-Restricted EatiNG After THerapy) Study

Обзор

This study will look at whether motivational sessions (including regular calls with a trained health coach) in combination with time-restricted eating (TRE) is an effective way to achieve weight loss and lower cardiometabolic risk in adult survivors of childhood cancer. The researchers will look at how effective this intervention is compared to the usual approach, which is to review educational materials and measure weight once a month. This study will not provide treatment for any disease or cancer.

Вмешательства

Другое Children's Oncology Group Heart Health Link
Educational materials on healthy lifestyle behaviors.
Другое Monthly weights
Weight (kg): measured remotely via Withings Body + scale, Height, weight, waist circumference, BP, and % body fat
Другое Fasting
(14-hour fast x 2 weeks; 15-hour fast x- 1 week; 16-hour fast for the remainder of the active intervention)
Другое Calls
Month 1-3: Bi-weekly call using motivational interviewing Months 4-6: Monthly call using motivational interviewing Support via SMS text
Другое Participant Questionnaires
Questions on worry, perceived self-efficacy, health beliefs and knowledge of late effects (adapted from EQUAL study), Behavioral Risk Factor Surveillance System, Physical Activity Questionnaire, Link to Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool with accompanying sleep module
Другое Dried blood spot
Glucose, insulin, hemoglobin A1c, lipids. Measured remotely in the fasting state via dried blood spots in the participant's home.

Первичные конечные точки

Percent change in weight [Срок оценки: at 12 months]

Вторичные конечные точки (3)

Change in glucose [Срок оценки: up to 12 months]
Change in insulin [Срок оценки: up to 12 months]
Change in HbA1c [Срок оценки: up to 12 months]

Критерии участия

Критерии включения

Enrolled in the Childhood Cancer Survivor Study (a cohort of 5+ year survivors of childhood cancer diagnosed at age < 21 between 1970-1999 at 31 participating institutions in North America)
Are ≥18 years old
Self-reported body mass index ≥ 25 kg/m2
Are not pregnant or do not intend to become pregnant in the next year
Stable weight over the past 3 months (+/- 10 pounds)
If on oral medication for insulin resistance (ie, metformin), elevated blood pressure, or dyslipidemia, medication dose must be stable (ie, unchanged > 3 months)
Have internet access (can be via smartphone or computer). If neither device is available, the study can loan participants a Wi-Fi enabled device.