A Study to See if an iPhone Weight Management App Can Help Promote Weight Loss in Adolescents and Young Adults After a Stem Cell Transplant
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: Interview, Media Intervention, Questionnaire Administration, Scale Device.
- Кому может быть актуально
- Состояния в реестре: Obesity, Malignant Neoplasm. Базовые параметры: 13 лет — 30 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 →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Behavioral Weight Loss Intervention Utilizing Mobile Health Technology in Hematopoietic Stem Cell Transplant Patients (BWL001)
Обзор
This early phase I trial studies how well a behavioral weight loss intervention consisting of a smartphone application and coaching works for the promotion of weight loss in adolescents and young adults after a stem cell transplant. This study may help researchers learn more about how adolescents and young adults can lose weight and develop healthy eating habits.
Подробное описание
PRIMARY OBJECTIVE:
I. To evaluate the effectiveness of an addiction-based weight loss intervention, embodied as a smartphone application (app) with telephone coaching, on weight outcomes of overweight and obese post hematopoietic stem cell transplantation (HSCT) adolescents and young adults.
SECONDARY OBJECTIVES:
I. To evaluate the changes in metabolic parameters and physical activity levels, in addition to modifications in addictive eating behaviors, motivation, and self-regulatory behaviors.
II. To evaluate the feasibility, adherence, and satisfaction of this intervention.
OUTLINE:
Patients receive an iPhone with W8Loss2Go app, a body scale and a digital food scale to weigh themselves and food daily. Patients interact with coaches via text messages for 4 days weekly and receive weekly 15 minute phone calls for appointment reminders, emotional support, progress discussion, and follow up on items discussed in a prior visit or phone call. Patients also have telemedicine interviews with the coach lasting 60 minutes at 2 and 4 months to elicit both positive and negative impacts on weight management and to identify barriers such as emotional eating, displacement behaviors, poor coping skills to life stressors, and social challenges. Patients who opt to extend the intervention until month 12 attend an additional telemedicine meeting with the coach. Patients also complete questionnaires over approximately 1.5 hours.
Вмешательства
- Другое Interview
Participate in interviews - Другое Media Intervention
Receive iPhone with W8Loss2Go app - Другое Questionnaire Administration
Complete questionnaires - Другое Scale Device
Receive body scale and food scale - Поведенческое Telephone-Based Intervention
Receive telephone calls - Другое Text Message
Receive text message
Первичные конечные точки
- Change in body mass index (BMI) status [Срок оценки: Baseline up to 12 months]
Вторичные конечные точки (12)
- Adherence [Срок оценки: Up to 12 months]
- Fasting lab test analysis: HbA1c [Срок оценки: At four months up to 12 months]
- Fasting lab test analysis: Total cholesterol [Срок оценки: At four months up to 12 months]
- Fasting lab test analysis: Low density lipoprotein [Срок оценки: At four months up to 12 months]
- Fasting lab test analysis: High density lipoprotein [Срок оценки: At four months up to 12 months]
- Fasting lab test analysis: triglycerides [Срок оценки: At four months up to 12 months]
- Fasting lab test analysis: aspartate/alanine aminotransferase [Срок оценки: At four months up to 12 months]
- Fasting lab test analysis: glucose [Срок оценки: At four months up to 12 months]
- Yale Food Addiction Scale [Срок оценки: Up to 12 months]
- Center for epidemiologic studies depression scale [Срок оценки: Up to 12 months]
- Perceived stress scale [Срок оценки: Up to 12 months]
- Satisfaction with program [Срок оценки: Up to 12 months]
Критерии участия
Критерии включения
- Patients with a history of HSCT of any type, at least 100 days post-transplant at initial consultation of the study, will be eligible for the study
- Patients must classify as obese, represented as body mass index (BMI) >= 85th percentile for age and gender
- Patients must also be able to read English since the app intervention is only available in English form
- No patients will be excluded for any specific underlying medical condition, but decisions will be made on a case by case basis if a patient's functioning is deemed to significantly interfere with intervention participation
- PARENT:
- His/her child meets all inclusion criteria
- >= 18 years of age
- Can speak English
Критерии исключения
- Patients who are < 100 days post-transplant at initial consultation will not be eligible for the study, but may become eligible if they are > 100 days post-transplant at their next consultation that falls within the enrollment window
- Patients whose BMI does not fall under the obese category will be excluded
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
- Поддерживающая терапия
Центры проведения
США · 1 центр
- UCLA / Jonsson Comprehensive Cancer Center — Los Angeles
Идентификаторы
NCT: NCT04453072 · 19-001992 · NCI-2020-02687