- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT01660685
Effects of Journaling on Weight Loss
Обзор исследования
Статус
Условия
Подробное описание
Participants will call study line given on recruitment materials and be screened over the phone.
Baseline visit:
Individuals who meet the screening criteria will be invited to a one-hour training session about the website and diet plan book. During the training, a coordinator will review the consent form with the participants and ask if they have any questions. The coordinator will take consented individuals' height, weight and blood pressure measurements. Participants will be given a pedometer to use during physical activities and a meal replacement book to use as a resource.
After baseline visit:
All participants will complete surveys online (Demographics, Three-Factor Eating Questionnaire, Motivation, Weight Loss Habits, Medication log, International Physical Activity Questionnaire) and be randomized into one of two groups. The intervention group will be asked to record their weight, physical activity steps, pre-portioned food items and journal entries on a daily basis. The control group will be sent an email informing them they will have access to the tracking, journals and website in three months.
Intervention Group:
Participants will receive daily emails with links to record their weight, physical activity steps and pre-portioned food items; participants will also complete a journaling response to two writing prompts. The emails will contain links to the website to be used as a resource. Every week, participants will enter whether they have an appointment with primary care provider in the next week. Participants will also receive weekly blogs from the principal investigator; participants can opt out of receiving the blog emails at any time. Coordinators will review the database weekly. If a participant has lost ten pounds, they will be emailed to call their doctor since weight loss can affect blood pressure and medication needs. If a participant has an upcoming primary care provider appointment, they will be emailed to print out their tracking graphs (weight, steps taken, meal replacements). Coordinators will also monitor journal responses; coordinators will contact participants who wrote useful entries to ask if the participant's responses can be shared with other participants. Shared posts will be anonymous; only the age of the individual will be given.
Month one and two visits:
Participants from both groups will be asked to come to Hershey Medical Center to have their height, weight and blood pressure measured.
Month three visit:
Participants from both groups will be asked to come to Hershey Medical Center to have their height, weight and blood pressure measured. Prior to their visit, participants will be asked to complete a series of surveys online (Three-Factor Eating Questionnaire, Motivation, Weight Loss Habits, Medication log, International Physical Activity Questionnaire, Satisfaction). Participants in the control group will be given a booklet containing the writing prompts, tracking and website address to complete on their own if they so choose.
Participants will be asked if they would like to come back for an optional video interview. The interview will consist of six questions about their experience with the study.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Pennsylvania
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Hershey, Pennsylvania, Соединенные Штаты, 17033
- Penn State Milton S. Hershey Medical Center
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- 21 to 65 years old
- Body mass index between 27 and 45
- E-mail and Internet access
- Able to read, write, and understand English
Exclusion Criteria:
- Weight loss of more than 5% of current body weight in previous 6 months
- Participated in weight loss research in previous 6 months
- Current use of weight loss medication or program
- History of or scheduled weight loss surgery
- Heart, liver, or kidney failure
- Been told by doctor of heart trouble
- Frequent pains in heart and chest
- Often feel faint or have spells of severe dizziness
- Bone or joint problem that has been or might be aggravated by exercise
- Physical reason for not following activity program
- History of sever cognitive impairment or major psychiatric illness
- Pregnant in previous 6 months, currently or planning to become pregnant in next 3 months
- Moving in next 6 months
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: Tracking + Journaling + Website
In addition to standard care, participants will complete daily tracking and journaling and receive weekly feedback based on their individual entries.
|
Participants will record their daily weight, physical activity steps and meal replacements online
Participants will journal to two online writing prompts: one on positive focus and one on goal setting
Participants will have access to resource website with stories and tips from people who successfully lost weight, blogs from investigators, quotes from other participants.
Participants will receive standard care of monthly height, weight and blood pressure measurements.
Participants will also receive a pedometer and a diet plan book on pre-portioned items.
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Активный компаратор: Enhanced Usual Care
Participants receive standard care
|
Participants will receive standard care of monthly height, weight and blood pressure measurements.
Participants will also receive a pedometer and a diet plan book on pre-portioned items.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Weight
Временное ограничение: 3 months
|
Weight will be measured by study staff using a Tanita BWB 800S Digital Scale.
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3 months
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Blood Pressure
Временное ограничение: 3 months
|
Blood pressure will be measured by study staff using an automatic blood pressure monitor.
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3 months
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Height
Временное ограничение: 3 months
|
Height will be measured using a portable stadiometer.
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3 months
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Sociodemographics and tobacco use
Временное ограничение: 3 months
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Age, gender, race, ethnicity, education, smoking status and other demographics will be measured by self-report
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3 months
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Three-factor Eating Questionnaire
Временное ограничение: 3 months
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Questionnaire asks participants about how their dietary restraint in specific circumstances
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3 months
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Motivation
Временное ограничение: 3 months
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Questionnaire asks participants to gauge their motivation to lose weight.
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3 months
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Weight Loss Habits
Временное ограничение: 3 months
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Questionnaire asks participants how often they use specific habits to lose weight
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3 months
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Blood Pressure Medication
Временное ограничение: 3 months
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Blood pressure medication names, doses and frequency measured by self-report
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3 months
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International Physical Activity Questionnaire
Временное ограничение: 3 months
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Questionnaire asks participants to estimate the frequency and duration of specific physical activities
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3 months
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Satisfaction Survey
Временное ограничение: 3 months
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Questionnaire asks participants about their satisfaction with specific aspects of the study
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3 months
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 39952EP
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