- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT01839708
Mothers in Motion Program to Prevent Weight Gain in WIC Mothers (MIM) (MIM)
27 апреля 2018 г. обновлено: Mei-Wei Chang, Ohio State University
Mothers in Motion Program to Prevent Weight Gain in Overweight/Obese WIC Mothers (MIM)
Mothers in Motion will draw on the successes of the pilot intervention of the same name and will promote healthy lifestyle behavior changes (eating more fruits and vegetables, increasing physical activity, dealing with stress) in low-income WIC mothers of young children.
The intervention group's weight change (difference between the initial enrollment and 3 months post intervention) will differ from the control group's weight change by an average of at least 2.8 pounds.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Подробное описание
Mothers in Motion will draw on the successes of the pilot intervention of the same name and will promote healthy lifestyle behavior changes (eating more fruits and vegetables, increasing physical activity, dealing with stress) in low-income WIC mothers of young children.
Both treatment groups will receive usual WIC care (nutrition counseling and similar services).
The control group will receive generic printed health and nutrition materials to read at their own pace if they wish.
The intervention group will watch the culturally sensitive DVD chapters according to a study calendar, complete action plan worksheets, and call in to peer support group teleconferences to discuss the DVD chapter contents.
The teleconferences will be led by moderators trained in motivational interviewing (MI) and group facilitation.
Participants will complete phone interviews and provide body weight measurements at baseline (T1), immediately after (T2) and 3 months after (T3) the intervention time period.
T3 body weight will be the primary outcome.
Тип исследования
Интервенционный
Регистрация (Действительный)
569
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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-
Michigan
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East Lansing, Michigan, Соединенные Штаты, 48824
- Michigan State University
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Ohio
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Columbus, Ohio, Соединенные Штаты, 43210
- The Ohio State University
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
От 18 лет до 39 лет (Взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Женский
Описание
Inclusion Criteria:
- African American or White
- Fluent in English
- 18-39 years old
- At least 6 weeks postpartum
- Body Mass Index (BMI) between 25.0 and 39.9
- Willing to provide address and up to 3 working phone numbers
- Willing to update their contact information monthly
- Willing to participate in the project for 9 months
- Willing to make 3 additional trips to WIC clinics for weight measures
- Working DVD player at home and access to a working phone.
Exclusion Criteria:
- Pregnant
- MIM Pilot study participation
- Plan to become pregnant or relocate to a location outside of study area during the trial
- Self-reported type 1 or 2 Diabetes
- Unable to walk more than 1 block without resting or shortness of breath.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Факторное присвоение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: Lifestyle Counseling
Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.
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The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.
Другие имена:
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Без вмешательства: No Lifestyle Counseling
Comparison group: usual WIC care; read printed materials at home
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Measured Body Weight
Временное ограничение: 3 months after the 16-week intervention (T3)
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measured body weight in person at WIC office
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3 months after the 16-week intervention (T3)
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
T1 Fat Intake
Временное ограничение: baseline
|
self-reported fat intake behavior using Rapid Food Screener (17 items total).
Responses to each fat intake item were rated on a 5-point scale ranging from 0 (1 time or less per month) to 4 (5 or more times per week).
Summed responses ranged from 0 to 68.
|
baseline
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T1 Fruit and Vegetable Intake
Временное ограничение: baseline
|
self-reported fruit and vegetable intake (7 items total).
Responses to each fruit and vegetable intake item were rated on a 6-point scale and were rated as 0 = less than 1 time per week, 1 = once a week, 2 = 2-3 times a week, 3 = 4-6 times a week, 4 = once a day, and 5 = 2 or more times a day.
Summed responses ranged from 0 to 35.
|
baseline
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T1 Physical Activity
Временное ограничение: baseline
|
Self-reported using the Pregnancy Infection and Nutrition 3 survey (24 items/activities).
Participants reported frequency and duration (in hours) of physical activity that was done in seven categories and in the past 7 days.
These categories were recreation (4 activities), indoor (5 activities) and outdoor (4 activities) household tasks, child and adult care (5 activities), transportation (2 activities) and activity at work and school (4 items).
We first calculated hours spent on (frequency x duration) each activity, then sum all activities from 7 categories to create the total hours of moderate physical activity in the past 7 days (range 0 to 72 hours/past 7 days).
The more hours, the more physical activity.
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baseline
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T1 Stress
Временное ограничение: baseline
|
Self-report using the Perceived Stress Scale (9 items) to measure stress perception.
Participants were asked about their perception of stress in the past month.
Response options were scored on a 4-point scale ranging from 1 (rarely or never) to 4 (usually or always).
The overall stress score was the mean of the 9-item scores, with a higher score indicating lower stress.
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baseline
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T2 Fat Intake
Временное ограничение: immediately after the 16-week intervention
|
self-reported fat intake behavior using Rapid Food Screener (17 items total).
Responses to each fat intake item were rated on a 5-point scale ranging from 0 (1 time or less per month) to 4 (5 or more times per week).
Summed responses ranged from 0 to 68.
|
immediately after the 16-week intervention
|
T3 Fat Intake
Временное ограничение: 3-month after the 16-week intervention
|
self-reported fat intake behavior using Rapid Food Screener (17 items total).
Responses to each fat intake item were rated on a 5-point scale ranging from 0 (1 time or less per month) to 4 (5 or more times per week).
Summed responses ranged from 0 to 68.
|
3-month after the 16-week intervention
|
T2 Fruit and Vegetable Intake
Временное ограничение: immediately after the 16-week intervention
|
self-reported fruit and vegetable intake (7 items total).
Responses to each fruit and vegetable intake item were rated on a 6-point scale and were rated as 0 = less than 1 time per week, 1 = once a week, 2 = 2-3 times a week, 3 = 4-6 times a week, 4 = once a day, and 5 = 2 or more times a day.
Summed responses ranged from 0 to 35.
|
immediately after the 16-week intervention
|
T3 Fruit and Vegetable Intake
Временное ограничение: 3-month after the 16-week intervention
|
self-reported fruit and vegetable intake (7 items total).
Responses to each fruit and vegetable intake item were rated on a 6-point scale and were rated as 0 = less than 1 time per week, 1 = once a week, 2 = 2-3 times a week, 3 = 4-6 times a week, 4 = once a day, and 5 = 2 or more times a day.
Summed responses ranged from 0 to 35.
|
3-month after the 16-week intervention
|
T2 Physical Activity
Временное ограничение: immediatly after the 16-week intervention
|
Self-reported using the Pregnancy Infection and Nutrition 3 survey (24 items/activities).
Participants reported frequency and duration (in hours) of physical activity that was done in seven categories and in the past 7 days.
These categories were recreation (4 activities), indoor (5 activities) and outdoor (4 activities) household tasks, child and adult care (5 activities), transportation (2 activities) and activity at work and school (4 items).
We first calculated hours spent on (frequency x duration) each activity, then sum all activities from 7 categories to create the total hours of moderate physical activity in the past 7 days (range 0 to 72 hours/past 7 days).
The more hours, the more physical activity.
|
immediatly after the 16-week intervention
|
T3 Physical Activity
Временное ограничение: 3-month after the 16-week intervention
|
Self-reported using the Pregnancy Infection and Nutrition 3 survey (24 items/activities).
Participants reported frequency and duration (in hours) of physical activity that was done in seven categories and in the past 7 days.
These categories were recreation (4 activities), indoor (5 activities) and outdoor (4 activities) household tasks, child and adult care (5 activities), transportation (2 activities) and activity at work and school (4 items).
We first calculated hours spent on (frequency x duration) each activity, then sum all activities from 7 categories to create the total hours of moderate physical activity in the past 7 days (range 0 to 72 hours/past 7 days).
The more hours, the more physical activity.
|
3-month after the 16-week intervention
|
T2 Stress
Временное ограничение: immediatly after the 16-week intervention
|
Self-report using the Perceived Stress Scale (9 items) to measure stress perception.
Participants were asked about their perception of stress in the past month.
Response options were scored on a 4-point scale ranging from 1 (rarely or never) to 4 (usually or always).
The overall stress score was the mean of the 9-item scores, with a higher score indicating lower stress.
|
immediatly after the 16-week intervention
|
T3 Stress
Временное ограничение: 3-month after the 16-week intervention
|
Self-report using the Perceived Stress Scale (9 items) to measure stress perception.
Participants were asked about their perception of stress in the past month.
Response options were scored on a 4-point scale ranging from 1 (rarely or never) to 4 (usually or always).
The overall stress score was the mean of the 9-item scores, with a higher score indicating lower stress.
|
3-month after the 16-week intervention
|
Measured Body Weight
Временное ограничение: Immediatly after the 16-week intervention (T2)
|
measured body weight in person at WIC office
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Immediatly after the 16-week intervention (T2)
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Mei-Wei Chang, Ph.D, Michigan State University College of Nursing
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- Chang MW, Brown R, Nitzke S. Results and lessons learned from a prevention of weight gain program for low-income overweight and obese young mothers: Mothers In Motion. BMC Public Health. 2017 Feb 10;17(1):182. doi: 10.1186/s12889-017-4109-y.
- Chang MW, Brown R, Wegener DT. Perceived stress linking psychosocial factors and depressive symptoms in low-income mothers. BMC Public Health. 2021 Jan 6;21(1):62. doi: 10.1186/s12889-020-10118-4.
- Chang MW, Robbins LB, Ling J, Brown R, Wegener DT. Mediators affecting the association between a lifestyle behavior intervention and stress in low-income overweight or obese mothers of young children. J Health Psychol. 2021 Sep;26(10):1625-1636. doi: 10.1177/1359105319887780. Epub 2019 Nov 21.
- Chang MW, Brown R, Wegener DT, Brill S, Schaffir J, Hu J. Chaos and psychosocial health in low-income overweight or obese women. Health Psychol. 2019 Dec;38(12):1159-1167. doi: 10.1037/hea0000813. Epub 2019 Oct 3.
- Chang MW, Tan A, Schaffir J, Wegener DT. Sleep and weight loss in low-income overweight or obese postpartum women. BMC Obes. 2019 Apr 1;6:12. doi: 10.1186/s40608-019-0236-6. eCollection 2019.
- Chang MW, Nitzke S, Brown R. Mothers In Motion intervention effect on psychosocial health in young, low-income women with overweight or obesity. BMC Public Health. 2019 Jan 14;19(1):56. doi: 10.1186/s12889-019-6404-2.
- Chang MW, Brown R, Nitzke S. A Community-Based Intervention Program's Effects on Dietary Intake Behaviors. Obesity (Silver Spring). 2017 Dec;25(12):2055-2061. doi: 10.1002/oby.21862. Epub 2017 Oct 31.
- Chang MW, Hales D, Brown R, Ward D, Resnicow K, Nitzke S. Validation of PIN 3 physical activity survey in low-income overweight and obese young mothers. BMC Public Health. 2015 Feb 10;15:121. doi: 10.1186/s12889-015-1493-z.
- Chang MW, Nitzke S, Brown R, Resnicow K. A community based prevention of weight gain intervention (Mothers In Motion) among young low-income overweight and obese mothers: design and rationale. BMC Public Health. 2014 Mar 25;14:280. doi: 10.1186/1471-2458-14-280.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
1 сентября 2011 г.
Первичное завершение (Действительный)
1 сентября 2015 г.
Завершение исследования (Действительный)
31 марта 2017 г.
Даты регистрации исследования
Первый отправленный
28 февраля 2013 г.
Впервые представлено, что соответствует критериям контроля качества
22 апреля 2013 г.
Первый опубликованный (Оценивать)
25 апреля 2013 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
24 мая 2018 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
27 апреля 2018 г.
Последняя проверка
1 апреля 2018 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 1R18DK083934-01A2 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
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