Mothers in Motion Program to Prevent Weight Gain in WIC Mothers (MIM) (MIM)
2018年4月27日 更新者：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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
569
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Michigan
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East Lansing、Michigan、美国、48824
- Michigan State University
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Ohio
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Columbus、Ohio、美国、43210
- The Ohio State University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 39年 (成人)
接受健康志愿者
不
有资格学习的性别
女性
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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.
其他名称：
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无干预：No Lifestyle Counseling
Comparison group: usual WIC care; read printed materials at home
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Measured Body Weight
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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T1 Fat Intake
大体时间：baseline
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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.
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baseline
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T1 Fruit and Vegetable Intake
大体时间：baseline
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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.
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baseline
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T1 Physical Activity
大体时间：baseline
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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
大体时间：baseline
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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
大体时间：immediately after the 16-week intervention
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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.
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immediately after the 16-week intervention
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T3 Fat Intake
大体时间：3-month after the 16-week intervention
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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.
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3-month after the 16-week intervention
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T2 Fruit and Vegetable Intake
大体时间：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.
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immediately after the 16-week intervention
|
|
T3 Fruit and Vegetable Intake
大体时间：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.
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3-month after the 16-week intervention
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T2 Physical Activity
大体时间：immediatly after the 16-week intervention
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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
|
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T3 Physical Activity
大体时间：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
|
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T2 Stress
大体时间：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
大体时间：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.
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3-month after the 16-week intervention
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Measured Body Weight
大体时间：Immediatly after the 16-week intervention (T2)
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measured body weight in person at WIC office
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Immediatly after the 16-week intervention (T2)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Mei-Wei Chang, Ph.D、Michigan State University College of Nursing
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2011年9月1日
初级完成 (实际的)
2015年9月1日
研究完成 (实际的)
2017年3月31日
研究注册日期
首次提交
2013年2月28日
首先提交符合 QC 标准的
2013年4月22日
首次发布 (估计)
2013年4月25日
研究记录更新
最后更新发布 (实际的)
2018年5月24日
上次提交的符合 QC 标准的更新
2018年4月27日
最后验证
2018年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Lifestyle Counseling的临床试验
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Medical University of South CarolinaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)完全的肥胖 | 心血管危险因素 | 糖尿病风险