第一批英雄：在头 1000 天让父亲参与 (First Heroes)
2026年4月17日 更新者：Elsie Taveras, MD、Massachusetts General Hospital
First Heroes 研究计划影响体重和健康轨迹，改变疾病风险，并改善来自种族/少数民族和健康差异人群的母亲-父亲-婴儿三合会的医疗保健服务。
这项研究是一项双臂随机对照试验，从马萨诸塞州总医院 (MGH) 的产科诊所招募人员。 这项研究将招募 250 名处于妊娠中期的父母双胞胎，并在他们的后代 1 岁生日期间进行干预。 每个参与的父亲-父亲组合将被随机分配到两个组中的一个：1. 产科和儿科护理标准 + 新父母参与干预组或； 2. 产科和儿科护理标准 + 安全控制臂。
研究概览
研究类型
介入性
注册 (实际的)
657
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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Massachusetts
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Boston、Massachusetts、美国、02114
- Massachusetts General Hospital
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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 及以上 (成人、年长者)
接受健康志愿者
不
描述
纳入标准：
- 父母二人组必须符合以下条件：
- 孕妇和婴儿的父亲，年龄均≥ 18 岁
- 单胎妊娠
- 在孩子生命的第一年计划参与
- 计划在 MassGeneral Brigham（合作伙伴）医疗保健系统内的任何儿科诊所接受儿童产后和儿科护理
- 能够说英语或西班牙语
- 能够给予同意
排除标准：
- 在 18-20 周的超声检查中发现未出生的孩子有严重缺陷或合并症的双胞胎。
- 没有孩子父亲的参与而打算独自抚养孩子的母亲。
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：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：新的家长干预
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该部门将接受 MGH 产科和儿科初级保健实践中提供的产科和儿科初级保健，并由健康教练额外积极和有针对性地参与新父母的参与。
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有源比较器：安全控制
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该部门将接受 MGH 产科和儿科初级保健实践中提供的产科和儿科初级保健，以及额外的婴儿安全教育材料。
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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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Number of Infants With Rapid Infant Weight Gain
大体时间：Birth to child age 6 months
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Defined as an increase in weight-for-age z-score of >0.67 units from birth to 6-months of infant age
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Birth to child age 6 months
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Number of Infants With Rapid Infant Weight Gain
大体时间：Birth to child age 12 months
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Defined as an increase in weight-for-age z-score of >0.67 units from birth to 12-months of infant age
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Birth to child age 12 months
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Number of Overweight Infant Participants (WHO Criteria)
大体时间：Birth to child age 12 months
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Weight-for-length ≥97.7th percentile based on World Health Organization (WHO) standards
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Birth to child age 12 months
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Number of Overweight Infant Participants (CDC Criteria)
大体时间：Birth to child age 12 months
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Weight-for-length ≥95 percentile based on Center for Disease Control
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Birth to child age 12 months
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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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父亲平均体重指数
大体时间：基线至产后 12 个月
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按体重（千克）和身高（米）计算的父亲肥胖的平均变化，以 kg/m^2 报告 BMI。
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基线至产后 12 个月
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Maternal Post-partum Weight Retention
大体时间：Pre-pregnancy to 6-month postpartum
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Difference between 6-month postpartum weight and pre-pregnancy weight in kilograms.
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Pre-pregnancy to 6-month postpartum
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Maternal Post-partum Weight Retention
大体时间：Prepregnancy to 12-month postpartum
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Difference between 12-month postpartum weight and pre-pregnancy weight in kilograms.
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Prepregnancy to 12-month postpartum
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Maternal Diet
大体时间：6-month postpartum
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Average weekly intake of fruits and vegetables
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6-month postpartum
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Maternal Diet
大体时间：12-month postpartum
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Frequent intake of fruits and vegetables, measured as those endorsing "nearly daily" or more often.
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12-month postpartum
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Maternal Physical Activity
大体时间：6-month postpartum
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Days per week physically active for at least 30 minutes per day
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6-month postpartum
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Maternal Physical Activity
大体时间：12-month postpartum
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Self-report (Yes/No) of participation in any moderate-vigorous physical activity.
Percentage below represents those endorsing YES to participating in moderate vigorous physical activity.
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12-month postpartum
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Maternal Adherence to Preventive Health Services
大体时间：12 months post-partum
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Endorsing PCP visit in the past year.
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12 months post-partum
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Paternal Mean Body Mass Index
大体时间：Baseline to 6-month postpartum
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Mean change in paternal BMI from baseline to 6 months postpartum, calculated by weight in kilograms and height in meters to report BMI in kg/m^2.
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Baseline to 6-month postpartum
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Paternal Prevalence of Obesity
大体时间：Baseline to 12-month postpartum
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Prevalence of BMI≥30 kg/m2 calculated by weight in kilograms and height in meters.
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Baseline to 12-month postpartum
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Paternal Adherence to Preventive Health Services
大体时间：12-month post-partum
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Endorsement of PCP visit in the past year.
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12-month post-partum
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Paternal Diet
大体时间：6 months post-partum
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Frequent intake of fruits and vegetables, measured as those endorsing "nearly daily" or more often.
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6 months post-partum
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Paternal Diet
大体时间：12 months post-partum
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Average daily intake of fruits and vegetables
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12 months post-partum
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Paternal Physical Activity
大体时间：6 months post-partum
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Days per week physically active for at least 30 minutes per day
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6 months post-partum
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Paternal Physical Activity
大体时间：12 months post-partum
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Participation in moderate/vigorous physical activity (Responding YES)
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12 months post-partum
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Parental Perceived Stress
大体时间：6 month post-partum
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Perceived Stress Scale - 4-item validated scale; Scores range from 0 to 16, with higher scores indicating higher perceived stress.
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6 month post-partum
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Prevalence of Parental Post-partum Depression Risk
大体时间：6 month post-partum
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Patient Health Questionnaire 2 (PHQ-2), scored from 0 to 6 with higher scores indicating increased risk. For purposes of this measure, 'low depression risk' included score 0-2 and 'depression risk' included score 3-6. The percentage reported below represents those with "Increased depression risk (3-6)" |
6 month post-partum
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Prevalence of Parental Post-partum Depression
大体时间：12 month post-partum
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Patient Health Questionnaire 2 (PHQ-2); PHQ-2 positive screen, Total score: 0-6; ≥ 3 → positive depression screen
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12 month post-partum
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Prevalence of Breastfeeding Initiation
大体时间：6 months post-partum
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Self-reported response questionnaire - has infant ever been breastfed?
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6 months post-partum
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Infant Introduction of Solid Foods
大体时间：6 months post-partum
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Age (months) at introduction of solid foods.
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6 months post-partum
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Family Enrollment in Food Assistance Programs
大体时间：12 months
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Responding YES to the question: "Does your family currently receive benefits from WIC?"
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12 months
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Family Housing Insecurity During Intervention Period
大体时间：Baseline
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National Survey of American Families - 2-item validated scale, response of YES to either question was determined positive screen ((1) During the last 12 months, was there a time when you and your family were not able to pay your mortgage, rent or utility bills?
(2) During the last 12 months, did you or your children move in with other people even for a little while because you could not afford to pay your mortgage, rent or utility bills?)
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Baseline
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Family Food Insecurity During Intervention Period
大体时间：Baseline
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Hager 2-question validated scale - responded YES to either of two questions relating to household food insecurity ((1) Within the past 12 months we worried whether our food would run out before we got money to buy more (2) Within the past 12 months the food we bought just didn't last and we didn't have money to get more)
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Baseline
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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：Elsie Taveras, MD、Massachusetts General Hospital
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
- Silver SR, Whooten RC, Kwete GM, Farrar-Muir H, Cournoyer RN, Barth EA, Kotelchuck M, Taveras EM. Stakeholder engagement in developing a father-inclusive early life obesity prevention intervention: First Heroes. BMC Pregnancy Childbirth. 2022 May 27;22(1):443. doi: 10.1186/s12884-022-04759-z.
- Whooten RC, Kwete GM, Farrar-Muir H, Cournoyer RN, Barth EA, Kotelchuck M, Taveras EM. Engaging fathers in the first 1000 days to improve perinatal outcomes and prevent obesity: Rationale and design of the First Heroes randomized trial. Contemp Clin Trials. 2021 Feb;101:106253. doi: 10.1016/j.cct.2020.106253. Epub 2020 Dec 17.
- Whooten RC, Kotelchuck M, Gonzalez AVC, Johnson N, Kwete G, Luo M, Muir HF, Barth EA, Smith N, Taveras EM. Expectant fathers' health behaviors, infant care intentions, and social-emotional wellbeing in the perinatal period: A latent class analysis and comparison to mothers. Prev Med Rep. 2023 Aug 26;36:102375. doi: 10.1016/j.pmedr.2023.102375. eCollection 2023 Dec.
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)
2020年8月4日
初级完成 (实际的)
2023年11月30日
研究完成 (实际的)
2023年11月30日
研究注册日期
首次提交
2020年7月8日
首先提交符合 QC 标准的
2020年7月15日
首次发布 (实际的)
2020年7月20日
研究记录更新
最后更新发布 (实际的)
2026年5月11日
上次提交的符合 QC 标准的更新
2026年4月17日
最后验证
2026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.