为准妈妈提供更健康的家庭餐 (Her HOME)
使用家庭送餐来减少高危女性妊娠期体重过度增加
This study is being done to test the feasibility, acceptability, and preliminary efficacy of a meal delivery intervention for managing gestational weight gain among pregnant women with overweight or obesity.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Alabama
-
Birmingham、Alabama、美国、35294
- University of Alabama at Birmingham
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age ≥ 18 years
- Gestational age ≤ 15 weeks as assessed by ultrasound
- Body mass index (BMI) ≥ 25 kg/m2
- Singleton viable pregnancy
- Receiving care and planning to deliver at UAB
- Residing within the delivery radius of the meal delivery company
- Wi-Fi or Bluetooth Internet connection in home (for digital Wi-Fi enabled study scale)
Exclusion Criteria:
- Self-reported major health conditions (e.g., heart disease, cancer, renal disease, and Type 1 or Type 2 diabetes)
- Current substance abuse
- Current treatment for serious psychiatric disorder (schizophrenia, bipolar disorder)
- Known fetal anomaly
- Planned termination of pregnancy
- Past history or current diagnosis of anorexia or bulimia
- Current use of one or more of the following medications:
- Metformin
- Systemic steroids
- Antipsychotic agents
- Anti-seizure medications or mood stabilizers that would be expected to have a significant impact on body weight
- Medications for ADHD including amphetamines and methylphenidate
- Any teratogenic agent Class D
- Participation in another dietary and/or weight management intervention during pregnancy
- Unwilling or unable to consume prepared meals delivered weekly
- Unable to understand and communicate in verbal and written English
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Intervention
Meal delivery intervention with brief behavioral support. |
10 healthy, home-delivered meals per week + brief weekly remote behavioral support |
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 |
|---|---|---|
|
Change in Weight From First to Last Prenatal Visit
大体时间：First prenatal visit (<=15 weeks gestation), last prenatal visit (35+ weeks gestation)
|
Weight measured at the first and last prenatal visits will be retrieved from medical records for all participants and used to calculate total weight change from the first to the last prenatal visit (i.e., gestational weight gain). |
First prenatal visit (<=15 weeks gestation), last prenatal visit (35+ weeks gestation)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Food Insecurity
大体时间：baseline (12-15 weeks gestation), (35-36 weeks gestation)
|
Determined using the 18-item United States (US) Household Food Security Survey Module based on the previous 30 days. Adult food security scores range from 0 to 10, with lower values indicating greater food security. Change in Food Security was calculated as food security score at follow up minus score at baseline, with negative values indicating an increase in food security from baseline to follow up. |
baseline (12-15 weeks gestation), (35-36 weeks gestation)
|
|
Change in Perceived Stress
大体时间：baseline (12-15 weeks gestation), (35-36 weeks gestation)
|
Determined using the 10-item Perceived Stress Scale (PSS-10) based on the last month. PSS-10 scores range from 0 to 40, with higher scores representing higher levels of perceived stress. Change in Perceived Stress score was calculated as score at follow up minus score at baseline, with positive values indicating an increase in perceived stress score from baseline to follow up. |
baseline (12-15 weeks gestation), (35-36 weeks gestation)
|
|
Change in Participant Satisfaction With Diet
大体时间：baseline (12-15 weeks gestation), (35-36 weeks gestation)
|
To assess satisfaction with the study intervention, the 28-item Diet Satisfaction Questionnaire (DSAT-28) will be used in which participants respond to 28 statements using a 5-point Likert scale. Responses to all 28-items are averaged to produce a total diet satisfaction score (designed to reflect satisfaction as it relates to following a weight-management diet) ranging from 1-5. Subscale scores for Cost Factor (reflects financial cost of the diet) and Planning & Preparation Factor (reflects amount of time and effort spent in planning and preparing) will also be calculated and range from 1-5. For the overall diet satisfaction score and subscale scores, higher scores represent greater satisfaction. Changes in overall diet satisfaction, as well as changes in subscale scores for Cost Factor and Planning & Preparation Factor are calculated as score at follow up minus score at baseline, with positive values indicating an increase in satisfaction) from baseline to follow up. |
baseline (12-15 weeks gestation), (35-36 weeks gestation)
|
|
Proportion of Women Exceeding Institute of Medicine Gestational Weight Gain Guidelines
大体时间：First prenatal visit (<=15 weeks gestation), last prenatal visit (35+ weeks gestation)
|
Weight at the first prenatal visit will be subtracted from weight at the last prenatal visit. Women will be categorized as exceeding 2009 Institute of Medicine gestational weight gain guidelines if the difference is > 11.5 kg gain for women with overweight or >9 kg for women with obesity at the first prenatal visit. |
First prenatal visit (<=15 weeks gestation), last prenatal visit (35+ weeks gestation)
|
合作者和调查者
调查人员
- 首席研究员：Gareth Dutton, PhD、University of Alabama at Birmingham
- 首席研究员：Camille Worthington, PhD、University of Alabama at Birmingham
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- IRB-300009275
- R21HD107325 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
De-identified individual participant data (IPD) that underlie the results reported in a publication will be made available upon request beginning 9 months and ending 36 months following article publication. The research team will keep a record of all individuals and/or research teams who request and receive a copy of the project data. Interested investigators will be asked to submit a document indicating the specific aims of the analyses, the analytic plan, available resources for completing the proposed project, proposed timeline, and goals (i.e., manuscripts, presentations, and/or grant applications). The PI and research team will review these requests to determine whether the proposed analyses constitute an innovative and significant exploration of the data, whether the proposed team has sufficient resources to complete the request, and whether data will be adequately protected and managed.
IPD 共享时间框架
Data requests can be submitted starting 9 months after publication of results and ending 36 months following article publication.
IPD 共享访问标准
Access to IPD stripped of all HIPAA identifiers (except age) for this study can be requested by qualified researchers engaging in independent scientific research whose proposed research has received Institutional Review Board approval, and will be provided following review and approval of a research proposal and timeline, statistical analysis plan, and goals (e.g., manuscripts, presentations, grant applications). The Principal Investigator (PI) and research team will review these requests to determine whether the proposed analyses constitute an innovative and significant exploration of the data, whether the proposed team has sufficient resources to complete the request, and whether data will be adequately protected and managed. Based on institutional policies, execution of a Data Sharing Agreement may be required prior to sharing of IPD. IPD requests can be made to the MPIs at gdutton@uabmc.edu or cschneid@uab.edu.
IPD 共享支持信息类型
- 研究方案
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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