NCT05605340进行中（未招募）不适用
Use of Home-delivered Meals to Reduce Excessive Gestational Weight Gain for High-risk Women
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Change in weight from first to last prenatal visit
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
盲法说明
All participants enrolled will receive the study intervention, so blinding is not possible.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Change in weight from first to last prenatal visit
时间窗: First prenatal visit (<15 weeks gestation), last prenatal visit (35+ weeks gestation)
Weight measured at each prenatal visit will be retrieved from medical records for all participants and used to model total weight change from the first to the last prenatal visit (i.e., gestational weight gain).
次要结局
- Change in Food Insecurity(baseline (12-15 weeks gestation), (35-36 weeks gestation))
- Change in Perceived Stress(baseline (12-15 weeks gestation), (35-36 weeks gestation))
- Change in Participant Satisfaction with Diet(baseline (12-15 weeks gestation), (35-36 weeks gestation))
- Proportion of Women Exceeding Institute of Medicine Gestational Weight Gain Guidelines(First prenatal visit (<15 weeks gestation), last prenatal visit (35+ weeks gestation))
研究者
Gareth R. Dutton PhD
Primary Investigator
University of Alabama at Birmingham
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Hearty Meals for Mom- Pilot Study of Meal Delivery for Cardiometabolic Health During PregnancyDiet, HealthyPregnancyNCT05512247University of Alabama at Birmingham17
已完成
不适用
Opaque Bottle StudyOpaque BottlesConventional, Clear BottlesNCT03711370California Polytechnic State University-San Luis Obispo152
招募中
2 期
Evaluating the effectiveness of at-home available food ingredients as disinfecting and storage medias for toothbrushesCTRI/2022/01/039322SGT Dental College Hospital and Research Center SGT University Budhera Gurgaon
已完成
不适用
Brighter Bites & UT Physicians Produce Rx ProgramObesity, ChildhoodNCT05556070The University of Texas Health Science Center, Houston150
终止
不适用
Study of a Home Delivered Meal Program on Obese Elderly African American Subjects With Type 2 Diabetes Mellitus (DM)DiabetesObesityNCT00743756Emory University38