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临床试验/NCT03210870
NCT03210870撤回不适用

Clatsop Astoria Maternal Partnership Study (CAMPS) - Healthy Eating in Pregnancy Intervention

Oregon Health and Science University2 个研究点 分布在 1 个国家开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Change in Heathy Eating Index Score (HEI)

研究概览

简要总结

Purpose of this study is to learn more about how nutritional advice given during pregnancy affects a mother's food choices and her baby's growth.

详细描述

The overall goal of this proposal is to effect change in women's nutritional behaviors that will improve not only their own health and that of their unborn child. Because solutions and needs for prevention of chronic diseases are unique and especially challenging for rural areas, we have chosen to stage our studies in the northern coast of Oregon, centered on the town of Astoria.

Our objective is to assess the effect on markers of maternal health and fetal growth of providing education that includes the rationale and practical aspects of healthy cooking during pregnancy to improve her baby's lifetime risk for cardiovascular disease and other chronic diseases. We will accomplish this objective through the completion of a nutritional education program for pregnant women that incorporates the biopsychosocial principles of the Satter Eating Competence Model in the curriculum, including:

  • Emphasizing healthy food choices:
  1. Whole foods
  2. Plant-based (fruits, vegetables, plant-based oils/fats) and whole grains
  3. Fish and lean meats
  4. Non-fat dairy
  • Avoiding / minimizing intake of unhealthy foods, such as processed foods/meals and sugar-added beverages
  • Improving eating competency by:
  1. Developing and maintaining positive attitudes about eating and food
  2. Acceptance skills that support eating an ever-increasing variety of the available food
  3. Following internal regulation signals that allow intuitively consuming enough food to give energy and stamina and to support stable body weight
  4. Enhancing skills and resources for orchestrating family meals

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 18 years and older
  • Early pregnancy (6-14 weeks)
  • Fluent in English

排除标准

  • Failure to provide informed consent
  • Active smokers or recreational drug users (including excessive alcohol defined as > 2 drinks per day)
  • Circumstances that would prevent participation in group classes and study-related activities
  • Diagnosis of type 1 or gestational diabetes at the time of entry
  • Moving away from the local area in less than 1 year
  • Planned delivery at a hospital other than Columbia Memorial Hospital in Astoria, Oregon

结局指标

主要结局

Change in Heathy Eating Index Score (HEI)

时间窗: The duration of study participation will last from early pregnancy through 6 months after delivery

The primary outcome will be the change in healthy eating index (HEI) score obtained from the food frequency questionnaire as a result of assignment to the nutrition intervention or usual care. This outcome will be assessed at three time points: at baseline (\~ 8 to 10 weeks gestation), after completion of the intervention (\~ 20 to 24 weeks), and 6-months postpartum.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jonathan Purnell

Professor and Associate Director

Oregon Health and Science University

研究点 (2)

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