Viewing Study NCT03210870



Ignite Creation Date: 2024-05-06 @ 10:16 AM
Last Modification Date: 2024-10-26 @ 12:27 PM
Study NCT ID: NCT03210870
Status: WITHDRAWN
Last Update Posted: 2021-08-09
First Post: 2017-05-25

Brief Title: Clatsop Astoria Maternal Partnership Study CAMPS - Healthy Eating in Pregnancy Intervention
Sponsor: Oregon Health and Science University
Organization: Oregon Health and Science University

Study Overview

Official Title: Clatsop Astoria Maternal Partnership Study CAMPS - Healthy Eating in Pregnancy Intervention
Status: WITHDRAWN
Status Verified Date: 2021-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Unable to recruit
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: CAMPS
Brief Summary: Purpose of this study is to learn more about how nutritional advice given during pregnancy affects a mothers food choices and her babys growth
Detailed Description: The overall goal of this proposal is to effect change in womens 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 babys 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 oilsfats and whole grains
3 Fish and lean meats
4 Non-fat dairy
Avoiding minimizing intake of unhealthy foods such as processed foodsmeals 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

3 Background

Developmental Origins of Health and Disease There is increasing evidence that the health of adult populations is influenced by the nutritional provision imparted to its members during their conception and through the first three years of their post-conception life reflecting the origination of the structures in an individuals body from developmental processes The links between early nutrition and later health initially came to light through the work of Dr David Barker who showed that in poorer regions of the UK those who survived infancy predominantly died of athersclerotic disease as adults and demonstrated an inverse relationship between birthweight and ischemic heart disease Similar relationships between low birth weights with increased risk of heart disease have now been replicated in the United States Scandinavian countries Finland the Netherlands and in India as well as in animal models of nutritional deprivation

Subsequent research has demonstrated that people who grew poorly before birth or as infants are at risk not only for heart disease but also for other adult chronic diseases including hypertension type 2 diabetes obesity asthma and osteoporosis Poor growth in early life has also been associated with compromised cognitive function It is now believed based on animal and human data that prenatal stressors in the form of nutrition high levels of stress hormone cortisol and hypoxia lead to structural and epigenetic changes that impart vulnerability for disease in later life The developmental response to these stressors is known as programming or the developmental origins of adult diseases

While the original work in this field focused on maternal undernutrition as a source of stress for the developing baby animal and human data suggest that exposure to a maternal diet that is calorically sufficient but of low-quality foods such as the consumption of increasingly processed foods by Western societies can result in similar in-utero programing and predisposition to obesity diabetes and cardiovascular disease in offspring Especially concerning about these findings is the implication that reversal of these effects will take generations to realize Transgenerational nutritional flow occurs because the eggs that will be fertilized to form babies in women of child-bearing age today began development in the ovaries of their mothers when their mothers were themselves in their grandmothers womb Thus the grandmother not only provided for the health of her own eggs which became the mother but also supplied the nutrients for the reproductive organs including ovaries in the mother as she developed from fetus to baby thereby influencing the programming of her future grandchildren Thus we can now link the health status of the current citizens of Oregon with generational nutritional flow over the past century Fortunately evidence shows that improving the environment of mothers-to-be by lowering stress and providing access to healthier foods can reverse many of the adverse effects that are programmed in early life though the full benefits of these efforts will take generations to realize

The serious nature of these findings is evident by virtually any indicator of current population health in America which point to a dramatic worsening over the last two decades with increasing rates of obesity and type 2 diabetes among adults and children greater numbers of people with uncontrolled hypertension increasing hospitalization rate of for heart failure and ever decreasing birthweight Recent studies predict further increases in these chronic disease rates based on current indicators Such disease rates will make health care financially unsustainable Worsening diets of mothers in recent decades has most certainly contributed to the deteriorating health status of Oregonians mandating that novel innovations in dietary interventions are needed to bring wholesome nutrition to large segments of the population

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None