Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT03210870 |
| Other study ID # |
IRB00011099 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2020 |
| Est. completion date |
August 2021 |
Study information
| Verified date |
August 2021 |
| Source |
Oregon Health and Science University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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
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 individual's 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.
