Pregnancy RelatedCAMPSNCT03210870
Clatsop Astoria Maternal Partnership Study (CAMPS) - Healthy Eating in Pregnancy Intervention
A study testing nutritional education classes in people with Pregnancy Related, run by Oregon Health and Science University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- nutritional education classes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2020to Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years and older
- Early pregnancy (6-14 weeks)
- Fluent in English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97201
About this study
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.
Read the detailed 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:
- Whole foods
- Plant-based (fruits, vegetables, plant-based oils/fats) and whole grains
- Fish and lean meats
- Non-fat dairy
- Avoiding / minimizing intake of unhealthy foods, such as processed foods/meals and sugar-added beverages
- Improving eating competency by:
- Developing and maintaining positive attitudes about eating and food
- Acceptance skills that support eating an ever-increasing variety of the available food
- Following internal regulation signals that allow intuitively consuming enough food to give energy and stamina and to support stable body weight
- Enhancing skills and resources for orchestrating family meals
- 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.
- Conditions
- Pregnancy Related
- Being tested
- nutritional education classes
- Keywords
- Maternal health, maternal nutrition, fetal health related to maternal nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritional education classesBehavioural
The objective to be accomplished through the completion of a nutritional education program for pregnant women that incorporates the biopsychosocial principles of the Satter Eating Competence Model. Emphasizing healthy food choices and improve eating competency.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | In-person nutritional education classes Receives: Behavioral: nutritional education classes |
| Control | No intervention | no in-person nutritional education classes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Heathy Eating Index Score (HEI)
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.
Measured: The duration of study participation will last from early pregnancy through 6 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start1 Apr 2020
- Primary completion1 Jun 2021 (estimated)
- Study completionAug 2021 (estimated)
Why it stopped: Unable to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Purnell, Oregon Health and Science University
- Investigators
- Jonathan Q Purnell, MD, Principal investigator, OHSU Knight Cardiovascular Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210870
- Sponsor's protocol ID
- IRB00011099
- Acronym
- CAMPS
- Status last verified
- Aug 2021
- First submitted
- 25 May 2017
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clatsop Astoria Maternal Partnership Study (CAMPS) - Healthy Eating in Pregnancy Intervention
- ClinicalTrials.gov ID
- NCT03210870
- Acronym / sponsor ID
- CAMPS / IRB00011099
- Conditions
- Pregnancy Related
- Keywords
- Maternal health, maternal nutrition, fetal health related to maternal nutrition
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 7 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- Whole foods
- Plant-based (fruits, vegetables, plant-based oils/fats) and whole grains
- Fish and lean meats
- Non-fat dairy
- Avoiding / minimizing intake of unhealthy foods, such as processed foods/meals and sugar-added beverages
- Improving eating competency by:
- Developing and maintaining positive attitudes about eating and food
- Acceptance skills that support eating an ever-increasing variety of the available food
- Following internal regulation signals that allow intuitively consuming enough food to give energy and stamina and to support stable body weight
- Enhancing skills and resources for orchestrating family meals
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Behavioral: nutritional education classesIn-person nutritional education classes |
| Control | No intervention | –no in-person nutritional education classes |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years and older
- Early pregnancy (6-14 weeks)
- Fluent in English
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutritional education classesThe objective to be accomplished through the completion of a nutritional education program for pregnant women that incorporates the biopsychosocial principles of the Satter Eating Competence Model. Emphasizing healthy food choices and improve eating competency. | Behavioural | Intervention |
Primary outcome
Change in Heathy Eating Index Score (HEI)
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Q Purnell, MD principal investigator
OHSU Knight Cardiovascular Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutritional education classes in people with Pregnancy Related, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Heathy Eating Index Score (HEI) (time frame: The duration of study participation will last from early pregnancy through 6 months after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.