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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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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
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

Other trials in United States

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:
  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
  5. 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.

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 groups in NCT03210870
Study groupRoleWhat they receive
InterventionOtherIn-person nutritional education classes
Receives: Behavioral: nutritional education classes
ControlNo interventionno in-person nutritional education classes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted7 Jul 2017
  2. Study start1 Apr 2020
  3. Primary completion1 Jun 2021 (estimated)
  4. Study completionAug 2021 (estimated)

Why it stopped: Unable to recruit

Resources

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)
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

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.

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