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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03210870
Recruitment Status : Not yet recruiting
First Posted : July 7, 2017
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Jonathan Purnell, Oregon Health and Science University

Brief 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.

Condition or disease Intervention/treatment Phase
Pregnancy Related Behavioral: nutritional education classes Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Clatsop Astoria Maternal Partnership Study (CAMPS) - Healthy Eating in Pregnancy Intervention
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Arm Intervention/treatment
Intervention
In-person nutritional education classes
Behavioral: nutritional education classes
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.

No Intervention: Control
no in-person nutritional education classes



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210870


Locations
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United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97201
Contact: Lisa Rhuman    503-494-2382    rhumanl@ohsu.edu   
Principal Investigator: Jonathan Q Purnell, MD         
Sponsors and Collaborators
Oregon Health and Science University
Investigators
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Principal Investigator: Jonathan Q Purnell, MD OHSU Knight Cardiovascular Institute
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Responsible Party: Jonathan Purnell, Professor and Associate Director, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03210870    
Other Study ID Numbers: IRB00011099
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jonathan Purnell, Oregon Health and Science University:
Maternal health
maternal nutrition
fetal health related to maternal nutrition