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

NCT03210870 | Withdrawn

• 1 other identifier: IRB00011099
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related

Keywords

Maternal health; maternal nutrition; fetal health related to maternal nutrition

Outcome Measures

Primary Outcomes (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.

  The duration of study participation will last from early pregnancy through 6 months after delivery

Study Arms (2)

Intervention

OTHER

In-person nutritional education classes

Behavioral: nutritional education classes

Control

NO INTERVENTION

no in-person nutritional education classes

Interventions

nutritional education classes BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97201, United States

Location

Study Officials

• Jonathan Q Purnell, MD

  OHSU Knight Cardiovascular Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Associate Director

Study Record Dates

• First Submitted: May 25, 2017
• First Posted: July 7, 2017
• Study Start: April 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: August 1, 2021
• Last Updated: August 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)