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CO-OP Trial: Community-based Outreach on Obesity in Pregnancy

NCT01841424 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2018-04-30

No results posted yet for this study

Summary

Obesity is becoming more common and disproportionately affects the younger generation, the poor and certain ethnic groups. Nearly 50% of reproductive aged women are obese or overweight. Obesity during pregnancy leads to higher rates of hypertensive disorders, stillbirth, less successful breastfeeding, obesity in their offspring, postpartum depression, and higher weight retention postpartum. Dietary counseling can prevent excessive maternal weight gain and is more effective than activity-based interventions. The two objectives of this study are 1) to use community-based techniques to improve dietary counseling for high risk women and 2) to randomize obese women to dietary counseling at Truman Medical Center and measure their success. The hypothesis is that dietary interventions can successfully be tailored for high risk women and that excessive weight gain during pregnancy can be avoided.

Conditions

Interventions

BEHAVIORAL

Dietary counseling. Maintain a food diary.

The dietary intervention will be conducted by a registered dietician once. The dietary guidelines for study participants will be similar to those for gestational diabetes including 18 to 24 kcal/kg diet with 40% carbohydrates, 30% protein, 30% fat. No participant will be given a diet that is less than 2,000 kcal per day. Study subjects will record a food diary and to bring it to prenatal visits. Study subjects will limit intake of high calorie dense and acellular processed foods to 1-2 times per week if at all and to increase total percentage of fruits and vegetables to 5-9 items per day.

Sponsors & Collaborators

  • Truman Medical Center

    collaborator OTHER

  • University of Missouri, Kansas City

    lead OTHER

Principal Investigators

  • Teresa A Orth, MD, PhD · UMKC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-06-30
Completion
2017-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01841424 on ClinicalTrials.gov