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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University of Missouri, Kansas City
Sponsor:
Collaborator:
Truman Medical Center
Information provided by (Responsible Party):
Teresa Orth, University of Missouri, Kansas City
ClinicalTrials.gov Identifier:
NCT01841424
First received: April 23, 2013
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Obesity
Pregnancy
Behavioral: Dietary counseling. Maintain a food diary.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CO-OP Trial: Community-based Outreach on Obesity in Pregnancy: Using Community-based Participatory Research to Modify Dietary Interventions to Prevent Excessive Weight Gain During Pregnancy in Obese and Under-resourced Women

Resource links provided by NLM:


Further study details as provided by University of Missouri, Kansas City:

Primary Outcome Measures:
  • Dietary intervention to prevent excessive maternal weight gain during pregnancy [ Time Frame: 12-18 months ] [ Designated as safety issue: No ]

    Primary outcome

    1. Does the optimized dietary intervention for obese, urban and under-resourced women prevent excessive maternal weight gain as measured in kilograms from enrollment prior to 16 weeks to the final measurement before delivery?



Secondary Outcome Measures:
  • Difference in complication rates between study and control group [ Time Frame: 12-18 months ] [ Designated as safety issue: Yes ]
    Are the rates of complications (diabetes, hypertension, fetal macrosomia, intrauterine growth restriction, cesarean section, birth injury, shoulder dystocia) different between the study group and the control group?

  • Differences between birth weights in the study and control groups [ Time Frame: 12-18 months ] [ Designated as safety issue: Yes ]
    Are birth weights comparable between the groups? How about the proportion of large for gestational age infants and small for gestational age infants?

  • Differences in leptin levels between study and control groups [ Time Frame: 12-18 months ] [ Designated as safety issue: No ]
    Are leptin levels improved in the study group and how do the leptin levels compare between groups in the 3rd trimester to determine success of dietary intervention?

  • Difference in food frequency questionnaire responses between study and control groups [ Time Frame: 18-24 months ] [ Designated as safety issue: No ]
    Do food frequency questionnaires correlate with total maternal weight gain or postpartum weight in mothers or infants? Is this different between the dietary intervention and control groups?

  • Is infant birth weight correlated with total gestational weight gain? [ Time Frame: 12-18 months ] [ Designated as safety issue: Yes ]
    Is infant birth weight correlated with total gestational weight gain?

  • Difference in infant body weight between study and control groups [ Time Frame: 24-30 months ] [ Designated as safety issue: No ]
    Does prevention of excessive maternal weight gain prevent infant obesity at 6 or 12 months?

  • Do study subjects use the food diary and bring to visits/subject compliance [ Time Frame: 12-18months ] [ Designated as safety issue: No ]
    What is food diary compliance in intervention group? (times brought to visits)

  • Barriers to healthful eating in study and control groups [ Time Frame: 24-30 months ] [ Designated as safety issue: No ]
    What are perceived barriers observed by participants to healthful eating?

  • Differences in quality of life between study and control groups [ Time Frame: 24-30 months ] [ Designated as safety issue: No ]
    Does dietary intervention alter quality of life in 3rd trimester or 12 months postpartum?

  • Differences in onset of lactation postpartum between study and control groups [ Time Frame: 12-18 months ] [ Designated as safety issue: No ]
    Does targeted dietary intervention improve onset of lactogenesis postpartum?

  • Differences in breastfeeding practices between study and control groups [ Time Frame: 24-30 months ] [ Designated as safety issue: No ]
    Is breastfeeding initiation or duration different between groups?


Estimated Enrollment: 100
Study Start Date: June 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Subjects receive usual care for pregnancy and postpartum.
Experimental: Dietary Counseling and Food Diary
Dietary counseling before 16 weeks of pregnancy Maintain food diary during pregnancy
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.
Other Names:
  • diet
  • advice
  • instruction
  • dietition
  • nutrition
  • nutritional
  • food log

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Less than 16 weeks pregnant
  • Obese (defined as BMI >30)
  • Willing to participate in the study

Exclusion Criteria:

  • Multiples (twins, triplets, etc.)
  • Abnormal 1 hour glucola prior to 16 weeks of pregnancy
  • Pregestational diabetes
  • Stillbirth or miscarriage prior to 20 weeks of pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01841424

Contacts
Contact: Teresa A Orth, MD, PhD 816-404-5155 teresa.orth@tmcmed.org
Contact: David Mundy, MD 816-404-5150 mundyd@umkc.edu

Locations
United States, Missouri
Truman Medical Center Recruiting
Kansas City, Missouri, United States, 64108
Contact: Teresa A Orth, MD, PhD    816-404-5155    teresa.orth@tmcmed.org   
Contact: David Mundy, MD    816-404-5150    mundyd@umkc.edu   
Principal Investigator: Teresa Orth, MD, PhD         
Principal Investigator: David Mundy, MD         
Saint Luke's Hospital Recruiting
Kansas City, Missouri, United States, 64114
Contact: Teresa Orth, MD/PhD    816-932-0440    teresa.orth@tmcmed.org   
Contact: John Yeast, MD    816-932-5705    jyeast@saint-lukes.org   
Principal Investigator: John Yeast, MD         
Principal Investigator: Teresa Orth, MD/PhD         
Sponsors and Collaborators
University of Missouri, Kansas City
Truman Medical Center
Investigators
Principal Investigator: Teresa A Orth, MD, PhD UMKC
  More Information

Additional Information:
No publications provided

Responsible Party: Teresa Orth, MD, PhD: Maternal Fetal Medicine Fellow, University of Missouri, Kansas City
ClinicalTrials.gov Identifier: NCT01841424     History of Changes
Other Study ID Numbers: 13-571
Study First Received: April 23, 2013
Last Updated: November 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Missouri, Kansas City:
dietary counseling
food diary
obesity
pregnancy
weight gain

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014