CO-OP Trial: Community-based Outreach on Obesity in Pregnancy (CO-OP)
|Study Design:||Allocation: Randomized
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|
- Dietary intervention to prevent excessive maternal weight gain during pregnancy [ Time Frame: 12-18 months ]
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?
- Difference in complication rates between study and control group [ Time Frame: 12-18 months ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]Does targeted dietary intervention improve onset of lactogenesis postpartum?
- Differences in breastfeeding practices between study and control groups [ Time Frame: 24-30 months ]Is breastfeeding initiation or duration different between groups?
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||December 2019|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
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.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01841424
|Contact: Teresa A Orth, MD, PhDfirstname.lastname@example.org|
|Contact: David Mundy, MDemail@example.com|
|United States, Missouri|
|Truman Medical Center||Recruiting|
|Kansas City, Missouri, United States, 64108|
|Contact: Teresa A Orth, MD, PhD 816-404-5155 firstname.lastname@example.org|
|Contact: David Mundy, MD 816-404-5150 email@example.com|
|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 firstname.lastname@example.org|
|Contact: John Yeast, MD 816-932-5705 email@example.com|
|Principal Investigator: John Yeast, MD|
|Principal Investigator: Teresa Orth, MD/PhD|
|Principal Investigator:||Teresa A Orth, MD, PhD||UMKC|