CO-OP Trial: Community-based Outreach on Obesity in Pregnancy (CO-OP)
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|ClinicalTrials.gov Identifier: NCT01841424|
Recruitment Status : Completed
First Posted : April 26, 2013
Last Update Posted : April 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obesity Pregnancy||Behavioral: Dietary counseling. Maintain a food diary.||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||December 2017|
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.
- 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?
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): NCT01841424
|United States, Missouri|
|Truman Medical Center|
|Kansas City, Missouri, United States, 64108|
|Saint Luke's Hospital|
|Kansas City, Missouri, United States, 64114|
|Principal Investigator:||Teresa A Orth, MD, PhD||UMKC|