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

Phase 1 will recruit 8-12 obese women from the target population. Initially, 4-6 women will explore dietary guidance and study interventions and to determine how best to tailor the intervention. A repeat set of structured interviews will be conducted with the community-based modifications to provide an assessment of the perceived efficacy of the intervention. Structured interviews will provide feedback on dietary interventions including specific advice on caloric recommendations during pregnancy, level of reassurance by negative ketonuria on urine specimens (which indicates the diet is supplying the nutrition necessary to maintain a healthy pregnancy), general level of trust/interaction with providers, maintaining food diary, and how obesity issues directly affect their lifestyles and health.

Phase 2 will be a prospective randomized trial in which obese women will be recruited in the first trimester. Study participants will be identified by providers in the Truman Medical Center clinic population and includes obese pregnant women less than 16 weeks in gestational age during the pregnancy. Dates will be confirmed by standard practices including using last menstrual period and obstetric ultrasound. Once potential women are identified they will be directed to study coordinators who will determine study eligibility (BMI >30, 16 weeks or less pregnant, willing to participate, singleton pregnancy, normal 1 hour glucola) and consent patients for the study. Women will be randomized to usual care or dietary intervention using opaque numbered envelopes that are generated by blinded statistician.

The dietary intervention will be conducted by a registered dietician once. Patients in the study arm will receive a detailed intake and specific dietary guidelines. 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. Recording daily food/beverage intake in a diary has been associated with improved adherence to dietary recommendations and is one of the more effective interventions for behavioral modification. Therefore, study participants will be asked to record a food/beverage diary and to bring it to prenatal visits. Recent evidence suggests that highly dense and acellular processed foods are associated with an inflammatory state that leads to more absorption of lipids and deposition of fat.18,19 Study participants will be counseled to limit intake of highly calorie dense and acellular processed foods and beverages to 1-2 times per week if at all and to increase total percentage of fruits and vegetables to 5-9 items per day.

It is expected that some women may lose weight during this clinical trial as 40% of women lost weight in a similar trial8. Although those women lost weight, there were no instances of starvation or ketonuria on routine screening and there was no difference in infant birth weights between the two groups.8 Routine urinalysis is performed during pregnancy and screening for ketonuria can indicate metabolic evidence of starvation.

Therefore, to monitor safety during our study, routine urinalysis will be inspected and evidence of starvation ketonuria (2+ on urine dip, or 40mg/dl) will prompt investigation by study staff on the cause and determine whether it is related to the study protocol. No evidence of maternal ketonuria was documented in over 200 women in the previous study.8