Study design and study population
This was a prospective cohort study. We obtained approval from the Research Ethics Committee of LuHe Hospital of Capital Medical University in Beijing, China before the commencement of this study, and obtained written informed consent from all participating patients.
We recruited obese (BMI ≥ 30 Kg/m2) or overweight (30 Kg/m2 > BMI ≥ 25Kg/m2) women who visited LuHe Hospital, Capital Medical University in Beijing, China, for their routine prenatal care at 10-13 weeks of gestation between May 1, 2017 and April 30, 2018. Women who took steroid medication or who were diagnosed with thyroid disease or were affected by pre-pregnant diabetes mellitus or for other reasons could not participate in REE or other assessments for the study were excluded. We divided the recruited women into two groups according to the period recruited into the study: those recruited between May 1, 2017 and November 30, 2017 were the control group with standard diet recommendations based on pre-pregnancy BMI and ideal weight, without REE monitoring during pregnancy; while those recruited between December 1, 2017 and April 30, 2018 were the intervention group with REE guided diet recommendations to manage GWG during pregnancy.
Intervention
For the intervention group, REE was measured at recruitment (1st trimester, 11-13 weeks of gestation) and then again at 2nd trimester (24-28 weeks of gestation) and 3rd trimester (32-36 Weeks of gestation). For this group, TEE was obtained by measuring REE and Physical Activity Index (PAI) at recruitment. The nutritionist made dietary recommendations based on TEE by the way of Food Exchange Share. The dietary recommendations were adjusted, depending on REE measured at 2nd trimester and 3rd trimester. TEE of the control group was calculated at recruitment (1st trimester) by the standard method involving ideal weight and pre-pregnant BMI only. Dietary recommendations for controls were based on TEE by the way of Food Exchange Share as well. An extra 300 Kcal was added to their TEE at 2nd trimester, and an extra 450 Kcal was added at 3rd trimester.20 Weight gain of two groups were monitored and recorded each month. Dietary recommendations for the two groups based on guidelines of GDM21. GDM guidelines were used because no dietary guideline exist specifically for pregnant women who are obese/overweight.22 Daily TEE was generally provided by approximately 50%-60% of energy from carbohydrate, 25-30% from fat, and 15-20% from protein, divided into three meals and three snacks.23
Below is the formula for TEE calculation for the two groups:
Intervention group:
TEE= BMR (REE) × PAI24
PAI was assessed using the International Physical Activity Questionnaire (IPAQ). Low level (PAI = 1.2): total physical activity of MET-minutes/week < 600; Moderate level (PAI=1.5): total physical activity of MET-minutes/week between 600 and 3000; and High level (PAI=1.7): total physical activity of MET-minutes/week > 3000. 24, 25
We used Vmax Encore 29n (product by CareFusion company USA) to measure REE. The measurement was conducted by a professional technician, at LuHe Hospital Adult Nutrition Research Center. Participants were asked to arrive at the nutrition center in the morning after a 12-h overnight fast. They were instructed to have a 30-min rest in a semi-recumbent position, remaining calm during this time. They were then escorted to a comfortable (temperature maintained at 21-22℃) room and asked to lie down quietly for 30-min. An instrument with a transparent plastic hood was positioned to cover the area from head to neck, with fresh air free flowing through the instrument. After the equilibration period, oxygen consumption (VO2) and carbon dioxide production (VCO2) were monitored continuously for 30-min while the participant remained awake, silent, and motionless. Minute by minute values of VO2, VCO2,respiratory quotient, and energy expenditure were monitored over the 30-min collection period to obtain the REE. REE and body composition were measured at recruitment (1st trimester, 11-13 gestational weeks), 2nd trimester (24-28 gestational weeks), and 3rd trimester (32-36 gestational weeks).
Control group:
TEE = (Height-105) Kg × EC.26
EC: Energy Coefficient according to the level of Pre-pregnant BMI; EC of overweight = 25-30Cal/Kg ; EC of obese = 20-25 Cal/Kg; Ideal Weight = Height-105 (Kg).14
Physical examination
At recruitment, height and pre-pregnant weight were obtained by patient’s recall. BMI was then calculated. During pregnancy, maternal weight was measured with an electronic scale accurate to 0.1 kg; women were asked to wear a gown of known weight and with no shoes or jewelry on. All measurements were done in duplicate on the same day and by personnel trained according to standard techniques. GWG was obtained by subtracting pre-pregnant weight from their weight before delivery.
Laboratory procedures
Venous blood was drawn from study participants after a 12- hour fast, as well as plasma and serum samples. The plasma and serum samples were stored at -80℃ before testing. Analyses of triglycerides, total cholesterol, high-density lipoproteins (HDL), and low-density lipoproteins (LDL) were conducted at the Biochemistry Laboratory of LuHe Hospital based on standard clinical laboratory procedures.
Demographic and clinical data collection
Demographic and clinical data including age, gravidity, gestational age, pregnancy complications, and birth weight were obtained by chart review. At LuHe Hospital, gestational age was based on last date of normal menstrual period and validated by ultrasound examination in early gestation.
Statistical analysis
Statistical analysis was performed using the SPSS 18.0 for Windows. Distribution of continuously distributed data was assessed by Kolmogorov-Smirnov’s test. If the P-value of the Kolmogorov-Smirnov’s test was higher than 0.05, the data was considered normally distributed and two independent samples Student’s t-test (two-tailed) was used to compare the mean differences between the two study groups. For categorical data, the differences between the two groups were compared by using the χ2 or Fisher’s exact test.