The Effect of Motivational Interviewing With Focus on Diet and Weight Gain on Prevention of Excessive Fetal Growth in Pregnant Women With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- Large for gestational age
研究概览
简要总结
The primary goal of this case control study is to investigate the effect of implementation of motivational interviewing with focus on diet and weight gain in addition to the routine treatment on prevention of excessive gestational weight gain and fetal growth in pregnant women with type 2 diabetes.
Design: Prospective cohort study where an unselected cohort of all pregnant women with type 2 diabetes are offered intervention with motivational interviewing in addition to routine treatment in the period 2015-2017. For comparison a historical cohort (2013-2015) treated with routine treatment only will be studied. With an inclusion period of 2 years, each cohort is expected to include 150 participants. The women in the study group will receive one-to-one coaching based on the principles of motivational interviewing, every second week throughout the pregnancy. Both cohorts receive the same routine care for pregnant women with type 2 diabetes. An appropriate GWG is targeted. Primary outcome measures are maternal gestational weight gain and the infants Large for Gestational Age.
详细描述
The Aims: First, to investigate the effect of implementation of motivational interviewing focusing on diet adherence in addition to routine treatment on prevention of excessive gestational weight gain and fetal overgrowth.
Secondly, to investigate the impact of quantity and quality of carbohydrate consumption on HbA1c, gestational weight gain and fetal overgrowth.
Thirdly, to explore the occurence of anxiety and depression and relation to pregnancy outcome.
Study design:
The study group will get a life-style intervention with motivational interviewing focusing on following the recommended diabetes diet and gestational weight gain recommendations in addition to routine care - as described below.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All pregnant women with type 2 diabetes and older than 18 years referred to Center for Pregnant Women with Diabetes, Rigshospitalet or Department of Obstetrics and Endocrinology, Odense University Hospital with a live singleton pregnancy will be included in the study group. All pregnant women with type 2 diabetes in the period August 2013 - August 2015 who received routine care only at the same centers will be included in the control group.´
- •Referral before 20 gestational weeks. Women with newly diagnosed type 2 diabetes before week 20 may be included (HbA1c ≥ 48 mmol/mol).
- •Able to read and understand the patient information sheet and to converse with the lifestyle coach in Danish.
排除标准
- •Previous bariatric surgery i.e. ether previous gastric bypass or gastric banding operation.
- •Women diagnosed with severe diseases which possibly could bias the weight gain or pregnancy outcome on the decision of the principal investigators.
结局指标
主要结局
Large for gestational age
时间窗: 2 years and 9 months
Birth weight ≥ 90th percentile, adjusted for gestational age and sex. Z-score ≥1.28.
HbA1c
时间窗: 2 years and 9 months
noted 3 times during pregnancy
Gestational weight gain
时间窗: 2 years and 9 months
The difference between weight measured at gestational week 35-37 and weight from preconception (self-reported) or if not available, at first pregnancy visit within first trimester.
次要结局
- Kidney involvement(2 years)
- Shoulder dystocia(2 years and 9 months)
- Microalbuminuria(2 years)
- Caesarean section:(2 years and 9 months)
- Major congenital malformations(3 years and 9 months)
- Birth weight z-score(2 years and 9 months)
- International neonatal hypoglycemia:(2 years and 9 months)
- Danish Neonatal hypoglycemia(2 years and 9 months)
- Perinatal morbidity(2 years and 9 months)
- Degree of rupture(2 years and 9 months)
- Small for Gestational Age (SGA)(2 years and 9 months)
- Pre-eclampsia:(2 years and 9 months)
- Preterm delivery(2 years and 9 months)
- Duration from induction of labor to delivery(2 years and 9 months)
- Duration of active labor(2 years and 9 months)
- Ponderal index(2 years and 9 months)
- Maternal waist circumference(2 years)
- Maternal ankle circumference(2 years)
- Transient tachypnea of the newborn (TTN)(2 years and 9 months)
- Hypoglycaemia(2 years)
- Diabetic nephropathy(2 years)
- Maternal neck circumference(2 years)
- Infants weight, length, and head circumference(2 years and 9 months)
- Maternal lipid profile at first visit(2 years)
- Post-partum weight retention(3 years and 9 months)
- Jaundice(2 years and 9 months)
- Apgar score(2 years and 9 months)
- Infants abdominal circumference, upper- and lower arm and upper- and lower leg circumference(2 years and 9 months)
- Maternal health during pregnancy(2 years)
- Perinatal mortality(2 years and 9 months)
- Body mass index (BMI)(2 years)
- Diabetic retinopathy(2 years)
- Ethnicity(2 years)
- Cord blood pH(2 years and 9 months)
- Infants skin fold measurements of triceps, quadriceps, subscapular and suprailiac region(2 years and 9 months)
- Baby´s morbidity the first year(3 years and 9 months)
- Baby´s weight at 1 year(3 years and 9 months)
- Maternal after measurement of subcutaneous skin folds (biceps, triceps, suprailiac and subscapular).(2 years)
研究者
Björg Ásbjörnsdóttir
MD, PhD student
Rigshospitalet, Denmark