An observational study in Type 2 Diabetes and Pregnancy, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-05.
Sponsored by Rigshospitalet, Denmark · Observational
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.
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.
The control group was given the same routine care with the same treatment goals, but without motivational interviewing.
Lifestyle intervention with motivational interviewing:
The individual sessions with a lifestyle coach will be scheduled for each participant and tailored to suite in the routine clinical visits of the patients. The women will follow routine visits and the lifestyle coaching is sought implemented in the routine clinical setting without excess use of one-to one contacts with a caregiver.
The lifestyle coaching is built op on principles of patient empowerment and cognitive behavioral techniques, inspired by motivational interviewing. In the program, one-to-one contact will be offered. The aim is to provide a one-to-one contact every second week of approximately 10 minutes duration. Women living in a long distance form the clinic may convert some of the one-to-one contact to telephone calls. The timing of these contacts and the time between these contacts are dependent on the preference of the participant and the availability of the lifestyle coach in order to deliver the intervention with the most appropriate timing and to optimize changes of the uptake of behavior change. However it is stressed that the one-to-one coaching sessions should be initiated within 14 days after first visit at the clinic and occurs before gestational week 20. The first phase of behavioral change is centered on intention formation (motivation). Current behavior will be assessed and motivation for change will be established. When the woman is ready to make the change, personal goals will be set. An action plan for improving dietary behavior will be made during the first session and evaluated in subsequent sessions. The following dietary objectives will be set for each participant to achieve or to maintain:
The lifestyle coaches have received a special training program containing motivational interviewing techniques. The doctors, dieticians and nurses taking care of the routine clinical visits will continue their usual care without focus on motivational interviewing. The lifestyle coaches are educated midwives, nurses or doctors and will also be trained in performing the routine clinical diabetes visits at the same visit as the coaching visit if possible, in order avoid excess expense of one-to-one contacts with a caregiver.
In addition to the motivational intervention the women are given unchanged routine care.
The routine care includes the following goals for both groups:
The aim for glycaemic control is according to the Danish National guidelines in essence aiming for preprandial plasma glucose values between 4-6 mmol/l and postprandial values between 4 and 8 mmol/l. Due to changes in measuring HbA1c in mmol/mol the goal for HbA1c is slightly modified to below 40 mmol/mol during pregnancy.
The goals for gestational weight gain follow the Copenhagen guidelines for pregnant diabetic women:
Pre-pregnancy BMI \<25 kg/m2: 10-15 kg in total with 100 g/week in first half of pregnancy and thereafter 400 g/week.
Pre-pregnancy BMI: 25-30 kg/m2: 5-8 kg in total with 100 gram per week in first half of pregnancy and thereafter 300g/week.
Pre-pregnancy BMI >30 kg/m2: 5 kg in total with 0 g/week in first half of pregnancy and thereafter 200 g/week.
Recommendations regarding diet and physical activity - in brief
The women will get a one-to-one consultation with certified dietitian once during pregnancy. The women will get information about recommended diabetes diet, education in carbohydrate counting and how to read a food label. Information about dietary apps is given to aid learning. The goals are as follows: A) Adequate nutrient intake to support a healthy pregnancy. B) Adequate but not excessive gestational weight gain within the Copenhagen guidelines for pregnant diabetic women according to pre-pregnancy BMI as stated above. C) Eating a total of approximately 175 grams of carbohydrate daily which is regarded to correspond to around150 g of the main sources of carbohydrates as bread, potatoes, rise, pasta, fruits, and dairy products. D) Diet mainly containing low GI carbohydrates. E) Aim for approximately 20-40-40 grams of carbohydrates at each main meal and 10-20 grams at 2-3 snacks daily from the main sources of carbohydrates. F) Consistent timing of three meals and 2-4 snacks daily.
Women without contraindications will be encouraged to be physical active for at least 30 min/day: mainly walking, cycling or swimming.
Procedure and data collection:
Clinical assessments will be made by a member of the research team at three time points: at baseline, 20-24 weeks and 35-37 weeks of gestation.
At first visit the following will be noted: the women´s self-reported weight before pregnancy. Height, current weight, waist, neck and ankle circumference and subcutaneous skinfolds will be measured. Consultations blood pressure but also a home blood pressure monitoring for 3 days will be registered. HbA1c concentration and plasma lipids (triglycerides, free fatty acids, total cholesterol, HDL cholesterol, LDL cholesterol) will be measured the same day. A dipstick of sterile urine will be screened for proteinuria/ketonuria. All medications including vitamins and total daily dose of insulin will be noted together with diabetes related complications (nephropathy or retinopathy). An ophthalmologist evaluates the presence or absence of diabetic retinopathy at first visit. Occurrence of mild and severe hypoglycaemia will be reported as well as the degree of nausea and vomiting. Women will be asked into the number of episodes of symptomatic mild hypoglycaemia the last week and in case of severe hypoglycaemia, details about the event will be documented in a structured way.
The women´s age, duration of diabetes, gestational age at first visit, parity, marital status, ethnicity, smoking, alcohol, sleeping pattern and social status (degree of education as well as current employment and shift work) will be noted.
The women will record 3 days of food diary with focus on content of carbohydrate from the main carbohydrate sources. These diaries will be used to evaluate the amount of carbohydrates and the amount of high/low glycemic index food with focus on the average daily total carbohydrate intake as well as the day-to-day variation. The degrees of leisure time physical activity will be sought evaluated by pregnancy physical activity questionnaire (PPAQ). Besides this, the women will complete a 6 item food frequency list, a Hospital Anxiety and Depression Scale (HADS) and a EuroQol-5D (EQ-5D).
At each clinical visit current weight and consultations blood pressure will be registered. HbA1c will be measured and a dipstick of sterile urine screened for ketone bodies and protein. All medications incl. total daily insulin dose will be noted together with information about the number of mild hypoglycaemic episodes the past week.
Additionally at study visits (20-24 weeks and 35-37 weeks) the women will complete a food diary for 3 days, 6 item food frequency list, PPAQ, HADS and EQ-5D. Information about smoking and sleeping patterns, nausea and vomiting will be noted. Bodyweight and waist, neck and ankle circumference and subcutaneous skinfolds will be measured. Consultations blood pressure as well as home blood pressure monitoring will be registered, presence of severe hypoglycaemia within the last year will be noted and detailed information about the episodes collected.
One year postpartum, the women will be contacted by telephone and asked for their current weight and in which degree the lifestyle-changes initiated during pregnancy are still followed according to their own judgment (licker scale). Information about duration of exclusive and total breastfeeding will be registered. Regarding the child, actual health, current weight as well as hospital admissions and presence of malformations will be obtained.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 189 is below the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.
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A cohorte of unselected consecutive pregnant women with type 2 diabetes. The inclusion period of the study group is planned from August 2015 to August 2017.
The control group consists of the cohort of women referred for pregnancy care in the period of August 2013 to August 2015 fulfilling the same inclusion criteria and followed the same routine care as the study group.
Each cohort is expected to include 150 women.
Exclusion Criteria:
Receives lifestyle intervention with motivational interviewing focusing on following the recommended diabetes diet and gestational weight gain recommendations in addition to routine care
Behavioral: Motivational interviewing
Was given the same routine care with the same treatment goals, but without motivational interviewing.
The aim is to provide a one-to-one contact every second week of approximately 10 minutes duration. An action plan for improving dietary behavior will be made during the first session and evaluated in subsequent sessions. The following dietary objectives will be set for each participant to achieve or to maintain: 1. Watch portion size - to be conscious about the amount of carbohydrates in each meal. 2. Eat mainly carbohydrates of low glycaemic index. 3. Reduce the intake of carbohydrate of high glycaemic index. 4. Watch daily weight changes - aim for the recommended weekly changes. In addition to the motivational intervention the women are given unchanged routine care.
Gestational weight gain
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.
Time frame: 2 years and 9 months
Large for gestational age
Birth weight ≥ 90th percentile, adjusted for gestational age and sex. Z-score ≥1.28.
Time frame: 2 years and 9 months
HbA1c
noted 3 times during pregnancy
Time frame: 2 years and 9 months
Pre-eclampsia:
De novo hypertension \>140/90 mmHg after 20 weeks and the coexistence of one or more of the following new onset conditions: 1. Proteinuria (spot urine protein/creatinine ratio ≥ 30 mg/mmol (0.3 mg/mg) or ≥ 300 mg/day or at least 1 g/L ('2+') on dipstick testing or albumin excretion (UAE) ≥ 190 mg/day or Albumin Creatine Ratio (UACR) ≥ 190 mg/g creatinine). 2. Other maternal organ dysfunction: * renal insufficiency (creatinine ≥90 umol/L) * liver involvement (elevated transaminases; at least twice upper limit of normal and right upper quadrant or epigastric abdominal pain * Neurological complications (including eclampsia, altered mental status, blindness, stroke, hyperreflexia when accompanied by clonus, severe headaches when accompanied by hyperreflexia and persistent visual scotomata) * Haematological complications (thrombocytopenia: platelet count \<150,000/dl, disseminated intravascular coagulation and haemolysis) 3. Uteroplacental dysfunction and fetal growth restriction I
Time frame: 2 years and 9 months
Preterm delivery
Birth before 37 completed gestational weeks (259 days).
Time frame: 2 years and 9 months
Caesarean section:
* Emergency: The procedure is made within 8 hours after clinical decision. * Elective: Planned C-section.
Time frame: 2 years and 9 months
Duration from induction of labor to delivery
The time in hours from onset of intervention (example Misoprostol, Cervical Ripening Balloon, amniotomy) to delivery.
Time frame: 2 years and 9 months
Duration of active labor
Regular labor with contractions ≤ 5 minutes interval and orificium is ≥ 4 cm dilated without persistant collum. The appraisal will be made by local midwives.
Time frame: 2 years and 9 months
Shoulder dystocia
Shoulder dystocia is a situation when the fetus's shoulders cannot pass below the mother's pubic symphysis after delivery of the head and specific obstetric maneuvers, usually Rubin´s or/and Wood´s maneuvers, are necessary to deliver the baby. Presence of fetal asphyxia, nerve lesions and fractures will be noted.
Time frame: 2 years and 9 months
Degree of rupture
1. degree: laceration is limited to the fourchette and superficial perineal skin or vaginal mucosa. 2. degree: laceration extends to perineal muscles and fascia. 3. degree: laceration extends to the anal sphincter. 4. degree: laceration extends to the rectal mucosa.
Time frame: 2 years and 9 months
Birth weight z-score
Number of standard deviations from the mean of a Nordic population, adjusted for gestational age and sex.
Time frame: 2 years and 9 months
Small for Gestational Age (SGA)
Birth weight ≤ 10th percentile, adjusted for gestational age and sex. Z-score ≤ 1.28.
Time frame: 2 years and 9 months
Ponderal index
Weight divided by the third power of body length.
Time frame: 2 years and 9 months
International neonatal hypoglycemia:
Neonatal hypoglycemia defined as a plasma glucose value below 2.2 mmol/L, measured within 4 hours of life.
Time frame: 2 years and 9 months
Danish Neonatal hypoglycemia
Neonatal hypoglycemia defined as a plasma glucose value below 2.5 mmol/L, measured within 4 hours of life.
Time frame: 2 years and 9 months
Jaundice
Need for phototherapy or exchange transfusion
Time frame: 2 years and 9 months
Transient tachypnea of the newborn (TTN)
A need for Continuous Positive Airway Pressure (CPAP) for more than 60 minutes.
Time frame: 2 years and 9 months
Major congenital malformations
Those leading to death, causing a substantial future handicap or requiring surgery.
Time frame: 3 years and 9 months
Perinatal mortality
Perinatal death includes infant deaths that occur at less than 28 days of age and fetal deaths with a stated or presumed period of gestation of 20 weeks or more.
Time frame: 2 years and 9 months
Perinatal morbidity
The occurrence of at least one of the following complications: neonatal hypoglycemia, jaundice, TTN, congenital malformations, perinatal mortality or admission to neonatal special care unit (NSCU).
Time frame: 2 years and 9 months
Apgar score
The examination immediately after birth on five criteria on a three point scale (0,1 and 2), with a maximum points of 10 after 5 minutes.
Time frame: 2 years and 9 months
Body mass index (BMI)
* Underweight: \< 18.5 kg/m2 * Normal weight: 18.5-24.9 kg/m2 * Overweight: 25.0-29.9 kg/m2 * Obese: ≥ 30.0 kg/m2
Time frame: 2 years
Hypoglycaemia
* Mild: Events with symptoms familiar to the patient as hypoglycemia and managed by the patient. * Severe: Events with symptoms of hypoglycemia requiring help from another person to actively administer oral carbohydrate or injection of glucagon or glucose in order to restore the blood glucose level.
Time frame: 2 years
Kidney involvement
Microalbuminuria or diabetic nephropathy.
Time frame: 2 years
Diabetic nephropathy
U-albumine \>300 mg/day or ACR, \>300 mg/g of creatinine or \>34 mg/mmol of creatinine
Time frame: 2 years
Microalbuminuria
30-300 mg/day albumin or ACR, 30-300 mg/g of creatinine or 3.4-34 mg/mmol of creatinine.
Time frame: 2 years
Diabetic retinopathy
Presence of any diabetic retinopathy at first visit.
Time frame: 2 years
Ethnicity
-Nordic Caucasian: When pregnant woman originates from Northern Europe.
Time frame: 2 years
Maternal waist circumference
measured at the level midway between the lowest ribcage and the iliac crest
Time frame: 2 years
Maternal neck circumference
Measured between midcervical spine and mid-anterio neck
Time frame: 2 years
Maternal ankle circumference
measured 5 cm above the malleolus
Time frame: 2 years
Infants weight, length, and head circumference
Time frame: 2 years and 9 months
Infants abdominal circumference, upper- and lower arm and upper- and lower leg circumference
Time frame: 2 years and 9 months
Infants skin fold measurements of triceps, quadriceps, subscapular and suprailiac region
Time frame: 2 years and 9 months
Maternal lipid profile at first visit
Time frame: 2 years
Cord blood pH
Time frame: 2 years and 9 months
Post-partum weight retention
Time frame: 3 years and 9 months
Baby´s weight at 1 year
Time frame: 3 years and 9 months
Baby´s morbidity the first year
Time frame: 3 years and 9 months
Maternal health during pregnancy
HADS questionnaire
Time frame: 2 years
Maternal after measurement of subcutaneous skin folds (biceps, triceps, suprailiac and subscapular).
Measured with a Harpenden caliper according to the method described by Durnin and Womersly
Time frame: 2 years
Plan to share: Undecided
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Rigshospitalet, Denmark