| Literature DB >> 31943785 |
Sharleen L O'Reilly1,2, Yvonne Leonard2, Kaberi Dasgupta3, Helle Terkildsen Maindal4.
Abstract
Diabetes prevention intervention studies in women with previous gestational diabetes have increased, but no consensus exists on core outcomes to support comparisons and synthesis of findings. We aimed to systematically catalogue outcomes in diabetes after pregnancy prevention interventions with the goal of developing a core outcome set. Embase, Medline, Cochrane Library, Cochrane Pregnancy and Childbirth Trials Register, and CINAHL were searched from inception to October 2017. Post-partum lifestyle and diabetes screening intervention studies in women with previous gestational diabetes and/or their families were eligible. No limits were placed on intervention type, duration, or location. Two authors independently screened and performed data extraction on outcomes, measurement tools, and relevant study characteristics. We analysed data from 38 studies (29 randomised controlled trials and 9 pre-post intervention evaluations) comprising 12,509 participants. Most publications (80%) occurred between the years 2012 and 2017. Among 172 outcomes, we identified 36 outcome groups and classified them under three domains: health status (body weight, body composition, diabetes risk, cardiometabolic risk, diabetes development, mental health, pregnancy outcomes, and fitness), health behaviours (dietary, physical activity, diabetes screening, behaviour change, and breastfeeding), and intervention processes (implementation). The health status domain contained the most commonly reported outcomes, but measurement tools were very heterogeneous. Despite the recent explosion in diabetes after pregnancy prevention studies, large variation in outcomes and measurement methods exists. Research is needed to define a core outcome set to standardise diabetes after pregnancy prevention interventions. The core outcome set should engage a wide group of stakeholders to identify impactful indicators for future trials.Entities:
Keywords: core outcome set; diabetes prevention; gestational diabetes
Mesh:
Year: 2020 PMID: 31943785 PMCID: PMC7296791 DOI: 10.1111/mcn.12947
Source DB: PubMed Journal: Matern Child Nutr ISSN: 1740-8695 Impact factor: 3.092
Figure 1PRISMA flow chart for assessment of diabetes after pregnancy prevention trials in women with previous gestational diabetes
Trial characteristics in diabetes prevention for women with previous gestational diabetes
| Characteristics | Health behaviour change trials ( | Diabetes screening trials ( | All trials ( |
|---|---|---|---|
| Trial participants, number (%) | |||
| Total participants | 9,575 | 2,934 | 12,509 |
| Intervention participants | 4,302 (45) | 2,130 (73) | 6,432 (51) |
| Trial publication year, number (%) | |||
| 2007–2017 | 28 (93) | 8 (100) | 36 (95) |
| 1996–2006 | 2 (7) | 0 | 2 (5) |
| Trial design, number (%) | |||
| Randomised controlled | 26 (87) | 4 (50) | 30 (79) |
| Pre–post intervention | 4 (13) | 4 (50) | 8 (21) |
| Country, number (%) | |||
| United States | 13 (43) | 4 (50) | 17 (45) |
| Australia | 8 (27) | 1 (13) | 9 (24) |
| Canada | 2 (7) | 3 (37) | 5 (13) |
| Other (Spain, China, Finland, Ireland, and Malaysia) | 7 (23) | 0 | 7 (18) |
| Follow‐up (weeks), median (interquartile range) | 28 (13–52) | 26 (13–52) | 26 (13–52) |
Figure 2Outcomes reporting matrix for trials to prevent diabetes after pregnancy in women with previous gestational diabetes
Outcome domains and measurement tools for prevention of diabetes after pregnancy trials in women with previous gestational diabetes
| Outcome domain | Outcome subdomain | Primary outcomes | Secondary outcomes | Measurement |
|---|---|---|---|---|
| Health status | Body weight |
Weight Post‐partum weight retention |
Weight Post‐partum weight retention |
BMI Weight (self‐reported, health records and actual) Height (self‐reported, health records and actual) |
| Body composition |
Body composition |
Body composition |
Waist/hip circumference (self‐reported and actual) Body fat (DEXA, CT scan, and bioelectrical impedance analyser) Basal metabolic rate (metabolic cart) | |
| Diabetes risk |
Glycaemic control |
Glycaemic control |
Fasting blood glucose Oral glucose tolerance test Glucose AUC HbA1c Urine glucose | |
|
Insulin |
Serum fasting insulin Insulin AUC | |||
|
Insulin resistance and sensitivity |
Matsuda index HOMA‐IR Insulin: Glucose ratio | |||
| Cardiometabolic risk |
Blood pressure |
Systolic and diastolic (automated and health records) | ||
|
Blood lipids |
Total cholesterol LDL cholesterol HDL cholesterol Triglycerides | |||
|
Inflammation |
Fetuin‐A Albumin: Creatinine ratio Apolipoprotein B Plasma uric acid TNF‐α Plasma gamma‐glutamyl transferase Adiponectin C‐reactive protein C‐peptide Leptin | |||
| Diabetes development |
Incidence |
Incidence |
Diagnosis (WHO, ADA guidelines) | |
| Mental health |
Depression Quality of life Anxiety Stress Well‐being |
Questionnaires (detail) Health records | ||
| Pregnancy outcomes |
Maternal |
Gestational hypertension Labour induction Caesarian section Maternal length of stay | ||
|
Infant |
Gender Birth weight and length Jaundice Neonatal length of stay | |||
| Fitness |
Fitness Flexibility Strength |
VO2 max 6‐min walk test Handgrip strength Sit and reach test | ||
| Health behaviour | Dietary |
Macronutrients |
Macronutrients |
Total energy and energy from fat and saturated fat Fibre intake Carbohydrate intake Glycaemic load (food frequency questionnaire/dietary recall/food diaries/self‐reported questionnaires) |
|
Dietary quality Eating behaviours |
Food group servings Eating out frequency Diet quality questionnaire Mediterranean diet score | |||
| Physical activity |
Volume |
Volume |
Steps/distance (pedometer) Activity counts (accelerometer) Time (questionnaires) Sitting time Sedentary behaviour (<5,000 steps/day) | |
|
Intensity |
Intensity |
Level of exertion sedentary/moderate/vigorous (questionnaire and accelerometer) | ||
| Diabetes screening |
Completing post‐partum test Sending of reminders |
Completing post‐partum test Sending of reminders |
Attending test Completion of OGTT/blood glucose/HbA1c Number of reminders/test orders sent | |
| Behaviour change |
Beliefs |
Beliefs |
Motivation to change Fatalism and cultural beliefs Perceived body image and diabetes risk | |
|
Self‐efficacy |
Perceived self‐efficacy Exercise self‐efficacy Diet self‐efficacy Weight self‐efficacy | |||
|
Barriers and enablers |
Identifying and addressing barriers and enablers Perceived barriers Social support Sleep quality | |||
|
Knowledge |
Knowledge |
Diabetes knowledge Healthy lifestyle behaviours Diabetes prevention behaviours | ||
| Breastfeeding |
Duration Exclusivity |
Feeding type Feeding duration | ||
| Implementation process | Implementation |
Engagement Feasibility |
Engagement Feasibility |
Intervention components engaged with/duration Completion of targets/activities Recruitment, retention, acceptability Adverse events |
|
Health economics |
Health status for cost evaluation Health service utilisation and cost |
Abbreviations: AUC, area under the curve; BMI, body mass index; CT, computed tomography; DEXA, dual‐energy X‐ray absorptiometry; HbA1c, haemoglobin A1c; HDL, high‐density lipoprotein; HOMA‐IR, homeostatic model assessment of insulin resistance; LDL, low‐density lipoprotein; OGTT, oral glucose tolerance test; TNF‐α, tumour necrosis factor alpha.