scholarly journals Safety and efficacy of antenatal milk expressing for women with diabetes in pregnancy: protocol for a randomised controlled trial

BMJ Open ◽  
2014 ◽  
Vol 4 (10) ◽  
pp. e006571 ◽  
Author(s):  
Della A Forster ◽  
Susan Jacobs ◽  
Lisa H Amir ◽  
Peter Davis ◽  
Susan P Walker ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Breast Milk ◽  
Standard Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Care Group ◽  
Diabetes In Pregnancy ◽  
Increased Risk ◽  
Randomised Controlled ◽  
In Pregnancy

IntroductionMany maternity providers recommend that women with diabetes in pregnancy express and store breast milk in late pregnancy so breast milk is available after birth, given (1) infants of these women are at increased risk of hypoglycaemia in the first 24 h of life; and (2) the delay in lactogenesis II compared with women without diabetes that increases their infant's risk of receiving infant formula. The Diabetes and Antenatal Milk Expressing (DAME) trial will establish whether advising women with diabetes in pregnancy (pre-existing or gestational) to express breast milk from 36 weeks gestation increases the proportion of infants who require admission to special or neonatal intensive care units (SCN/NICU) compared with infants of women receiving standard care. Secondary outcomes include birth gestation, breastfeeding outcomes and economic impact.Methods and analysisWomen will be recruited from 34 weeks gestation to a multicentre, two arm, unblinded randomised controlled trial. The intervention starts at 36 weeks. Randomisation will be stratified by site, parity and diabetes type. Women allocated to the intervention will be taught expressing and encouraged to hand express twice daily for 10 min and keep an expressing diary. The sample size of 658 (329 per group) will detect a 10% difference in proportion of babies admitted to SCN/NICU (85% power, α 0.05). Data are collected at recruitment (structured questionnaire), after birth (abstracted from medical record blinded to group), and 2 and 12 weeks postpartum (telephone interview). Data analysis: the intervention group will be compared with the standard care group by intention to treat analysis, and the primary outcome compared using χ2 and ORs.Ethics and disseminationResearch ethics approval will be obtained from participating sites. Results will be published in peer-reviewed journals and presented to clinicians, policymakers and study participants.Trial registration numberAustralian Controlled Trials Register ACTRN12611000217909.

scholarly journals Mild gestational diabetes in pregnancy and the adipoinsular axis in babies born to mothers in the ACHOIS randomised controlled trial

2007 ◽  
Vol 7 (1) ◽  
Author(s):  
Louise K Pirc ◽  
Julie A Owens ◽  
Caroline A Crowther ◽  
Kristyn Willson ◽  
Miles J De Blasio ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Gestational Diabetes ◽  
Controlled Trial ◽  
Diabetes In Pregnancy ◽  
Randomised Controlled ◽  
In Pregnancy

scholarly journals Effects of therapeutic play on children undergoing cast-removal procedures: a randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e021071 ◽  
Author(s):  
Cho Lee Wong ◽  
Wan Yim Ip ◽  
Blondi Ming Chau Kwok ◽  
Kai Chow Choi ◽  
Bobby King Wah Ng ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Age Groups ◽  
Intervention Group ◽  
Control Group ◽  
Play Intervention ◽  
Score Difference ◽  
Randomised Controlled ◽  
Therapeutic Play

ObjectivesTo examine (1) the effectiveness of therapeutic play in reducing anxiety and negative emotional manifestations among children undergoing cast-removal procedures and (2) the satisfaction of parents and cast technicians with cast-removal procedures.DesignA randomised controlled trial.SettingAn orthopaedic outpatient department of a regional teaching hospital in Hong Kong.ParticipantsChildren (n=208) aged 3–12 undergoing cast-removal procedure were invited to participate.InterventionsEligible children were randomly allocated to either the intervention (n=103) or control group (n=105) and stratified by the two age groups (3–7 and 8–12 years). The intervention group received therapeutic play intervention, whereas the control group received standard care only. Participants were assessed on three occasions: before, during and after completion of the cast-removal procedure.Outcome measuresChildren’s anxiety level, emotional manifestation and heart rate. The satisfaction ratings of parents and cast technicians with respect to therapeutic play intervention were also examined.ResultsFindings suggested that therapeutic play assists children aged 3–7 to reduce anxiety levels with mean differences between the intervention and control group was −20.1 (95% CI −35.3 to −4.9; p=0.01). Overall, children (aged 3–7 and 8–12) in the intervention groups exhibited fewer negative emotional manifestations than the control group with a mean score difference −2.2 (95% CI −3.1 to −1.4; p<0.001). Parents and technicians in the intervention group also reported a higher level of satisfaction with the procedures than the control group with a mean score difference of 4.0 (95% CI −5.6 to 2.3; p<0.001) and 2.6 (95% CI 3.7 to 1.6; p<0.001), respectively.ConclusionTherapeutic play effectively reduces anxiety and negative emotional manifestations among children undergoing cast-removal procedures. The findings highlight the importance of integrating therapeutic play into standard care, in particular for children in younger age.Trial registration numberChiCTR-IOR-15006822; Pre-results.

scholarly journals Efficacy of a Multi-Component m-Health Diet, Physical Activity, and Sleep Intervention on Dietary Intake in Adults with Overweight and Obesity: A Randomised Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 2468
Author(s):  
Sasha Fenton ◽  
Tracy L. Burrows ◽  
Clare E. Collins ◽  
Anna T. Rayward ◽  
Beatrice Murawski ◽  
...  
Keyword(s):  
Physical Activity ◽  
Weight Loss ◽  
Randomised Controlled Trial ◽  
Dietary Intake ◽  
Controlled Trial ◽  
Intervention Group ◽  
Weight Loss Intervention ◽  
Traditional Group ◽  
Traditional Diet ◽  
Randomised Controlled

This three-arm randomised controlled trial evaluated whether (1) a multi-component weight loss intervention targeting diet, physical activity (PA), and sleep was effective at improving dietary intake over six months and 12 months, compared with a control, and (2) the enhanced diet, PA, and sleep intervention was more effective at improving dietary intake than the traditional diet and PA intervention. A total of 116 adults (70% female, 44.5 years, BMI 31.7 kg/m2) were randomised to either traditional diet and PA intervention; enhanced diet, PA, and sleep intervention; or wait-list control. To examine between-group differences, intervention groups were pooled and compared with the control. Then, the two intervention groups were compared. At six months, the pooled intervention group consumed 1011 fewer kilojoules/day (95% CI −1922, −101), less sodium (−313.2 mg/day; 95% CI −591.3, −35.0), and higher %EI from fruit (+2.1%EI; 95% CI 0.1, 4.1) than the controls. There were no differences in intake between the enhanced and traditional groups at six months. At 12 months, the pooled intervention and control groups reported no significant differences. However, compared to the traditional group, the enhanced reported higher %EI from nutrient-dense foods (+7.4%EI; 95% CI 1.3, 13.5) and protein (+2.4%EI; 95% CI 0.1, 4.6), and reduced %EI from fried/takeaway foods (−3.6%EI; 95% CI −6.5, −0.7), baked sweet products (−2.0%EI; 95% CI −3.6, −0.4), and packaged snacks (−1.1%EI; 95% CI −2.2, −0.3). This weight loss intervention reduced total energy and sodium intakes as well as increased fruit intake in adults at six months. The enhanced intervention group reported improved dietary intake relative to the traditional group at 12 months.

Randomised Controlled Trial of Ultrasonographic Screening in Pregnancy

1985 ◽  
Vol 40 (3) ◽  
pp. 151-152
Author(s):  
LEIV S. BAKKETEIG ◽  
GEIR JACOBSEN ◽  
CHRISTIAN J. BRODTKORB ◽  
BJARNE C. ERIKSEN ◽  
STURLA H. EIK-NES ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Randomised Controlled ◽  
In Pregnancy
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