Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: study protocol for a randomized controlled trial (original) (raw)
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Journal of Affective Disorders, 2010
This study aims to evaluate the effectiveness of an antenatal psycho-educational intervention to prevent postpartum depression in Mexican women.Pregnant women at high risk for depression were randomized to intervention or a usual care condition. Assessments of depression (SCID, BDI-II) occurred during pregnancy, 6 weeks and 4–6 months postnatally, and subjective impact of the intervention in the postpartum.Of the 6484 women approached, 377 were eligible and consented to randomization (250 intervention, 127 control). Sixty-eight intervention (27.2%) and 68 (53.5%) control participants completed the three assessment periods. The cumulative incidence of major depression over three time periods was significantly lower (p < 0.05) in the intervention (10.7%) than the control group (25%). Repeated-measures analysis of variance showed a significant reduction of BDI-II in both groups, but no significant treatment effect. Even when controlling for initial levels of depressive and anxiety symptoms, a treatment effect on depressive symptoms could not be confirmed, although there was a trend demonstrating that intervention participants with high initial symptoms had a larger reduction of BDI-II. Most participants that completed the intervention reported that it had a medium to great influence on their well-being, depression, current problems, role as mothers and their relationship with the baby.Attrition was the most salient methodological problem in this study.This is the first randomized control depression prevention trial in high-risk pregnant Mexican women. Available data are consistent with the possibility that the incidence of depression may have been reduced by the intervention, but differential attrition makes interpretation of the findings difficult.
BMC Pregnancy and Childbirth, 2013
Women who are diagnosed with gestational diabetes mellitus (GDM) are at increased risk for developing prediabetes and type 2 diabetes mellitus (T2DM). To date, there have been few interdisciplinary interventions that target predominantly ethnic minority low-income women diagnosed with GDM. This paper describes the rationale, design and methodology of a 2-year, randomized, controlled study being conducted in North Carolina. Using a two-group, repeated measures, experimental design, we will test a 14- week intensive intervention on the benefits of breastfeeding, understanding gestational diabetes and risk of progression to prediabetes and T2DM, nutrition and exercise education, coping skills training, physical activity (Phase I), educational and motivational text messaging and 3 months of continued monthly contact (Phase II). A total of 100 African American, non-Hispanic white, and bilingual Hispanic women between 22-36 weeks of pregnancy who are diagnosed with GDM and their infants will be randomized to either the experimental group or the wait-listed control group. The first aim of the study is to determine the feasibility of the intervention. The second aim of study is to test the effects of the intervention on maternal outcomes from baseline (22-36 weeks pregnant) to 10 months postpartum. Primary maternal outcomes will include fasting blood glucose and weight (BMI) from baseline to 10 months postpartum. Secondary maternal outcomes will include clinical, adiposity, health behaviors and self-efficacy outcomes from baseline to 10 months postpartum. The third aim of the study is to quantify the effects of the intervention on infant feeding and growth. Infant outcomes will include weight status and breastfeeding from birth through 10 months of age. Data analysis will include general linear mixed-effects models. Safety endpoints include adverse event reporting. Findings from this trial may lead to an effective intervention to assist women diagnosed with GDM to improve maternal glucose homeostasis and weight as well as stabilize infant growth trajectory, reducing the burden of metabolic disease across two generations. NCT01809431.
Journal of Women's Health, 2014
Background: Lifestyle interventions are effective in preventing type 2 diabetes (T2D). Women with history of gestational diabetes mellitus (GDM) may have barriers to lifestyle changes, and the previous results of lifestyle interventions are contradictory reporting either favorable outcomes or no significant beneficial effects. Our aim was to compare cardio-metabolic risk profile and responses to a 1-year lifestyle intervention program in women with and without history of GDM. Methods: The Implementation Project of the Program for Prevention of Type 2 Diabetes (FIN-D2D) was conducted in Finland in five hospital districts. Altogether 1,661 women aged £ 45 years participated in the program. One-year follow-up was available for 393 women who did not have screen-detected T2D at baseline, and 265 of them had at least one intervention visit [115 (43.4%) women with history of GDM and 150 (56.6%) without history of GDM]. Results: At baseline, women with GDM had similar baseline glucose tolerance but better anthropometric characteristics, blood pressure, and lipid profile than women without GDM after adjustment for age. Beneficial changes in cardiovascular risk profile existed among women with and without GDM during follow-up and the effect of lifestyle intervention was similar between the groups, except that low-density lipoprotein cholesterol improved only in women with GDM. Altogether, 4.0% of those with GDM and 5.0% of those without GDM developed T2D (p = 0.959 adjustment for age). Conclusions: The effect of a 1-year lifestyle intervention in primary healthcare setting was similar regardless of history of GDM, both women with and without GDM benefitted from participation in the lifestyle intervention.
BMJ Open Diabetes Research & Care, 2020
IntroductionMothers with gestational diabetes mellitus (GDM) are at high risk of future diabetes. An active area of research examines health behavior change strategies in women within 5 years of a GDM pregnancy to prevent diabetes after pregnancy. We aimed to develop a core outcome set (COS) to facilitate synthesis and comparison across trials.Research design and methodsCandidate outcomes were identified through systematic review and scored for importance (1–9) by healthcare professionals, researchers, and women with prior GDM through an international two-round electronic-Delphi survey. Outcomes retained required round two scores above prespecified thresholds (≥70% scoring 7–9) or expert panel endorsement when scores were indeterminate. The panel organized the COS by domain.Results115 stakeholders participated in the survey and 56 completed both rounds. SD of scores decreased by 0.24 (95%CI 0.21 to 0.27) by round 2, signaling convergence. The final COS includes 19 domains (50 outcom...
Open Journal of Obstetrics and Gynecology, 2016
This study is aimed to evaluate the effectiveness of an intensive lifestyle counselling (ILC) designed to prevent gestational diabetes mellitus (GDM) among high risk mothers. A quasi-experimental trial was conducted in four selected health clinics (two clinics for intervention and two clinics for control) in Negeri Sembilan, Malaysia. Of the 320 subjects recruited, 148 respondents in the intervention group and 150 respondents in the control group had completed the study (response rate 93.1%). The intervention group was given a routine antenatal care (RC) and a package of structured ILC sessions on diet, physical activity (PA) and information on appropriate gestational weight gain (GWG) in five routine antenatal care visits until 39 weeks' gestation. The controls received only the RC. Both groups are comparable for sociodemographic characteristics (p < 0.05). GDM incidence is higher in control group (16.7%) compared to intervention group (6.1%), p = 0.046. After controlling the covariates, the intervention group consistently showed protective for developing GDM, (aOR: 0.25, CI: 0.18-0.23, p = 0.003). The intervention group had significantly increased in PA (moderate intensity) mean score (660.3 ± 289.4 Met/min) compared to control group (571.36 ± 230.38 Met/min), F(1, 296) = 10.418, p < 0.001 and comply to dietary recommendation (50.7% in intervention versus 16.7% in control), p < 0.001. Total GWG significantly lesser in intervention (11.4 ± 2.5 Kg) than the control group (12.7 ± 2.9 Kg), p < 001. An ILC can reduce GDM incidence, by increasing PA, increase compliance to the dietary intake recommendation and lesser total GWG among high risk mothers.
International Journal of Qualitative Methods, 2021
Background Process evaluations of randomised controlled trials (RCTs) can provide insight and inform us on the intervention implementation, the causal mechanisms and the contextual factors. This will inform about interventions’ success or failure due to their implementation or the interventions themselves. We aim to consolidate the methodology from previous process evaluations of complex interventions upon their findings on facilitators and barriers to address the prevention of type 2 diabetes mellitus among women with gestational diabetes mellitus (GDM). Methods Comprehensive search will be conducted on electronic databases and reference lists of recent reviews for RCTs of complex interventions which address process evaluations of diabetes prevention intervention (DPI) for women with GDM in healthcare settings. There is no restriction on the language of the papers and year of publication until December 2020. Data from each study will be extracted by two reviewers independently usin...
The Melbourne Diabetes Prevention Study (MDPS): study protocol for a randomized controlled trial
Trials, 2013
Background: Worldwide, type 2 diabetes (T2DM) prevalence has more than doubled over two decades. In Australia, diabetes is the second highest contributor to the burden of disease. Lifestyle modification programs comprising diet changes, weight loss and moderate physical activity, have been proven to reduce the incidence of T2DM in high risk individuals. As part of the Council of Australia Governments, the State of Victoria committed to develop and support the diabetes prevention program 'Life! Taking action on diabetes' (Life!) which has direct lineage from effective clinical and implementation trials from Finland and Australia. The Melbourne Diabetes Prevention Study (MDPS) has been set up to evaluate the effectiveness and cost-effectiveness of a specific version of the Life! program. Methods/design: We intend to recruit 796 participants for this open randomized clinical trial; 398 will be allocated to the intervention arm and 398 to the usual care arm. Several methods of recruitment will be used in order to maximize the number of participants. Individuals aged 50 to 75 years will be screened with a risk tool (AUSDRISK) to detect those at high risk of developing T2DM. Those with existing diabetes will be excluded. Intervention participants will undergo anthropometric and laboratory tests, and comprehensive surveys at baseline, following the fourth group session (approximately three months after the commencement of the intervention) and 12 months after commencement of the intervention, while control participants will undergo testing at baseline and 12 months only. The intervention consists of an initial individual session followed by a series of five structured-group sessions. The first four group sessions will be carried out at two week intervals and the fifth session will occur eight months after the first group session. The intervention is based on the Health Action Process Approach (HAPA) model and sessions will empower and enable the participants to follow the five goals of the Life! program. Discussion: This study will determine whether the effect of this intervention is larger than the effect of usual care in reducing central obesity and cardiovascular risk factors and thus the risk of developing diabetes and cardiovascular disease. Also it will evaluate how these two options compare economically. Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12609000507280