Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention

study protocol for a randomized controlled trial

Sophy Shih, Nathalie Davis-Lameloise, Edward Janus, Carol Wildey, Vincent Versace, Virginia Hagger, Dino Asproloupos, Sharleen O'Reilly, Paddy Phillips, Michael Ackland, Timothy Skinner, Jeremy Oats, Rob Carter, James Best, James Dunbar

    Research output: Contribution to journalComment/debateResearch

    1 Downloads (Pure)

    Abstract

    Background: Gestational diabetes mellitus (GDM) is defined as glucose intolerance with its onset or first recognition during pregnancy. Post-GDM women have a life-time risk exceeding 70% of developing type 2 diabetes mellitus (T2DM). Lifestyle modifications reduce the incidence of T2DM by up to 58% for high-risk individuals.


    Methods/Design: The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial aiming to assess the effectiveness of a structured diabetes prevention intervention for post-GDM women. This trial has an intervention group participating in a diabetes prevention program (DPP), and a control group receiving usual care from their general practitioners during the same time period. The 12-month intervention comprises an individual session followed by five group sessions at two-week intervals, and two follow-up telephone calls. A total of 574 women will be recruited, with 287 in each arm. The women will undergo blood tests, anthropometric measurements, and self-reported health status, diet, physical activity, quality of life, depression, risk perception and healthcare service usage, at baseline and 12 months. At completion, primary outcome (changes in diabetes risk) and secondary outcome (changes in psychosocial and quality of life measurements and in cardiovascular disease risk factors) will be assessed in both groups.


    Discussion: This study aims to show whether MAGDA-DPP leads to a reduction in diabetes risk for post-GDM women. The characteristics that predict intervention completion and improvement in clinical and behavioral measures will be useful for further development of DPPs for this population.

    Original languageEnglish
    Article number339
    Pages (from-to)1-10
    Number of pages10
    JournalTrials
    Volume14
    DOIs
    Publication statusPublished - 17 Oct 2013

    Fingerprint

    Gestational Diabetes
    Randomized Controlled Trials
    Mothers
    Hematologic Tests
    Telephone
    General Practitioners
    Health Status
    Life Style
    Cardiovascular Diseases
    Quality of Life
    Exercise
    Depression
    Diet
    Delivery of Health Care
    Pregnancy
    Control Groups
    Incidence
    Population

    Cite this

    Shih, Sophy ; Davis-Lameloise, Nathalie ; Janus, Edward ; Wildey, Carol ; Versace, Vincent ; Hagger, Virginia ; Asproloupos, Dino ; O'Reilly, Sharleen ; Phillips, Paddy ; Ackland, Michael ; Skinner, Timothy ; Oats, Jeremy ; Carter, Rob ; Best, James ; Dunbar, James. / Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention : study protocol for a randomized controlled trial. In: Trials. 2013 ; Vol. 14. pp. 1-10.
    @article{53e0a8520e304ed9b3952c583a17e176,
    title = "Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: study protocol for a randomized controlled trial",
    abstract = "Background: Gestational diabetes mellitus (GDM) is defined as glucose intolerance with its onset or first recognition during pregnancy. Post-GDM women have a life-time risk exceeding 70{\%} of developing type 2 diabetes mellitus (T2DM). Lifestyle modifications reduce the incidence of T2DM by up to 58{\%} for high-risk individuals. Methods/Design: The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial aiming to assess the effectiveness of a structured diabetes prevention intervention for post-GDM women. This trial has an intervention group participating in a diabetes prevention program (DPP), and a control group receiving usual care from their general practitioners during the same time period. The 12-month intervention comprises an individual session followed by five group sessions at two-week intervals, and two follow-up telephone calls. A total of 574 women will be recruited, with 287 in each arm. The women will undergo blood tests, anthropometric measurements, and self-reported health status, diet, physical activity, quality of life, depression, risk perception and healthcare service usage, at baseline and 12 months. At completion, primary outcome (changes in diabetes risk) and secondary outcome (changes in psychosocial and quality of life measurements and in cardiovascular disease risk factors) will be assessed in both groups. Discussion: This study aims to show whether MAGDA-DPP leads to a reduction in diabetes risk for post-GDM women. The characteristics that predict intervention completion and improvement in clinical and behavioral measures will be useful for further development of DPPs for this population.",
    keywords = "cholesterol, glucose, hemoglobin A1c, high density lipoprotein cholesterol, low density lipoprotein cholesterol, article, attitude to health, Australia, blood pressure, body weight, cardiovascular disease, cardiovascular risk, cholesterol blood level, controlled study, depression, diet supplementation, female, follow up, general practitioner, glucose blood level, health care utilization, health status, hemoglobin blood level, human, intervention study, lifestyle modification, major clinical study, multicenter study, non insulin dependent diabetes mellitus, outcome assessment, physical activity, postnatal care, pregnancy diabetes mellitus, quality of life, randomized controlled trial, risk assessment, risk factor, self report, teleconsultation, waist circumference, Clinical Protocols, Diabetes Mellitus, Type 2, Diabetes, Gestational, Female, Humans, Postnatal Care, Pregnancy, Prospective Studies, Research Design, Risk Factors, Risk Reduction Behavior, Time Factors, Treatment Outcome",
    author = "Sophy Shih and Nathalie Davis-Lameloise and Edward Janus and Carol Wildey and Vincent Versace and Virginia Hagger and Dino Asproloupos and Sharleen O'Reilly and Paddy Phillips and Michael Ackland and Timothy Skinner and Jeremy Oats and Rob Carter and James Best and James Dunbar",
    year = "2013",
    month = "10",
    day = "17",
    doi = "10.1186/1745-6215-14-339",
    language = "English",
    volume = "14",
    pages = "1--10",
    journal = "Trials",
    issn = "1745-6215",
    publisher = "BioMed Central",

    }

    Shih, S, Davis-Lameloise, N, Janus, E, Wildey, C, Versace, V, Hagger, V, Asproloupos, D, O'Reilly, S, Phillips, P, Ackland, M, Skinner, T, Oats, J, Carter, R, Best, J & Dunbar, J 2013, 'Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: study protocol for a randomized controlled trial', Trials, vol. 14, 339, pp. 1-10. https://doi.org/10.1186/1745-6215-14-339

    Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention : study protocol for a randomized controlled trial. / Shih, Sophy; Davis-Lameloise, Nathalie; Janus, Edward; Wildey, Carol; Versace, Vincent; Hagger, Virginia; Asproloupos, Dino; O'Reilly, Sharleen; Phillips, Paddy; Ackland, Michael; Skinner, Timothy; Oats, Jeremy; Carter, Rob; Best, James; Dunbar, James.

    In: Trials, Vol. 14, 339, 17.10.2013, p. 1-10.

    Research output: Contribution to journalComment/debateResearch

    TY - JOUR

    T1 - Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention

    T2 - study protocol for a randomized controlled trial

    AU - Shih, Sophy

    AU - Davis-Lameloise, Nathalie

    AU - Janus, Edward

    AU - Wildey, Carol

    AU - Versace, Vincent

    AU - Hagger, Virginia

    AU - Asproloupos, Dino

    AU - O'Reilly, Sharleen

    AU - Phillips, Paddy

    AU - Ackland, Michael

    AU - Skinner, Timothy

    AU - Oats, Jeremy

    AU - Carter, Rob

    AU - Best, James

    AU - Dunbar, James

    PY - 2013/10/17

    Y1 - 2013/10/17

    N2 - Background: Gestational diabetes mellitus (GDM) is defined as glucose intolerance with its onset or first recognition during pregnancy. Post-GDM women have a life-time risk exceeding 70% of developing type 2 diabetes mellitus (T2DM). Lifestyle modifications reduce the incidence of T2DM by up to 58% for high-risk individuals. Methods/Design: The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial aiming to assess the effectiveness of a structured diabetes prevention intervention for post-GDM women. This trial has an intervention group participating in a diabetes prevention program (DPP), and a control group receiving usual care from their general practitioners during the same time period. The 12-month intervention comprises an individual session followed by five group sessions at two-week intervals, and two follow-up telephone calls. A total of 574 women will be recruited, with 287 in each arm. The women will undergo blood tests, anthropometric measurements, and self-reported health status, diet, physical activity, quality of life, depression, risk perception and healthcare service usage, at baseline and 12 months. At completion, primary outcome (changes in diabetes risk) and secondary outcome (changes in psychosocial and quality of life measurements and in cardiovascular disease risk factors) will be assessed in both groups. Discussion: This study aims to show whether MAGDA-DPP leads to a reduction in diabetes risk for post-GDM women. The characteristics that predict intervention completion and improvement in clinical and behavioral measures will be useful for further development of DPPs for this population.

    AB - Background: Gestational diabetes mellitus (GDM) is defined as glucose intolerance with its onset or first recognition during pregnancy. Post-GDM women have a life-time risk exceeding 70% of developing type 2 diabetes mellitus (T2DM). Lifestyle modifications reduce the incidence of T2DM by up to 58% for high-risk individuals. Methods/Design: The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial aiming to assess the effectiveness of a structured diabetes prevention intervention for post-GDM women. This trial has an intervention group participating in a diabetes prevention program (DPP), and a control group receiving usual care from their general practitioners during the same time period. The 12-month intervention comprises an individual session followed by five group sessions at two-week intervals, and two follow-up telephone calls. A total of 574 women will be recruited, with 287 in each arm. The women will undergo blood tests, anthropometric measurements, and self-reported health status, diet, physical activity, quality of life, depression, risk perception and healthcare service usage, at baseline and 12 months. At completion, primary outcome (changes in diabetes risk) and secondary outcome (changes in psychosocial and quality of life measurements and in cardiovascular disease risk factors) will be assessed in both groups. Discussion: This study aims to show whether MAGDA-DPP leads to a reduction in diabetes risk for post-GDM women. The characteristics that predict intervention completion and improvement in clinical and behavioral measures will be useful for further development of DPPs for this population.

    KW - cholesterol

    KW - glucose

    KW - hemoglobin A1c

    KW - high density lipoprotein cholesterol

    KW - low density lipoprotein cholesterol

    KW - article

    KW - attitude to health

    KW - Australia

    KW - blood pressure

    KW - body weight

    KW - cardiovascular disease

    KW - cardiovascular risk

    KW - cholesterol blood level

    KW - controlled study

    KW - depression

    KW - diet supplementation

    KW - female

    KW - follow up

    KW - general practitioner

    KW - glucose blood level

    KW - health care utilization

    KW - health status

    KW - hemoglobin blood level

    KW - human

    KW - intervention study

    KW - lifestyle modification

    KW - major clinical study

    KW - multicenter study

    KW - non insulin dependent diabetes mellitus

    KW - outcome assessment

    KW - physical activity

    KW - postnatal care

    KW - pregnancy diabetes mellitus

    KW - quality of life

    KW - randomized controlled trial

    KW - risk assessment

    KW - risk factor

    KW - self report

    KW - teleconsultation

    KW - waist circumference

    KW - Clinical Protocols

    KW - Diabetes Mellitus, Type 2

    KW - Diabetes, Gestational

    KW - Female

    KW - Humans

    KW - Postnatal Care

    KW - Pregnancy

    KW - Prospective Studies

    KW - Research Design

    KW - Risk Factors

    KW - Risk Reduction Behavior

    KW - Time Factors

    KW - Treatment Outcome

    U2 - 10.1186/1745-6215-14-339

    DO - 10.1186/1745-6215-14-339

    M3 - Comment/debate

    VL - 14

    SP - 1

    EP - 10

    JO - Trials

    JF - Trials

    SN - 1745-6215

    M1 - 339

    ER -