Limiting weight gain in overweight and obese women during pregnancy to improve health outcomes: the LIMIT randomised controlled trial
Background Obesity is a significant global health problem, with the proportion of women entering pregnancy with a body mass index greater than or equal to 25 kg/$ m^{2} $ approaching 50%. Obesity during pregnancy is associated with a well-recognised increased risk of adverse health outcomes both for...
Ausführliche Beschreibung
Autor*in: |
Dodd, Jodie M [verfasserIn] |
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E-Artikel |
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Englisch |
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2011 |
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Anmerkung: |
© Dodd et al; licensee BioMed Central Ltd. 2011 |
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Übergeordnetes Werk: |
Enthalten in: BMC pregnancy and childbirth - London : BioMed Central, 2001, 11(2011), 1 vom: 26. Okt. |
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Übergeordnetes Werk: |
volume:11 ; year:2011 ; number:1 ; day:26 ; month:10 |
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DOI / URN: |
10.1186/1471-2393-11-79 |
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SPR027566153 |
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520 | |a Background Obesity is a significant global health problem, with the proportion of women entering pregnancy with a body mass index greater than or equal to 25 kg/$ m^{2} $ approaching 50%. Obesity during pregnancy is associated with a well-recognised increased risk of adverse health outcomes both for the woman and her infant, however there is more limited information available regarding effective interventions to improve health outcomes. The aims of this randomised controlled trial are to assess whether the implementation of a package of dietary and lifestyle advice to overweight and obese women during pregnancy to limit gestational weight gain is effective in improving maternal, fetal and infant health outcomes. Methods/Design Design: Multicentred randomised, controlled trial. Inclusion Criteria: Women with a singleton, live gestation between $ 10^{+0} $-$ 20^{+0} $ weeks who are obese or overweight (defined as body mass index greater than or equal to 25 kg/$ m^{2} $), at the first antenatal visit. Trial Entry & Randomisation: Eligible, consenting women will be randomised between $ 10^{+0} $ and $ 20^{+0} $ weeks gestation using a central telephone randomisation service, and randomisation schedule prepared by non-clinical research staff with balanced variable blocks. Stratification will be according to maternal BMI at trial entry, parity, and centre where planned to give birth. Treatment Schedules: Women randomised to the Dietary and Lifestyle Advice Group will receive a series of inputs from research assistants and research dietician to limit gestational weight gain, and will include a combination of dietary, exercise and behavioural strategies. Women randomised to the Standard Care Group will continue to receive their pregnancy care according to local hospital guidelines, which does not currently include routine provision of dietary, lifestyle and behavioural advice. Outcome assessors will be blinded to the allocated treatment group. Primary Study Outcome: infant large for gestational age (defined as infant birth weight ≥ $ 90^{th} $ centile for gestational age). Sample Size: 2,180 women to detect a 30% reduction in large for gestational age infants from 14.40% (p = 0.05, 80% power, two-tailed). Discussion This is a protocol for a randomised trial. The findings will contribute to the development of evidence based clinical practice guidelines. Trial Registration Australian and New Zealand Clinical Trials Registry ACTRN12607000161426 | ||
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700 | 1 | |a Crowther, Caroline A |4 aut | |
700 | 1 | |a Robinson, Jeffrey S |4 aut | |
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10.1186/1471-2393-11-79 doi (DE-627)SPR027566153 (SPR)1471-2393-11-79-e DE-627 ger DE-627 rakwb eng Dodd, Jodie M verfasserin aut Limiting weight gain in overweight and obese women during pregnancy to improve health outcomes: the LIMIT randomised controlled trial 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Dodd et al; licensee BioMed Central Ltd. 2011 Background Obesity is a significant global health problem, with the proportion of women entering pregnancy with a body mass index greater than or equal to 25 kg/$ m^{2} $ approaching 50%. Obesity during pregnancy is associated with a well-recognised increased risk of adverse health outcomes both for the woman and her infant, however there is more limited information available regarding effective interventions to improve health outcomes. The aims of this randomised controlled trial are to assess whether the implementation of a package of dietary and lifestyle advice to overweight and obese women during pregnancy to limit gestational weight gain is effective in improving maternal, fetal and infant health outcomes. Methods/Design Design: Multicentred randomised, controlled trial. Inclusion Criteria: Women with a singleton, live gestation between $ 10^{+0} $-$ 20^{+0} $ weeks who are obese or overweight (defined as body mass index greater than or equal to 25 kg/$ m^{2} $), at the first antenatal visit. Trial Entry & Randomisation: Eligible, consenting women will be randomised between $ 10^{+0} $ and $ 20^{+0} $ weeks gestation using a central telephone randomisation service, and randomisation schedule prepared by non-clinical research staff with balanced variable blocks. Stratification will be according to maternal BMI at trial entry, parity, and centre where planned to give birth. Treatment Schedules: Women randomised to the Dietary and Lifestyle Advice Group will receive a series of inputs from research assistants and research dietician to limit gestational weight gain, and will include a combination of dietary, exercise and behavioural strategies. Women randomised to the Standard Care Group will continue to receive their pregnancy care according to local hospital guidelines, which does not currently include routine provision of dietary, lifestyle and behavioural advice. Outcome assessors will be blinded to the allocated treatment group. Primary Study Outcome: infant large for gestational age (defined as infant birth weight ≥ $ 90^{th} $ centile for gestational age). Sample Size: 2,180 women to detect a 30% reduction in large for gestational age infants from 14.40% (p = 0.05, 80% power, two-tailed). Discussion This is a protocol for a randomised trial. The findings will contribute to the development of evidence based clinical practice guidelines. Trial Registration Australian and New Zealand Clinical Trials Registry ACTRN12607000161426 Obese Woman (dpeaa)DE-He213 Gestational Weight Gain (dpeaa)DE-He213 Body Mass Index Category (dpeaa)DE-He213 Lifestyle Advice (dpeaa)DE-He213 Maternal Body Mass Index (dpeaa)DE-He213 Turnbull, Deborah A aut McPhee, Andrew J aut Wittert, Gary aut Crowther, Caroline A aut Robinson, Jeffrey S aut Enthalten in BMC pregnancy and childbirth London : BioMed Central, 2001 11(2011), 1 vom: 26. Okt. (DE-627)335489087 (DE-600)2059869-5 1471-2393 nnns volume:11 year:2011 number:1 day:26 month:10 https://dx.doi.org/10.1186/1471-2393-11-79 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 11 2011 1 26 10 |
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10.1186/1471-2393-11-79 doi (DE-627)SPR027566153 (SPR)1471-2393-11-79-e DE-627 ger DE-627 rakwb eng Dodd, Jodie M verfasserin aut Limiting weight gain in overweight and obese women during pregnancy to improve health outcomes: the LIMIT randomised controlled trial 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Dodd et al; licensee BioMed Central Ltd. 2011 Background Obesity is a significant global health problem, with the proportion of women entering pregnancy with a body mass index greater than or equal to 25 kg/$ m^{2} $ approaching 50%. Obesity during pregnancy is associated with a well-recognised increased risk of adverse health outcomes both for the woman and her infant, however there is more limited information available regarding effective interventions to improve health outcomes. The aims of this randomised controlled trial are to assess whether the implementation of a package of dietary and lifestyle advice to overweight and obese women during pregnancy to limit gestational weight gain is effective in improving maternal, fetal and infant health outcomes. Methods/Design Design: Multicentred randomised, controlled trial. Inclusion Criteria: Women with a singleton, live gestation between $ 10^{+0} $-$ 20^{+0} $ weeks who are obese or overweight (defined as body mass index greater than or equal to 25 kg/$ m^{2} $), at the first antenatal visit. Trial Entry & Randomisation: Eligible, consenting women will be randomised between $ 10^{+0} $ and $ 20^{+0} $ weeks gestation using a central telephone randomisation service, and randomisation schedule prepared by non-clinical research staff with balanced variable blocks. Stratification will be according to maternal BMI at trial entry, parity, and centre where planned to give birth. Treatment Schedules: Women randomised to the Dietary and Lifestyle Advice Group will receive a series of inputs from research assistants and research dietician to limit gestational weight gain, and will include a combination of dietary, exercise and behavioural strategies. Women randomised to the Standard Care Group will continue to receive their pregnancy care according to local hospital guidelines, which does not currently include routine provision of dietary, lifestyle and behavioural advice. Outcome assessors will be blinded to the allocated treatment group. Primary Study Outcome: infant large for gestational age (defined as infant birth weight ≥ $ 90^{th} $ centile for gestational age). Sample Size: 2,180 women to detect a 30% reduction in large for gestational age infants from 14.40% (p = 0.05, 80% power, two-tailed). Discussion This is a protocol for a randomised trial. The findings will contribute to the development of evidence based clinical practice guidelines. Trial Registration Australian and New Zealand Clinical Trials Registry ACTRN12607000161426 Obese Woman (dpeaa)DE-He213 Gestational Weight Gain (dpeaa)DE-He213 Body Mass Index Category (dpeaa)DE-He213 Lifestyle Advice (dpeaa)DE-He213 Maternal Body Mass Index (dpeaa)DE-He213 Turnbull, Deborah A aut McPhee, Andrew J aut Wittert, Gary aut Crowther, Caroline A aut Robinson, Jeffrey S aut Enthalten in BMC pregnancy and childbirth London : BioMed Central, 2001 11(2011), 1 vom: 26. Okt. (DE-627)335489087 (DE-600)2059869-5 1471-2393 nnns volume:11 year:2011 number:1 day:26 month:10 https://dx.doi.org/10.1186/1471-2393-11-79 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 11 2011 1 26 10 |
allfields_unstemmed |
10.1186/1471-2393-11-79 doi (DE-627)SPR027566153 (SPR)1471-2393-11-79-e DE-627 ger DE-627 rakwb eng Dodd, Jodie M verfasserin aut Limiting weight gain in overweight and obese women during pregnancy to improve health outcomes: the LIMIT randomised controlled trial 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Dodd et al; licensee BioMed Central Ltd. 2011 Background Obesity is a significant global health problem, with the proportion of women entering pregnancy with a body mass index greater than or equal to 25 kg/$ m^{2} $ approaching 50%. Obesity during pregnancy is associated with a well-recognised increased risk of adverse health outcomes both for the woman and her infant, however there is more limited information available regarding effective interventions to improve health outcomes. The aims of this randomised controlled trial are to assess whether the implementation of a package of dietary and lifestyle advice to overweight and obese women during pregnancy to limit gestational weight gain is effective in improving maternal, fetal and infant health outcomes. Methods/Design Design: Multicentred randomised, controlled trial. Inclusion Criteria: Women with a singleton, live gestation between $ 10^{+0} $-$ 20^{+0} $ weeks who are obese or overweight (defined as body mass index greater than or equal to 25 kg/$ m^{2} $), at the first antenatal visit. Trial Entry & Randomisation: Eligible, consenting women will be randomised between $ 10^{+0} $ and $ 20^{+0} $ weeks gestation using a central telephone randomisation service, and randomisation schedule prepared by non-clinical research staff with balanced variable blocks. Stratification will be according to maternal BMI at trial entry, parity, and centre where planned to give birth. Treatment Schedules: Women randomised to the Dietary and Lifestyle Advice Group will receive a series of inputs from research assistants and research dietician to limit gestational weight gain, and will include a combination of dietary, exercise and behavioural strategies. Women randomised to the Standard Care Group will continue to receive their pregnancy care according to local hospital guidelines, which does not currently include routine provision of dietary, lifestyle and behavioural advice. Outcome assessors will be blinded to the allocated treatment group. Primary Study Outcome: infant large for gestational age (defined as infant birth weight ≥ $ 90^{th} $ centile for gestational age). Sample Size: 2,180 women to detect a 30% reduction in large for gestational age infants from 14.40% (p = 0.05, 80% power, two-tailed). Discussion This is a protocol for a randomised trial. The findings will contribute to the development of evidence based clinical practice guidelines. Trial Registration Australian and New Zealand Clinical Trials Registry ACTRN12607000161426 Obese Woman (dpeaa)DE-He213 Gestational Weight Gain (dpeaa)DE-He213 Body Mass Index Category (dpeaa)DE-He213 Lifestyle Advice (dpeaa)DE-He213 Maternal Body Mass Index (dpeaa)DE-He213 Turnbull, Deborah A aut McPhee, Andrew J aut Wittert, Gary aut Crowther, Caroline A aut Robinson, Jeffrey S aut Enthalten in BMC pregnancy and childbirth London : BioMed Central, 2001 11(2011), 1 vom: 26. Okt. (DE-627)335489087 (DE-600)2059869-5 1471-2393 nnns volume:11 year:2011 number:1 day:26 month:10 https://dx.doi.org/10.1186/1471-2393-11-79 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 11 2011 1 26 10 |
allfieldsGer |
10.1186/1471-2393-11-79 doi (DE-627)SPR027566153 (SPR)1471-2393-11-79-e DE-627 ger DE-627 rakwb eng Dodd, Jodie M verfasserin aut Limiting weight gain in overweight and obese women during pregnancy to improve health outcomes: the LIMIT randomised controlled trial 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Dodd et al; licensee BioMed Central Ltd. 2011 Background Obesity is a significant global health problem, with the proportion of women entering pregnancy with a body mass index greater than or equal to 25 kg/$ m^{2} $ approaching 50%. Obesity during pregnancy is associated with a well-recognised increased risk of adverse health outcomes both for the woman and her infant, however there is more limited information available regarding effective interventions to improve health outcomes. The aims of this randomised controlled trial are to assess whether the implementation of a package of dietary and lifestyle advice to overweight and obese women during pregnancy to limit gestational weight gain is effective in improving maternal, fetal and infant health outcomes. Methods/Design Design: Multicentred randomised, controlled trial. Inclusion Criteria: Women with a singleton, live gestation between $ 10^{+0} $-$ 20^{+0} $ weeks who are obese or overweight (defined as body mass index greater than or equal to 25 kg/$ m^{2} $), at the first antenatal visit. Trial Entry & Randomisation: Eligible, consenting women will be randomised between $ 10^{+0} $ and $ 20^{+0} $ weeks gestation using a central telephone randomisation service, and randomisation schedule prepared by non-clinical research staff with balanced variable blocks. Stratification will be according to maternal BMI at trial entry, parity, and centre where planned to give birth. Treatment Schedules: Women randomised to the Dietary and Lifestyle Advice Group will receive a series of inputs from research assistants and research dietician to limit gestational weight gain, and will include a combination of dietary, exercise and behavioural strategies. Women randomised to the Standard Care Group will continue to receive their pregnancy care according to local hospital guidelines, which does not currently include routine provision of dietary, lifestyle and behavioural advice. Outcome assessors will be blinded to the allocated treatment group. Primary Study Outcome: infant large for gestational age (defined as infant birth weight ≥ $ 90^{th} $ centile for gestational age). Sample Size: 2,180 women to detect a 30% reduction in large for gestational age infants from 14.40% (p = 0.05, 80% power, two-tailed). Discussion This is a protocol for a randomised trial. The findings will contribute to the development of evidence based clinical practice guidelines. Trial Registration Australian and New Zealand Clinical Trials Registry ACTRN12607000161426 Obese Woman (dpeaa)DE-He213 Gestational Weight Gain (dpeaa)DE-He213 Body Mass Index Category (dpeaa)DE-He213 Lifestyle Advice (dpeaa)DE-He213 Maternal Body Mass Index (dpeaa)DE-He213 Turnbull, Deborah A aut McPhee, Andrew J aut Wittert, Gary aut Crowther, Caroline A aut Robinson, Jeffrey S aut Enthalten in BMC pregnancy and childbirth London : BioMed Central, 2001 11(2011), 1 vom: 26. Okt. (DE-627)335489087 (DE-600)2059869-5 1471-2393 nnns volume:11 year:2011 number:1 day:26 month:10 https://dx.doi.org/10.1186/1471-2393-11-79 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 11 2011 1 26 10 |
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10.1186/1471-2393-11-79 doi (DE-627)SPR027566153 (SPR)1471-2393-11-79-e DE-627 ger DE-627 rakwb eng Dodd, Jodie M verfasserin aut Limiting weight gain in overweight and obese women during pregnancy to improve health outcomes: the LIMIT randomised controlled trial 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Dodd et al; licensee BioMed Central Ltd. 2011 Background Obesity is a significant global health problem, with the proportion of women entering pregnancy with a body mass index greater than or equal to 25 kg/$ m^{2} $ approaching 50%. Obesity during pregnancy is associated with a well-recognised increased risk of adverse health outcomes both for the woman and her infant, however there is more limited information available regarding effective interventions to improve health outcomes. The aims of this randomised controlled trial are to assess whether the implementation of a package of dietary and lifestyle advice to overweight and obese women during pregnancy to limit gestational weight gain is effective in improving maternal, fetal and infant health outcomes. Methods/Design Design: Multicentred randomised, controlled trial. Inclusion Criteria: Women with a singleton, live gestation between $ 10^{+0} $-$ 20^{+0} $ weeks who are obese or overweight (defined as body mass index greater than or equal to 25 kg/$ m^{2} $), at the first antenatal visit. Trial Entry & Randomisation: Eligible, consenting women will be randomised between $ 10^{+0} $ and $ 20^{+0} $ weeks gestation using a central telephone randomisation service, and randomisation schedule prepared by non-clinical research staff with balanced variable blocks. Stratification will be according to maternal BMI at trial entry, parity, and centre where planned to give birth. Treatment Schedules: Women randomised to the Dietary and Lifestyle Advice Group will receive a series of inputs from research assistants and research dietician to limit gestational weight gain, and will include a combination of dietary, exercise and behavioural strategies. Women randomised to the Standard Care Group will continue to receive their pregnancy care according to local hospital guidelines, which does not currently include routine provision of dietary, lifestyle and behavioural advice. Outcome assessors will be blinded to the allocated treatment group. Primary Study Outcome: infant large for gestational age (defined as infant birth weight ≥ $ 90^{th} $ centile for gestational age). Sample Size: 2,180 women to detect a 30% reduction in large for gestational age infants from 14.40% (p = 0.05, 80% power, two-tailed). Discussion This is a protocol for a randomised trial. The findings will contribute to the development of evidence based clinical practice guidelines. Trial Registration Australian and New Zealand Clinical Trials Registry ACTRN12607000161426 Obese Woman (dpeaa)DE-He213 Gestational Weight Gain (dpeaa)DE-He213 Body Mass Index Category (dpeaa)DE-He213 Lifestyle Advice (dpeaa)DE-He213 Maternal Body Mass Index (dpeaa)DE-He213 Turnbull, Deborah A aut McPhee, Andrew J aut Wittert, Gary aut Crowther, Caroline A aut Robinson, Jeffrey S aut Enthalten in BMC pregnancy and childbirth London : BioMed Central, 2001 11(2011), 1 vom: 26. Okt. (DE-627)335489087 (DE-600)2059869-5 1471-2393 nnns volume:11 year:2011 number:1 day:26 month:10 https://dx.doi.org/10.1186/1471-2393-11-79 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 11 2011 1 26 10 |
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Limiting weight gain in overweight and obese women during pregnancy to improve health outcomes: the LIMIT randomised controlled trial |
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Background Obesity is a significant global health problem, with the proportion of women entering pregnancy with a body mass index greater than or equal to 25 kg/$ m^{2} $ approaching 50%. Obesity during pregnancy is associated with a well-recognised increased risk of adverse health outcomes both for the woman and her infant, however there is more limited information available regarding effective interventions to improve health outcomes. The aims of this randomised controlled trial are to assess whether the implementation of a package of dietary and lifestyle advice to overweight and obese women during pregnancy to limit gestational weight gain is effective in improving maternal, fetal and infant health outcomes. Methods/Design Design: Multicentred randomised, controlled trial. Inclusion Criteria: Women with a singleton, live gestation between $ 10^{+0} $-$ 20^{+0} $ weeks who are obese or overweight (defined as body mass index greater than or equal to 25 kg/$ m^{2} $), at the first antenatal visit. Trial Entry & Randomisation: Eligible, consenting women will be randomised between $ 10^{+0} $ and $ 20^{+0} $ weeks gestation using a central telephone randomisation service, and randomisation schedule prepared by non-clinical research staff with balanced variable blocks. Stratification will be according to maternal BMI at trial entry, parity, and centre where planned to give birth. Treatment Schedules: Women randomised to the Dietary and Lifestyle Advice Group will receive a series of inputs from research assistants and research dietician to limit gestational weight gain, and will include a combination of dietary, exercise and behavioural strategies. Women randomised to the Standard Care Group will continue to receive their pregnancy care according to local hospital guidelines, which does not currently include routine provision of dietary, lifestyle and behavioural advice. Outcome assessors will be blinded to the allocated treatment group. Primary Study Outcome: infant large for gestational age (defined as infant birth weight ≥ $ 90^{th} $ centile for gestational age). Sample Size: 2,180 women to detect a 30% reduction in large for gestational age infants from 14.40% (p = 0.05, 80% power, two-tailed). Discussion This is a protocol for a randomised trial. The findings will contribute to the development of evidence based clinical practice guidelines. Trial Registration Australian and New Zealand Clinical Trials Registry ACTRN12607000161426 © Dodd et al; licensee BioMed Central Ltd. 2011 |
abstractGer |
Background Obesity is a significant global health problem, with the proportion of women entering pregnancy with a body mass index greater than or equal to 25 kg/$ m^{2} $ approaching 50%. Obesity during pregnancy is associated with a well-recognised increased risk of adverse health outcomes both for the woman and her infant, however there is more limited information available regarding effective interventions to improve health outcomes. The aims of this randomised controlled trial are to assess whether the implementation of a package of dietary and lifestyle advice to overweight and obese women during pregnancy to limit gestational weight gain is effective in improving maternal, fetal and infant health outcomes. Methods/Design Design: Multicentred randomised, controlled trial. Inclusion Criteria: Women with a singleton, live gestation between $ 10^{+0} $-$ 20^{+0} $ weeks who are obese or overweight (defined as body mass index greater than or equal to 25 kg/$ m^{2} $), at the first antenatal visit. Trial Entry & Randomisation: Eligible, consenting women will be randomised between $ 10^{+0} $ and $ 20^{+0} $ weeks gestation using a central telephone randomisation service, and randomisation schedule prepared by non-clinical research staff with balanced variable blocks. Stratification will be according to maternal BMI at trial entry, parity, and centre where planned to give birth. Treatment Schedules: Women randomised to the Dietary and Lifestyle Advice Group will receive a series of inputs from research assistants and research dietician to limit gestational weight gain, and will include a combination of dietary, exercise and behavioural strategies. Women randomised to the Standard Care Group will continue to receive their pregnancy care according to local hospital guidelines, which does not currently include routine provision of dietary, lifestyle and behavioural advice. Outcome assessors will be blinded to the allocated treatment group. Primary Study Outcome: infant large for gestational age (defined as infant birth weight ≥ $ 90^{th} $ centile for gestational age). Sample Size: 2,180 women to detect a 30% reduction in large for gestational age infants from 14.40% (p = 0.05, 80% power, two-tailed). Discussion This is a protocol for a randomised trial. The findings will contribute to the development of evidence based clinical practice guidelines. Trial Registration Australian and New Zealand Clinical Trials Registry ACTRN12607000161426 © Dodd et al; licensee BioMed Central Ltd. 2011 |
abstract_unstemmed |
Background Obesity is a significant global health problem, with the proportion of women entering pregnancy with a body mass index greater than or equal to 25 kg/$ m^{2} $ approaching 50%. Obesity during pregnancy is associated with a well-recognised increased risk of adverse health outcomes both for the woman and her infant, however there is more limited information available regarding effective interventions to improve health outcomes. The aims of this randomised controlled trial are to assess whether the implementation of a package of dietary and lifestyle advice to overweight and obese women during pregnancy to limit gestational weight gain is effective in improving maternal, fetal and infant health outcomes. Methods/Design Design: Multicentred randomised, controlled trial. Inclusion Criteria: Women with a singleton, live gestation between $ 10^{+0} $-$ 20^{+0} $ weeks who are obese or overweight (defined as body mass index greater than or equal to 25 kg/$ m^{2} $), at the first antenatal visit. Trial Entry & Randomisation: Eligible, consenting women will be randomised between $ 10^{+0} $ and $ 20^{+0} $ weeks gestation using a central telephone randomisation service, and randomisation schedule prepared by non-clinical research staff with balanced variable blocks. Stratification will be according to maternal BMI at trial entry, parity, and centre where planned to give birth. Treatment Schedules: Women randomised to the Dietary and Lifestyle Advice Group will receive a series of inputs from research assistants and research dietician to limit gestational weight gain, and will include a combination of dietary, exercise and behavioural strategies. Women randomised to the Standard Care Group will continue to receive their pregnancy care according to local hospital guidelines, which does not currently include routine provision of dietary, lifestyle and behavioural advice. Outcome assessors will be blinded to the allocated treatment group. Primary Study Outcome: infant large for gestational age (defined as infant birth weight ≥ $ 90^{th} $ centile for gestational age). Sample Size: 2,180 women to detect a 30% reduction in large for gestational age infants from 14.40% (p = 0.05, 80% power, two-tailed). Discussion This is a protocol for a randomised trial. The findings will contribute to the development of evidence based clinical practice guidelines. Trial Registration Australian and New Zealand Clinical Trials Registry ACTRN12607000161426 © Dodd et al; licensee BioMed Central Ltd. 2011 |
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Limiting weight gain in overweight and obese women during pregnancy to improve health outcomes: the LIMIT randomised controlled trial |
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Turnbull, Deborah A McPhee, Andrew J Wittert, Gary Crowther, Caroline A Robinson, Jeffrey S |
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