PubMed:23829946 JSONTXT

{"target":"https://pubannotation.org/docs/sourcedb/PubMed/sourceid/23829946","sourcedb":"PubMed","sourceid":"23829946","source_url":"http://www.ncbi.nlm.nih.gov/pubmed/23829946","text":"DALI: Vitamin D and lifestyle intervention for gestational diabetes mellitus (GDM) prevention: an European multicentre, randomised trial - study protocol.\nBACKGROUND: Gestational diabetes mellitus (GDM) is an increasing problem world-wide. Lifestyle interventions and/or vitamin D supplementation might help prevent GDM in some women.\nMETHODS/DESIGN: Pregnant women at risk of GDM (BMI ≥ 29 (kg/m(2))) from 9 European countries will be invited to participate and consent obtained before 19+6 weeks of gestation. After giving informed consent, women without GDM will be included (based on IADPSG criteria: fasting glucose\u003c5.1 mmol; 1 hour glucose \u003c10.0 mmol; 2 hour glucose \u003c8.5 mmol) and randomized to one of the 8 intervention arms using a 2 × (2 × 2) factorial design: (1) healthy eating (HE), 2) physical activity (PA), 3) HE+PA, 4) control, 5) HE+PA+vitamin D, 6) HE+PA+placebo, 7) vitamin D alone, 8) placebo alone), pre-stratified for each site. In total, 880 women will be included with 110 women allocated to each arm. Between entry and 35 weeks of gestation, women allocated to a lifestyle intervention will receive 5 face-to-face, and 4 telephone coaching sessions, based on the principles of motivational interviewing. The lifestyle intervention includes a discussion about the risks of GDM, a weight gain target \u003c5 kg and either 7 healthy eating 'messages' and/or 5 physical activity 'messages' depending on randomization. Fidelity is monitored by the use of a personal digital assistance (PDA) system. Participants randomized to the vitamin D intervention receive either 1600 IU vitamin D or placebo for daily intake until delivery. Data is collected at baseline measurement, at 24-28 weeks, 35-37 weeks of gestation and after delivery. Primary outcome measures are gestational weight gain, fasting glucose and insulin sensitivity, with a range of obstetric secondary outcome measures including birth weight.\nDISCUSSION: DALI is a unique Europe-wide randomised controlled trial, which will gain insight into preventive measures against the development of GDM in overweight and obese women.\nTRIAL REGISTRATION: ISRCTN70595832.","tracks":[{"project":"Allie","denotations":[{"id":"SS1_23829946_0_0","span":{"begin":47,"end":76},"obj":"expanded"},{"id":"SS2_23829946_0_0","span":{"begin":78,"end":81},"obj":"abbr"},{"id":"SS1_23829946_2_0","span":{"begin":167,"end":196},"obj":"expanded"},{"id":"SS2_23829946_2_0","span":{"begin":198,"end":201},"obj":"abbr"},{"id":"SS1_23829946_6_0","span":{"begin":775,"end":789},"obj":"expanded"},{"id":"SS2_23829946_6_0","span":{"begin":791,"end":793},"obj":"abbr"},{"id":"SS1_23829946_6_1","span":{"begin":799,"end":816},"obj":"expanded"},{"id":"SS2_23829946_6_1","span":{"begin":818,"end":820},"obj":"abbr"},{"id":"SS1_23829946_10_0","span":{"begin":1473,"end":1500},"obj":"expanded"},{"id":"SS2_23829946_10_0","span":{"begin":1502,"end":1505},"obj":"abbr"}],"relations":[{"id":"AE1_23829946_0_0","pred":"abbreviatedTo","subj":"SS1_23829946_0_0","obj":"SS2_23829946_0_0"},{"id":"AE1_23829946_2_0","pred":"abbreviatedTo","subj":"SS1_23829946_2_0","obj":"SS2_23829946_2_0"},{"id":"AE1_23829946_6_0","pred":"abbreviatedTo","subj":"SS1_23829946_6_0","obj":"SS2_23829946_6_0"},{"id":"AE1_23829946_6_1","pred":"abbreviatedTo","subj":"SS1_23829946_6_1","obj":"SS2_23829946_6_1"},{"id":"AE1_23829946_10_0","pred":"abbreviatedTo","subj":"SS1_23829946_10_0","obj":"SS2_23829946_10_0"}],"attributes":[{"subj":"SS1_23829946_0_0","pred":"source","obj":"Allie"},{"subj":"SS2_23829946_0_0","pred":"source","obj":"Allie"},{"subj":"SS1_23829946_2_0","pred":"source","obj":"Allie"},{"subj":"SS2_23829946_2_0","pred":"source","obj":"Allie"},{"subj":"SS1_23829946_6_0","pred":"source","obj":"Allie"},{"subj":"SS2_23829946_6_0","pred":"source","obj":"Allie"},{"subj":"SS1_23829946_6_1","pred":"source","obj":"Allie"},{"subj":"SS2_23829946_6_1","pred":"source","obj":"Allie"},{"subj":"SS1_23829946_10_0","pred":"source","obj":"Allie"},{"subj":"SS2_23829946_10_0","pred":"source","obj":"Allie"}]},{"project":"PubmedHPO","denotations":[{"id":"T1","span":{"begin":167,"end":187},"obj":"HP_0009800"},{"id":"T2","span":{"begin":179,"end":196},"obj":"HP_0000819"}],"attributes":[{"subj":"T1","pred":"source","obj":"PubmedHPO"},{"subj":"T2","pred":"source","obj":"PubmedHPO"}]},{"project":"maxiaofeng52_800_3","denotations":[{"id":"T1","span":{"begin":6,"end":15},"obj":"CI"},{"id":"T2","span":{"begin":271,"end":280},"obj":"CI"},{"id":"T3","span":{"begin":854,"end":863},"obj":"CI"},{"id":"T4","span":{"begin":886,"end":895},"obj":"CI"},{"id":"T5","span":{"begin":1546,"end":1555},"obj":"CI"},{"id":"T6","span":{"begin":1592,"end":1601},"obj":"CI"},{"id":"T7","span":{"begin":1605,"end":1612},"obj":"CI"},{"id":"T8","span":{"begin":874,"end":881},"obj":"CI"},{"id":"T9","span":{"begin":906,"end":913},"obj":"CI"}],"attributes":[{"subj":"T1","pred":"source","obj":"maxiaofeng52_800_3"},{"subj":"T2","pred":"source","obj":"maxiaofeng52_800_3"},{"subj":"T3","pred":"source","obj":"maxiaofeng52_800_3"},{"subj":"T4","pred":"source","obj":"maxiaofeng52_800_3"},{"subj":"T5","pred":"source","obj":"maxiaofeng52_800_3"},{"subj":"T6","pred":"source","obj":"maxiaofeng52_800_3"},{"subj":"T7","pred":"source","obj":"maxiaofeng52_800_3"},{"subj":"T8","pred":"source","obj":"maxiaofeng52_800_3"},{"subj":"T9","pred":"source","obj":"maxiaofeng52_800_3"}]},{"project":"wangzhuo19_800_3","denotations":[{"id":"T1","span":{"begin":6,"end":15},"obj":"CI"},{"id":"T2","span":{"begin":271,"end":280},"obj":"CI"},{"id":"T3","span":{"begin":854,"end":863},"obj":"CI"},{"id":"T4","span":{"begin":886,"end":895},"obj":"CI"},{"id":"T5","span":{"begin":1546,"end":1555},"obj":"CI"},{"id":"T6","span":{"begin":1592,"end":1601},"obj":"CI"},{"id":"T7","span":{"begin":874,"end":881},"obj":"CI"},{"id":"T8","span":{"begin":906,"end":913},"obj":"CI"},{"id":"T9","span":{"begin":1605,"end":1612},"obj":"CI"}],"attributes":[{"subj":"T1","pred":"source","obj":"wangzhuo19_800_3"},{"subj":"T2","pred":"source","obj":"wangzhuo19_800_3"},{"subj":"T3","pred":"source","obj":"wangzhuo19_800_3"},{"subj":"T4","pred":"source","obj":"wangzhuo19_800_3"},{"subj":"T5","pred":"source","obj":"wangzhuo19_800_3"},{"subj":"T6","pred":"source","obj":"wangzhuo19_800_3"},{"subj":"T7","pred":"source","obj":"wangzhuo19_800_3"},{"subj":"T8","pred":"source","obj":"wangzhuo19_800_3"},{"subj":"T9","pred":"source","obj":"wangzhuo19_800_3"}]}],"config":{"attribute types":[{"pred":"source","value type":"selection","values":[{"id":"Allie","color":"#93baec","default":true},{"id":"PubmedHPO","color":"#d4ec93"},{"id":"maxiaofeng52_800_3","color":"#ea93ec"},{"id":"wangzhuo19_800_3","color":"#93ecd0"}]}]}}