Category
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Primary study
Registry of Trials»ANZCTR
Year
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2010
INTERVENTION: A six session group behaviour intervention program was run.The first session, an individual session with participant and facilitator, a risk assessment and goal setting session was facilitatored either face to face or over the phone, if difficulties meeting up arose. The individual session took up to an hour to complete. The remaining 5 sessions commenced two weeks after the individual session and were group based, at two week intervals. Topics included: physical activity, fats, fibre, sleep. Each session was run for approximately 2 hours, each with up to 12 participants. The sessions were run by specially trained facilitators who have a health‐related background, the intention was to have the same facilitator run all the sessions for the same group, independently as to build a rapport with the participants. Along with the topics listed before each session covered goal setting, motivation and managing setbacks. At three and six months, there was a telephone follow up, maintenance sessions with the same facilitator that took the group sessions. An additional amendment allowed a small group of women in the study (31) to receive a telephone based lifestyle intervention program. These participants had NOT attended the MAGDA face to face group intervention. To differentiate this group the intervention was called TeleMAGDA. The intervention was based on the same topics as the group based MAGDA program but was done over seven, individual, 30‐60 minute telephone coaching sessions, again one every 2 weeks. As for MAGDA the phone coach/facilitator was run by specially trained facilitators who had a health‐related background, the intention was to have the same facilitator run all the sessions for the same individual. CONDITION: Gestational Diabetes Mellitus PRIMARY OUTCOME: The estimation of reduction in the risk of type 2 diabetes imputed form the outcomes of clinical trials, using extrapolation of the changes in weight and waist circumference. Previous research has shown that by using an international benchmark study (The Diabetes Prevention Study) as a reference population, a single pretest and post test study design can be used to calculate diabetes risk reduction. Weight, waist, fasting glucose levels. All procedures are to follow the international recommendations outlined in the WHO MONICA Protocol and the European Health Risk Monitoring Project. All primary outcome measures were collected by trained nurse or phlebotomist. Standard operating procedures were followed and quality of data collection was assessed quarterly. Weight was measured by a Weight Scale MS3200 (Charder). Participants removed all heavy garments and shoes and emptied their pockets. The scale was placed on a hard surface and weight measured in kg. Waist circumference was measured using a tape measure – brand Seca 203. Waist was measured at a level midway between the lower rib margin and the iliac crest with a tape around the body in a horizontal position. Waist circumference was recorded to the resolution of the tape measure rule to the closest 1mm with data collector at eye level. Fasting glucose was measured by serum assay via venepuncture following a minimum of 8 hours fasting. ; ; SECONDARY OUTCOME: Comparative information from behavioural measures (as assessed by validated clinical tools, including: Hospital Depression and Anxiety Scale, Fat and Fibre barometer and Quality of Life Questionnaire) from intervention and control participants Comparative information from clinical measures (blood pressure, hip measurements, and blood lipids/fats/glucose) from intervention and control participants. More specifically, blood pressure will be assessed using a simple mercury sphygmomanometer; hip measurements will be taken using a plastic tailors measuring tape; and blood lipids/fats and glucose will be assessed by blood analysis of blood taken from the vein in the antecubital fossa. Health economic information about the Lifestyle program (and comparison with usual care) will be assessed by combining the cost data with the clinical and behaviuoral data to produce a range of incremental cost‐effectiveness ratios (ICER). This ICER will be comapred to a reference threshold (i.e $50,000 per quality‐adjusted life years (QALY)) to determine 'value for money'. The modelled evaluation will use a Markov appraoch to estimate the health impacts of changes in diabetes risk status over the lifetime of participants. INCLUSION CRITERIA: Women with a diagnosis of Gestational Diabetes who gave birth after 1/1/2007 at participating hospitals will be invited to participate. All potential participants will have an oral glucose tolerance test to confirm that they do not have diabetes prior to entering the study.
Epistemonikos ID: 206195b1384d1ea9b6847bcc464febe7ba833991
First added on: Aug 25, 2024