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Interested individuals were telephone screened for eligibility [by AC], sent a participant information sheet and given a baseline appointment.
A baseline appointment will then be made with a trained Exercise Specialist to collect all relevant baseline clinical/laboratory information at each centralized PCN location using point-of-care instruments.
If deemed potentially eligible, they attend a baseline appointment at one of two large teaching hospitals, the Princess Alexandra Hospital (PAH) or the Royal Brisbane and Women's Hospital (RBWH) in Brisbane, where they are provided with a comprehensive explanatory statement.
Eligible women participated in a baseline appointment in which they reviewed and signed a written informed consent form, completed a demographic questionnaire, and received the first of three sensors, including instructions for wear (Table 1).
Those Latino individuals who were ≥ 25 years of age, had a BMI ≥ 24 kg/mand a ≥ 30% likelihood of developing diabetes in 7.5 years as predicted by the Stern equation were determined to be pre-eligible and invited to schedule a baseline appointment in 3 4 weeks.
Individuals with moderate vitamin B-12 deficiency who did not have anemia (serum vitamin B-12 concentrations ≥107 and <210 pmol/L [Beckman Coulter assay (1)] and hemoglobin concentrations ≥110 g/L for women and ≥120 g/L for men) were eligible to join the trial and were invited to attend a baseline appointment at King's College Hospital, London.
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Patients entering the intervention will have a two-hour baseline appointment with the CM.
At the baseline appointment, patients received a professional dental cleaning, oral hygiene methods were reviewed, and photographs were taken to capture a baseline assessment of the decalcification index (DI).
Among the remaining 235 women, 222 (94.5%) agreed to participate and made a baseline visit appointment; 197 (83.8%) women attended the baseline visit, gave informed consent, and were randomized.
Contacted individuals will be requested to return a reply slip confirming or declining their interest in taking part; those who wish to take part will be contacted by the study team where a baseline consent appointment is arranged.
Finally, prior to departing from their baseline appointment, participants will receive an initialised accelerometer to objectively measure physical activity levels along with a corresponding wear-time log.
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