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Data were collected before the intervention, at the end of the 5th and 10th group sessions, and 2 weeks after the 10th (or last) session.
Facilities' ART readiness scores exceeded 80% before the intervention at both intervention and comparison sites.
Measures were obtained once at the start of the study (before the intervention at Time 1) and once after the intervention roughly a year later (Time 2; see Table 1).
Clinical measurements included height, weight, waist, hip and blood pressure measurements, all of which were taken by study nurses before the intervention, at three months, and at one year.
The model included terms to evaluate the following variables: a constant term (for levels before the intervention at baseline), a term for linear trends before the intervention, terms to estimate level and trend changes after the intervention, and a residual term.
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6 18 19 In order to detect a 7% difference between the (control vs intervention period) groups (ie, 12% vs 5%), or an OR of at least 2.6, using a two-sided Cochran-Mantel-Haenszel (CMH) test conducted at the 5% significance level with 80% power, 750 patients per group (250 before and 250 after the intervention at each of the three hospitals) are required in the study.
The evaluation of the effects on patients will be based on a pragmatic randomized experimental design with delayed intervention for the control group and measurements taken before and after the intervention (at six-month follow-up).
Individual interviews will be conducted to determine the patients' assessment of chronic illness care, degree of self-enablement, and access to care before implementation of the intervention, at intermediate moments and at the end of the study.
Lipid profiles will be determined before and after the intervention at weeks 0 and 12. Participants will be sent to have blood samples taken and pathology testing conducted by a reputable pathology collection centre.
CRP will be determined before and after the intervention at weeks 0 and 12. Participants will be sent to have blood samples taken and pathology testing conducted by a reputable pathology collection centre.
Glucose profiles will be determined before and after the intervention at weeks 0 and 12. Participants will be sent to have blood samples taken and pathology testing conducted by a reputable pathology collection centre.
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