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Pharmacists were unaware of whether participants were assigned to the enhanced or minimal intervention group until discharge.
For the minimal intervention group it is arbitrary because they only receive a one time, five to ten minutes instruction on the exercise program.
Participants were similar in terms of chronic conditions, smoking status and alcohol intake at baseline, though baseline medications were slightly higher in the minimal intervention group compared to controls (p = 0.0009) (Table 1).
It is however possible that patients ending up in the minimal intervention group will feel they are missing out on "treatment" and on their own seek care similar to the hip school or the manual therapy.
Second, including a control group or minimal intervention group is common in clinical trials that examine the effectiveness of non-pharmacological interventions particularly when long-term follow-up is performed in order to investigate efficiency and cost-effectiveness [ 48- 51].
All three groups are expected to comply with the exercise regimes from the hip school but it is anticipated that the minimal intervention group might not comply at the same level as the other two groups due to lack of continuous positive reinforcement during the intervention period.
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The intervention in the enhanced or minimal intervention groups began immediately after randomization with a visit from a study pharmacist and, if subjects were in the enhanced intervention group, it continued for 3 5 days post-discharge when participants were telephoned.
While this is a modest, albeit statistically significant decrease, it is in accordance with findings from recent meta-analyses of RCTs that showed that when pooled together, outpatient childhood obesity treatment programs produced a decrease in BMI-Z of 0.06 to 0.10 compared to control or minimal intervention groups [ 23, 24].
A suggested modification by investigators and outside consultants has resulted in the replacement of the medication group with a minimal intervention control group (ie, self-care advice).
We compared six weight loss programmes with a minimal intervention comparator group provided with 12 vouchers enabling free entrance to a local leisure (fitness) centre.
All programmes, including the minimal intervention comparator group, achieved statistically significant weight loss from baseline to the three month end of programme, with the mean weight loss ranging from 4.4 (SD 4.3) kg (Weight Watchers) to 1.4 (4.1) kg (general practice provision) in the primary analysis (missing data imputed with baseline value) (table 2).
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minimal followup group
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minimal intervention effect
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minimal intervention treatment
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