Coppins 2011.

Methods	A randomised controlled trial conducted over 2 years. Dates trial conducted not reported. Outcomes were measured at 6 (n=58), 12 (n=55), 18 (n=48) and 24 (n=46) months follow‐up. However this was a cross‐over trial with the intervention being delivered to one group in the first 12 months and the other group in the second twelve months. Collaborating partners Lead agency: Health Strategic involvement (policy making and service planning): health, education, sport Commissioning (implementing strategy taking account of resources available): health, education, sport Operational (providing services directly): Community health, health promotion, education, sport Set in UK
Participants	65 participants (Intervention = 35; Control = 30) aged 6 to 14 years with a BMI above the 91st centile and who were able to participate in the intervention activities. Participants were recruited from referrals from healthcare professionals (n=33) or by self‐referral (n=32) as a result of media advertising via the local newspaper and television channel. Sixty‐five people were screened and all gave consent to participate. None were excluded on medical grounds that would affect their ability to participate in the activities. Male 31.7% (intervention group), 30.0% (controls) Mean age 133.4 months (intervention group), 116.9 (controls)
Interventions	Intervention consisted of two Saturday morning workshops (8 hours in total) in a school, 1 to 2 weeks apart, focused on healthy eating, physical activity, reducing sedentary behaviour, behaviour change and psychological well‐being. In addition, two one‐hour physical activity sessions per week during term‐time through the year‐long intervention period, consisting of junior gym sessions, bikes, circuits, trampolining, rock climbing, table tennis, basketball, tennis, badminton, football and the bleep test. Siblings aged 6 to 14 years and parents/guardians were also encouraged to participate. The workshops were designed and delivered by a dietician, physical activity health promotion officer, an educational or clinical psychologist and physical activity instructors. The physical activity sessions were led by physical activity instructors.  The control group received no input in the first year but crossed over in the second year to receive the full intervention and the original intervention group received no input in the second year.
Outcomes	Primary outcome measure was change in BMI SDS (BMI Z score). Secondary clinical outcomes were changes in waist circumference SDS (Z score), percentage body fat, lifestyle outcomes of diet composition and physical activity levels.
Notes	Intervention and control groups were not comparable at baseline. There was significant difference for age (p=0.007), height (p=0.011) and sum of skinfolds (p=0.018). Cost per child was estimated at £403 compared with £45 for usual care of 1.5 hours of individual dietetic consultations. 4 participants in the intervention group were excluded after 12 months because they continued with the programme in the second year. Attendance at the physical activity sessions was very low in both groups (mean attendance 24.1% 95% CI 15.4 – 32.9 in the group receiving the intervention in the first year and 31.7% in the group receiving the intervention in the second year. Overall risk of bias was high
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	High risk	RCT but no detail given on method of randomisation
Blinding (performance bias and detection bias) All outcomes	High risk	Lead researcher was not blind to treatment allocation
Incomplete outcome data (attrition bias) All outcomes	Low risk	Primary outcome measures reported fully but not all secondary outcome measures
Selective reporting (reporting bias)	Low risk	All outcomes have been reported
Other bias	Unclear risk	Sixty percent of the group receiving the intervention in the first year were self referred compared to 36.7% of the control group.   The mean difference in age, with the intervention group significantly older than control group by 16 months, poses a risk of confounding as the age range includes the time of onset of puberty for many children, a time when body fat and BMI can change abruptly.
Randomisation adequately described/protected?	High risk	Method not described
Protection against contamination?	Low risk	Though the participants allocated to wait for a year before receiving the intervention may have started to change their behaviours in the waiting period.
Follow‐up rate adequate?	Low risk	55/65 participants at cross‐over at 12 months
Reliable primary outcome measure?	Unclear risk	Good outcome measure but disparate age of participant groups may make it less reliable in this trial.
Groups measured at baseline?	High risk	Significant differences at baseline between the two groups
Appropriate choice of controls (CBA studies only)?	Unclear risk	N/A
Contemporaneous data collection (CBA studies only)?	Unclear risk	N/A
IS THE STUDY AT LOW RISK OF BIAS?	High risk	OVERAL RISK OF BIAS WAS HIGH