Trial | Intervention(s): drug component (route, frequency, total dose/day), behaviour changing component | Comparator(s): drug component (route, frequency, total dose/day), behaviour changing component |
Atabek 2008 |
Metformin: oral, twice daily, 500 mg x 2 (1 g)/d, 6 months Diet and physical activity advice: individual consultation sessions with a nutritionist, completed food diary at beginning and end of trial, advised to perform 30 min of aerobic physical activity per day, 6 months |
Placebo: oral, twice daily, 2 tablets/d, 6 months Diet and physical activity advice: same as the intervention group |
Berkowitz 2003 |
Sibutramine: oral, 1 dose per day, placebo (week 1) 5 mg/d sibutramine (week 2) 10 mg/d (weeks 3 to 6) 15 mg/d (week 7 to month 6), length = 6 months (plus an open‐label phase for additional 6 months) Behavioural programme: in phase 1 (drug‐placebo phase) participants attended 13 weekly group sessions while in phase 2 (drug, open label) group sessions were held biweekly then monthly. Parents met separately from participants. Instructed to consume 1200 kcal/d to 1500 kcal/d and to engage in 120 min of walking or similar activity per week. Eating and activity logs kept daily. Length = 12 months |
Placebo: oral, 1 dose per day, (months 1 to 6), 6 months Behavioural programme: same as intervention group |
Berkowitz 2006 |
Sibutramine: oral, 1 dose per day, 10 mg/d (baseline to month 6), 15 mg/d from month 6 in participants who had not lost more than 10% of their initial BMI, 12 months Behavioural therapy programme: each individual centre implemented flexible lifestyle modification approaches that were specific to participants' needs. This included self‐monitoring of eating habits and physical activity, stress management, stimulus control, problem solving, contingency management, cognitive restructuring and social support. Participants were given counselling at each visit and nutritional counselling. Length = 12 months |
Placebo: oral, 1 dose per day, placebo (baseline to month 6), uptitrated after 6 months in participants who had not lost more than 10% of their initial BMI, 12 months Behavioural therapy programme: same as intervention group |
Chanoine 2005 |
Orlistat: oral, dose 3 times per day, 120 mg x 3 (360 mg)/d, 1 year Behavioural therapy: participants were prescribed a nutritionally balanced, hypocaloric diet and at each trial visit the dietitian spoke about compliance. Behavioural modification involved techniques to limit calorie and fat intake, eating more slowly, avoiding snacks and avoiding overeating. Guidelines were given to encourage regular physical activity and reduce sedentary behaviour; compliance was monitored by a behavioural psychologist at each visit. Length = 54 weeks |
Placebo: oral, dose 3 times per day, 1 year Behavioural therapy: same as intervention group |
Clarson 2009 |
Metformin: oral, 3 times daily, 500 mg x 3 (1.5 g), 6 months Behaviour changing intervention: monthly individual visits and 2 group sessions. Fitness specialist supervised participants in an individual 30‐min exercise sessions every 2 months. Diet advice and physical activity advice given. Progress monitored by weekly telephone calls and monthly visits. Length = 6 months |
No placebo (N/A) Behaviour changing intervention: same as intervention group |
Franco 2014 |
Sibutramine: oral, once daily, 10 mg, 6 months Dietary guidance: the dietary guideline proposal was of a low‐calorie diet with restriction of 25% of the total recommended calories for a teenager |
Placebo: oral, once daily, 10 mg, 6 months Dietary guidance: same as intervention group |
Freemark 2001 |
Metformin: oral, 2 doses per day, 500 mg x 2 (1g)/d, 6 months No behaviour changing intervention |
Placebo: oral, 2 doses per day, 6 months No behaviour changing intervention |
Garcia‐Morales 2006 |
Sibutramine: oral, 1 dose per day, 10 mg/d, 6 months Diet + exercise: diet and exercise advice was tailored to each participant. Advice was given on recommended food portions and possible combinations, and all participants were advised to perform at least 30 min of aerobic physical activity per day. Each participant also attended individual consultation sessions with a registered paediatric nutritionist. A detailed food consumption questionnaire was completed at the beginning and end of trial medication period. Length = 6 months |
Placebo: oral, 1 dose per day, 6 months Diet + exercise: same as intervention group |
Godoy‐Matos 2005 |
Sibutramine: oral, 1 dose per day, 10 mg/d, 6 months Hypocaloric diet + exercise: participants were given dietary counselling to achieve an energy deficit of 500 kcal/d at the start of the run‐in phase (no further visits after). Physical activity instructions were delivered by the attendant doctors in a brief written protocol aimed to obtain mainly aerobic moderate exercises for at least 30 min/d. A lifestyle intervention was not given during 6‐month trial |
Placebo: oral, 1 dose per day, 6 months Hypocaloric diet + exercise: same as intervention group |
Kendall 2013 |
Metformin: oral, twice daily, 500 mg x 2 + 500 mg (1.5 g), 6 months Healthy lifestyle advice: participants provided with a standardised healthy lifestyle advice at the start in a 1‐to‐1 sessions, including a healthy diet advice sheet and increased levels of exercise (available upon request). A lifestyle intervention was not given during the 6‐month trial |
Placebo: oral, twice daily, 2 + 1 (3) tablets/d, 6 months Healthy lifestyle advice : same as intervention group |
Maahs 2006 |
Orlistat: oral, 3 doses per day, 120 mg x 3 (360 mg)/d, 6 months Diet + exercise therapy: the goal caloric intake was calculated using the Harris‐Benedict equation with ambulating activity factor (500 calories was subtracted from the final number to obtain daily calorie level). Participants were instructed to increase activity using a paediatric activity pyramid and encouraged to exercise for at least 30 min, 3 times per week. Monthly follow‐up visits with a dietitian reinforced this advice. Log sheets and diet records were also completed. Length = 6 months |
Placebo: oral, 3 doses per day, 6 months Diet + exercise therapy: same as intervention group |
Mauras 2012 |
Metformin: oral, twice daily, 500 mg or 1000 mg (dependent on age), 6 months Diet + exercise intervention: dietary counselling provided with recommended decrease of 250 calories/d to 500 calories/d. Intense follow‐up provided by dietitian. Participants given free membership to YMCA or gym. Encouraged to exercise at least 3 times per week for 30 min per sessions. Activity diary kept and pedometer worn. Length = 6 months |
No placebo Diet + exercise intervention: same as intervention group |
NCT00001723 |
Orlistat: 120 mg 3 times daily for 6 months Behavioural weight loss programme: 12‐week intensive programme |
Placebo: 120 mg 3 times daily for 6 months Behavioural weight loss programme: same as intervention group |
Ozkan 2004 |
Orlistat: oral, 3 doses per day, 120 mg x 3 (360 mg)/d, mean 11.7 months ‐ length of treatment was not consistent across participants Conventional treatment: the lifestyle modification programme included reducing daily calories. Was administered by a team comprising of a paediatric endocrinologist, paediatrician and a dietitian. Participants seen by dietitian monthly and in the outpatient clinic every 2 months. Length = between 6 and 17 months |
No placebo Conventional treatment: same as intervention group; length between 6 and 17 months |
Prado 2012 |
Metformin: oral, once daily, 500 mg, 3 months Nutritional guide and exercise programme: according to pattern 1500 kcal/d. Exercise classes once per week and exercise guide to be practiced twice per week. Length = 3 months |
Placebo: oral, once daily, 3 months Nutritional guide and exercise programme: same as intervention group |
Rezvanian 2010 |
Metformin: oral, once daily, 1500 mg/d, 12 weeks Healthy eating and physical activity advice: physical activity advice included reducing sedentary time and taking part in 30 min of enjoyable, moderate‐intensity physical activity per day. A registered dietitian conducted a nutrition education session with recommendations on diet such as increasing consumption of fruit and vegetables and not using hydrogenated fat |
Placebo: oral, once daily, 12 weeks Healthy eating and physical activity advice: same as intervention group |
Fluoxetine: oral, once daily, 20 mg/d, 12 weeks Healthy eating and physical activity advice: same as the other intervention groups | ||
Metformin + fluoxetine: oral, once daily, dosage not given, 12 weeks Healthy eating and physical activity advice: same as the other intervention groups | ||
Srinivasan 2006 |
Metformin: oral, 2 doses per day, dose gradually built up to 1g x 2 (2 g)/d, 6 months "Standardised information on healthy eating and exercise": no further information given |
Placebo: oral, 2 doses per day, dose gradually built up to 1 g x 2 (2 g)/d, 6 months "Standardised information on healthy eating and exercise": same as intervention group |
Van Mil 2007 |
Sibutramine: oral, once daily, 5 mg/d, 12 weeks Energy‐restricted diet and exercise plan: the energy prescription calculated from measured basal metabolic rate multiplied by an estimated physical activity level minus 500 kcal. Physical activity prescribed based on individual preferences and information obtained by physical activity questionnaire. It contained a daily bout of exercise of at least 30 min. Length = 12 weeks |
Placebo: oral, once daily, 5 mg/d, 12 weeks Energy‐restricted diet and exercise plan: same as intervention group |
Wiegand 2010 |
Metformin: oral, twice daily, 2 x 500 mg (1 g)/d, 6 months Multiprofessional behaviour changing intervention: an interview was performed before randomisation to determine 1 to 3 individually chosen tasks (goals). Multiprofessional reinforcement sessions took place every 4 to 8 weeks. Regarding physical activity, participants and their families attended specialised sport classes (2 sport classes per week, 45 min each, was recommended) in addition to regular sport classes at school. Length = 6 months |
Placebo: oral, twice daily, 6 months Multiprofessional behaviour changing intervention: same as intervention group |
Wilson 2010 |
Metformin: oral, 4 times daily, 4 x 500 mg (2 g)/d, 48 weeks Behaviour changing intervention: used the Weigh of Life LITE programme developed at Texas Children's Hospital, Houston. There were 10 individualised "intensive" sessions at weekly intervals and monthly follow‐up sessions for the reminder of the trial. Sessions led by trained health specialist and parent/guardians were invited. Length = 48 weeks |
Placebo: oral, 4 times daily, 48 weeks Behaviour changing intervention: same as intervention group |
Yanovski 2011 |
Metformin: oral, twice daily, 2 x 1000 mg (2000 mg)/d, 6 months Dietitian‐administered weight‐reduction programme: each participant and parent/guardian met with a dietitian monthly, who promoted a reduced‐energy diet, increased physical activity and decreased inactivity. Participants trained to completed a 7‐day food diary which was used to prescribe a "traffic light" style 500 kcal/d deficit diet, and exercise was encouraged for 30 min/d, monitored by pedometers readings. Length = 6 months |
Placebo: oral, twice daily, 6 months Dietitian‐administered weight‐reduction programme: same as intervention group |
"‐" denotes not reported. BMI: body mass index; /d: per day; kcal: kilocalories; min: minute; N/A: not applicable; YMCA: Young Men's Christian Association. |