Use the Back button in your browser to see the other results of your search or to select another record.

Detailed Search Results

Outcomes and costs of primary care surveillance and intervention for overweight or obese children: the LEAP 2 randomised controlled trial [with consumer summary]
Wake M, Baur LA, Gerner B, Gibbons K, Gold L, Gunn J, Levickis P, McCallum Z, Naughton G, Sanci L, Ukoumunne OC
BMJ 2009 Sep 3;339:b3308
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: To determine whether ascertainment of childhood obesity by surveillance followed by structured secondary prevention in primary care improved outcomes in overweight or mildly obese children. DESIGN: Randomised controlled trial nested within a baseline cross sectional survey of body mass index (BMI). Randomisation and outcomes measurement, but not participants, were blinded to group assignment. SETTING: 45 family practices (66 general practitioners) in Melbourne, Australia. PARTICIPANTS: 3,958 children visiting their general practitioner in May 2005 to July 2006 were surveyed for BMI. Of these, 258 children aged 5 years 0 months up to their 10th birthday who were overweight or obese by International Obesity Taskforce criteria were randomised to intervention (n = 139) or control (n = 119) groups. Children who were very obese (UK BMI z score >= 3.0) were excluded. INTERVENTION: Four standard consultations over 12 weeks targeting change in nutrition, physical activity, and sedentary behaviour, supported by purpose designed family materials. MAIN OUTCOMES MEASURES: Primary measure was BMI at 6 and 12 months after randomisation. Secondary measures were mean activity count/min by 7-day accelerometry, nutrition score from 4-day abbreviated food frequency diary, and child health related quality of life. Differences were adjusted for socioeconomic status, age, sex, and baseline BMI. RESULTS: Of 781 eligible children, 258 (33%) entered the trial; attrition was 3.1% at 6 months and 6.2% at 12 months. Adjusted mean differences (intervention minus control) at 6 and 12 months were, for BMI -0.12 (95% CI -0.40 to 0.15, p = 0.4) and -0.11 (-0.45 to 0.22, p = 0.5); for physical activity in counts/min 24 (-4 to 52, p = 0.09) and 11 (-26 to 49, p = 0.6); and, for nutrition score 0.2 (-0.03 to 0.4, p = 0.1) and 0.1 (-0.1 to 0.4, p = 0.2). There was no evidence of harm to the child. Costs to the healthcare system were significantly higher in the intervention arm. CONCLUSIONS: Primary care screening followed by brief counselling did not improve BMI, physical activity, or nutrition in overweight or mildly obese 5 to 10 year olds, and it would be very costly if universally implemented. These findings are at odds with national policies in countries including the US, UK, and Australia. TRIAL REGISTRATION: ISRCTN52511065 (www.isrctn.org).
Reproduced with permission from the BMJ Publishing Group.

Full text (sometimes free) may be available at these link(s):      help