Bibi Gerner

Outcomes and costs of primary care surveillance and intervention for overweight or obese children: the LEAP 2 randomised controlled trial

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 3958 children visiting their general practitioner in May 2005-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 − 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 5-10 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 ISRCTN 52511065 (www.isrctn.org)

Outcome data from the LEAP (Live, Eat and Play) trial: a randomized controlled trial of a primary care intervention for childhood overweight/mild obesity

Objectives:To reduce gain in body mass index (BMI) in overweight/mildly obese children in the primary care setting.Design:Randomized controlled trial (RCT) nested within a baseline cross-sectional BMI survey.Setting:Twenty nine general practices, Melbourne, Australia.Participants:(1) BMI survey: 2112 children visiting their general practitioner (GP) April–December 2002; (2) RCT: individually randomized overweight/mildly obese (BMI z-score <3.0) children aged 5 years 0 months–9 years 11 months (82 intervention, 81 control).Intervention:Four standard GP consultations over 12 weeks, targeting change in nutrition, physical activity and sedentary behaviour, supported by purpose-designed family materials.Main outcome measures:Primary: BMI at 9 and 15 months post-randomization. Secondary: Parent-reported child nutrition, physical activity and health status; child-reported health status, body satisfaction and appearance/self-worth.Results:Attrition was 10%. The adjusted mean difference (intervention–control) in BMI was −0.2 kg/m2 (95% CI: −0.6 to 0.1; P=0.25) at 9 months and −0.0 kg/m2 (95% CI: −0.5 to 0.5; P=1.00) at 15 months. There was a relative improvement in nutrition scores in the intervention arm at both 9 and 15 months. There was weak evidence of an increase in daily physical activity in the intervention arm. Health status and body image were similar in the trial arms.Conclusions:This intervention did not result in a sustained BMI reduction, despite the improvement in parent-reported nutrition. Brief individualized solution-focused approaches may not be an effective approach to childhood overweight. Alternatively, this intervention may not have been intensive enough or the GP training may have been insufficient; however, increasing either would have significant cost and resource implications at a population level.

A Parent-Focused Intervention to Reduce Infant Obesity Risk Behaviors: A Randomized Trial

OBJECTIVE: To assess the effectiveness of a parent-focused intervention on infants’ obesity-risk behaviors and BMI. METHODS: This cluster randomized controlled trial recruited 542 parents and their infants (mean age 3.8 months at baseline) from 62 first-time parent groups. Parents were offered six 2-hour dietitian-delivered sessions over 15 months focusing on parental knowledge, skills, and social support around infant feeding, diet, physical activity, and television viewing. Control group parents received 6 newsletters on nonobesity-focused themes; all parents received usual care from child health nurses. The primary outcomes of interest were child diet (3 × 24-hour diet recalls), child physical activity (accelerometry), and child TV viewing (parent report). Secondary outcomes included BMI z-scores (measured). Data were collected when children were 4, 9, and 20 months of age. RESULTS: Unadjusted analyses showed that, compared with controls, intervention group children consumed fewer grams of noncore drinks (mean difference = –4.45; 95% confidence interval [CI]: –7.92 to –0.99; P = .01) and were less likely to consume any noncore drinks (odds ratio = 0.48; 95% CI: 0.24 to 0.95; P = .034) midintervention (mean age 9 months). At intervention conclusion (mean age 19.8 months), intervention group children consumed fewer grams of sweet snacks (mean difference = –3.69; 95% CI: –6.41 to –0.96; P = .008) and viewed fewer daily minutes of television (mean difference = –15.97: 95% CI: –25.97 to –5.96; P = .002). There was little statistical evidence of differences in fruit, vegetable, savory snack, or water consumption or in BMI z-scores or physical activity. CONCLUSIONS: This intervention resulted in reductions in sweet snack consumption and television viewing in 20-month-old children.

Impact of a behavioural sleep intervention on symptoms and sleep in children with attention deficit hyperactivity disorder, and parental mental health: randomised controlled trial

Objective To examine whether behavioural strategies designed to improve children’s sleep problems could also improve the symptoms, behaviour, daily functioning, and working memory of children with attention deficit hyperactivity disorder (ADHD) and the mental health of their parents. Design Randomised controlled trial. Setting 21 general paediatric practices in Victoria, Australia. Participants 244 children aged 5-12 years with ADHD attending the practices between 2010 and 2012. Intervention Sleep hygiene practices and standardised behavioural strategies delivered by trained psychologists or trainee paediatricians during two fortnightly consultations and a follow-up telephone call. Children in the control group received usual clinical care. Main outcome measures At three and six months after randomisation: severity of ADHD symptoms (parent and teacher ADHD rating scale IV—primary outcome), sleep problems (parent reported severity, children’s sleep habits questionnaire, actigraphy), behaviour (strengths and difficulties questionnaire), quality of life (pediatric quality of life inventory 4.0), daily functioning (daily parent rating of evening and morning behavior), working memory (working memory test battery for children, six months only), and parent mental health (depression anxiety stress scales). Results Intervention compared with control families reported a greater decrease in ADHD symptoms at three and six months (adjusted mean difference for change in symptom severity −2.9, 95% confidence interval −5.5 to −0.3, P=0.03, effect size −0.3, and −3.7, −6.1 to −1.2, P=0.004, effect size −0.4, respectively). Compared with control children, intervention children had fewer moderate-severe sleep problems at three months (56% v 30%; adjusted odds ratio 0.30, 95% confidence interval 0.16 to 0.59; P<0.001) and six months (46% v 34%; 0.58, 0.32 to 1.0; P=0.07). At three months this equated to a reduction in absolute risk of 25.7% (95% confidence interval 14.1% to 37.3%) and an estimated number needed to treat of 3.9. At six months the number needed to treat was 7.8. Approximately a half to one third of the beneficial effect of the intervention on ADHD symptoms was mediated through improved sleep, at three and six months, respectively. Intervention families reported greater improvements in all other child and family outcomes except parental mental health. Teachers reported improved behaviour of the children at three and six months. Working memory (backwards digit recall) was higher in the intervention children compared with control children at six months. Daily sleep duration measured by actigraphy tended to be higher in the intervention children at three months (mean difference 10.9 minutes, 95% confidence interval −19.0 to 40.8 minutes, effect size 0.2) and six months (9.9 minutes, −16.3 to 36.1 minutes, effect size 0.3); however, this measure was only completed by a subset of children (n=54 at three months and n=37 at six months). Conclusions A brief behavioural sleep intervention modestly improves the severity of ADHD symptoms in a community sample of children with ADHD, most of whom were taking stimulant medications. The intervention also improved the children’s sleep, behaviour, quality of life, and functioning, with most benefits sustained to six months post-intervention. The intervention may be suitable for use in primary and secondary care. Trial registration Current Controlled Trials ISRCTN68819261.

Can Australian general practitioners tackle childhood overweight/obesity? Methods and processes from the LEAP (Live, Eat and Play) randomized controlled trial

Background:  General practitioners (GPs) could make an important contribution to management of childhood overweight. However, there are no efficacy data to support this, and the feasibility of this approach is unknown.

Are general practitioners equipped to detect child overweight/obesity? Survey and audit

Aim:  To ascertain the extent to which general practitioners (GPs) routinely weigh, measure and calculate body mass index (BMI) in children, and to assess the accuracy and accessibility of their anthropometric equipment.

Anxiety in Children With Attention-Deficit/Hyperactivity Disorder

OBJECTIVES: Although anxiety is common in children with attention-deficit/hyperactivity disorder (ADHD), it is unclear how anxiety influences the lives of these children. This study examined the association between anxiety comorbidities and functioning by comparing children with ADHD and no, 1, or ≥2 anxiety comorbidities. Differential associations were examined by current ADHD presentation (subtype). METHODS: Children with diagnostically confirmed ADHD (N = 392; 5–13 years) were recruited via 21 pediatrician practices across Victoria, Australia. Anxiety was assessed by using the Anxiety Disorders Interview Schedule for Children—IV. Functional measures included parent-reported: quality of life (QoL; Pediatric Quality of Life Inventory 4.0), behavior and peer problems (Strengths and Difficulties Questionnaire), daily functioning (Daily Parent Rating of Evening and Morning Behavior), and school attendance. Teacher-reported behavior and peer problems (Strengths and Difficulties Questionnaire) were also examined. Linear and logistic regression controlled for ADHD severity, medication use, comorbidities, and demographic factors. RESULTS: Children with ≥2 anxiety comorbidities (n = 143; 39%) had poorer QoL (effect size: –0.8) and more difficulties with behavior (effect size: 0.4) and daily functioning (effect size: 0.3) than children without anxiety (n = 132; 36%). Poorer functioning was not observed for children with 1 anxiety comorbidity (n = 95; 26%). Two or more anxiety comorbidities were associated with poorer functioning for children with both ADHD-Inattentive and ADHD-Combined presentation. CONCLUSIONS: Children with ADHD demonstrate poorer QoL, daily functioning and behavior when ≥2 anxiety comorbidities are present. Future research should examine whether treating anxiety in children with ADHD improves functional outcomes.

Economic Evaluation of a Primary Care Trial to Reduce Weight Gain in Overweight/Obese Children: The LEAP Trial

BACKGROUND A common policy response to the childhood obesity epidemic is to recommend that primary care physicians screen for and offer counseling to the overweight/obese. As the literature suggests, this approach may be ineffective; it is important to document the opportunity costs incurred by brief primary care obesity interventions that ultimately may not alter body mass index (BMI) trajectory. METHODS Live, Eat and Play (LEAP) was a randomized controlled trial of a brief secondary prevention intervention delivered by family physicians in 2002-2003 that targeted overweight/mildly obese children aged 5 to 9 years. Primary care utilization was prospectively audited via medical records, and parents reported family resource use by written questionnaire. Outcome measures were BMI (primary) and parent-reported physical activity and dietary habits (secondary) in intervention compared with control children. RESULTS The cost of LEAP per intervention family was AU

Physical Activity and 3-Year BMI Change in Overweight and Obese Children

4094 greater than for control families, mainly due to increased family resources devoted to child physical activity. Total health sector costs were AU

Study protocol: the sleeping sound with attention-deficit/hyperactivity disorder project

873 per intervention family and AU