The objective was to evaluate a manualized theory-driven primary preventive intervention aimed at early childhood obesity. The intervention was embedded in Swedish child health services, starting when eligible children were 9 to 10 months of age and continuing until the children reached age 4. METHODS:Child health care centers in 8 Swedish counties were randomized into intervention and control units and included 1355 families with 1369 infants. Over ∼39 months, families in the intervention group participated in 1 group session and 8 individual sessions with a nurse trained in motivational interviewing, focusing on healthy food habits and physical activity. Families in the control group received care as usual. Primary outcomes were children's BMI, overweight prevalence, and waist circumference at age 4. Secondary outcomes were children's and mothers' food and physical activity habits and mothers' anthropometrics. Effects were assessed in linear and log-binominal regression models using generalized estimating equations.RESULTS: There were no statistically significant differences in children's BMI (β = -0.11, 95% confidence interval [CI]: -0.31 to 0.08), waist circumference (β = -0.48, 95% CI: -0.99 to 0.04), and prevalence of overweight (relative risk = 0.95, 95% CI: 0.69 to 1.32). No significant intervention effects were observed in mothers' anthropometric data or regarding mothers' and children's physical activity habits. There was a small intervention effect in terms of healthier food habits among children and mothers.CONCLUSIONS: There were no significant group differences in children's and mothers' anthropometric data and physical activity habits. There was, however, some evidence suggesting healthier food habits, but this should be interpreted with caution.

Despite methodological advances in the field of economic evaluations of interventions, economic evaluations of obesity prevention programmes in early childhood are seldom conducted. The aim of the present study was to explore existing methods and applications of economic evaluations, examining their limitations and making recommendations for future cost-effectiveness assessments. A systematic literature search was conducted using PubMed, Cochrane Library, the British National Health Service Economic Evaluation Databases and EconLit. Eligible studies included trial-based or simulation-based cost-effectiveness analyses of obesity prevention programmes targeting preschool children and/or their parents. The quality of included studies was assessed. Of the six studies included, five were intervention studies and one was based on a simulation approach conducted on secondary data. We identified three main conceptual and methodological limitations of their economic evaluations: Insufficient conceptual approach considering the complexity of childhood obesity, inadequate measurement of effects of interventions, and lack of valid instruments to measure child-related quality of life and costs. Despite the need for economic evaluations of obesity prevention programmes in early childhood, only a few studies of varying quality have been conducted. Moreover, due to methodological and conceptual weaknesses, they offer only limited information for policy makers and intervention providers. We elaborate reasons for the limitations of these studies and offer guidance for designing better economic evaluations of early obesity prevention.

BackgroundChildhood obesity is a growing concern in Sweden. Children with overweight and obesity run a high risk of becoming obese as adults, and are likely to develop comorbidities. Despite the immense demand, there is still a lack of evidence-based comprehensive prevention programmes targeting pre-school children and their families in primary health care settings. The aims are to describe the design and methodology of the PRIMROSE cluster-randomised controlled trial, assess the relative validity of a food frequency questionnaire, and describe the baseline characteristics of the eligible young children and their mothers.Methods/DesignThe PRIMROSE trial targets first-time parents and their children at Swedish child health centres (CHC) in eight counties in Sweden. Randomisation is conducted at the CHC unit level. CHC nurses employed at the participating CHC received training in carrying out the intervention alongside their provision of regular services. The intervention programme, starting when the child is 8-9 months of age and ending at age 4, is based on social cognitive theory and employs motivational interviewing. Primary outcomes are children’s body mass index and waist circumference at four years. Secondary outcomes are children’s and mothers’ eating habits (assessed by a food frequency questionnaire), and children’s and mothers’ physical activity (measured by accelerometer and a validated questionnaire), and mothers’ body mass index and waist circumference.DiscussionThe on-going population-based PRIMROSE trial, which targets childhood obesity, is embedded in the regular national (routine) preventive child health services that are available free-of-charge to all young families in Sweden. Of the participants (n = 1369), 489 intervention and 550 control mothers (75.9%) responded to the validated physical activity and food frequency questionnaire at baseline (i.e., before the first intervention session, or, for children in the control group, before they reached 10 months of age). The food frequency questionnaire showed acceptable relative validity when compared with an 8-day food diary. We are not aware of any previous RCT, concerned with the primary prevention of childhood obesity through sessions at CHC that addresses healthy eating habits and physical activity in the context of a routine child health services programme.Trial registrationISRCTN16991919

BackgroundChildhood obesity is a major clinical and economic health concern. Alongside the clinical understanding of obesity, there is a growing interest in designing and implementing interventions that are worth their money given the scarce resources in the health care sector. This study is one of the first efforts to provide evidence by assessing the effects and costs of a population-based primary prevention intervention targeting pre-school children attending child health centers in Sweden.MethodsThe economic evaluation is based on the PRIMROSE cluster-randomized controlled trial aiming to establish healthy eating and physical activity among pre-school children (9–48 months of age) through motivational interviewing applied by trained nurses at child health centers. The cost-effectiveness is assessed over the trial period from a societal perspective. The primary outcome was BMI at age 4. Cost data was prospectively collected alongside the trial. Scenario analyses were carried out to identify uncertainty.ResultsThe estimated additional mean total costs of the PRIMROSE intervention were 342 Euro (95% CI: 334; 348) per child. During pre-school years direct costs mainly consist of training costs and costs for the additional time used by nurses to implement the intervention compared to usual care. Early indirect costs mainly consist of parents’ absence from work due to their participation in the intervention. The incremental cost-effectiveness ratio in the base case analysis was 3,109 Euro per 1 BMI unit prevented.ConclusionWe cannot provide evidence that the PRIMROSE intervention is cost-effective, given the uncertainty in the effect measure. Until further evidence is provided, we recommend resources to be spent elsewhere within the field of obesity prevention. Furthermore, to achieve valid and reliable cost-effectiveness results, the economic evaluation of obesity prevention programs in early childhood should incorporate the life time impact to capture all relevant costs and benefits.

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