Primary prevention of childhood obesity through counselling sessions at Swedish child health centres: design, methods and baseline sample characteristics of the PRIMROSE cluster-randomised trial

Abstract

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

Motivational Interviewing to Prevent Childhood Obesity: A Cluster RCT

“…The training and assessment of the nurses' MI proficiency are described in detail elsewhere. [26][27][28] Families in intervention CHCs took part in 9 sessions (1 group, 6 individual, and 2 individual telephone sessions) in a time frame of ∼39 months. The parents, in conjunction with the nurses, formulated goals for changes in unhealthy behaviors and for maintenance of healthy physical activity and food habits.…”

“…In consecutive sessions, the nurses reinforced the parents' motivation for and commitment to health promotion and behavior change when needed. 26 Families in the control CHCs were only offered the regular age-related health checkups of Swedish child health services, which focus on physical development and immunizations 29 and in which less attention is paid to children's health behaviors. 30 …”

“…The study protocol contains detailed descriptions of the instruments and measurements used. 26 In brief, food habits were assessed by a semiquantitative food frequency questionnaire (FFQ) validated against a food diary kept for 2 periods of 4 days. 26 The following items were chosen as outcome variables: fruit, vegetables, fish, french fries, sugared drinks, and discretionary calories.…”

“…26 In brief, food habits were assessed by a semiquantitative food frequency questionnaire (FFQ) validated against a food diary kept for 2 periods of 4 days. 26 The following items were chosen as outcome variables: fruit, vegetables, fish, french fries, sugared drinks, and discretionary calories. According to the Swedish National Food Administration, these food items reflect the quality of dietary intake and are indicators of healthy and unhealthy food habits.…”

“…37,38 At baseline and follow-up, families also reported on their socioeconomic and sociodemographic circumstances. 26 …”