The Healthy School Start Plus Intervention Study
Condition: Prevention; Overweight and Obesity; Dietary Habits; Physical Activity; Parent-Child Relations
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      The proposed study is a cluster randomized trial to test the effectiveness of a parental
      support programme in pre-school class to promote healthy dietary habits and physical activity
      and prevent obesity, delivered by teachers and school health services and in collaboration
      with primary care. The control condition is standard care in schools. The 6-month programme
      is carried out in schools in disadvantaged areas and is universal. It is based on Social
      Cognitive Theory and consists of four components: 1) Health information to parents regarding
      the child; 2) Motivational Interviewing with the parents by the school nurse concerning the
      child; 3) classroom activities for the children with home assignments; and 4) a web-based
      self-test of type-2 diabetes risk by parents, with follow-up in primary health care. The
      primary outcome is assessed as the difference between the intervention and the control group
      directly after the end of intervention at 6-months post baseline, and at follow-up 18 months
      post baseline, adjusted for baseline values. The outcome variables are the intake of
      unhealthy foods, unhealthy drinks, and healthy foods assessed by a newly developed method
      using photo-based dietary assessment. The secondary outcomes are physical activity and time
      spent sedentary measured by accelerometry, and measured BMI and waist circumference.
      Hypothetical mediator variables are parental self-efficacy and parenting practices regarding
      diet and physical activity assessed by questionnaire. Process evaluation will be performed
      through interviews and questionnaires to study how well the programme was implemented in
      terms of dose, fidelity, acceptability and feasibility. The programme is in line with the
      latest evidence regarding the prevention of childhood obesity: that schools should be a focal
      point of prevention efforts, interventions should involve multiple components, and include
      the home environment. If effective, it will fill a large knowledge gap concerning
      evidence-based health promotion practice within school health services to prevent overweight
      and obesity and in the long term reduce social inequalities in health.
    

Detailed description: 
      Research questions:

        1. What are the effects of the programme on children's dietary habits, physical activity,
           sedentary behaviour and body weight compared to standard care?

        2. How is the programme implemented with regard to dose, fidelity, feasibility and
           acceptability?

        3. What are the mediators of the effects of the programme?

      Recruitment of schools, participants and setting:

      Key persons in municipalities in the Stockholm region received a one-page invitation letter
      explaining the aim and content of the intervention and were invited to contact the project
      leader for more information. Primary schools were eligible to participate if the proportion
      of parents with university education was less than 50 percent compared to 57 percent at
      national level. In total 18 schools with 18 school nurses agreed to participate but one
      school dropped out before recruitment of parents had started. All parents with a child in
      pre-school class (5-7 years old) were eligible to participate. Informed, written consent was
      obtained from all participating parents (350 children and families).

      Study design:

      The study will be conducted as a cluster-randomised parallel trial with randomisation at
      school level, with a wait-list control group. Baseline data was collected in
      September-October 2017 (T0). Data will again be collected 6 months after the baseline at the
      end of the intervention in April-May 2018 (T1), and at follow-up in April-May 2019 (18 months
      post baseline, T2). Mediators will also be measured on one occasion during the intervention,
      in February 2018 (TM). After the T2 measurement, the control schools will be offered the
      intervention, including MI-training of the school nurses.

      The intervention:

      The programme builds on Social Cognitive Theory and consists of four components:

        1. Health information: A 12-page brochure based on Swedish guidelines for diet and physical
           activity contains facts and advice concerning parenting in relation to healthy food and
           family meal times, sweets, snacks, ice-cream, soft drinks, fruit and vegetables,
           physical activity, sedentary behaviour, screen time, sleep, and a theme regarding
           cooperation between parents. The text is simple and short with many illustrations and
           available in Swedish, English, and Arabic. Parents will receive a printed version of the
           brochure from the school before the first MI session and it will also be available on
           the project website throughout the intervention.

        2. The MI session will be scheduled by the school nurse as part of the ordinary health
           visit, where the child's height and weight is measured, and which also includes a
           discussion about the child´s overall health. The aim of the MI session is to increase
           positive parenting and interplay regarding the child's dietary and physical activity
           behaviour in the home environment. Parents in the intervention group will be offered one
           20 to 30 minute face-to-face MI session by the trained school nurse and another session,
           depending on need, as determined by the nurse. During the session (conducted without the
           presence of the child), the parents choose a specific behaviour that they wish to change
           or maintain. Parents are supported in identifying a target behaviour using an
           agenda-setting tool and in the exploration of personal values and the advantages of
           change or maintenance, and assisted in goal-setting if applicable. School nurses will
           undergo MI training. MI competence will be measured prior to start, post training and at
           the end of the intervention.

        3. Nine manual-based classroom sessions of approximately 30 minutes duration will be
           delivered by the teacher to the children. Various pedagogic materials are provided for
           the sessions including a workbook for children to be completed with the parents.
           Teachers will receive video-recorded instructions of how to use the teacher's manual
           ahead of the start of the intervention.

        4. Parents complete a web-based test of their own risk of developing type 2 diabetes in
           order to make them become conscious of a healthy lifestyle for the whole family. The
           test contains 8 questions and yields a score between 0 and 26 points. Based on the
           result, the parent is classified as being at low, somewhat elevated, medium, high or
           very high risk. In case of medium or higher risk (≥15 points) the parent will be advised
           by automatic feed-back to consult the local primary health care centre. General
           information on health behaviours that minimise the risk for diabetes is provided to all
           parents who take the test, regardless of score.

      Control group:

      Children in the control schools will receive treatment as usual according to prevailing
      guidelines for school health services and in addition parents receive the 12-page health
      information brochure (component 1 of the intervention). Usual treatment means a visit of the
      child accompanied by parents to the school nurse soon after the child begins school for a
      discussion regarding the school situation, the child's overall well-being, relations with
      friends, possible health and learning problems, and diet and physical activity. The
      curriculum in pre-school class prescribes that pupils should be provided with opportunities
      to experience different forms of physical activity, and to develop an understanding of how
      health is affected and can be promoted in various ways.

      Outcome evaluation:

      All questionnaires are filled in via the project website (www.enfriskskolstartplus.se) with
      personal accounts for each family. Paper versions will also be available. In order to
      increase the response rate to the questionnaires, weekly reminders are sent out via e-mail
      and text messages. All outcomes are assessed as the difference between the intervention and
      the control group directly after the end of intervention at 6-months post baseline, and at
      follow-up 18 months post baseline, adjusted for baseline values.

      Primary outcomes:

      The primary outcome is the intake at home of a composite score of indicator foods of
      importance for energy-balance and health. Intake will be assessed using food frequency
      questionnaire, the Children's Eating Habits Questionnaire which measures intake
      retrospectively in the home during the preceding month. A new smartphone-based method will
      also be used to estimate the intake of indicator foods eaten at home (volume) prospectively
      through standardised photos taken by parents over two weekdays and one weekend day. A
      relative validation study will be conducted in parallel during baseline, where both methods
      will be compared to multiple 24-hour recalls. The intention is to use the photo-based method
      for the primary outcome in the intervention study, if shown to be valid.

      Secondary outcomes:

      Secondary outcomes are physical activity and time spent sedentary, which will be measured
      objectively using accelerometers worn on a belt at the right hip (GT3X+, Actigraph, LCC,
      Pensacola, USA) over 7 consecutive days. Children with at least 500 min of activity
      registration per day for a minimum of three days, including at least one weekend day, will be
      included in the analyses. Body composition (height, weight and waist circumference) will be
      measured using standardised procedures using SECA instruments. Waist circumference will be
      measured over the umbilicus, with the child standing upright with arms alongside the body and
      after exhalation. BMI status will be defined according to the International Obesity Task
      Force. BMI standard deviation score (BMI sds) will be calculated according to the
      International Obesity Task Force references.

      Covariates:

      Parental educational level and occupation is self-reported and a composite score will be used
      to define socio-economic position consisting of the highest level of education attained, and
      the occupation (according to Statistics Sweden) by either of the parents. A dichotomised
      variable indicating low and high socio-economic position will be created. In addition, child
      sex will be used.

      Process evaluation:

      The process evaluation will include intervention dose, fidelity, feasibility, acceptability
      and a description of the context.

      The dose will be estimated quantitatively in the following way. Parents will be asked in a
      non-judgmental way by the school nurse if they have read the brochure. The number of MI
      sessions per family will be noted. Compliance with the teaching sessions and workbook
      completion will be monitored by teachers in a logbook and whether they made any adaptations.
      The result of the diabetes test will be available from the website.

      All MI sessions will be recorded and a random selection of 10-20 percent will be coded for MI
      competence/fidelity using a standardised protocol by reliable coders. The MI competence of
      all nurses in the intervention and control group will be assessed before the first MI
      training in May 2017 by recording them having a standardised conversation with a trained
      actor posing as a parent. This will be repeated after MI training in August/September 2017,
      and again after the end of intervention in May 2018.

      After the end of the intervention, semi-structured interviews with parents, school nurses and
      head teachers will be performed to explore their views on the acceptability and feasibility
      of the intervention. In addition, focus groups will be conducted with the children to explore
      their perceptions of the activities in class and the home assignments.

      The hypothetical mediators parental self-efficacy and observational learning/role modelling
      will be measured by questionnaire in both mothers and fathers. The instrument used assesses
      parental self-efficacy for influencing physical activity during the weekend, intake of
      vegetables, sweets and chocolates, and sugar-sweetened beverages, each in three challenging
      situations. Parental feeding practices, including modelling, will be measured using the
      Comprehensive Feeding Practices Questionnaire covering both positive and negative practices.
      The questionnaire will assess the parental feeding practices of involvement, environment,
      food restriction for weight control, restriction for health reasons, encouragement of
      balance, pressure to eat, monitoring, emotion regulation, food as reward, and modelling. For
      assessment of parenting practices regarding children's physical activity, 25 items will be
      used from an item bank currently being developed for this purpose. The items cover the
      parenting practices modelling, pressure, encouragement, guided choice, involvement/praise,
      co-participation, facilitation, monitoring, and restriction.

      Data management:

      All participants will receive a code and data will be depersonalised. All data collected
      through the project website and otherwise will be stored electronically in password protected
      folders on a secure data server at Karolinska Institutet. Measures to prevent loss of data
      will be taken through the use of systematic back-up routines throughout data collection and
      by data storage on servers with complete data back-up on a daily basis. Access to data will
      be restricted to the research personnel working directly with data entry or analyses.

      Data analysis:

      Differences in continuous demographic variables at baseline between intervention and control
      group will tested using independent t-tests for normally distributed data. Non-normally
      distributed variables will be analysed by non-parametric tests. For categorical variables,
      differences will be analysed by chi-square test. Effectiveness with regard to primary and
      secondary outcomes will be analysed by mixed-effect regression analyses with two levels
      (individual and school) with data at T1 or T2 as outcomes, according to the principle of
      intention to treat. First, a crude model will be tested for all outcomes at T1 or T2 with
      group as the predictor and adjusted for baseline values of the relevant outcome. Interaction
      between group and child sex or group and parental SEP will be tested and analyses stratified
      if significant interaction terms are found. All children with measurements at T0 will be
      included and missing data will be handled with multiple imputation. The effect that any
      missing data might have on results will be assessed by performing sensitivity analyses of
      augmented data sets. Analysis will also be performed per protocol including only those
      children whose parents have attended at least one MI session.

      All statistical analysis will be performed blinded to group allocation. Interviews and focus
      groups will be transcribed verbatim and analysed using qualitative content analysis.

      Sample size calculation:

      Dietary intake of unhealthy foods, unhealthy drinks and healthy foods is the primary outcome.
      In the previous study, the intake of unhealthy foods was 1.7 ± 2.0 portions/day. In this
      study, the aim is to achieve a difference in intake of unhealthy foods of 0.8 portions/day
      between the intervention and the control group. With a power of 80% and significance level of
      5% and an intra-class correlation coefficient of 2% (clustering at school level), at least 17
      schools with 15 children in each school need to be recruited, 255 children in total.
    

Intervention name(s): A Healthy School Start Plus intervention
Intervention type(s): Behavioral
Intervention description(s): Intervention for prevention of childhood overweight and obesity in disadvantaged areas through parental support in the school setting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prevention, obesity, parenting, diet, physical activity