Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03390725 |
| Other study ID # |
KI 4-2891/2016 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2017 |
| Est. completion date |
December 31, 2021 |
Study information
| Verified date |
January 2022 |
| Source |
Karolinska Institutet |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
