Effectiveness of a Family Support Model for Prevention and Management of Overweight and Obesity in Children 6-12 Years

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorKarolinska Institutet

About this trial

The study will evaluate a coherent model of family support including school health care, primary health care and pediatric clinics. The model combines two evidence based programs: the universal "A Healthy School Start" provided to all children and their families during grade 1 and the targeted parental support program "More and Less" provided to parents of children with overweight or obesity.

The hypothesis is that combining the Healthy School Start and More and Less programs in a coherent model will increase the collaboration between regional and municipal stakeholders, ensure early identification of families in need, ultimately improving prevention and treatment of childhood overweight and obesity. The aim of this study is to evaluate the implementation of a coherent model of family support provided through school and primary health care.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

A parent of a child between 6-12 years of age.

The child attends a school providing the Healthy School Start program.

The child has been diagnosed with overweight (age standardized BMI of 25 or above) or obesity (age standardized BMI of 30 or above) by a health care personnel.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • More and Less

    Behavioral

    Dose: 10 group sessions + 6 individual booster sessions Frequency: 10 weekly group sessions (10 weeks) 6 booster sessions every 6th week

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

BMI z-score

The effects on children's BMI z-score (IOTF cut offs) whose parents receive the More and Less program over a 12-month period, compared to children receiving standard treatment

Time frame
Measured at baseline, 3 and 12 months.

Secondary outcomes

1

The child's dietary habits

Assessed using the Eating and Physical Activity Questionnaire (EPAQ). Parents are asked to recall the child's intake of unhealthy and healthy foods and unhealthy drinks. Questions are answered as amounts (deciliters, glasses or portions) of 0 to 7 or more. For unhealthy foods - higher numbers are worse, for healthy foods - higher numbers are better.

Time frame
Measured at baseline, 3 and 12 months follow-up
2

The child's physical activity level

Assessed through three questions from the Public Health Agency's annual school survey to children, with questions asked to the parents. Questions are answered by estimating the number of days a week with physical activity (0-7), number of times a week with exercise (0-7) and time spent sedentary during the week (0-5) - higher numbers are better.

Time frame
Measured at baseline, 3 and 12 months
3

The child's eating behavior

Assessed using the validated Children's Eating Behavior Questionnaire (CEBQ) including 35 questions on eight different scales that help identify behavioral traits that may contribute to obesity or disordered eating and is answered by a parent. Answers: Parents rate their child's eating behavior on a five-point Likert scale (never, rarely, sometimes, often, always)

Time frame
Measured at baseline, 3 and 12 months
4

Parental feeding practices

Assessed using the validated Comprehensive Parental Feeding Questionnaire (CPFQ) including five factors: Monitoring of children's food intake, pressure to eat, restriction of food, use of food for emotional regulation, and healthy eating guidance. Answers: parents rate their feeding practices on a four-point Likert scale (rarely, sometimes, often, very often) or (disagree, somewhat disagree, somewhat agree, agree).

Time frame
Measured at baseline, 3 and 12 months

Other outcomes

Sponsors and contacts

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