The More & Less Study: A Trial Testing Different Treatment Approaches to Obesity in Preschoolers
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Obesity has been shown to be resistant to treatment in adults, adolescents, and in school age
      children, but not during early childhood. Yet knowledge on the effectiveness of early
      childhood treatment programs for obesity is still very limited, preventing the widespread
      implementation of such programs. The overarching purpose of this study is to evaluate the
      effectiveness of early treatment of childhood obesity. The investigators plan to perform a
      carefully-designed randomized controlled trial that will evaluate different treatment options
      offered to families with children with obesity, organized within the healthcare system and
      followed up for at least 1 year post-baseline. Participants will be children aged 4-6 years
      (N=180) with obesity and their parents. This study will facilitate a close examination of key
      treatment components and mechanisms of change. Results from this study will lead to better
      healthcare options for obesity treatment during childhood and ultimately to the prevention of
      obesity later in life from a public health perspective.
    

Detailed description: 
      The proposed randomized controlled trial has four specific aims:

      Specific Aim #1: PARENTING OR LIFESTYLE? To determine the effectiveness of two obesity
      treatment conditions: 1) parent training (n=90) and 2) treatment as usual focused on
      lifestyle changes (n=90). The two treatment conditions will be evaluated with respect to
      child weight status (BMI SDS; primary outcome), psychosocial and metabolic health, lifestyle
      choices, and family functioning (secondary outcomes).

      Specific Aim #2: OPTIMAL LENGTH OF TREATMENT AND FOLLOW-UP? To understand the influence of
      treatment duration we will compare the effectiveness of the parent training program
      administered for 10 wks only and for 10 wks plus additional booster sessions at 8-week
      intervals for the following year. All groups will be followed up for at least one year
      post-baseline.

      Specific Aim #3: TO START AT AGE 4,5 OR 6? To assess the influence of child age at the start
      of treatment on the treatment outcomes.

      Specific Aim #4: MEDIATORS AND MODERATORS? To determine whether changes in targeted parenting
      skills (such as limit setting, monitoring and problem-solving) will mediate child obesity
      outcomes by examining all treatment groups. In addition, we will examine moderators of
      intervention effects (e.g. socioeconomic status (SES), parental weight status, and
      depression).
    

Intervention name(s): Parent training group; Standard treatment with focus on lifestyle; Parent training group with booster sessions
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The More & Less group will focus on how to use positive parenting practices (e.g., reinforcement/encouragement, limit setting, monitoring, problem-solving, positive involvement, and emotion regulation) instead of ineffective practices (e.g., coercive behavior, negative reciprocity, escalation, and negative reinforcement). Using a parent-group approach to intervention administration, each of the twelve More & Less sessions (1.5h/wk) consist of introduction to effective parenting practices followed by a discussion and practice using role play and home practice assignments. The information and procedures will be tailored to focus on changes in the home environment, mostly related to child food habits and physical activity.; The treatment will be provided by local pediatricians in outpatient pediatric departments and will be based on lifestyle modifications, as recommended in the action plan for Stockholm County.; Parent training group with additional booster sessions at 8-week intervals for the following year.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: children; obesity; treatment; family