The More & Less Study: A Randomized Controlled Trial Testing Different Treatment Approaches to Obesity in Preschoolers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- Karolinska Institutet
- Enrollment
- 177
- Locations
- 1
- Primary Endpoint
- Change in Body Mass Index (BMI) SDS
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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).
Investigators
Paulina Nowicka
Associate Professor
Karolinska Institutet
Eligibility Criteria
Inclusion Criteria
- •age 4-6 years old
- •obesity as defined by international cut-offs (Cole T. J. et al. BMJ, 2000).
Exclusion Criteria
- •weight affecting diseases
Outcomes
Primary Outcomes
Change in Body Mass Index (BMI) SDS
Time Frame: 1 year
Measurements of children's weight and height
Secondary Outcomes
- Change in child's physical activity(1 year)
- Change in parent's functioning(1 year)
- Waist circumference(Baseline, 3 months, 1 year)
- Change in parenting practices, general and specific(1 year)
- Change in child's dietary intake and behaviour(1 year)
- Change in child's metabolic health(1 year)
- Change in family functioning(1 year)
- Change in socioeconomic status(1 year)
- Change in child's functioning(1 year)