An interventional study of Parent training group and Standard treatment with focus on lifestyle in Obesity, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 4 Years to 6 Years. Per ClinicalTrials.gov, last updated 2023-10-06.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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.
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).
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 177 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
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Exclusion Criteria:
To determine the effectiveness of two obesity treatment interventions: 1) parent training group (n=90) and 2) standard treatment with focus on lifestyle (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). This design will allow us to assess whether a program targeting only parents and focusing on parenting practices will result in better outcomes than treatment as usual emphasizing lifestyle changes.
Behavioral: Parent training group · Behavioral: Standard treatment with focus on lifestyle
To understand the influence of treatment duration by comparing the effectiveness of two obesity treatment interventions: the parent training group administered for 12 wks only (n=45) and the parent training group with booster sessions which include additional booster sessions at 8-week intervals for the following year (n=45). Thus we will randomize families to either a group with booster sessions or without. This design will allow us to evaluate if prolonged care is necessary to maintain intervention effects, or if a 12-week program is equally effective.
Behavioral: Parent training group · Behavioral: Parent training group with booster sessions
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.
Change in Body Mass Index (BMI) SDS
Measurements of children's weight and height
Time frame: 1 year
Change in parenting practices, general and specific
Measured with validated questionnaires such as Child Feeding Questionnaire, Child Eating Behaviour Questionnaire and Lifestyle Behaviour Checklist. Parent's general parenting will be assessed with a questionnaire specifically developed for this study.
Time frame: 1 year
Change in child's dietary intake and behaviour
Measured using validated questionnaires such as Child Eating Behaviour Questionnaire and Food Frequency Questionnaire.
Time frame: 1 year
Change in child's physical activity
With questions about child's physical activity and screen time using Lifestyle Behaviour Checklist.
Time frame: 1 year
Change in family functioning
Using a validated questionnaire Family Assessment Device (FAD).
Time frame: 1 year
Change in child's metabolic health
Assessed by measurements of children's blood pressure, lipids, fasting glucose, insulin, and homeostasis model of insulin resistance. All these measurements are routinely assessed in all children with obesity in Stockholm. Blood tests are not required to participate in the study.
Time frame: 1 year
Change in parent's functioning
Measured by a validated questionnaire, the Beck Depression Inventory.
Time frame: 1 year
Waist circumference
Measured in children and parents
Time frame: Baseline, 3 months, 1 year
Change in child's functioning
Measured with a validated questionnaire, the Child Behaviour Checklist.
Time frame: 1 year
Change in socioeconomic status
With a questionnaire developed for this study based on routine assessments at the Child Health Care and a questionnaire used at the Oregon Social Learning Center (OSLC) for similar population (families with young children).
Time frame: 1 year
Plan to share: No
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Karolinska Institutet