The More & Less Study: A Trial Testing Different Treatment Approaches to Obesity in Preschoolers

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: Parent training group; Behavioral: Parent training group with booster sessions; Behavioral: Standard treatment with focus on lifestyle

• Registration Number: NCT01792531
• Lead Sponsor: Karolinska Institutet

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).

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-02-12
• Study First Submitted QC: 2013-02-14
• Study First Posted: 2013-02-15
• Primary Completion: 2017-11
• Study Completion: 2022-12-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-05
• Last Update Posted: 2023-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 177

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Length of treatment	Parent training group with booster sessions	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.
Treatment focus - Parenting vs lifestyle	Parent training group	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.
Treatment focus - Parenting vs lifestyle	Standard treatment with focus on lifestyle	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.
Length of treatment	Parent training group	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.

Primary Outcome Measures

Name	Time	Method
Change in Body Mass Index (BMI) SDS	1 year	Measurements of children's weight and height

Secondary Outcome Measures

Name	Time	Method
Change in child's physical activity	1 year	With questions about child's physical activity and screen time using Lifestyle Behaviour Checklist.
Change in parent's functioning	1 year	Measured by a validated questionnaire, the Beck Depression Inventory.
Waist circumference	Baseline, 3 months, 1 year	Measured in children and parents
Change in parenting practices, general and specific	1 year	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.
Change in child's dietary intake and behaviour	1 year	Measured using validated questionnaires such as Child Eating Behaviour Questionnaire and Food Frequency Questionnaire.
Change in child's metabolic health	1 year	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.
Change in family functioning	1 year	Using a validated questionnaire Family Assessment Device (FAD).
Change in socioeconomic status	1 year	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).
Change in child's functioning	1 year	Measured with a validated questionnaire, the Child Behaviour Checklist.

Trial Locations

Locations (1)

Karolinska Institute; 🇸🇪 Stockholm, Sweden