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NCT Number: NCT01792531

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institute

Stockholm, 141 57, Sweden

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Parent training group

Behavioral

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.

Standard treatment with focus on lifestyle

Behavioral

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 booster sessions

Behavioral

Parent training group with additional booster sessions at 8-week intervals for the following year.

Primary outcomes

  1. Change in Body Mass Index (BMI) SDS

    Time frame: 1 year

    Measurements of children's weight and height

Secondary outcomes

  1. Change in parenting practices, general and specific

    Time frame: 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.

  2. Change in child's dietary intake and behaviour

    Time frame: 1 year

    Measured using validated questionnaires such as Child Eating Behaviour Questionnaire and Food Frequency Questionnaire.

  3. Change in child's physical activity

    Time frame: 1 year

    With questions about child's physical activity and screen time using Lifestyle Behaviour Checklist.

  4. Change in family functioning

    Time frame: 1 year

    Using a validated questionnaire Family Assessment Device (FAD).

  5. Change in child's metabolic health

    Time frame: 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.

  6. Change in parent's functioning

    Time frame: 1 year

    Measured by a validated questionnaire, the Beck Depression Inventory.

  7. Waist circumference

    Time frame: Baseline, 3 months, 1 year

    Measured in children and parents

  8. Change in child's functioning

    Time frame: 1 year

    Measured with a validated questionnaire, the Child Behaviour Checklist.

  9. Change in socioeconomic status

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Oregon Social Learning Center

Registry information

Official study title

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

Acronym: M&L

Important dates

Study start
2013
Primary completion
2017
Study completion
2022
First posted
Feb 15, 2013
Registry last updated
Oct 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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