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

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ClinicalTrials.gov Identifier: NCT01792531
Recruitment Status : Active, not recruiting
First Posted : February 15, 2013
Last Update Posted : August 14, 2019
Sponsor:
Collaborator:
Oregon Social Learning Center
Information provided by (Responsible Party):
Paulina Nowicka, 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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Parent training group Behavioral: Standard treatment with focus on lifestyle Behavioral: Parent training group with booster sessions Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 177 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The More & Less Study: A Randomized Controlled Trial Testing Different Treatment Approaches to Obesity in Preschoolers
Actual Study Start Date : January 2013
Actual Primary Completion Date : November 2017
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Toddler Health

Arm Intervention/treatment
Experimental: Treatment focus - Parenting vs 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.
Behavioral: Parent training group
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.

Behavioral: Standard treatment with focus on lifestyle
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.

Experimental: Length of treatment
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
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.

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




Primary Outcome Measures :
  1. Change in Body Mass Index (BMI) SDS [ Time Frame: 1 year ]
    Measurements of children's weight and height


Secondary Outcome Measures :
  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).



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01792531


Locations
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Sweden
Karolinska Institute
Stockholm, Sweden, 141 57
Sponsors and Collaborators
Karolinska Institutet
Oregon Social Learning Center
Investigators
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Principal Investigator: Paulina Nowicka, Ph.D. Karolinska Institutet

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Paulina Nowicka, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01792531    
Other Study ID Numbers: ML2012
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Paulina Nowicka, Karolinska Institutet:
children
obesity
treatment
family
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms