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

Obesity Clinical Trial

— M&L  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01792531
• Other study ID #: ML2012
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: December 31, 2022
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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

Locations

Country	Name	City	State
Sweden	Karolinska Institute	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Oregon Social Learning Center

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Mass Index (BMI) SDS	Measurements of children's weight and height	1 year
Secondary	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.	1 year
Secondary	Change in child's dietary intake and behaviour	Measured using validated questionnaires such as Child Eating Behaviour Questionnaire and Food Frequency Questionnaire.	1 year
Secondary	Change in child's physical activity	With questions about child's physical activity and screen time using Lifestyle Behaviour Checklist.	1 year
Secondary	Change in family functioning	Using a validated questionnaire Family Assessment Device (FAD).	1 year
Secondary	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.	1 year
Secondary	Change in parent's functioning	Measured by a validated questionnaire, the Beck Depression Inventory.	1 year
Secondary	Waist circumference	Measured in children and parents	Baseline, 3 months, 1 year
Secondary	Change in child's functioning	Measured with a validated questionnaire, the Child Behaviour Checklist.	1 year
Secondary	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).	1 year