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

The More & Less Study: A Randomized Controlled 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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Parent training group; Behavioral: Standard treatment with focus on lifestyle; Behavioral: Parent training group with booster sessions

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 Type: Interventional
• Enrollment (Actual): 177
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 141 57
    • Karolinska Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 6 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body Mass Index (BMI) SDS	Measurements of children's weight and height	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Oregon Social Learning Center
• Investigators: Principal Investigator: Paulina Nowicka, Ph.D., Karolinska Institutet

Publications and helpful links

General Publications

• Sandvik P, Ek A, Eli K, Somaraki M, Bottai M, Nowicka P. Picky eating in an obesity intervention for preschool-aged children - what role does it play, and does the measurement instrument matter? Int J Behav Nutr Phys Act. 2019 Sep 3;16(1):76. doi: 10.1186/s12966-019-0845-y.
• Ek A, Lewis Chamberlain K, Sorjonen K, Hammar U, Etminan Malek M, Sandvik P, Somaraki M, Nyman J, Lindberg L, Nordin K, Ejderhamn J, Fisher PA, Chamberlain P, Marcus C, Nowicka P. A Parent Treatment Program for Preschoolers With Obesity: A Randomized Controlled Trial. Pediatrics. 2019 Aug;144(2):e20183457. doi: 10.1542/peds.2018-3457. Epub 2019 Jul 12.
• Ek A, Chamberlain KL, Ejderhamn J, Fisher PA, Marcus C, Chamberlain P, Nowicka P. The More and Less Study: a randomized controlled trial testing different approaches to treat obesity in preschoolers. BMC Public Health. 2015 Aug 1;15:735. doi: 10.1186/s12889-015-1912-1.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: February 12, 2013
• First Submitted That Met QC Criteria: February 14, 2013
• First Posted (Estimated): February 15, 2013

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: treatment; family; obesity; children
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: ML2012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO