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

NCT01792531 | Completed

• 1 other identifier: ML2012
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

children; obesity; treatment; family

Outcome Measures

Primary Outcomes (1)

• Change in Body Mass Index (BMI) SDS

  Measurements of children's weight and height

  1 year

Secondary Outcomes (9)

• Change in parenting practices, general and specific

  1 year

• Change in child's dietary intake and behaviour

  1 year

• Change in child's physical activity

  1 year

• Change in family functioning

  1 year

• Change in child's metabolic health

  1 year

Study Arms (2)

Treatment focus - Parenting vs lifestyle

EXPERIMENTAL

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; Behavioral: Standard treatment with focus on lifestyle

Length of treatment

EXPERIMENTAL

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; Behavioral: Parent training group with booster sessions

Interventions

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.

Length of treatment; Treatment focus - Parenting vs lifestyle

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.

Treatment focus - Parenting vs lifestyle

Parent training group with booster sessions BEHAVIORAL

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

Length of treatment

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age 4-6 years old
• obesity as defined by international cut-offs (Cole T. J. et al. BMJ, 2000).

You may not qualify if:

• weight affecting diseases

Sponsors & Collaborators

• Karolinska Institutet: lead
• Oregon Social Learning Center: collaborator

Study Sites (1)

Karolinska Institute

Stockholm, 141 57, Sweden

Location

Related Publications (4)

• Ek A, Brissman M, Nordin K, Eli K, Nowicka P. A long-term follow-up of treatment for young children with obesity: a randomized controlled trial. Int J Obes (Lond). 2023 Nov;47(11):1152-1160. doi: 10.1038/s41366-023-01373-7. Epub 2023 Oct 25.

  PMID: 37723272 DERIVED

• 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.

  PMID: 31481062 DERIVED

• 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.

  PMID: 31300528 DERIVED

• 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.

  PMID: 26231850 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Paulina Nowicka, Ph.D.

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 12, 2013
• First Posted: February 15, 2013
• Study Start: January 1, 2013
• Primary Completion: November 1, 2017
• Study Completion: December 31, 2022
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)