The More & Less Study: A Trial Testing Different Treatment Approaches to Obesity in Preschoolers
NCT ID: NCT01792531
Last Updated: 2023-10-06
Study Results
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Basic Information
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COMPLETED
NA
177 participants
INTERVENTIONAL
2013-01-31
2022-12-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Parent training group with booster sessions
Parent training group with additional booster sessions at 8-week intervals for the following year.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* obesity as defined by international cut-offs (Cole T. J. et al. BMJ, 2000).
Exclusion Criteria
4 Years
6 Years
ALL
No
Sponsors
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Oregon Social Learning Center
OTHER
Karolinska Institutet
OTHER
Responsible Party
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Paulina Nowicka
Associate Professor
Principal Investigators
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Paulina Nowicka, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Karolinska Institute
Stockholm, , Sweden
Countries
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References
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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.
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.
Other Identifiers
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ML2012
Identifier Type: -
Identifier Source: org_study_id
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