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ObesityM&LNCT01792531

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

A study testing Parent training group, Standard treatment with focus on lifestyle and Parent training group with booster sessions in people with Obesity, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 4 to 6 years
Conditions the study is for
Obesity
What is being tested?
Parent training group, Standard treatment with focus on lifestyle and Parent training group with booster sessions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
177 participants
Where
1 siteSweden
Study dates
Jan 2013to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 6 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • weight affecting diseases

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Karolinska Institute

    Stockholm, 141 57

Other trials in Sweden

About this study

Official title: 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.

Read the 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).

Conditions
Obesity
Being tested
Parent training group, Standard treatment with focus on lifestyle, Parent training group with booster sessions
Keywords
children, obesity, treatment, family
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Parent training groupBehavioural

    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 lifestyleBehavioural

    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 sessionsBehavioural

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

Study groups in NCT01792531
Study groupRoleWhat they receive
Treatment focus - Parenting vs lifestyleExperimentalTo 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.
Receives: Behavioral: Parent training group; Behavioral: Standard treatment with focus on lifestyle
Length of treatmentExperimentalTo 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.
Receives: Behavioral: Parent training group; Behavioral: Parent training group with booster sessions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Body Mass Index (BMI) SDS

    Measurements of children's weight and height

    Measured: 1 year

Secondary outcomes (9)

  1. 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.

    Measured: 1 year

  2. Change in child's dietary intake and behaviour

    Measured using validated questionnaires such as Child Eating Behaviour Questionnaire and Food Frequency Questionnaire.

    Measured: 1 year

  3. Change in child's physical activity

    With questions about child's physical activity and screen time using Lifestyle Behaviour Checklist.

    Measured: 1 year

  4. Change in family functioning

    Using a validated questionnaire Family Assessment Device (FAD).

    Measured: 1 year

  5. 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.

    Measured: 1 year

  6. Change in parent's functioning

    Measured by a validated questionnaire, the Beck Depression Inventory.

    Measured: 1 year

  7. Waist circumference

    Measured in children and parents

    Measured: Baseline, 3 months, 1 year

  8. Change in child's functioning

    Measured with a validated questionnaire, the Child Behaviour Checklist.

    Measured: 1 year

  9. 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).

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionNov 2017
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
177 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01792531
Sponsor's protocol ID
ML2012
Acronym
M&L
Status last verified
Oct 2023
First submitted
12 Feb 2013
Last updated
6 Oct 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37723272

  • 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.

    PubMed 31481062

  • 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.

    PubMed 31300528

  • 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.

    PubMed 26231850

Questions about this trial

What is this clinical trial studying?

A study testing Parent training group, Standard treatment with focus on lifestyle and Parent training group with booster sessions in people with Obesity, run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Body Mass Index (BMI) SDS (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01792531, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.

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M&L Clinical Trial NCT01792531 | AzTrials