Childhood Obesity, Lifestyle Interventions and Psychosocial Well-being

August 12, 2024 updated by: University of Aarhus

Impact of Multifactorial Lifestyle Interventions on Psychosocial Well-being for Children Living With Obesity

Childhood obesity has been associated with an increased risk of impaired psychosocial well-being and the development of depression and anxiety.

This study includes approximately 200 children with obesity aged 5-10 treated within one of two multifactorial family-centered lifestyle intervention in the time-period 2014-2020. Additionally, this study includes 150 children with obesity in the same age group, who were never invited into the multifactorial family-centered lifestyle interventions. During that period the children annually completed the Danish Nation Well-being Questionnaire (DNWQ) in school. The DNWQ is a national questionnaire used to examine the well-being and learning environment in Danish schoolchildren.

The aim is to investigate the long-term impact on psychosocial well-being in children with obesity following participation in one of two multifactorial family-centered lifestyle interventions: a one-year and three-year intervention. Further, to compare this alteration in psychosocial well-being between the intervention groups and with a reference group of children who were never invited to participate in the interventions.

The study will combine data from mandatory health check-ups at school, the Danish National Registries, and the Danish agency for IT and Learning (STIL), The ministry of Education.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The continuous rise in obesity among children has become a critical public health issue, due to the associated risks of continuous obesity and development of metabolic disorders in adulthood. While these consequences may not become apparent until later in life, the obesity-related complications commonly observed in childhood are associated with impaired psychosocial well-being (i.e. reduced self-image, bullying, and stigmatization). Children and adolescents with obesity have a higher risk of impaired health-related quality of life (QoL) and are more likely to suffer from depression and anxiety, compared to their lean peers. Furthermore, these mental health related complications can typical be observed in childhood opposite the somatic complications.

While there is agreement that obesity is associated with overall reduced psychosocial well-being in children and adolescents, studies comparing how different, or no lifestyle interventions affects psychosocial well-being remain scarce. It is therefore necessary to identify effective lifestyle interventions, that can handle and improve this issue.

The aim of this study is therefore to investigate the long-term impact on psychosocial well-being in children with obesity following participation in one of two multifactorial family-centered lifestyle interventions: a one-year and a three-year intervention. Further, to compare this alteration in psychosocial well-being between the intervention groups and with a reference group of children who were never invited to participate in the interventions. Additionally, the study aims to eliminate the potential impact of weight change on the association between exposure and change in psychosocial well-being.

Study design: This observational cohort study will combine data from obligatory health check-ups at school, the Danish National Registries, and the Ministry of Education for children aged 5-10 with obesity living in two municipalities in Denmark between August 1st, 2014, and June 30th, 2020. The last possible day of follow-up will be February 1st, 2023.

The interventions:

The one-year intervention: A multifactorial family-centered lifestyle intervention offering a maximum duration of one year, corresponding to three-four visits. Participants were offered complimentary weekly supervised physical activity. The day-to-day intervention was managed by specialized health care nurses at local treatment centers, at the participants' homes, or in a local clinic.

The three-year intervention: A multifactorial family-centered lifestyle intervention extending up to three years, with clinical visits at local healthcare centers occurring approximately every eight weeks, managed by specialized nurses.

The participants:

Children in the intervention groups were 5 to 10 years of age and participated in one of two different family-centered interventions: a one-year or three-year intervention. Children with obesity living in one of the municipalities, who were never invited to participate in the interventions will act as a reference group for this study. The inclusion visit for this group is defined as the initial observation with obesity.

Obesity will be defined by the International Obesity Task Force (IOTF) guideline as a BMI >= 30 kg/m2 adjusted for age and sex.

The following children will be included in this trial:

  • 107 children with obesity treated with the one-year intervention
  • 66 children with obesity treated with the three-year intervention
  • 146 children with obesity who were not invited to participate in the interventions (non intervention group)

Data-collection and analyses:

Children who participated in one of the two interventions will be identified by using data from TM-Sund and NOVAX. Data recorded at health check-ups at the school containing height and weight will also be extracted from TM-Sund and NOVAX. TM-Sund and NOVAX are data capturing tools used by the community health care nurses employed at the two municipalities. The reference group will be identified in TM-Sund.

The DNWQ data will be obtained from the Danish agency for IT and Learning (STIL), The ministry of Education.

Data on socioeconomic status (SES), immigration, family structure, and psychiatric diagnoses will be obtained from the national Danish registries through Statistics Denmark.

Ethics & Permissions:

The local committee on health ethics have approved the overall project and data transfer (rec.no 1-45-70-27-20). The project is internally reported to the University of Aarhus (rec no. 3518). The project has achieved approval from The Danish Data Protection Agency and the Principal Investigator has been granted accessed to data from registers from Danish Statistics.

The researchers have no conflict of interest to declare.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
319

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus N, Denmark, 8200
        • Steno Diabetes Center Aarhus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children with obesity, 5-10 years of age living in two municipalities in Denmark between August 1st, 2014, and June 30th, 2020. The children have either received treatment with one of the multifactorial family-centered lifestyle interventions or where never invited into the interventions.

Description

Inclusion Criteria:

  • Inclusion visit between August 1st, 2014, and June 30th, 2020.
  • Obesity at time of referral as defined by the IOTF guideline as a BMI >= 30 kg/m2 adjusted for age and sex.
  • Obesity at time of referral as defined by the IOTF guideline as a BMI >= 30 kg/m2 adjusted for age and sex.
  • Age between 5 and 10 years at inclusion visit.
  • A completed DNWQ within a timeframe of 10 months prior to 2 months after inclusion.
  • A completed DNWQ at follow-up (1 to 3 years after inclusion visit).

Exclusion Criteria:

  • Children declining participation in a community-based lifestyle intervention.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
The one-year intervention group
Children aged 5-10 with obesity who participated in the one-year multifactorial family-centered lifestyle intervention.
Behavioral: The one-year intervention
A multifactorial family-centered lifestyle intervention with a maximum duration of one year, corresponding to three-four visits. Participants were offered complimentary weekly supervised physical activity. The day-to-day intervention was managed by specialized nurses at local healthcare centers, at the participants' homes, or in a local clinic.
The three-year intervention group
Children aged 5-10 with obesity who participated in the three-year multifactorial family-centered lifestyle intervention.
Behavioral: The three-year intervention
A multifactorial family-centered lifestyle intervention extending up to three years, with clinical visits at local healthcare centers which included repeatedly visits (up to 8 times / year). The intervention was managed by specialized nurses.
The non-intervention group
Children with obesity living in one of the municipalities who were never invited to participate in the interventions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in psychosocial well-being as assessed by the DNWQ, obtained from the Danish agency for IT and Learning (STIL), The ministry of Education.
Time Frame: Annually from August 1st, 2014, to February 1st, 2023)

The impact on psychosocial well-being will be assessed with responses to specific questions regarding psychosocial well-being related to school from the DNWQ at time of inclusion and at follow-up.

The DNWQ is a national questionnaire completed annually in primary school and used to examine how primary schoolchildren perceive their well-being and learning environment in school.

The following four questions have been selected as our primary outcomes.

  1. Question:

    Are you happy with your school?

  2. Questions:

    Do you feel lonely at school? (0-3 grade) Do you feel lonely? (4-9 grade)

  3. Question:

    Is anyone teasing you so that you feel sad? (0-3 grade) Have you been bullied this school year? (4-9 grade)

  4. Question:

Does your stomach ache when you are at school? (0-3 grade) How often does your stomach ache? (4-9 grade)
Annually from August 1st, 2014, to February 1st, 2023)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in psychosocial well-being as assessed by the DNWQ, obtained from the Danish agency for IT and Learning (STIL), The ministry of Education.
Time Frame: Annually from August 1st, 2014, to February 1st, 2023)

Same as primary outcome measure, but with other questions chosen from the DNWQ.

The following three questions has been selected as our secondary outcome.

A. Question:

Are you good at solving your problems? (0-3 grade) How often can you find a solution to problems, just by trying hard enough? (4-9 grade)

B. Question:

Can you concentrate during class?

C. Question:

Are you good at helping each other in class? (0-3 grade) Most students in my class are friendly and helpful. (4-9 grade)
Annually from August 1st, 2014, to February 1st, 2023)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Randers Municipality, Denmark
Aarhus Municipality

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3518

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Participant data (IPD) will be available on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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