Long-term Follow-up After Childhood Obesity

ConditionOverweight , Obesity

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age7-30

SponsorUlla Toft

About this trial

The goal of this observational study is to learn about the long-term effects on health and well-being of treatment for overweight in childhood or adolescence using the Children's Obesity Clinic Treatment protocol (the Holbæk Model) (HM).

The study has two parts:

* An active follow-up study, where participants are invited to take part in new measurements and questionnaires * A register-based study, which uses existing data on diagnoses, medication use, and school well-being The submitted protocol primarily focuses on the active follow-up study. The register-based study covers diagnoses, medication use, and school-related well-being and is described in the section "Detailed description".

In the active follow-up study, researchers will examine:

* Body measurements such as height, weight, and waist circumference * Body composition * Psychosocial well-being and mental health * Eating behaviors in young adults Participants will be followed for up to 20 years after treatment initiation. Where possible, results will be compared with a group of people of the same age from the same area who did not receive this treatment. This will help show whether their development differs from that of the general population.

The aim is to use the findings to improve future follow-up care and support for people who were treated for overweight as children.

The study includes two groups:

1. A treatment group of individuals treated at the Holbæk Pediatric Department between 2008 and 2025 2. A comparison group from the general population, recruited between 2010 and 2016

The study will take place in two phases:

* A pilot phase (about 1.5 years) to test procedures and recruitment * A main phase (about 3 years)

Participants are invited to one follow-up visit. During this visit:

* Body measurements will be taken * Body composition will be assessed * Participants will complete questionnaires The study team will ensure that all participants are treated respectfully and without stigma. Flexible options, including home visits, are offered to make participation easier.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

At least one treatment contact for childhood overweight or obesity at the Children's Obesity Clinic at Holbæk Hospital during 1.1.2008-31.12.2025

Age 5 -17 at treatment initiation

Age 7 - 30 years at invitation to follow-up

Disqualifiers

Died

Living abroad

Previously declined to be contacted for future research purposes

Participated in the reference cohort previously established by Holbæk Hospital during year 2010-2016.

Trial population

Treatment cohort: Holbæk Hospital has established a research cohort of all individuals who were enrolled in pediatric obesity treatment at the Holbæk Hospital Children's Obesity Clinic from March 2007 and onwards. The present study will include the subset of this cohort who initiated treatment from 1.1.2008-31.12.2025, were aged 5-17 years at treatment start, and are aged 7-30 years at follow-up (expected n=3,400) . Reference cohort: As the reference cohort, a subset of a previously established cohort recruited from the general population in the Capital and Zealand Regions during 2010-2016 will be used. In the original cohort, 3,811 children and adolescents aged 2-19 years were recruited from schools and municipal dental clinics in 11 municipalities. For the present study, the investigators will invite the subset of the reference cohort who were aged 5-17 years at enrolment and are aged 18-30 years at follow-up (expected n=2,700).

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

The AFTER study - Assessing Future Trajectories of hEalth- and well-being among childhood obesity treatment Recipients
Other intervention
The study design is observational, with a single long-term follow-up measurement and register data. The AFTER study includes long-term follow-up for prior patients treated with "The Holbæk-model" (The Holbaek Study), which is a treatment approach for pediatric obesity developed and implemented since 2008 at the Department of Pediatrics at Holbæk Hospital in Denmark. The Holbæk-model a is family-centered treatment plan to individually balance and mitigate obesity-related risk factors in the child's life by providing individually tailored lifestyle advice in a detailed plan. Patients aged \<20 years with age- and sex-specific body mass index (BMI) above the 99th percentile are eligible for treatment, and these persons are usually referred by their general practitioner or school nurse. Visit frequency is highly variable, depending on the individual patient's needs. The treatment has no time limit, but patients can remain in treatment only until age 24.

Treatment groups

6,100 Participants

are divided into 2 treatment groups

Group A: Treatment cohort1 intervention

Group B: Population-based reference cohort1 intervention

Trial outcomes

Primary outcomes

Body Mass Index z-scores

Body Mass Index (BMI) z-scores will be calculated from height and weight measurements for all participants using the LMS method with national reference data.

Time frame

From enrollment in "The Holbaek Study" to the individual follow-up visit (follow-up visit: approximately 40 minutes in total)

Secondary outcomes

Strengths and Difficulties Questionnaire, total score

A total difficulty score for overall difficulties based on four domains (the sum of the Emotional symptoms scale + Conduct problems scale + Hyperactivity scale + Peer problems scale), scaled from 0-40 points. Higher values indicating a higher level of difficulties (0-13 points: Normal, 14-16 points: Borderline, 17-40 points: Abnormal).

Time frame

During the individual follow-up visit (lasting approximately 40 minutes in total)

The Strengths and Difficulties Questionnaire (SDQ) impact score

An overall distress and impairment score from four domains (ranges from 0 to 10 for parent- and self-report)

Time frame

During the individual follow-up visit (lasting approximately 40 minutes in total)

The Pediatric Quality of Life Inventory, total scale score

Total scale score for The Pediatric Quality of Life Inventory. Four subscales, each answered on a 5-point Likert scale from 0 (Never) to 4 (Almost always) or a 3-point Likert scale from 0 (Not at all), 2 (Sometimes) and 4 (A lot). Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Higher scores indicating better health related quality of life.

Time frame

From enrollment in "The Holbaek Study" to the individual follow-up visit (follow-up visit: approximately 40 minutes in total)

Body mass index

Body Mass Index (BMI). Calculated for participants \> 18 years by the equation: BMI = weight (kg) / (height (m) \* height (m)). Following categories applies: Below 18,5: Under weight 18,5 - 24,9: Normal weight 25,0 - 29,9: Overweight Over 30,0: Severe overweight

Time frame

From enrollment in "The Holbaek Study" to the individual follow-up visit (follow-up visit: approximately 40 minutes in total)

Other outcomes

Tanner Stage (self-assesment)

The Tanner scale divides puberty into 5 distinct stages (Stage 1 = pre-puberty, Stage 5 = adult development). The questionnaire include standardized line drawings, allowing the child/adolescent to select the image that most accurately matches their own body.

Time frame

At follow-up visit (lasting approximately 40 minutes in total)

Weight categories

Weight categories will be determined using the extended international (IOTF) BMI cut-offs for children and BMI cut-offs as defined by WHO for adults

Time frame

During the individual follow-up visit (lasting approximately 40 minutes in total)

Treatment for overweight (self-reported)

Questions to obtain information about current or past treatment for overweight

Time frame

At follow-up visit (lasting approximately 40 minutes ti total)

Perceived overall experience with the treatment with the Children's Obesity Clinic's Treatment protocol

Open-ended question to report perceived experience (positive or negative) with the Children's Obesity Clinic's Treatment protocol

Time frame

At the follow-up visit (lasting approximately 40 minutes in total)

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ulla Toft

Lead sponsor

Steno Diabetes Center Copenhagen

Sponsor institution

Centre for Childhood Health

Collaborator

The Children's Obesity Clinic, Holbaek Hospital

Collaborator

Source ClinicalTrials.gov

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