Child ObesitySTOMPNCT03219658
STOMP Early Years: A Pilot RCT of an Intensive, Family-Centred, Home Visiting Intervention for Young Children With Severe Obesity
A study testing Parenting education sessions in people with Child Obesity, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
This internal pilot study will determine whether a highly promising primary care based intervention that combines group based parenting skills training and public health nurse home visits with a focus on healthy nutrition, activity and sleep, will lead to improved weight status in 1 to 5 year old children with severe… Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Child Obesity
- What is being tested?
- Parenting education sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2017to 1 Nov 2019
- 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 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with obesity and severe obesity (BMI ≥97th percentile) and at least one parent (primary caregiver), and families who are fluent in English (written and oral) will be eligible to participate.
Who cannot join
- Children with diagnosed Prader-Willi syndrome; severe developmental delay; and families who reside beyond the Toronto Public Health catchment area for home visiting.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: STOMP Early Years: A Pilot Randomized Controlled Trial of an Intensive, Family-Centred, Home Visiting Intervention for Young Children With Severe Obesity
This internal pilot study will determine whether a highly promising primary care based intervention that combines group based parenting skills training and public health nurse home visits with a focus on healthy nutrition, activity and sleep, will lead to improved weight status in 1 to 5 year old children with severe obesity.
Children with severe obesity will be identified through the obesity management clinical program at The Hospital for Sick Children called STOMP (SickKids Team Obesity Management Program). The STOMP Early Years Program is a unique and intensive, paediatric obesity management program designed for 1 to 5 year-olds with severe obesity and their families. Families who participate in this study will be randomly assigned (having an equal chance of being in either group) to one of the two study groups that will run for 6 months:
Read more
Group A: Ten weeks of group parenting education sessions with 2-4 public health nurse home visits and four one-on-one check-ins with an interdisciplinary team at STOMP.
Group B: Wait listed to receive parenting education sessions; receive one-on-one checks with an interdisciplinary team at STOMP.
In addition to the measures collected as part of STOMP, families will complete the following questionnaires before the start of the trial, and after 6 months:
Parenting Scale, Parenting Stress Index, Depression, Anxiety, and Stress Scale (DASS-21), Cost Questionnaire, and Children's Behaviour Questionnaire (CBQ).
- Conditions
- Child Obesity
- Being tested
- Parenting education sessions
- Keywords
- Parenting, Home visiting, Childhood obesity treatment
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenting education sessionsBehavioural
If assigned to the parenting education session group, families will start with the 10-week group parenting education sessions and 2-4 home visits immediately after being enrolled. During this time, they will also come in for four one-on-one check-ins with the STOMP team. Each check-in will be approximately 1 hour. At least one parent/caregiver will attend weekly parenting sessions which will take place at SickKids. The Toronto Public Health Nurse will arrange 2-4 home visits with the family during the 6 month period of the study. The home visits will focus on helping to apply the messages and skills from the group sessions in their homes, and making connections in the neighbourhood to recreational or nutrition programs or other supports for the family.
| Study group | Role | What they receive |
|---|---|---|
| Parenting education sessions | Experimental | Receive 10 weeks of group parenting education sessions with 2-4 public health nurse home visits. Receives: Behavioral: Parenting education sessions |
| Control | No intervention | Attend one-on-one check-ins with the interdisciplinary team at STOMP; wait-listed control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
zBMI
Measure the difference in age and sex-standardized BMI z-score (zBMI)
Measured: 6 months post-intervention
Secondary outcomes (2)
Mental health
Assess mental health by Strengths and Difficulties Questionnaire
Measured: 6 months post-intervention
Eating behaviour and dietary intake
Assess eating behaviour and dietary intake using the Nutrition Screening Tool for Every Preschooler (NutriSTEP)
Measured: 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study start1 Oct 2017
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child ObesityStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Birken, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219658
- Sponsor's protocol ID
- 1000054922
- Acronym
- STOMP
- Status last verified
- Oct 2021
- First submitted
- 27 Jun 2017
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kinlin LM, Oreskovich SM, Dubrowski R, Ball GDC, Barwick M, Dettmer E, Haines J, Hamilton J, Kim THM, Klaassen M, Luca P, Maguire JL, Moretti ME, Stasiulis E, Toulany A, Birken CS. Managing Obesity in Young Children: A Multiple Methods Study Assessing Feasibility, Acceptability, and Implementation of a Multicomponent, Family-Based Intervention. Child Obes. 2022 Sep;18(6):409-421. doi: 10.1089/chi.2021.0221. Epub 2022 Jan 26.
PubMed 35085455
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STOMP Early Years: A Pilot Randomized Controlled Trial of an Intensive, Family-Centred, Home Visiting Intervention for Young Children With Severe Obesity
- ClinicalTrials.gov ID
- NCT03219658
- Acronym / sponsor ID
- STOMP / 1000054922
- Conditions
- Child Obesity
- Keywords
- Parenting, Home visiting, Childhood obesity treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 17 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This internal pilot study will determine whether a highly promising primary care based intervention that combines group based parenting skills training and public health nurse home visits with a focus on healthy nutrition, activity and sleep, will lead to improved weight status in 1 to 5 year old children with severe obesity.
Children with severe obesity will be identified through the obesity management clinical program at The Hospital for Sick Children called STOMP (SickKids Team Obesity Management Program). The STOMP Early Years Program is a unique and intensive, paediatric obesity management program designed for 1 to 5 year-olds with severe obesity and their families. Families who participate in this study will be randomly assigned (having an equal chance of being in either group) to one of the two study groups that will run for 6 months:
Group A: Ten weeks of group parenting education sessions with 2-4 public health nurse home visits and four one-on-one check-ins with an interdisciplinary team at STOMP.
Group B: Wait listed to receive parenting education sessions; receive one-on-one checks with an interdisciplinary team at STOMP.
In addition to the measures collected as part of STOMP, families will complete the following questionnaires before the start of the trial, and after 6 months:
Parenting Scale, Parenting Stress Index, Depression, Anxiety, and Stress Scale (DASS-21), Cost Questionnaire, and Children's Behaviour Questionnaire (CBQ).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parenting education sessions | Experimental | Behavioral: Parenting education sessionsReceive 10 weeks of group parenting education sessions with 2-4 public health nurse home visits. |
| Control | No intervention | –Attend one-on-one check-ins with the interdisciplinary team at STOMP; wait-listed control group. |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with obesity and severe obesity (BMI ≥97th percentile) and at least one parent (primary caregiver), and families who are fluent in English (written and oral) will be eligible to participate.
Key exclusion criteria (1 listed)
- Children with diagnosed Prader-Willi syndrome; severe developmental delay; and families who reside beyond the Toronto Public Health catchment area for home visiting.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parenting education sessionsIf assigned to the parenting education session group, families will start with the 10-week group parenting education sessions and 2-4 home visits immediately after being enrolled. During this time, they will also come in for four one-on-one check-ins with the STOMP team. Each check-in will be approximately 1 hour. At least one parent/caregiver will attend weekly parenting sessions which will take place at SickKids. The Toronto Public Health Nurse will arrange 2-4 home visits with the family during the 6 month period of the study. The home visits will focus on helping to apply the messages and skills from the group sessions in their homes, and making connections in the neighbourhood to recreational or nutrition programs or other supports for the family. | Behavioural | Parenting education sessions |
Primary outcome
zBMI
Time frame: 6 months post-intervention
Measure the difference in age and sex-standardized BMI z-score (zBMI)
2 secondary outcomes
Mental health
Time frame: 6 months post-intervention
Eating behaviour and dietary intake
Time frame: 6 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Derived from this study: PubMed 35085455Kinlin LM, Oreskovich SM, Dubrowski R, Ball GDC, Barwick M, Dettmer E, Haines J, Hamilton J, Kim THM, Klaassen M, Luca P, Maguire JL, Moretti ME, Stasiulis E, Toulany A, Birken CS. Managing Obesity in Young Children: A Multiple Methods Study Assessing Feasibility, Acceptability, and Implementation of a Multicomponent, Family-Based Intervention. Child Obes. 2022 Sep;18(6):409-421. doi: 10.1089/chi.2021.0221. Epub 2022 Jan 26.
- Individual participant dataSharing planned: No
Related trials for Child Obesity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
RecruitingPhase 3
Efficacy, Safety, and Pharmacokinetics of Tirzepatide (LY3298176) Once Weekly Versus Placebo in Pediatric Participants 6 to Less Than 12 Years of Age Who Have Obesity (ADVANCE-SURMOUNT-KIDS)
Obesity
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
Active, not recruitingObservational study
Guangzhou Preterm and Term Birth Cohort Study
Preterm Birth, Neurodevelopmental Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parenting education sessions in people with Child Obesity, run by The Hospital for Sick Children at 1 site in Canada.
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 1 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 1 Nov 2021. 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 Canada. 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?
zBMI (time frame: 6 months post-intervention). 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 NCT03219658, which also lists 1 linked publication.
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 1 Nov 2021.