Obesity, ChildhoodNCT04711707
Addressing the Social Needs of Children With Obesity
A study testing Community navigator and Self-Navigation in people with Obesity, Childhood, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
This study aims to improve the treatment of a common, chronic health concern for children: obesity. It has the potential to improve the care we provide by testing an intervention that addresses social needs and the important upstream factors that influences health outcomes. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Community navigator and Self-Navigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 25 Jan 2021to Dec 2021
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Enrollment in the weight management program
Who cannot join
- Children in the care of child protection services and/or living in group or foster care. Children in these settings will not be living within typical family-systems to have social needs addressed by this intervention.
- Parents who cannot read and write in English
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Kimberley Krasevich
Hamilton, Ontario, L9C3L7
Kimberley Krasevich, BSc,BEd, 9055212100 ext. 73517, krasevich@hhsc.ca
Wahi Gita, MD,MSc, 9055212100, wahig@mcmaster.ca
About this study
Official title: Addressing the Social Needs of Children Attending a Weight Management Program: a Pilot Randomized Controlled Trial
This study aims to improve the treatment of a common, chronic health concern for children: obesity. It has the potential to improve the care we provide by testing an intervention that addresses social needs and the important upstream factors that influences health outcomes.
Read the detailed description
Addressing the social needs of children attending a weight management program. The specific aims of this pilot randomized controlled trial are the following:
- To determine the feasibility of implementation and delivery of a screening-referral intervention versus usual care to address social needs of children with obesity enrolled in a pediatric weight management program at McMaster Children's Hospital, which will include recruitment rates, uptake of the intervention, and follow-up of participants.
- To understand impact on health outcomes of a screening-referral intervention versus usual care to address social needs of children with obesity enrolled in a pediatric weight management program including change in i) body mass index z score (zBMI); ii) change in body composition; and iii) change in health-related quality of life.
Hypothesis: We hypothesize that health outcomes of children with obesity are connected to the social determinants of health, and that an intervention which screens for and refers to community supports will improve child obesity outcomes.
- Conditions
- Obesity, Childhood
- Being tested
- Community navigator, Self-Navigation
- Keywords
- Social Determinants of Health, Obesity, Child Health, Social needs
- Medical subject headings
- Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community navigatorOther
All patients who consent to participate in the study will complete a pediatric social history tool to identify social needs. The intervention group will receive support through a community navigator to guide and understand appropriate services for their specific needs. This arm will receive guidance and bimonthly check-ins.
Self-NavigationOther
The control group will receive an electronic or paper copy of community resources that address the identified social needs.
| Study group | Role | What they receive |
|---|---|---|
| Community navigator | Experimental | This group is guided through the resources and provided bi-monthly support with a community navigator Receives: Other: Community navigator |
| Self-Navigation | Other | This group receives the social needs resources to self-navigation Receives: Other: Self-Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rates
Recruitment rate refers to the number of participants enrolled and is measured by the number of consent forms signed or implied. Recruitment will be successful if 80% of our target sample is met.
Measured: 6 months
Uptake of Intervention
Uptake of the intervention refers to the number of enrolled families who completed all aspect of the intervention. Elements that are part of the uptake include: social history following enrollment as well as the quality of life questionnaires and use of service questionnaire at enrolment and 6-months. Uptake will be considered successful if >80% of families complete the intervention.
Measured: 6 months
Follow-up of Participants
Follow-up of participants refers to the participants attending all of their scheduled study visits. The study will be considered successful if >90% of participants complete all study visits.
Measured: 6 months
Secondary outcomes (3)
Change in Body Mass Index Z-Score
The body mass index Z-score (zBMI) is calculated using WHO growth charts, for age and sex. Height and weight of the child will be collected from the chart at baseline and from every visit the participant has in clinic until the end of the intervention. BMI will be calculated by dividing weight in kilograms by the square of the body height in metres squared.
Measured: 6 Months
Change in Body Composition
Body fat will be assessed at baseline and at the end of the intervention using the Quantum II BIA analyzer (RJL Systems). Bioelectrical impedance analysis (BIA) is non-invasive and portable. It measures electrical impedance of tissues by applying alternating current to the body tissues (not felt by the participant), which is used in regression equations to approximate body fat and fat free mass. This will be collected at baseline from the chart and from every visit the participant has in clinic until the end of the intervention.
Measured: 6 Months
Change in Quality of Life
Quality of life will be measured using the Pediatrics Quality of Life Inventory (PedsQL™). Both the patient and the parent or guardian will be asked to complete the PedsQL™. The minimum possible score for this inventory is 0 and the highest is 100. Higher scores indicate a better Health Related Quality of Life (HRQOL).
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start25 Jan 2021
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants who screen positive for social needs will be randomized to receive one of two possible interventions. An allocation ratio of 1:1 with random permuted blocks of varying size will be used. Random block size will help to ensure that investigators or outcome assessors will not be able to decipher the block size and anticipate future allocations. Allocation concealment is the process that prevents any trial participant or investigator from knowing in advance the treatment to which subjects will be assigned and seeks to prevent selection bias.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gita Wahi, MD, MSc, Principal investigator, McMaster Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04711707
- Sponsor's protocol ID
- 12697
- Status last verified
- Apr 2021
- First submitted
- 13 Jan 2021
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data collected for the purposes of this study will only be made available to the principal investigator, co-investigators and the research staff associated with the study.
Publications
Oliver LN, Hayes MV. Neighbourhood socio-economic status and the prevalence of overweight Canadian children and youth. Can J Public Health. 2005 Nov-Dec;96(6):415-20. doi: 10.1007/BF03405180.
PubMed 16350864Hadjiyannakis S, Ibrahim Q, Li J, Ball GDC, Buchholz A, Hamilton JK, Zenlea I, Ho J, Legault L, Laberge AM, Thabane L, Tremblay M, Morrison KM. Obesity class versus the Edmonton Obesity Staging System for Pediatrics to define health risk in childhood obesity: results from the CANPWR cross-sectional study. Lancet Child Adolesc Health. 2019 Jun;3(6):398-407. doi: 10.1016/S2352-4642(19)30056-2. Epub 2019 Apr 3.
PubMed 30952624COUNCIL ON COMMUNITY PEDIATRICS. Poverty and Child Health in the United States. Pediatrics. 2016 Apr;137(4):e20160339. doi: 10.1542/peds.2016-0339. Epub 2016 Mar 9.
PubMed 26962238Gottlieb LM, Wing H, Adler NE. A Systematic Review of Interventions on Patients' Social and Economic Needs. Am J Prev Med. 2017 Nov;53(5):719-729. doi: 10.1016/j.amepre.2017.05.011. Epub 2017 Jul 5.
PubMed 28688725Fox CK, Cairns N, Sunni M, Turnberg GL, Gross AC. Addressing Food Insecurity in a Pediatric Weight Management Clinic: A Pilot Intervention. J Pediatr Health Care. 2016 Sep-Oct;30(5):e11-5. doi: 10.1016/j.pedhc.2016.05.003. Epub 2016 Jun 16.
PubMed 27321679Fazalullasha F, Taras J, Morinis J, Levin L, Karmali K, Neilson B, Muskat B, Bloch G, Chan K, McDonald M, Makin S, Ford-Jones EL. From office tools to community supports: The need for infrastructure to address the social determinants of health in paediatric practice. Paediatr Child Health. 2014 Apr;19(4):195-9. doi: 10.1093/pch/19.4.195.
PubMed 24855416Kenyon C, Sandel M, Silverstein M, Shakir A, Zuckerman B. Revisiting the social history for child health. Pediatrics. 2007 Sep;120(3):e734-8. doi: 10.1542/peds.2006-2495. No abstract available.
PubMed 17766513Colvin JD, Bettenhausen JL, Anderson-Carpenter KD, Collie-Akers V, Plencner L, Krager M, Nelson B, Donnelly S, Simmons J, Higinio V, Chung PJ. Multiple Behavior Change Intervention to Improve Detection of Unmet Social Needs and Resulting Resource Referrals. Acad Pediatr. 2016 Mar;16(2):168-74. doi: 10.1016/j.acap.2015.06.001. Epub 2015 Jul 14.
PubMed 26183003Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
PubMed 11468499Chen E, Martin AD, Matthews KA. Trajectories of socioeconomic status across children's lifetime predict health. Pediatrics. 2007 Aug;120(2):e297-303. doi: 10.1542/peds.2006-3098. Epub 2007 Jul 2.
PubMed 17606533Ligthart KAM, Buitendijk L, Koes BW, van Middelkoop M. The association between ethnicity, socioeconomic status and compliance to pediatric weight-management interventions - A systematic review. Obes Res Clin Pract. 2017 Sep-Oct;11(5 Suppl 1):1-51. doi: 10.1016/j.orcp.2016.04.001. Epub 2016 Apr 20.
PubMed 27108215Wahi G, Marjerrison S, Gill S, Krasevich K, Morrison KM, Thabane L. Addressing unmet social needs of children with obesity: a pilot randomized controlled trial. Pilot Feasibility Stud. 2024 Nov 14;10(1):141. doi: 10.1186/s40814-024-01570-9.
PubMed 39543718Lalji R, Koh L, Francis A, Khalid R, Guha C, Johnson DW, Wong G. Patient navigator programmes for children and adolescents with chronic diseases. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD014688. doi: 10.1002/14651858.CD014688.pub2.
PubMed 39382077Wahi G, Marjerrison S, Gutierrez C, Krasevich K, Morrison KM, Thabane L. Screening and addressing social needs of children and families enrolled in a pediatric weight management program: a protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2022 Jun 18;8(1):129. doi: 10.1186/s40814-022-01080-6.
PubMed 35717284
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing the Social Needs of Children Attending a Weight Management Program: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04711707
- Acronym / sponsor ID
- 12697
- Conditions
- Obesity, Childhood
- Keywords
- Social Determinants of Health, Obesity, Child Health, Social needs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 15 Jan 2021 (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 study aims to improve the treatment of a common, chronic health concern for children: obesity. It has the potential to improve the care we provide by testing an intervention that addresses social needs and the important upstream factors that influences health outcomes.
Detailed description
Addressing the social needs of children attending a weight management program. The specific aims of this pilot randomized controlled trial are the following:
- To determine the feasibility of implementation and delivery of a screening-referral intervention versus usual care to address social needs of children with obesity enrolled in a pediatric weight management program at McMaster Children's Hospital, which will include recruitment rates, uptake of the intervention, and follow-up of participants.
- To understand impact on health outcomes of a screening-referral intervention versus usual care to address social needs of children with obesity enrolled in a pediatric weight management program including change in i) body mass index z score (zBMI); ii) change in body composition; and iii) change in health-related quality of life.
Hypothesis: We hypothesize that health outcomes of children with obesity are connected to the social determinants of health, and that an intervention which screens for and refers to community supports will improve child obesity outcomes.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants who screen positive for social needs will be randomized to receive one of two possible interventions. An allocation ratio of 1:1 with random permuted blocks of varying size will be used. Random block size will help to ensure that investigators or outcome assessors will not be able to decipher the block size and anticipate future allocations. Allocation concealment is the process that prevents any trial participant or investigator from knowing in advance the treatment to which subjects will be assigned and seeks to prevent selection bias.
| Arm | Type | Receives |
|---|---|---|
| Community navigator | Experimental | Other: Community navigatorThis group is guided through the resources and provided bi-monthly support with a community navigator |
| Self-Navigation | Other | Other: Self-NavigationThis group receives the social needs resources to self-navigation |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Enrollment in the weight management program
Key exclusion criteria (2 listed)
- Children in the care of child protection services and/or living in group or foster care. Children in these settings will not be living within typical family-systems to have social needs addressed by this intervention.
- Parents who cannot read and write in English
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 |
|---|---|---|
| Community navigatorAll patients who consent to participate in the study will complete a pediatric social history tool to identify social needs. The intervention group will receive support through a community navigator to guide and understand appropriate services for their specific needs. This arm will receive guidance and bimonthly check-ins. | Other | Community navigator |
| Self-NavigationThe control group will receive an electronic or paper copy of community resources that address the identified social needs. | Other | Self-Navigation |
Primary outcome
Recruitment Rates
Time frame: 6 months
Recruitment rate refers to the number of participants enrolled and is measured by the number of consent forms signed or implied. Recruitment will be successful if 80% of our target sample is met.
Uptake of Intervention
Time frame: 6 months
Uptake of the intervention refers to the number of enrolled families who completed all aspect of the intervention. Elements that are part of the uptake include: social history following enrollment as well as the quality of life questionnaires and use of service questionnaire at enrolment and 6-months. Uptake will be considered successful if >80% of families complete the intervention.
Follow-up of Participants
Time frame: 6 months
Follow-up of participants refers to the participants attending all of their scheduled study visits. The study will be considered successful if >90% of participants complete all study visits.
3 secondary outcomes
Change in Body Mass Index Z-Score
Time frame: 6 Months
Change in Body Composition
Time frame: 6 Months
Change in Quality of Life
Time frame: 6 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Background: PubMed 16350864Oliver LN, Hayes MV. Neighbourhood socio-economic status and the prevalence of overweight Canadian children and youth. Can J Public Health. 2005 Nov-Dec;96(6):415-20. doi: 10.1007/BF03405180.
- Background: PubMed 30952624Hadjiyannakis S, Ibrahim Q, Li J, Ball GDC, Buchholz A, Hamilton JK, Zenlea I, Ho J, Legault L, Laberge AM, Thabane L, Tremblay M, Morrison KM. Obesity class versus the Edmonton Obesity Staging System for Pediatrics to define health risk in childhood obesity: results from the CANPWR cross-sectional study. Lancet Child Adolesc Health. 2019 Jun;3(6):398-407. doi: 10.1016/S2352-4642(19)30056-2. Epub 2019 Apr 3.
- Background: PubMed 26962238COUNCIL ON COMMUNITY PEDIATRICS. Poverty and Child Health in the United States. Pediatrics. 2016 Apr;137(4):e20160339. doi: 10.1542/peds.2016-0339. Epub 2016 Mar 9.
- Background: PubMed 28688725Gottlieb LM, Wing H, Adler NE. A Systematic Review of Interventions on Patients' Social and Economic Needs. Am J Prev Med. 2017 Nov;53(5):719-729. doi: 10.1016/j.amepre.2017.05.011. Epub 2017 Jul 5.
- Background: PubMed 27321679Fox CK, Cairns N, Sunni M, Turnberg GL, Gross AC. Addressing Food Insecurity in a Pediatric Weight Management Clinic: A Pilot Intervention. J Pediatr Health Care. 2016 Sep-Oct;30(5):e11-5. doi: 10.1016/j.pedhc.2016.05.003. Epub 2016 Jun 16.
- Background: PubMed 24855416Fazalullasha F, Taras J, Morinis J, Levin L, Karmali K, Neilson B, Muskat B, Bloch G, Chan K, McDonald M, Makin S, Ford-Jones EL. From office tools to community supports: The need for infrastructure to address the social determinants of health in paediatric practice. Paediatr Child Health. 2014 Apr;19(4):195-9. doi: 10.1093/pch/19.4.195.
- Background: PubMed 17766513Kenyon C, Sandel M, Silverstein M, Shakir A, Zuckerman B. Revisiting the social history for child health. Pediatrics. 2007 Sep;120(3):e734-8. doi: 10.1542/peds.2006-2495. No abstract available.
- Background: PubMed 26183003Colvin JD, Bettenhausen JL, Anderson-Carpenter KD, Collie-Akers V, Plencner L, Krager M, Nelson B, Donnelly S, Simmons J, Higinio V, Chung PJ. Multiple Behavior Change Intervention to Improve Detection of Unmet Social Needs and Resulting Resource Referrals. Acad Pediatr. 2016 Mar;16(2):168-74. doi: 10.1016/j.acap.2015.06.001. Epub 2015 Jul 14.
- Background: PubMed 11468499Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
- Background: PubMed 17606533Chen E, Martin AD, Matthews KA. Trajectories of socioeconomic status across children's lifetime predict health. Pediatrics. 2007 Aug;120(2):e297-303. doi: 10.1542/peds.2006-3098. Epub 2007 Jul 2.
- Background: PubMed 27108215Ligthart KAM, Buitendijk L, Koes BW, van Middelkoop M. The association between ethnicity, socioeconomic status and compliance to pediatric weight-management interventions - A systematic review. Obes Res Clin Pract. 2017 Sep-Oct;11(5 Suppl 1):1-51. doi: 10.1016/j.orcp.2016.04.001. Epub 2016 Apr 20.
- Derived from this study: PubMed 39543718Wahi G, Marjerrison S, Gill S, Krasevich K, Morrison KM, Thabane L. Addressing unmet social needs of children with obesity: a pilot randomized controlled trial. Pilot Feasibility Stud. 2024 Nov 14;10(1):141. doi: 10.1186/s40814-024-01570-9.
- The World Health Organization's Department of Social Determinants of Health webpage. It provides information about the social, physical and economic conditions in society that impact upon health.Link provided by the sponsor.
- Produced by Public Health Ontario, tt provides access to the Ontario Marginalization Index (ON-MARG). ON-MARG is a multifaceted index which measures axes of deprivation in Ontario, including economic, ethno-racial, age based and social.Link provided by the sponsor.
- Access to an electronic database of Ontario's government and community based social services.Link provided by the sponsor.
- Individual participant dataSharing planned: No. The data collected for the purposes of this study will only be made available to the principal investigator, co-investigators and the research staff associated with the study.
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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.
Gita Wahi, MD, MSc principal investigator
McMaster Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community navigator and Self-Navigation in people with Obesity, Childhood, run by Hamilton Health Sciences Corporation 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 2 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: status not confirmed, as of the sponsor's last update on 28 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gita Wahi, MD, MSc (905-521-2100, wahig@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rates (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT04711707, which also lists 14 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 28 Apr 2021.