Obesity, ChildhoodNCT03165474
Intervention INC: Interactive Nutrition Comics for Urban Minority Youth
A study testing Web-based comic and newsletters and Didactic health information in people with Obesity, Childhood, run by Hunter College of City University of New York at 1 site in United States.
Trial summary
The primary purpose of this study is to assess the feasibility and participant acceptability of an interactive, internet/mobile-enabled dietary self management intervention. The secondary purpose of this study is to determine if the intervention improves knowledge, attitudes and food preferences associated with the… Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Web-based comic and newsletters and Didactic health information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2017to 30 Apr 2018
- 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 9 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- Participants involved in Aim 1 or Aim 2 of study previously exposed to components of intervention
Trial locations and contacts
1 site in 1 country.
About this study
The primary purpose of this study is to assess the feasibility and participant acceptability of an interactive, internet/mobile-enabled dietary self management intervention. The secondary purpose of this study is to determine if the intervention improves knowledge, attitudes and food preferences associated with the targeted behaviors, to reduce childhood obesity risk from baseline to post-test.
Read the detailed description
Based on inclusion/exclusion criteria, potential study participants (child and parent) will be identified by the Collaborating Site PI/primary contact and sent a recruitment letter signed by the Primary Investigator and a Collaborating Site PI/primary contact.
Children's Aid Society (CAS) and Weill Cornell Medical College (WCMC) will act as collaborating sites. WCMC PI is Dr. Allison Gorman, who will assist with identifying potential study participants from their government insured medical clinics. All recruitment protocols will be approved by the IRB at WCMC (pending Hunter IRB approval). Once the letter of approval has been received from WCMC, it will be forwarded to CUNY's HRPP. CAS primary contact is Alyson Abrami. Ms. Abrami and the CAS Milbank Medical Clinic will facilitate access to potential study participants. CAS is aware of the study protocols and the administration is in support of the study and its potential impact on their patient population.
Study staff will contact potential study participants by phone and ask additional screening questions to determine study eligibility. A baseline in-person study visit will be scheduled for eligible participants. We are aiming to recruit a total of 82 child/parent dyads (41 in the intervention and control group, respectively). In the intervention group, children will have access to a web-based interactive nutrition comic and receive health messages from comic characters by email and/or text, while parents will receive weekly newsletters related to nutrition and health by email and/or text. In the control group, children and parents will receive didactic health information and resources by email and/or text. The delivery mode of the health messages will be based on based on personal preference.
Aside from usage data of the online tool by each child/parent (e.g. average time spent per login using online tool, collected on an ongoing basis throughout 6-week intervention), data will be collected at four different times points in the study: baseline (T1), after 3 weeks or halfway through the intervention (T2-only children), after 6 weeks or at the end of the intervention (T3), and 3 months post-intervention (T4). T1 and T4 will be in-person study visits at either CUNY Hunter College or CAS Milbank. At baseline (T1), the child's height and weight will be measured to confirm meeting BMI eligibility criteria. After the child and parent completes consent/assent forms, they will be randomized to either the intervention group or control group. Both the child and parent will complete baseline survey measures (will take 20-30 minutes to complete) and attend a study orientation session (10-15 minutes). The baseline visit should take about 1 hour. At T2 (child-only) and T3 (child and parent), data collection (survey measures and open-ended questions) will be conducted either on the phone or by videochat in a private area, according to the participant preference, and will take approximately 30 minutes per person. At T4, the child's height and weight will be measured, and both the child and parent will complete survey measures (will take approximately 45 minutes to complete). Both the child and parent will be compensated for completing survey measures (see Participants-Compensation section for more details).
Open-ended questions collected at timepoint T3 (over the phone or videochat) will be audio recorded (only intervention arm participants). Even though participants will have signed consent to be audio recorded during data collection, the participant will be asked during the phone call or videochat session at T3 if the following open-ended questions could be audio recorded to be reviewed in more detail afterwards. Additionally, open-ended questions related to the experience and context of using the web-based nutrition comic will be asked of a subset of parents and children (intervention arm only) at timepoint T3 (over the phone or videochat). Their responses will also be audio recorded as this is qualitative data that will be transcribed and analyzed separately from survey data.
- Conditions
- Obesity, Childhood
- Being tested
- Web-based comic and newsletters, Didactic health information
- Keywords
- childhood obesity, mhealth, digital health, nutrition, intervention
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based comic and newslettersOther
Web-based comic and health messages (child component) and health newsletters (parent component)
Didactic health informationOther
Didactic health information and resources by email and/or text
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | In the control group, children and parents will receive didactic health information and resources by email and/or text. The delivery mode of the health messages will be based on based on personal preference. Receives: Other: Didactic health information |
| Intervention Arm | Experimental | In the intervention group, children will have access to a web-based interactive nutrition comic and receive health messages from comic characters by email and/or text, while parents will receive weekly newsletters related to nutrition and health by email and/or text. Receives: Other: Web-based comic and newsletters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usage - Child
Usage analytics measured at the individual-level: min, max, average logins per day/week; min, max, average time spent on website per login; min, max, average link clicks per session (links to unique website areas)
Measured: Daily throughout study duration (~4.5 months)
Usability - Child
Survey measure to assess usability, usefulness, ease of use, ease of learning, and satisfaction (taken from SUS, USE, and SUPR-Q survey)
Measured: T2 (after 3 weeks or halfway through the intervention) and T3 (after 6 weeks or at the end of the intervention)
Context of Use - Child
Open-ended questions regarding experience and context using the web app, as well as acceptability and satisfaction
Measured: T3 (after 6 weeks or at the end of the intervention)
Secondary outcomes (6)
Change in child knowledge & attitudes - Child
Survey measuring change in child knowledge, self-efficacy, preferences, and outcome expectancies related to eating fruits/vegetables and consuming water
Measured: T1 (baseline), T2 (after 3 weeks or halfway through the intervention), T3 (after 6 weeks or at the end of the intervention),T4 (3 months post-intervention)
Change in child dietary intake - Child
Survey measuring change in child intake of specified fruits/vegetables, and water
Measured: T1 (baseline), T3 (after 6 weeks or at the end of the intervention),T4 (3 months post-intervention)
Change in BMI percentile - Child
Change in BMI percentile calculated based on measured height and weight
Measured: T1 (baseline) and T4 (3 months post-intervention)
Usage - Parent
Usage analytics measured at the individual-level: min, max, average logins per day/week; min, max, average time spent on website per login; min, max, average link clicks per session (links to unique website areas)
Measured: Daily throughout study duration (~4.5 months)
Change in parent feeding practices - Parent
Survey measuring child involvement, parent encouragement, parent modeling, and parent instruction about fruits/vegetables and water intake
Measured: T1 (baseline), T3 (after 6 weeks or at the end of the intervention),T4 (3 months post-intervention)
Change in physical home food environment
Survey measuring home availability and accessibility of fruits/vegetables and water
Measured: T1 (baseline), T3 (after 6 weeks or at the end of the intervention),T4 (3 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 posted24 May 2017
- Study start11 Aug 2017
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunter College of City University of New York
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Aid, Weill Medical College of Cornell University
- Responsible party
- Sponsor
- Investigators
- May May Leung, PhD, RDN, Principal investigator, Hunter College of City University of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03165474
- Sponsor's protocol ID
- HunterCCUNY
- Status last verified
- Aug 2018
- First submitted
- 15 May 2017
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leung MM, Mateo KF, Dublin M, Harrison L, Verdaguer S, Wyka K. Testing a Web-Based Interactive Comic Tool to Decrease Obesity Risk Among Racial and Ethnic Minority Preadolescents: Randomized Controlled Trial. JMIR Form Res. 2025 Jan 15;9:e58460. doi: 10.2196/58460.
PubMed 39813083DeFrank G, Singh S, Mateo KF, Harrison L, Rosenthal A, Gorman A, Leung MM. Key recruitment and retention strategies for a pilot web-based intervention to decrease obesity risk among minority youth. Pilot Feasibility Stud. 2019 Sep 5;5:109. doi: 10.1186/s40814-019-0492-8. eCollection 2019.
PubMed 31516726Leung MM, Mateo KF, Verdaguer S, Wyka K. Testing a Web-Based Interactive Comic Tool to Decrease Obesity Risk Among Minority Preadolescents: Protocol for a Pilot Randomized Control Trial. JMIR Res Protoc. 2018 Nov 9;7(11):e10682. doi: 10.2196/10682.
PubMed 30413399
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention INC: Interactive Nutrition Comics for Urban Minority Youth
- ClinicalTrials.gov ID
- NCT03165474
- Acronym / sponsor ID
- HunterCCUNY
- Conditions
- Obesity, Childhood
- Keywords
- childhood obesity, mhealth, digital health, nutrition, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Hunter College of City University of New YorkUniversity, hospital or other
- Collaborators
- Children's Aid, Weill Medical College of Cornell University
- Study start
- 11 Aug 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 24 May 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.
The primary purpose of this study is to assess the feasibility and participant acceptability of an interactive, internet/mobile-enabled dietary self management intervention. The secondary purpose of this study is to determine if the intervention improves knowledge, attitudes and food preferences associated with the targeted behaviors, to reduce childhood obesity risk from baseline to post-test.
Detailed description
Based on inclusion/exclusion criteria, potential study participants (child and parent) will be identified by the Collaborating Site PI/primary contact and sent a recruitment letter signed by the Primary Investigator and a Collaborating Site PI/primary contact.
Children's Aid Society (CAS) and Weill Cornell Medical College (WCMC) will act as collaborating sites. WCMC PI is Dr. Allison Gorman, who will assist with identifying potential study participants from their government insured medical clinics. All recruitment protocols will be approved by the IRB at WCMC (pending Hunter IRB approval). Once the letter of approval has been received from WCMC, it will be forwarded to CUNY's HRPP. CAS primary contact is Alyson Abrami. Ms. Abrami and the CAS Milbank Medical Clinic will facilitate access to potential study participants. CAS is aware of the study protocols and the administration is in support of the study and its potential impact on their patient population.
Study staff will contact potential study participants by phone and ask additional screening questions to determine study eligibility. A baseline in-person study visit will be scheduled for eligible participants. We are aiming to recruit a total of 82 child/parent dyads (41 in the intervention and control group, respectively). In the intervention group, children will have access to a web-based interactive nutrition comic and receive health messages from comic characters by email and/or text, while parents will receive weekly newsletters related to nutrition and health by email and/or text. In the control group, children and parents will receive didactic health information and resources by email and/or text. The delivery mode of the health messages will be based on based on personal preference.
Aside from usage data of the online tool by each child/parent (e.g. average time spent per login using online tool, collected on an ongoing basis throughout 6-week intervention), data will be collected at four different times points in the study: baseline (T1), after 3 weeks or halfway through the intervention (T2-only children), after 6 weeks or at the end of the intervention (T3), and 3 months post-intervention (T4). T1 and T4 will be in-person study visits at either CUNY Hunter College or CAS Milbank. At baseline (T1), the child's height and weight will be measured to confirm meeting BMI eligibility criteria. After the child and parent completes consent/assent forms, they will be randomized to either the intervention group or control group. Both the child and parent will complete baseline survey measures (will take 20-30 minutes to complete) and attend a study orientation session (10-15 minutes). The baseline visit should take about 1 hour. At T2 (child-only) and T3 (child and parent), data collection (survey measures and open-ended questions) will be conducted either on the phone or by videochat in a private area, according to the participant preference, and will take approximately 30 minutes per person. At T4, the child's height and weight will be measured, and both the child and parent will complete survey measures (will take approximately 45 minutes to complete). Both the child and parent will be compensated for completing survey measures (see Participants-Compensation section for more details).
Open-ended questions collected at timepoint T3 (over the phone or videochat) will be audio recorded (only intervention arm participants). Even though participants will have signed consent to be audio recorded during data collection, the participant will be asked during the phone call or videochat session at T3 if the following open-ended questions could be audio recorded to be reviewed in more detail afterwards. Additionally, open-ended questions related to the experience and context of using the web-based nutrition comic will be asked of a subset of parents and children (intervention arm only) at timepoint T3 (over the phone or videochat). Their responses will also be audio recorded as this is qualitative data that will be transcribed and analyzed separately from survey data.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Other: Didactic health informationIn the control group, children and parents will receive didactic health information and resources by email and/or text. The delivery mode of the health messages will be based on based on personal preference. |
| Intervention Arm | Experimental | Other: Web-based comic and newslettersIn the intervention group, children will have access to a web-based interactive nutrition comic and receive health messages from comic characters by email and/or text, while parents will receive weekly newsletters related to nutrition and health by email and/or text. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Participants involved in Aim 1 or Aim 2 of study previously exposed to components of intervention
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 |
|---|---|---|
| Web-based comic and newslettersWeb-based comic and health messages (child component) and health newsletters (parent component) | Other | Intervention Arm |
| Didactic health informationDidactic health information and resources by email and/or text | Other | Control Arm |
Primary outcome
Usage - Child
Time frame: Daily throughout study duration (~4.5 months)
Usage analytics measured at the individual-level: min, max, average logins per day/week; min, max, average time spent on website per login; min, max, average link clicks per session (links to unique website areas)
Usability - Child
Time frame: T2 (after 3 weeks or halfway through the intervention) and T3 (after 6 weeks or at the end of the intervention)
Survey measure to assess usability, usefulness, ease of use, ease of learning, and satisfaction (taken from SUS, USE, and SUPR-Q survey)
Context of Use - Child
Time frame: T3 (after 6 weeks or at the end of the intervention)
Open-ended questions regarding experience and context using the web app, as well as acceptability and satisfaction
6 secondary outcomes
Change in child knowledge & attitudes - Child
Time frame: T1 (baseline), T2 (after 3 weeks or halfway through the intervention), T3 (after 6 weeks or at the end of the intervention),T4 (3 months post-intervention)
Change in child dietary intake - Child
Time frame: T1 (baseline), T3 (after 6 weeks or at the end of the intervention),T4 (3 months post-intervention)
Change in BMI percentile - Child
Time frame: T1 (baseline) and T4 (3 months post-intervention)
Usage - Parent
Time frame: Daily throughout study duration (~4.5 months)
Change in parent feeding practices - Parent
Time frame: T1 (baseline), T3 (after 6 weeks or at the end of the intervention),T4 (3 months post-intervention)
Change in physical home food environment
Time frame: T1 (baseline), T3 (after 6 weeks or at the end of the intervention),T4 (3 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 28 Aug 2018.
- Derived from this study: PubMed 39813083Leung MM, Mateo KF, Dublin M, Harrison L, Verdaguer S, Wyka K. Testing a Web-Based Interactive Comic Tool to Decrease Obesity Risk Among Racial and Ethnic Minority Preadolescents: Randomized Controlled Trial. JMIR Form Res. 2025 Jan 15;9:e58460. doi: 10.2196/58460.
- Derived from this study: PubMed 31516726DeFrank G, Singh S, Mateo KF, Harrison L, Rosenthal A, Gorman A, Leung MM. Key recruitment and retention strategies for a pilot web-based intervention to decrease obesity risk among minority youth. Pilot Feasibility Stud. 2019 Sep 5;5:109. doi: 10.1186/s40814-019-0492-8. eCollection 2019.
- Derived from this study: PubMed 30413399Leung MM, Mateo KF, Verdaguer S, Wyka K. Testing a Web-Based Interactive Comic Tool to Decrease Obesity Risk Among Minority Preadolescents: Protocol for a Pilot Randomized Control Trial. JMIR Res Protoc. 2018 Nov 9;7(11):e10682. doi: 10.2196/10682.
- Individual participant dataSharing planned: No
Related trials for Obesity, Childhood
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
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
Not yet recruitingObservational study
Brain and Obesity Longitudinal Development: Neurobiological Mechanisms of Semaglutide Treatment of Adolescent Obesity
Pediatric Obesity, Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
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.
May May Leung, PhD, RDN principal investigator
Hunter College of City University of New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based comic and newsletters and Didactic health information in people with Obesity, Childhood, run by Hunter College of City University of New York at 1 site in United States.
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 0 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 28 Aug 2018. 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 United States. 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?
Usage - Child (time frame: Daily throughout study duration (~4.5 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 NCT03165474, which also lists 3 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 Aug 2018.