NCT03165474

Brief 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 targeted behaviors, to reduce childhood obesity risk from baseline to post-test.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 24, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

August 11, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

August 28, 2018

Status Verified

August 1, 2018

Enrollment Period

9 months

First QC Date

May 15, 2017

Last Update Submit

August 24, 2018

Conditions

Obesity, Childhood

Keywords

childhood obesitymhealthdigital healthnutritionintervention

Outcome Measures

Primary Outcomes (3)

  • 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)

    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)

    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

    T3 (after 6 weeks or at the end of the intervention)

Secondary Outcomes (6)

  • Change in child knowledge & attitudes - Child

    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

    T1 (baseline), T3 (after 6 weeks or at the end of the intervention),T4 (3 months post-intervention)

  • Change in BMI percentile - Child

    T1 (baseline) and T4 (3 months post-intervention)

  • Usage - Parent

    Daily throughout study duration (~4.5 months)

  • Change in parent feeding practices - Parent

    T1 (baseline), T3 (after 6 weeks or at the end of the intervention),T4 (3 months post-intervention)

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Other: Web-based comic and newsletters

Interventions

Web-based comic and newslettersOTHER

Web-based comic and health messages (child component) and health newsletters (parent component)

Intervention Arm
Didactic health informationOTHER

Didactic health information and resources by email and/or text

Control Arm

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Identify as Black, African-American, and/or Hispanic/Latino
  • age 9-12 years old by start of the intervention
  • English-speaking
  • either received care at the WCMC clinic or CAS Milbank clinic within the last 2 years -
  • has BMI percentile at or above 5% as indicated in their electronic health record (based on CDC sex-specific BMI-for-age- growth chart)
  • has regular internet access via tablet, smartphone, and/or computer/laptop
  • has regular phone access with texting ability
  • has no allergies, food aversions, food disorders, or medications with side-effects that impact diet/eating that would prevent participation in the study
  • has a parent/guardian willing to participate in the study

You may not qualify if:

  • English- or Spanish-speaking
  • has regular internet access via tablet, smartphone, and/or computer/laptop
  • has regular phone access with texting ability
  • willing and able to give permission for their child to participate in the study
  • Participants involved in Aim 1 or Aim 2 of study previously exposed to components of intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunter College

New York, New York, 10035, United States

Location

Related Publications (3)

  • 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.

    PMID: 39813083DERIVED

  • DeFrank 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.

    PMID: 31516726DERIVED

  • Leung 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.

    PMID: 30413399DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • May May Leung, PhD, RDN

    Hunter College of City University of New York

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be randomized into intervention or control arm and will be provided with different orientations.
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2017

First Posted

May 24, 2017

Study Start

August 11, 2017

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

August 28, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)