Intervention INC: An Interactive Family-centered mHealth Tool to Reduce Obesity Risk in Urban Minority Preadolescents

Obesity, Childhood Clinical Trial

Official title:

Intervention INC: An Interactive Family-centered mHealth Tool to Reduce Obesity Risk in Urban Minority Preadolescents

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05935592
• Other study ID #: STUDY00004065
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: August 2026

Study information

• Verified date: May 2024
• Source: Tufts University
• Contact: May May Leung, PhD, RDN
• Phone: 617-636-3676
• Email: maymay.leung[@]tufts.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Using a two-group randomized study design, this study aims to evaluate the effectiveness of the adapted family-centered mHealth tool on child BMI z-score (primary outcome), child dietary behaviors, and parental feeding practices, from baseline to 12-month follow-up, among 200 child-parent dyads. It is hypothesized that children in the experimental group will demonstrate larger BMI-z score improvements between baseline and 12-month follow-up compared to children in the comparison group.

Description:

Childhood obesity continues to be a serious clinical and public health issue in the United States (US), particularly within low-income, minority groups. Effective, yet engaging interventions, such as the one developed by our team, are needed to capture the attention of children living in a multi-media environment.

Potentially eligible pediatric patients (and their parent/caregiver) will be recruited from two of Children's Aid community-based clinics in NYC - Dunlevy Milbank Center based in Harlem and the Bronx Health Center based in the South Bronx. A variety of recruitment methods will be deployed, including in-person/flyer-based recruitment in clinic waiting rooms, healthcare provider referrals, and direct calls.

At baseline, eligible participants will be randomized to either the experimental group or comparison group (allocation ratio 1:1). Randomization will be performed at the dyad level and will be balanced on child ethnicity (Hispanic or Non-Hispanic), child biological sex (male, female), and clinic site.

The experimental group will receive access to Intervention INC, a theory-guided interactive, family-centered web-based tool promoting healthy dietary behaviors. The comparison group will receive access to web-based newsletters focused on promoting healthy dietary behaviors. To minimize bias, participants will be blinded to the study's hypothesis.

Data will be collected at four timepoints: baseline (T1), main intervention end (T2), maintenance intervention end (T3), and at 12-month follow-up (T4). The primary outcome measure (BMI z-score) will be calculated using height and weight data captured via combined scale/stadiometer by a trained healthcare provider at T1, T3, T4. Secondary measures (dietary intake and dietary knowledge & attitudes of child participants; feeding practices and the home food environment by the parent/caregiver) will be captured via questionnaires at T1, T2, T3, T4.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: August 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 12 Years

Eligibility

Inclusion Criteria (child):

• self-identifies as Black/African-American and/or Latino

• between ages 9 and 12 years (preadolescents) at time of scheduled baseline visits

• reads and speaks in English

• has a Body Mass Index percentile at or above 5% at baseline (categorized as healthy, overweight, or obese)

• has regular internet access via a tablet device, smartphone, or computer/laptop

• has regular access to a phone with texting capability

• is comfortable reading/viewing material on electronic devices

• is comfortable speaking with study staff about thoughts/experiences while participating in study

• has a legal parent/guardian willing to participate in study

Inclusion Criteria (parent):

• legal parent/guardian of child willing to participate in study

• reads and speaks in English or Spanish

• primarily responsible for preparing/purchasing food for child

• has regular internet access via a tablet device, smartphone, or computer/laptop

• has regular access to a phone with texting capability

• comfortable reading/viewing material on electronic devices

• able to attend in-person study visits and complete online questionnaires with their child over the full duration of study

Exclusion Criteria (child):

• has allergies, food aversions, food disorders, or medications with side-effects that may impact participation in study

• has a pacemaker or heart condition

• in foster care

Related Conditions & MeSH terms

• Obesity
• Obesity, Childhood
• Pediatric Obesity

Intervention

Behavioral:
• Web-based comic and newsletters
Web-based comic and health messages (child component) and health newsletters (parent component)
• Didactic health information
Web-based newsletters (for child and parent) by email and/or text

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
Tufts University	Agency for Healthcare Research and Quality (AHRQ), Children's Aid, New York City, City University of New York, School of Public Health, Hunter College of City University of New York, University of Massachusetts, Amherst, Washington University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in BMI z-score	BMI z-score calculation based on measured height and weight	T1 (baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)
Secondary	Change in child dietary intake	17-item questionnaire completed by child participants assessing frequency of consumption of fruit/vegetables, water, junk food, and sugary drinks during the past seven days	T1 (baseline), T2 (intervention end, 12-weeks post-baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)
Secondary	Change in child dietary knowledge and attitudes	45-item questionnaire completed by child participants assessing knowledge, outcome expectations, self-efficacy, and behavioral intention regarding behaviors associated with fruit/vegetables, water, junk food, and sugary drinks	T1 (baseline), T2 (intervention end, 12-weeks post-baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)
Secondary	Change in parent feeding practices	27-item questionnaire completed by parent participants assessing multiple parental feeding practices	T1 (baseline), T2 (intervention end, 12-weeks post-baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)
Secondary	Change in home food environment	6-item questionnaire completed by parent participants assessing availability of fruits/vegetables and water in their home and how often they store fruits/vegetables and water in a place easily seen by their child	T1 (baseline), T2 (intervention end, 12-weeks post-baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)