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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-12
SponsorTufts University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

between ages 8 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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Web-based comic and newsletters

    Behavioral

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

  • Didactic health information

    Behavioral

    Web-based newsletters (for child and parent) by email and/or text

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Experimental GroupExperimental treatment 1 intervention
Group B: Comparison GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in BMI z-score

BMI z-score calculation based on measured height and weight

Time frame
T1 (baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)

Secondary outcomes

1

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

Time frame
T1 (baseline), T2 (intervention end, 12-weeks post-baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)
2

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

Time frame
T1 (baseline), T2 (intervention end, 12-weeks post-baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)
3

Change in parent feeding practices

27-item questionnaire completed by parent participants assessing multiple parental feeding practices

Time frame
T1 (baseline), T2 (intervention end, 12-weeks post-baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)
4

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

Time frame
T1 (baseline), T2 (intervention end, 12-weeks post-baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tufts University

Lead sponsor

Children's Aid, New York City

Collaborator

Washington University School of Medicine

Collaborator

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Hunter College of City University of New York

Collaborator

City University of New York, School of Public Health

Collaborator

University of Massachusetts, Amherst

Collaborator