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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Web-based comic and newsletters
BehavioralWeb-based comic and health messages (child component) and health newsletters (parent component)
Didactic health information
BehavioralWeb-based newsletters (for child and parent) by email and/or text
Treatment groups
Trial outcomes
Primary outcomes
Change in BMI z-score
BMI z-score calculation based on measured height and weight
Secondary outcomes
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
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
Change in parent feeding practices
27-item questionnaire completed by parent participants assessing multiple parental feeding practices
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
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