NCT05935592 · Tufts University
Intervention INC: An Interactive Family-centered mHealth Tool to Reduce Obesity Risk in Urban Minority Preadolescents
What this study is about
Using a two-group randomly assigned 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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)
- 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
- 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
Where
- New York, New York
- The Bronx, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 10, 2025 · Source of record for eligibility and locations