Obesity, ChildhoodNCT05935592
Intervention INC: An Interactive Family-centered mHealth Tool to Reduce Obesity Risk in Urban Minority Preadolescents
A study testing Web-based comic and newsletters and Didactic health information in people with Obesity, Childhood, run by Tufts University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Web-based comic and newsletters and Didactic health information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Feb 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 16Show fewer
- 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
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Milbank Health Center - Children's Aid
New York, New York, 10026
Bronx Health Center - Children's Aid
The Bronx, New York, 10460
About this study
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.
Read the detailed 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.
- Conditions
- Obesity, Childhood
- Being tested
- Web-based comic and newsletters, Didactic health information
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based comic and newslettersBehavioural
Web-based comic and health messages (child component) and health newsletters (parent component)
Didactic health informationBehavioural
Web-based newsletters (for child and parent) by email and/or text
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The experimental group will receive access to Intervention INC, a theory-guided interactive, family-centered web-based tool promoting healthy dietary behaviors. Receives: Behavioral: Web-based comic and newsletters |
| Comparison Group | Active comparator | The comparison group will receive access to web-based newsletters focused on promoting healthy dietary behaviors. Receives: Behavioral: Didactic health information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI z-score
BMI z-score calculation based on measured height and weight
Measured: T1 (baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)
Secondary outcomes (4)
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
Measured: T1 (baseline), T2 (intervention end, 12-weeks post-baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)
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
Measured: T1 (baseline), T2 (intervention end, 12-weeks post-baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)
Change in parent feeding practices
27-item questionnaire completed by parent participants assessing multiple parental feeding practices
Measured: T1 (baseline), T2 (intervention end, 12-weeks post-baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)
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
Measured: T1 (baseline), T2 (intervention end, 12-weeks post-baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start27 Feb 2025
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Why it stopped: The study was terminated early after the study funder issued a Notice of Non-Award, resulting in loss of funding to continue study activities.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Aid, New York City, Washington University School of Medicine, Agency for Healthcare Research and Quality (AHRQ), Hunter College of City University of New York, City University of New York, School of Public Health, University of Massachusetts, Amherst
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935592
- Sponsor's protocol ID
- STUDY00004065
- Other IDs
- 5R01HS028650-03
- Status last verified
- Sep 2026
- First submitted
- 29 Jun 2023
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention INC: An Interactive Family-centered mHealth Tool to Reduce Obesity Risk in Urban Minority Preadolescents
- ClinicalTrials.gov ID
- NCT05935592
- Acronym / sponsor ID
- STUDY00004065
- Conditions
- Obesity, Childhood
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early after the study funder issued a Notice of Non-Award, resulting in loss of funding to continue study activities.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Children's Aid, New York City, Washington University School of Medicine, Agency for Healthcare Research and Quality (AHRQ), Hunter College of City University of New York, City University of New York, School of Public Health, University of Massachusetts, Amherst
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Web-based comic and newslettersThe experimental group will receive access to Intervention INC, a theory-guided interactive, family-centered web-based tool promoting healthy dietary behaviors. |
| Comparison Group | Active comparator | Behavioral: Didactic health informationThe comparison group will receive access to web-based newsletters focused on promoting healthy dietary behaviors. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based comic and newslettersWeb-based comic and health messages (child component) and health newsletters (parent component) | Behavioural | Experimental Group |
| Didactic health informationWeb-based newsletters (for child and parent) by email and/or text | Behavioural | Comparison Group |
Primary outcome
Change in BMI z-score
Time frame: T1 (baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)
BMI z-score calculation based on measured height and weight
4 secondary outcomes
Change in child dietary intake
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)
Change in child dietary knowledge and attitudes
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)
Change in parent 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)
Change in home food environment
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)
Results and safety
The study was stopped early (reason given: The study was terminated early after the study funder issued a Notice of Non-Award, resulting in loss of funding to continue study activities.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based comic and newsletters and Didactic health information in people with Obesity, Childhood, run by Tufts University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was terminated early after the study funder issued a Notice of Non-Award, resulting in loss of funding to continue study activities.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BMI z-score (time frame: T1 (baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.