Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5R01HS028650-03 | U.S. AHRQ Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Children's Aid, New York City | UNKNOWN |
| Washington University School of Medicine | OTHER |
| Agency for Healthcare Research and Quality (AHRQ) | FED |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Comparison Group | Active Comparator | The comparison group will receive access to web-based newsletters focused on promoting healthy dietary behaviors. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Web-based comic and newsletters | Behavioral | Web-based comic and health messages (child component) and health newsletters (parent component) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Inclusion Criteria (child):
Inclusion Criteria (parent):
Exclusion Criteria (child):
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| May May Leung, PhD, RDN | Contact | 617-636-3676 | maymay.leung@tufts.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Milbank Health Center - Children's Aid | Recruiting | New York | New York | 10026 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
Not provided
Not provided
| Hunter College of City University of New York |
| OTHER |
| City University of New York, School of Public Health | OTHER |
| University of Massachusetts, Amherst | OTHER |
Not provided
Not provided
Not provided
Not provided
| Didactic health information | Behavioral | Web-based newsletters (for child and parent) by email and/or text |
|
| 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) |
| 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) |
| 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) |
| Bronx Health Center - Children's Aid | Recruiting | The Bronx | New York | 10460 | United States |
|
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |