Intervention INC: An Interactive Family-centered mHealth Tool to Reduce Obesity Risk in Urban Minority Preadolescents
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- Change in BMI z-score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Experimental Group
The experimental group will receive access to Intervention INC, a theory-guided interactive, family-centered web-based tool promoting healthy dietary behaviors.
干预措施: Web-based comic and newsletters (Behavioral)
Comparison Group
The comparison group will receive access to web-based newsletters focused on promoting healthy dietary behaviors.
干预措施: Didactic health information (Behavioral)
结局指标
主要结局
Change in BMI z-score
时间窗: 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
次要结局
- Change in child dietary intake(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(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(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(T1 (baseline), T2 (intervention end, 12-weeks post-baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2))