Obesity and Caries in Young South Asian Children: A Common Risk Factor Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 380
- 试验地点
- 8
- 主要终点
- Quantity of (Combined) Sippy Cup and/or Bottles (Common Risk/Behavioral)
研究概览
简要总结
The CHALO ("Child Health Action to Lower Oral Caries and Obesity") -- from an Urdu word meaning "Let's go!"-is a multi-level strategy to reduce pediatric obesity and dental caries risk in South Asian (SA) children. Obesity and caries are the two most prominent health disparities of early childhood. Both caries and obesity: a) disproportionately impact low-income children of color, b) share common risk behaviors, i.e., feeding practices, and c) can most effectively be reduced or prevented prevention in infancy and early childhood. SA immigrant children are at high risk for both. CHALO includes both a randomized controlled trial (RCT) aimed at reducing risk behavior, and a Knowledge Translation project to raise awareness in SA lay and professional communities regarding child health risks.
详细描述
CHALO builds upon the team's prior research re: cariogenic (R34-DE-022282) and obesogenic behaviors (10, 14, 15). CHALO's intervention components-- home visits, phone support, and "patient navigation" to dental visits-- proved to be feasible and acceptable. In the pilot R34, there were promising behavioral change on all measures. CHALO builds on this work, with the addition of: a) sippy cups as an intervention target, b) an iPad-based dietary recall tool, "MySmileBuddy," c) caries and obesity data, and; d) increased intervention contacts- consistent with recent child obesity and caries interventions (16, 17).
An RCT (Aim 1) will enroll 360 mothers of children 4-6 month olds from New York City (n=3) and New Jersey (n=2) pediatric practices in SAPPHIRE ("SA Practice Partnership for Health Improvement and Research"). The Community Health Worker intervention includes: a) home visits with mothers/families (n=6 visits over one year) and follow up telephone support; b) patient navigation to make/keep timely dental visits (2x by 18 months). The Knowledge Translation component (Aim 2) will raise awareness of child health risks in SA communities and among professionals who provide their care. The campaign will include both traditional and social media components and will be evaluated using multiple metrics.
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
- Single (Outcomes Assessor)
盲法说明
Research Assessment- at 6, 12, and 18 months will be conducted by RAs. Data collected include a computerized 24 hour recall: MySmileBuddy (see below); and questionnaires. The T2 interview, in addition, will include the Intra-oral Camera Caries Assessment. Study identifiers will not include indication of group assignment. The REDCap database will include group assignment in a field that is not accessible to RAs
Caries Outcomes- Intra-oral camera images will be transmitted electronically to the University of Rochester; no group assignment identifier will be included.
Obesity Outcomes- RAs will obtained weight and length measures in the home- see above.
入排标准
- 年龄范围
- 3 Months 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: Child is < 6 months of age at time of recruitment
- •Insurance: Child is enrolled in either Medicaid or CHIP
- •Nativity- Mother was born in India, Pakistan, or Bangladesh)
- •Language- Mother speaks standard Bengali, English or Hindi/Urdu
- •Agency- Mother is index child's primary caretaker.
排除标准
- •Inability to provide informed consent per RA judgment
- •Plans to travel for > 1 month during follow-up, and
- •child health condition barring participation (per pediatrician review of recruitment lists).
研究组 & 干预措施
Intervention
An RCT will enroll 360 mothers (total) of children 4-6 month olds from New York City (n=3) and New Jersey (n=2) pediatric practices. Half (180) will be assigned to the Community Health Worker intervention comprised of: a) home visits with mothers/families (n=6 visits over one year) and follow up telephone support; b) patient navigation to make/keep timely dental visits (2x by 18 months).
干预措施: Intervention (Behavioral)
Enhanced Usual Care (EUC)
Community Health Workers (CHWs)- will deliver the EUC to all study participants at their 6 month well-child visit, which will occur just after their T0 Baseline Interview, just prior to randomization. EUC Components: 1) Pamphlet- CHWs will hand out and review deliver and review a pamphlet with basic ECC and Obesity prevention messages for parents of 6-18 month olds; and 2) Dental Referral List of dentists who will see 12 month olds, and who accept most insurance plans in the pediatric practices we are recruiting from.
Thus, the EUC will be delivered to n=180 families in the EUC Control and n=180 families in the Intervention group.
干预措施: Enhanced Usual Care (EUC) (Behavioral)
结局指标
主要结局
Quantity of (Combined) Sippy Cup and/or Bottles (Common Risk/Behavioral)
时间窗: 18 months of age (final follow-up [T2])
Number and amount of sippy cups + bottles/day consumed by child, obtained by RA assessment using MySmileBuddy
次要结局
- Added Sweeteners/Solids (Common Risk/Behavioral)(18 months of age (final follow-up [T2]))
- Fruits & Vegetables (Common Risk/Behavioral)(18 months of age (final follow-up [T2]))
- Juice & Sweet Drinks (Common Risk/Behavioral)(18 months of age (final follow-up [T2]))
- Use of Bottles/Sippy Cups at Nap or Bedtime (Common Risk/Behavioral)(18 months of age (final follow-up [T2]))
- Sweet & Salty Snacks (Common Risk/Behavioral)(18 months of age (final follow-up [T2]))
- Physical Activity (Obesity/Behavioral)(18 months of age (final follow-up [T2]))
- Screen Time (Obesity/Behavioral)(18 months of age (final follow-up [T2]))
- Tooth Brushing (Caries/Behavioral)(18 months of age (final follow-up [T2]))
- Dental Visits (Caries/Behavioral)(18 months of age (final follow-up [T2]))
- Visible Caries(18 months of age (T2).)
- Caries Severity(18 months of age (T2))
- Weight-for-length(18 months of age (T2))
- Change in Weight Velocity Z Scores(see above)