Reducing Childhood Obesity Using Ecological Momentary Intervention (EMI) and Video Feedback at Family Meals
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- Child Dietary Quality
研究概览
简要总结
The proposed study is a 12-month, individual randomized controlled trial (RCT). The main aim of the study is to decrease cardiovascular disease risk (BMI percentile, neck circumference) and improve child diet quality in children ages 5-10 years old by increasing family meal quality (i.e., dietary intake, interpersonal atmosphere) and quantity (i.e., frequency of family meals) via innovative technology (i.e., ecological momentary intervention (EMI), video feedback) and partnerships with primary care and Community Health Workers (CHWs).
详细描述
The RCT has the following three arms: (1) Ecological Momentary Intervention (EMI); (2) EMI + HV + Video feedback (virtual); (3) EMI + HV + Video feedback (hybrid). Delivery of the intervention will last 6 months for each family, with a 6-month post-intervention evaluation visit. All arms will receive EMI family meal tips via smartphones for 16 weeks. Arms 2 and 3 will also receive 16 weeks of in-home training (arm 2 will be virtual, arm 3 will be hybrid virtual/in-home), with 8 weeks (every other week) in-home education visits with a CHW focused on family meal quality and quantity and family meal preparation activities and 8 weeks "Try it Yourself" activities that reinforce the messages and skills taught by a CHW. Additionally, Arms 2 and 3 will receive video feedback from family's video-recorded family meals by a CHW focusing on family behaviors related to family meal quality and quantity. (EMI, in-home training, and video-feedback will occur during the same 16-week period.) After families have completed 16 weeks of the intervention, a 8-week maintenance phase will ensue. Having a maintenance phase is an evidence-based intervention component and will provide incrementally less support to families to build self-efficacy and increase sustainability of new behaviors. Over time, participants will receive less study support to evaluate if participants have internalized healthful behaviors. During the maintenance phase EMI meal tips will be reduced to only the days in which parents report their highest stress levels for all arms. The study will last 12 months, with three assessment time points including, baseline, 6 months (i.e., post-intervention) and 12 months.
Children ages 5-10 and family members (i.e., parent/primary caregiver, siblings) from low-income and diverse households (i.e., African American, Asian, Hispanic, Native American, White) - who are at high risk for cardiovascular disease - will be recruited for the study. Theory informs the intervention study design, research questions and related hypotheses, methods, measurement, and analysis. Family Systems Theory drives the decision to direct the intervention at the "family unit" to increase the likelihood of individual and family-level weight and weight-related behavior change and sustainability. Additionally, partnerships with existing community-based healthcare systems and CHWs will be utilized to reach participants in community settings.
This study utilizes innovative and research-informed intervention components (i.e., in-home visiting, EMI, video-feedback) to increase the likelihood of intervention effectiveness and sustainability.
Specific Aims of the Intervention Include:
• Aim 1 (Primary Outcomes): Conduct a three-arm RCT comparing EMI, EMI+HV, and EMI+HV+Video Feedback in diverse children ages 5-10 and their families to test the hypotheses that:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Like most behavioral interventions, it is not possible to double blind this RCT because interventionists will be delivering the in-home visiting components to participants. However, the proposed study incorporates participant, study staff, physician, and investigator blinding as much as possible. The intervention will be administered by trained staff assigned to the intervention team, who will not be involved with evaluation team responsibilities/meetings. Evaluation team members will carry out all measurement home visits and will be blinded to participant study arm assignment. They will not be involved with intervention team responsibilities/meetings. Specific co-investigators are responsible for training and supervising staff within the intervention team versus the evaluation team in to order to blind as many co-investigators as possible.
入排标准
- 年龄范围
- 5 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Child Dietary Quality
时间窗: 12-months post-baseline
Child three-day, 24-hour dietary recalls will be used to calculate a Healthy Eating Index (HEI) score, which measures overall dietary quality.
Child Neck Circumference
时间窗: 12-months post-baseline
Measured neck circumference on child
Child BMI percentile
时间窗: 12-months post-baseline
Based on Centers for Disease Control and Prevention (CDC) guidelines, child age and sex will be used to calculate an adjusted BMI percentiles. Measured at three time points over 12 months by study staff.
次要结局
- Parent Coping Skills(12-months post-baseline)
- Family Meal Quantity(12-months post-baseline)
- Family Meal Dietary Healthfulness(12-months post-baseline)
- Family Meal Emotional Atmosphere Quality(12-months post-baseline)
- Sibling BMI percentile(12-months post-baseline)
- Parent Feeding Practices(12-months post-baseline)
- Family Meal Quantity(12-months post-baseline)
- Family Meal Dietary Healthfulness(12-months post-baseline)
- Family Meal Emotional Atmosphere Quality(12-months post-baseline)
- Sibling BMI percentile(12-months post-baseline)
- Parent Feeding Practices(12-months post-baseline)
- Parent Coping Skills(12-months post-baseline)