Feasibility, Acceptability, and Preliminary Efficacy of the i Heart Rhythm Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Treatment Acceptability
研究概览
简要总结
This pilot study will examine the feasibility, acceptability, and preliminary efficacy of the intervention. This will ensure that all aspects of the research protocol and procedures work as desired and are acceptable to families in preparation for the fully powered randomized controlled trial. The proposed study will assess our ability to: 1)recruit, consent, and retain participants, 2) deliver the intervention, 3) implement study and assessment procedures 4) assess the reliability of the proposed measures in this sample, 5) determine whether modifications to the intervention, procedures, and measures are needed prior to conducting a fully powered study, and 6) willingness of participants to participate in the intervention.
详细描述
The current study employs a 2 group randomized control design (treatment and no-treatment control) with randomization occurring after baseline (time 0) and 3 additional evaluation periods (end of intervention (time 1), and 9 months (time 2) and 12 months post intervention (time 3)). Because the the i♥rhythm project is intended to prevent children from beginning a trajectory toward overweight/obesity in elementary school, the impact of the intervention on change in standardized BMI (BMIz) during the following summer (time 2 and 3) will be explored, identifying whether a maintenance intervention is needed. Following the intervention and final data assessment (time 1 and 3), qualitative interviews will explore the acceptability of the intervention, treatment barriers and facilitators, difficulties with study procedures, maintenance of improvements, and self-efficacy to maintain improvements. A third treatment condition controlling for the effect of attention was beyond the scope of the current feasibility study.
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 (Investigator)
盲法说明
key personnel will be masked
入排标准
- 年龄范围
- 5 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The index child is 5-8 years old and currently enrolled in kindergarten, first, or second grade
- •Parent reports being a daily user of social media
- •Parent willing to engage in an mobile health intervention that includes social media
- •Parent owns a smart phone
- •At least 1 parent is comfortable participating in the intervention and responding to questionnaires in English
- •Index child has a BMI >50th percentile
- •families live in the greater Houston area and able to attend in-person data collection at the Children's Nutrition Research Center.
排除标准
- •Per parent report, the child does not have a chronic medical condition affecting sleep, eating behaviors, weight status, or behavioral rhythms (e.g., obstructive sleep apnea, attention deficit hyperactivity disorder, autism). The inclusion and exclusion criteria will be assessed using a screening questionnaire and assessments which will be administered following the consenting procedures.
- •Per parent report, the child is not being treated with a medication or supplement known to affect sleep.
- •Child has not participated in an obesity prevention or obesity treatment program in the last 6 months
- •Child had not been retaine 2 or more grades for academic reason or has intellectual difficulities that would influence their ability to complet questionnaires or participate in interviews.
结局指标
主要结局
Treatment Acceptability
时间窗: 3 months
Treatment Acceptability Report Form-Revised(TARF-R) 185 is a 20-item global measure of treatment acceptability for behavioral interventions. The TARF-R has demonstrated good internal consistency (αs\>.69) and evidence of construct validity. A favorable rating is considered 4 or greater.
Feasibility Criteria: ability to recruit the needed sample size
时间窗: 3 months
The feasibility of the intervention will be established by our ability to recruit the needed sample size and retain at least 80% at Time 1 and 60% at Time 3; favorable acceptability ratings by 80% of the sample, participation in greater than 60% of daily diaries, views of intervention materials by 80% of participants. Decisions regarding changes to the intervention will be made based on the attainment of feasibility criteria and post-assessment interviews. Decisions regarding changes to the intervention will be made based on the attainment of feasibility criteria and post-assessment interviews.
次要结局
- Social Support (Parent)(0 months, 3 months, 12 months and 15 months)
- Dietary Assessment(0 months, 3 months, 12 months and 15 months)
- Actigraphy for the measurement of sleep, sleep/wake patterns, physical activity, and light exposure.(0 months, 3 months, 12 months and 15 months)
- Parenting Structure(0 months, 3 months, 12 months and 15 months)
- Measurement of endogenous circadian rhythms(0 months, 3 months, 12 months and 15 months)
- Motivation to Continue in the Program(3 months)
- Body composition(0 months, 3 months, 12 months and 15 months)
- Bedtime Routines(0 months, 3 months, 12 months and 15 months)
- Summer Care Arrangements(0 months, 3 months, 12 months and 15 months)
- Stress (Parent)(0 months, 3 months, 12 months and 15 months)
- Anthropometrics(0 months, 3 months, 12 months and 15 months)
研究者
Jennette P. Moreno
Assistant Professor
Baylor College of Medicine