Greenlight Plus Study: A Randomized Study of Approaches to Early Childhood Obesity Prevention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 900
- 试验地点
- 12
- 主要终点
- Child Weight for Length Trajectory
研究概览
简要总结
A randomized controlled trial enrolling 900 parent-infant dyads (English and Spanish speaking) comparing Greenlight (control), a behavioral intervention focusing on nutrition, physical activity, media use, and sleep as compared to Greenlight Plus (intervention) which includes the above materials plus a health information technology (HIT) intervention aimed at supporting family goal-setting and behavior change during well-child checks throughout the first 2 years of life.
详细描述
The investigators propose a randomized trial to compare the effectiveness of two different approaches to early childhood obesity prevention in children 0-2 years of age. The investigators will randomize 900 parent-infant dyads, recruited from six newborn nurseries/primary care clinics. The participating organizations are part of both CORNET, a national practice-based research network of pediatric residency primary care practices supported by the Academic Pediatric Association (APA), and PCORnet, the national research network supported by PCORI. In the nursery or at the first newborn clinic visit, eligible families will be consented and randomized to one of two arms. In Arm 1 ("Greenlight"), during each of the recommended well child visits from 0-24 months, pediatric residents, trained in clear health communication skills and shared goal-setting, will use the Greenlight Toolkit of low literacy, age-specific, parent education booklets to promote healthy family behaviors and obesity prevention. In Arm 2 ("Greenlight Plus"), families will receive the Greenlight intervention plus a health information technology (HIT) intervention aimed at supporting family goal-setting and behavior change. This design allows us to determine if HIT and the asynchronous support it provides between well-child visits can promote additional behavior change and obesity prevention.
Specific Aims & Hypotheses (H) include:
Aim 1: Compare the effectiveness of the 2 arms on weight-for-length and other weight measures through age 2.
H1: Arm 2 will be significantly better than Arm 1 in supporting healthy child weight-for-length trajectory over 2 years;
Aim 2: Compare the effectiveness of the two approaches on parent-reported outcomes, including child feeding and physical activity behaviors, parent feeding beliefs and behaviors, media use, and quality of doctor-patient communication.
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 (Investigator, Outcomes Assessor)
盲法说明
All Greenlight Plus personnel that are in a position to change the study protocol or its implementation in study participants should be blinded to information that may allow them to do so, from when the study starts until the study ends, with specific exceptions. This means that all investigators and study staff should be blinded to study data aggregated by study arm that have the potential to impact the study's outcome.
The study statistician and programmers s/he designates will be unblinded to post-randomization outcome, mediator, moderator and process data for the purposes of generating DSMB reports.
The study statistician will remain objective when carrying out the activities of conducting the trials - preparing randomization schemes, processing of the data, cleaning and editing the data, preparation of analyses/reports of outcome, mediator, moderator and blinded process data, and transmitting those data to the DSMB.
入排标准
- 年龄范围
- — 至 21 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For this study, eligible caregiver/infant dyads will be those with:
- •an English- or Spanish-speaking parent/legal guardian,
- •infant born in the newborn nursery with plans to have care in the local clinic OR presenting in that clinic for the first newborn visit (1-21 days of life),
- •attendance at first newborn clinic visit
- •no plans to leave the clinic within 2 years
- •Completion of baseline data collection (survey data, child weight and length measures prior to randomization).
- •Own a smartphone with access to data services
排除标准
- •Infant exclusion criteria:
- •born prior to 34 weeks gestation or birth weight <1500 grams; weight <3rd %tile at enrollment (World Health Organization growth curves); or
- •any chronic medical problem that may affect weight gain (e.g., metabolic disease, uncorrected congenital heart disease, renal disease, high-calorie formula; cleft palate; Down syndrome).
- •Caregiver exclusion criteria include:
- •<18 years old;
- •serious mental or neurologic illness that impairs ability to consent/participate;
- •poor visual acuity (corrected vision worse than 20/50 with Rosenbaum Screener).
- •biological mother is HIV-positive
结局指标
主要结局
Child Weight for Length Trajectory
时间窗: Baseline to 24 months
The primary outcome was child weight for length (kg/m) trajectory over 2 years. Weight and length measurements were obtained during pediatric care visits and abstracted from the medical record.
次要结局
- Child BMI Z-score Trajectory(Baseline to 24 months)
- Child Weight-for-length Z-score Trajectory(Baseline to 24 months)
- Child Overweight and/or Obesity(at 24 months)
研究者
Bill Heerman
Assistant Professor, Internal Medicine and Pediatrics
Vanderbilt University Medical Center