Reducing Obesity Through Play: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Weight Status
研究概览
简要总结
The purpose of this study is to test various ways to help toddlers develop healthy eating and activity behaviors. Parents and toddlers, who participate in this research will be randomly assigned to either 1) continue their lifestyle behaviors for 10-weeks and then receive a health club membership for 1-month, 2) attend a health promotion playgroup together for 10 weeks, or 3) to attend an educational class for parents while toddlers are in childcare for 10-weeks. Physical measures of toddlers (height, weight, dietary intake, activity) will be collected. Parent-report surveys with questions about parenting, toddler diet, toddler temperament, food security status, demographic qualities, and satisfaction with group assignment will be collected. Last, the interactions between parents and toddlers will be observed and assessed during short play tasks via Zoom. All measures will be collected immediately upon signing up for the study (week 0), 10-weeks later (post), and 24-weeks after signing up for the study.
详细描述
In this randomized control trial, 300 parent-toddler dyads will be recruited and randomly assigned to one of three groups for 10-weeks. Those dyads assigned to the usual lifestyle group will not make any changes and will maintain their normal behaviors. Dyads assigned to the Families Understanding Nutrition and Physically Activity Lifestyles (FUNPALs) Playgroup will be invited to attend weekly playgroup sessions together. For those assigned to the Healthy Toddler Parent Group, parents will attend weekly health education classes where toddler health behaviors will be discussed. At baseline (week 0), immediate follow up (week 10-11), and long term follow up (week 24) parent report, physical, and observational measures of diet, activity, parenting, child temperament, food insecurity status, and quality of life will be completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parents: Primary custodian (i.e., legal guardian) of a toddler, >18 years, have regular and frequent access to internet, fluent in English.
- •Toddlers: >/=18 and </=36 months of age, and walking.
排除标准
- •Parents or toddlers who have mental or physical conditions that would prevent engagement in nutrition, physical activity, play, or instructional activities in a group setting or families unwilling to commit to the whole program (e.g., planning to move) will be excluded because participants may be randomly assigned to group interventions where engagement in these activities will be expected.
- •Parents who are not fluent in English will be excluded because this study was developed, and pilot tested on an English-speaking population. All study materials are in English, the interventions will be offered in English, and most of the surveys are not available or have been validated for non-English speaking audiences.
- •Parents who are not willing or able to participate in parent-toddler interaction assessments via Zoom will be excluded. This assessment is an important study variable.
- •Parents who are not willing to be recorded will be excluded because all Families Understanding Nutrition and Physically Active LIfestyles (FUNPALs) Playgroup sessions will be recorded for facilitator supervision purposes, and the parent-toddler interaction assessments will be recorded for later coding.
- •Only one toddler and one parent per family will be eligible, but all children and siblings within a household will be able to attend playgroups or childcare while parents are in Healthy Toddler Parent Group (HTPG) classes.
- •Parents and toddlers who received 1 or more sessions of the FUNPALs Playgroup or the HTPG. This study will be running 1 cohort per quarter for 4 years, so it is possible that families may drop out and want to re-enroll in a later cohort or enroll when younger siblings are eligible. They will not be eligible. Also, families from the community will be invited to participate in practice sessions of FUNPALs or HTPG to train the facilitators. These families will not be eligible to participate in the study.
结局指标
主要结局
Weight Status
时间窗: baseline (T1), 10-11 weeks after baseline (T2), and 24- weeks after baseline (T3)
Weight-for-length (WFL) percentile for toddlers \<24 months. Length and weight measures will each be taken two times and averaged. Trained research assistants will measure height to the nearest 0.1 cm using a recumbent height board for children \<24 months. Weight will be measured to the nearest 0.1 kg using an electronic self-calibrating digital scale. For toddlers \<24 months, weight for length (WFL) will be calculated. Sex- and age-standardized WFL will be determined from Centers for Disease Control and Prevention (CDC) growth charts. Age and gender corrected WFL will be used to categorize weight status groups: \<5th percentile WFL will be considered underweight, 5th-84.99th percentile will be considered normal weight, \>85 percentile will be considered overweight and \>95 percentile will be considered obese per CDC guidelines.
次要结局
- Toddler Dietary Intake.(baseline (T1), 10-11 weeks after baseline (T2), and 24- weeks after baseline (T3))
- Toddler carotenoid (FV) intake.(baseline (T1), 10-11 weeks after baseline (T2), and 24- weeks after baseline (T3))
- Activity(baseline (T1), 10-11 weeks after baseline (T2), and 24- weeks after baseline (T3))
研究者
Tracey Ledoux
Associate Professor
University of Houston