A Coordinated Parent/Child Dyad Weight Loss Intervention: Dyad Plus (Feasibility)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- BMI z-score
研究概览
简要总结
The purpose of this research is to develop a coordinated program (Dyad Plus) that would help to facilitate self-monitoring, positive communication, joint problem solving, and social support to increase physical activity, healthy eating, and weight loss. Participants of the Brenner FIT (Families In Training) pediatric weight management program and their parent/guardian will co-enroll in weight loss programs. Parents/guardians will receive the components of By Design Essentials.
详细描述
Participation in this study will involve participation in six, one-hour sessions in addition to those required by your weight loss program. These sessions will work to facilitate an increase in self-monitoring, positive communication, problem solving, and social support to increase healthy physical activity and eating behaviors to increase the effectiveness of the weight loss programs. Joint goal setting and tracking will be enabled by commercially available devices and apps. Each caregiver and child will receive an activity monitor, activity app, and a food app (digital food diary) that allows self-monitoring of consumption and "social accountability," which will allow caregivers and the Brenner FIT team to monitor and encourage. Furthermore, two home visits will be conducted to evaluation the home food and activity environments to inform tailored feedback to families.
Brenner FIT is a family-based pediatric weight management clinic for youth 2-18 years old referred by a physician for overweight or obesity.11-14 By Design is an adult (>18yrs) weight loss clinic that includes tailored dietary and physical activity behavioral counseling. The preliminary data suggest that most adolescent youth who enroll in Brenner FIT have at least one adult caregiver who is eligible and would benefit from enrollment in By Design Essentials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible for enrollment in Brenner FIT and/or By Design Essentials
- •Caregiver who lives in the house with a BMI > 30
- •No contraindication for physical activity or caloric restriction
- •Must be able to read and write English
排除标准
- •Over the age of 65
- •BMI < 30
- •Contraindication for physical activity or caloric restriction
- •Cannot read or write English
结局指标
主要结局
BMI z-score
时间窗: 6 months
Weight status of caregivers and youth will be quantified through calculation of BMI derived from measurement of height and weight at the intake and follow-up visits. Both height (plus or minus 0.1 cm) and weight (plus or minus 0.5 kg) will be recorded twice and values will be averaged to produce the final value using a Tanita (registered trademark) digital scale and a Seca (registered trademark) Height Rod (respectively). BMI will be calculated as kg /m2. BMI z-score will be calculated using CDC growth charts.
次要结局
- Physical Activity Assessed by Accelerometry(6 months)
- Physical Activity Assessed by PAQ-A(6 months)
- Caloric intake expressed in kcals(6 months)
- Alanine Aminotransferase-Levels of ALT for all participants, measured in units per liter(6 months)
- Physical Activity Assessed by IPAQ(6 months)
- Concentration of fasting glucose for all participants, mg/dL(6 months)
- Concentration of fasting Insulin for all participants, mg/dL(6 months)
- Hemoglobin A1c concentration for all participants, measured in percentage(6 months)
- Aspartate Aminotransferase -Levels of AST for all participants, measured in units per liter (IU/L)(6 months)
- Concentration of total cholesterol (mg/dL)(6 months)
- Economic costs of the three intervention arms over duration of program (USD)(Baseline through 6 months)