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临床试验/NCT02767440
NCT02767440已完成不适用

Families on Track: A Digital Health Behavioral Intervention for Parents Seeking Treatment for Their Child With Obesity

Duke University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
change in parent weight over 6 months

研究概览

简要总结

Current models of outpatient childhood obesity treatment focus on the child's health habits, with limited efficacy. In part, this may be because childhood obesity is highly sensitive to parental lifestyle habits, who are often not a direct target of child obesity interventions. This study aims to target weight loss among overweight parents of 2-16 year old children with obesity enrolled in the Duke Healthy Lifestyles Program (HL) in order to augment child body mass index reduction. The intervention, " Families on Track" is a digital health intervention platform using the Interactive Obesity Treatment Approach (iOTA).

详细描述

Parents in the program will receive the family-based treatment protocol provided by the Healthy Lifestyles clinic. First, families attend a half-day session at the clinic where child anthropometrics and labs are obtained, and nutrition and physical activity group counseling is provided. Height and weight of the primary adult caregiver are measured and BMI is calculated. Second, families return 2 weeks later to meet individually with a pediatric obesity medical provider and a registered dietitian. Thereafter, frequency of visits is determined based on the families needs with a final visit 1 year after starting treatment. The ideal is to have visits with the HL staff at intervals of 4-6 weeks for 5 more visits to complete the primary phase of the program over 6 months.

Parents enrolled in the study will also receive the Track intervention. The investigators will use a modified version of the Track intervention, which utilized the Interactive Obesity Treatment Approach (iOTA). iOTA uses a computer algorithm to assign 3-4 personalized behavioral goals known to create an energy deficit to produce weight loss (e.g., sugary drinks, fast food consumption walk 10,000 steps/day, etc). The team at Duke Digital Health has shown that iOTA can be successfully delivered to adults on multiple modalities -- web, text messaging and interactive voice response phone calls. Each week, participants will receive a prompt from the Track intervention system in order to self-monitoring these behaviors goals. These prompts will be delivered either via interactive voice response or text message. Intervention participants will also receive an analog bathroom scale and a pedometer to self-monitor daily weights and steps.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18-60 years
  • BMI: 25-50 kg/m2
  • English speaking
  • Mobile phone ownership
  • Willingness to send and receive multiple text messages/day
  • living in the same household as a Healthy Lifestyles patient ages 2-16

排除标准

  • Current pregnancy or lactation
  • Prior or planned bariatric surgery Both child and parent participation in other obesity trials - including the evaluation of the Bull City Fit Program at the Healthy Lifestyles program
  • History of heart attack, stroke, bipolar disorder schizophrenia or recent cancer diagnosis
  • Plans to relocate within 1 year

研究组 & 干预措施

Families on Track Intervention

Experimental

This is a pre-post study. Enrolled parents will receive the Families on Track intervention plus usual care at the Healthy Lifestyles clinic at Duke University.

干预措施: Families on Track Intervention (Behavioral)

结局指标

主要结局

change in parent weight over 6 months

时间窗: baseline, 6 months

次要结局

  • change in parent waist circumference over 6 months(baseline, 6 months)
  • change in parent BMI over 6 months(baseline, 6 months)
  • change in parent blood pressure over 6 months(baseline, 6 months)
  • change in child lipid panel (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides) over 6 months(baseline, 6 months)
  • change in child glucose, insulin, and HbA1c over 6 months(baseline, 6 months)
  • change in parent exercise behaviors over 6 months(baseline, 6 months)
  • change in child number of minutes of physical activity(baseline, 6 months)
  • change in child z-BMI over 6 months(baseline, 6 months)
  • change in child cardiovascular fitness/physical conditioning(baseline, 6 months)
  • change in child consumption of fruits and vegetables over 6 months(baseline, 6 months)
  • change in child number of minutes of screen time(baseline, 6 months)
  • change in parent depression over 6 months(baseline, 6 months)
  • change in parent perceived healthy eating and physical activity social/environmental support over 6 months(baseline, 6 months)
  • change in home food environment over 6 months(baseline, 6 months)
  • change in child blood pressure over 6 months(baseline, 6 months)
  • change in child consumption of sugar sweetened beverages over 6 months(baseline, 6 months)
  • change in parent diet over 6 months(baseline, 6 months)
  • change in child consumption of sugary snacks over 6 months(baseline, 6 months)
  • change in child quality of life over 6 months(baseline, 6 months)
  • change in child perceived healthy eating and physical activity social/environmental support over 6 months(baseline, 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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