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临床试验/NCT03867981
NCT03867981已完成不适用

Phone Coaching and Internet-delivered Weight Loss

The Miriam Hospital2 个研究点 分布在 1 个国家目标入组 452 人开始时间: 2019年3月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
452
试验地点
2
主要终点
Percent Weight Change at 12 Months

研究概览

简要总结

The purpose of this study is to examine whether adding phone coaching to an Internet-based weight loss program can improve weight loss outcomes at 4 months and 1 year. All individuals will receive a 4-month, Internet-delivered weight loss program followed by an 8-month Internet-delivered weight loss maintenance program. Some individuals will also be selected to receive either 3 weeks or 12 weeks of phone coaching. Assessments of weight, diet, physical activity, and psychosocial factors will occur at baseline, 4 months, and 1 year.

详细描述

All individuals enrolled in this study will receive a 4-month Internet-based weight loss program followed by an 8-month Internet-based weight loss maintenance program. During the first 4 months, each week individuals will be asked to view a 10-15-minute multi-media lesson (one per week). These lessons focus on behavioral principles for changing diet and physical activity behaviors. Participants are also given weight loss, calorie intake, and physical activity goals. They are taught how to self-monitor this information and are instructed to submit it weekly on the study website. Automated, weekly individualized feedback is provided. Following the 4-month weight loss program participants will receive an 8-month weight loss maintenance program. During this time, they will be asked to view monthly video lessons which focus on strategies for successful WL maintenance and instructed to continue to self-monitor weight, calorie intake, and physical activity minutes on the study website for one week per month. Automated, monthly feedback is provided.

In addition to the Internet program described above, some individuals enrolled in this study will be selected to receive phone coaching. Those selected for 'brief' phone coaching will be asked to complete 3 phone calls with a coach between weeks 5-8 of the study and those selected to receive 'extended' phone coaching will be asked to complete 12 phone calls with a coach between weeks 5-16. The first coaching call will be approximately 45 minutes in duration and all subsequent calls will be approximately 15 minutes in duration. The coach will assist participants in developing a meal plan, problem solving around current barriers, and goal setting. Upon completion of all coaching calls participants will have no additional interaction with the coach, but will remain enrolled in the Internet program.

Assessments will occur at baseline, 4, and 12 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-70
  • BMI: 25-45 kg/m2
  • Regular internet access

排除标准

  • Currently pregnant, <6 months post-partum, nursing, or planning to become pregnant within the next 12 months.
  • Current enrollment in a commercial weight loss program or other weight loss research study
  • Currently taking weight loss medications
  • Previously had bariatric surgery
  • Inability to walk 2 blocks without stopping
  • Any medical condition for which weight loss, dietary restriction, or physical activity is contraindicated

结局指标

主要结局

Percent Weight Change at 12 Months

时间窗: 12 months after start of weight loss program

Weight change was assessed using weight at baseline and 12 months

Percent Weight Change at 4 Months

时间窗: 4 months after start of weight loss program

Weight change was assessed using weight at baseline and 4 months

次要结局

  • Cost of Supplemental Coaching Per kg of Weight Loss(12 months after start of weight loss program)
  • Self-monitoring of Calorie Intake(4 months after start of weight loss program)
  • Change in Dietary Intake (Kcals)(4 months after start of weight loss program)
  • Change in Physical Activity Minutes (Min/wk)(4 months after study enrollment)
  • Video Lesson Viewing(4 months after start of weight loss program)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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