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临床试验/NCT06875622
NCT06875622招募中不适用

Comparison of Behaviorally-Based Remote Approaches to Optimize Weight Loss and Identification of Factors Which Characterize Treatment Response

The Miriam Hospital1 个研究点 分布在 1 个国家目标入组 490 人开始时间: 2025年3月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
490
试验地点
1
主要终点
Percent weight change

研究概览

简要总结

The purpose of this trial is to compare two delivery formats for weight loss (automated online program vs. group-based videoconference program) and to examine the added effect of individual coaching (vs. no coaching) for individuals with overweight or obesity. All participants enrolled in this study will receive a 12-month behavioral weight loss program (varying in delivery format and individual support), and will be provided with weight loss, calorie intake, and exercise goals. Assessments will occur at baseline, 6 (mid-treatment), 12 (post-treatment), and 18 months (following 6 months of no intervention). We will also seek to determine which combination of intervention approaches works best for whom and develop algorithms which can be used to refer patients into remote programs in clinical settings or future trials.

详细描述

Participants will be randomized at baseline to one of four weight loss intervention conditions: 1) automated program + coaching, 2) automated program + no coaching, 3) group videoconference program + coaching, and 4) group videoconference program + no coaching. All participants will be provided with weekly goals, instructed to self-monitor diet, exercise, and weight daily, and provided with feedback based upon these data. Those receiving the online program will also be instructed to view video lessons (24 in total, 10-15 min each) which focus on behavioral strategies for changing diet and exercise. Individuals randomized to the videoconference program will participate in 24 group sessions (1 hour each) designed to mimic in-person treatment and allow for participant interaction via large and small group discussions. The content across conditions will be similar and the lessons will be provided weekly during months 1-3, twice per month during months 4-6, and monthly during months 7-12. Those receiving coaching will have individual, monthly meetings with a coach via videoconference (~15 min each). Coaching sessions will focus on individual barriers, problem solving, goal setting, and fostering support and accountability.

The primary aim of this study is to examine the effects of delivery format (automated online vs. videoconference) and coaching (individualized vs. none) on weight loss at 12 months. Secondary aims will examine the effects of delivery format and coaching on intervention engagement (e.g., frequency of self-monitoring), psychosocial outcomes (e.g., perceived support, self-efficacy, and motivation), 18-month weight loss, and the cost per kilogram of weight loss (to examine whether the addition of human support is cost-effective). Two algorithms will also be developed to predict which treatment type should be recommended to whom, using only baseline characteristics: 1) a 'widely-applicable' algorithm which will use metrics common to electronic medical records (sex, BMI, age, race, ethnicity), and 2) a 'more comprehensive' algorithm which will further include additional baseline characteristics (e.g., education, household income, health literacy, group preference, etc).

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
None

入排标准

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

入选标准

  • •Body Mass Index between 25-45 kg/m2
  • •Daily, home Internet access

排除标准

  • •Currently pregnant, planning to become pregnant within the next 18 months, or pregnant within the past 6 months
  • •Current or recent enrollment (<2 years) in a weight loss program
  • •Presence of any medical condition for which exercise, weight loss, or dietary restriction is contraindicated
  • •Recent weight loss (≥10 pounds within the past 6 months)
  • •Currently taking weight loss medications or history of bariatric surgery
  • •Inability to walk 2 blocks without stopping
  • •Non-English speaking
  • •A member of one's household is participating in the study
  • •History of anorexia or bulimia nervosa

研究组 & 干预措施

Automated online program + coaching

Experimental

Participants randomized to this condition will receive a 12-month automated weight loss program delivered via the Internet plus monthly, individual coaching sessions delivered via videoconference.

干预措施: Automated online weight loss program (Behavioral)

Automated online program + coaching

Experimental

Participants randomized to this condition will receive a 12-month automated weight loss program delivered via the Internet plus monthly, individual coaching sessions delivered via videoconference.

干预措施: Individual coaching (Behavioral)

Automated online program only

Experimental

Participants randomized to this condition will receive a 12-month automated weight loss program delivered via the Internet.

干预措施: Automated online weight loss program (Behavioral)

Group videoconference program + coaching

Experimental

Participants randomized to this condition will receive a 12-month, group-based behavioral weight loss program delivered via videoconference plus monthly, individual coaching sessions delivered via videoconference.

干预措施: Individual coaching (Behavioral)

Group videoconference program + coaching

Experimental

Participants randomized to this condition will receive a 12-month, group-based behavioral weight loss program delivered via videoconference plus monthly, individual coaching sessions delivered via videoconference.

干预措施: Group-based, videoconference-delivered weight loss (Behavioral)

Group videoconference program only

Experimental

Participants randomized to this condition will receive a 12-month, group-based behavioral weight loss program delivered via videoconference.

干预措施: Group-based, videoconference-delivered weight loss (Behavioral)

结局指标

主要结局

Percent weight change

时间窗: 12 months

Weight change will be assessed via smart scales using weight at baseline and 12 months and calculated as follows: (\[12-month weight minus baseline weight\] / baseline weight \* 100).

Change in perceived support

时间窗: 12 months

Perceived support will be measured via the Important Others Questionnaire. Scores on this questionnaire range from 12 to 84 with higher scores indicating a greater perception of support from important others. Change in perceived support will be calculated as follows: 12-month perceived support minus baseline perceived support.

次要结局

  • Percent weight change(18 months)
  • Self-monitoring of calorie intake(12 months)
  • Self-efficacy for exercise(12 months)
  • Change in autonmous motivation(12 months)
  • Change in controlled motivation(12 months)
  • Cost per kilogram of weight loss(12 months)
  • Change in self-efficacy for diet(12 months)
  • Frequency of self-monitoring weight(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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