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临床试验/NCT05180448
NCT05180448已完成不适用

Sharing Digital Self-Monitoring Data With Others to Enhance Long-Term Weight Loss: A Randomized Trial Using a Factorial Design

Drexel University2 个研究点 分布在 1 个国家目标入组 322 人开始时间: 2022年1月3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
322
试验地点
2
主要终点
Weight

研究概览

简要总结

Adults attempting weight loss through lifestyle modification (LM) typically find maintenance of behavior change difficult. Outcomes might be improved if participants are provided with sustained sources of accountability and support and ongoing opportunities to reflect with others on goal progress. This study proposes that sharing digital data with other parties has the potential to improve long-term weight loss. The proposed study will enroll adults ("index participants") (N = 320) with overweight/obesity in a 24-month LM program and instruct them to use digital tools for self-monitoring of weight, physical activity, and eating on a daily basis.

详细描述

Adults attempting weight loss through lifestyle modification (LM) typically find maintenance of behavior change difficult. Outcomes might be improved if participants are provided with sustained sources of accountability and support and ongoing opportunities to reflect with others on goal progress. This study proposes that sharing digital data with other parties has the potential to improve long-term weight loss. The proposed study will enroll adults ("index participants") (N = 320) with overweight/obesity in a 24-month LM program and instruct them to use digital tools for self-monitoring of weight, physical activity, and eating on a daily basis. Groups will meet remotely each week in months 1-3 to initiate weight loss. In months 4-24, intervention contact will be remote and will include the following: quarterly group meetings held via videoconference; brief phone calls with the coach held twice per quarter; and monthly text messages with the coach, with a small group of fellow group participants, and with a friend or family member outside of the program. Text message content will vary according to treatment condition, i.e. three types of data sharing partnerships: Coach Share, Group Share, and Friend/Family Share. Outcomes will be measured at months 0, 3, 6, 12, and 24. Primary aims include determining if Coach Share, Group Share, and Friend/ Family Share each improve long-term weight loss, PA, and calorie intake, and examining if effects are additive when participants are assigned to engage in more than one type of data sharing partnership. The secondary aim is to explore mediators and moderators of intervention effects. The tertiary aim is to determine how the quality of relationship with coach, group members, and friends/family member over time may differentially moderate treatment effects and predict data sharing efficacy. As digital technology makes data sharing increasingly feasible, it is critical to determine how to optimize these partnerships to improve long-term outcomes in LM.

研究设计

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

盲法说明

Outcomes assessors will be blind to condition.

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

  • Individuals must be of overweight or obese BMI (27-50 kg/m2)
  • Individuals must be adults (aged 18-70)
  • Able to engage in physical activity (defined as walking two city blocks without stopping)
  • Access and willingness to use a smartphone and internet
  • Has one adult friend or family member who indicates willingness to serve in a support role
  • Satisfactory completion of all enrollment procedures
  • English Speaking

排除标准

  • Medical or psychiatric condition (e.g., cancer, type I diabetes, psychosis, full-threshold eating disorder) that may pose a risk to the participant during intervention or cause a change in weight, or limit ability to comply with the program or participate appropriately in group-based treatment
  • Currently pregnant or breastfeeding, or planning to become pregnant in the next 24 months
  • Use of insulin or a medication that can cause significant change in weight
  • History of bariatric surgery
  • Weight loss of greater than or equal to 5% in the previous 3 months
  • Weight loss of greater than or equal to 10% in the past 3 years that is currently being maintained

结局指标

主要结局

Weight

时间窗: 0 month, 3 month, 6 month, 12 month, 24 month

Weight will be measured using a wireless scale. In order to maximize accuracy, we will (1) provide instructions (e.g., place scale on flat, hard surface; weigh upon waking, without clothes, after using the bathroom), (2) require participants to confirm that they are following instructions at each assessment point, (3) remove errant weights (e.g., \>1 kg change in 1 day).

次要结局

  • Calorie Intake(0 month, 3 month, 6 month, 12 month, 24 month)
  • Physical Activity(0 month, 3 month, 6 month, 12 month, 24 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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