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临床试验/NCT03246672
NCT03246672已完成不适用

Development of a Weight Maintenance Intervention for Bariatric Surgery Patients

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2018年1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
已完成
入组人数
33
试验地点
1
主要终点
Retention Rate

研究概览

简要总结

Although bariatric surgery is highly effective for inducing significant weight loss and resolution of comorbidities, weight regain following surgery is a common problem. This pilot study will test the feasibility and acceptability of an intervention designed to help bariatric surgery patients maintain weight loss. Findings from this pilot will provide the foundation for a randomized controlled trial to evaluate the efficacy of the intervention.

详细描述

The first intervention telephone call will occur one week following the baseline assessment. Calls will be made weekly in the first month (weeks 1, 2, 3, 4) and biweekly calls during months 2-4 (weeks 6, 8, 10, 12, 14). The goal of this intervention is to increase adherence to recommendations that patients are already receiving from their bariatric team as part of standard of care. Thus, each call will address maintenance skill building and anticipatory problem solving based on the processes outlined in the investigators' conceptual model and operationalized in the investigators' previous weight loss maintenance protocol. Relapse prevention planning will help patients identify situations in which overeating is common in the bariatric population (e.g., loss of control eating related to emotions, disinhibition).

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Bariatric surgery at a participating VA site
  • •Laparoscopic Roux-en-Y gastric bypass (RYGB) or laparoscopic vertical sleeve gastrectomy (SG) six to 18 months prior to the time of data pull
  • •English as preferred language
  • •Regular access to a telephone

排除标准

  • •Receipt of procedure to prevent gastric cancer
  • •Revisional bariatric surgery
  • •Hearing impairment
  • •Cancer not in remission

研究组 & 干预措施

maintenance

Experimental

behavioral intervention to increase adherence to lifestyle recommendations

干预措施: maintenance intervention (Behavioral)

结局指标

主要结局

Retention Rate

时间窗: 16-week outcome assessment

Percentage of patients with baseline data who complete 16-week outcome assessments

Recruitment Rate

时间窗: week 0

Percentage of contacted patients who consent to be in the study

次要结局

  • Weight(16 weeks)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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