The Comparative Effectiveness of Clinic-Based Weight Loss Strategies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 163
- 试验地点
- 2
- 主要终点
- Absolute weight loss in pounds
研究概览
简要总结
The purpose of this study is to compare the effectiveness of text message-based support to usual care at promoting weight loss in patients with pre-diabetes.
详细描述
Text messaging has been shown to be effective for weight-loss in very limited testing. DH has experience with both text message based intervention and weight management intervention. This study aims to enhance Denver Health's (DH) existing Patient Relationship Management (PRM) text message (SMS) infrastructure to include culturally-appropriate outreach to promote weight loss.
Subjects will be randomized into one of two arms:
- Usual care: Patients randomized to this arm will not receive text messages or any other weight-loss support besides usual care provided at DH. They will receive a weight loss educational packet and be asked to follow up with their primary care provider to further discuss their efforts at weight loss with additional follow-up as directed by their provider. They will be contacted periodically to be weighed. Providers will not be made aware that their patients are participating in the study's control arm.
- Text Message-based weight loss support. Patients will receive the same weight loss educational packet as those randomized to usual care. Patients will be assisted in choosing a self-management goal related to exercise and to eating behaviors. They will receive text messages at a frequency up to 1x daily; input from focus groups will guide text message frequency.
SMS content is similar to the Diabetes Prevention Program (DPP) curriculum and will fall into the following categories:
- Outgoing "tips of the day"
- Interactive messages that solicit a simple response for the day from the participant
- Outgoing reminders to inform participant about events in the community and about clinic appointments with their primary care provider.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •≥ 18 years of age or older
- •Ownership of a cell phone with SMS capabilities
- •HbA1c greater than 5.6 but less than 6.5
- •BMI ≥ 25 kg/m2 and less than 50 kg/m2
- •English or Spanish speakers.
排除标准
- •Individuals with co-morbid illness with life expectancy less than 12 months (e.g., terminal cancer, Child's Class C hepatic cirrhosis)
- •Diabetes based on an ICD-9 code in previous 3 years
- •Institutionalized individuals
- •Individuals not planning to stay in the area at least 6 months.
结局指标
主要结局
Absolute weight loss in pounds
时间窗: 12 months
Outcomes will be analyzed at baseline and at 6-month and 12-month follow-ups.
次要结局
- Changes in systolic and diastolic blood pressure(12 months)
- Change in LDL-cholesterol(12 months)
- Operating costs per participant receiving intervention(12 months)
- Percent weight loss(12 months)
- Percent of patients who maintain or lose weight(12 months)
- Change in glycemic control as measured by HbA1c and fasting glucose(12 months)
- Patient Engagement Measures(12 months)
研究者
Henry Fischer
Physician - Internal Medicine
Denver Health and Hospital Authority