NCT06206954Enrolling By Invitation不适用
Increasing Initiation of Evidence-based Weight Loss Treatment
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 864
- 试验地点
- 1
- 主要终点
- Proportion initiating treatment
研究概览
简要总结
This study will test the effects of a brief, individually tailored intervention aiming to increase initiation of comprehensive behavioral weight loss treatment on weight.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigators (with exception of statistician) will be masked to study condition. Outcome assessors and all staff engaging directly with participants will be masked to study condition, except those staff who are sending intervention content.
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
- •Age 18 or older
- •Body Mass Index (BMI) ≥ 30 kg/m2 based on self-report body weight and height, or BMI ≥ 27-29.9 kg/m2 with a weight related comorbidity of hypertension, type 2 diabetes, pre-diabetes, dyslipidemia, or obstructive sleep apnea, gastroesophageal reflux disease, or coronary artery disease.
- •Self-report weight ≤ 375 lbs (the maximum weight that BodyTrace scales can accurately detect is 397 lbs, thus 375 lbs provides a buffer to allow detection of at least 20 lbs weight gain).
- •Has a desire to weigh less
- •Has valid email address in Electronic Health Record
- •Has an appointment scheduled with enrolled PCP about 21-28 days after electronic data pull
- •Speaks and reads English
- •Has either WiFi internet access at home or a phone or tablet with a data plan.
排除标准
- •Currently enrolled in evidence-based comprehensive weight loss treatment
- •Pregnant or planning to become pregnant in the next 6 months
- •Currently breastfeeding (or pumping breastmilk) more than 3 times per day.
- •Currently undergoing treatment for cancer
- •Had cardiovascular event in the past 60 days
- •Severe depression symptoms on PHQ-8 (total score ≥20)
- •Inpatient psychiatric treatment in the past 6 months
- •Eating disorder in past 5 years
- •Congestive heart failure resulting in recent (past 6 months) hospitalization or contributing to difficulty breathing or difficulty doing daily activities.
- •Dementia diagnosis
- •Bariatric surgery in the past year or currently undergoing evaluation for bariatric surgery
- •Currently taking doctor-prescribed medication for weight loss
- •Inability to stand on body weight scale independently
- •Impaired hearing
- •Unable to read content on websites without assistance
研究组 & 干预措施
MyHealthPath Guide
Active Comparator
Receive MyHealthPath Guide intervention
干预措施: MyHealthPath Guide (Behavioral)
MyHealthPath Tool
Experimental
Receive MyHealthPath Tool intervention.
干预措施: MyHealthPath Tool (Behavioral)
结局指标
主要结局
Proportion initiating treatment
时间窗: Within 2 months of PCP appointment date
Attend at least one intervention session of comprehensive behavioral weight loss intervention. Documented by interventionist/program.
次要结局
- Number of treatment sessions attended(6 months)
- Proportion achieving 5% weight loss(6 months)
- Percent weight loss(6 months)
- Proportion discussing weight-related topic with PCP(at completion of PCP visit (occuring up to 4 weeks after enrollment))
研究者
研究点 (1)
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