Technology-Assisted Weight Management Intervention Within Patient-Centered Medical Homes: The GEM (Goals for Eating and Moving) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 489
- 试验地点
- 1
- 主要终点
- Change in Weight From Baseline
研究概览
简要总结
The GEM intervention leverages the patient-centered medical home model by using the GEM tool to provide individually tailored, patient-centered care, promote standardized weight management counseling by health coaches and primary team members, coordinate care between teams and other weight management service providers/programs (e.g., dietitians, health educators, DPP), and provide feedback to the provider and primary care team about patients' weight management-related goals, progress, and care.
详细描述
To establish the efficacy of the GEM intervention, investigators will conduct a cluster randomized controlled 12-month intervention of 19 primary care teams at two urban healthcare systems with Medical Home models of care to compare the GEM intervention (intervention arm) with Enhanced Usual Care (educational materials; control arm).
The specific aims of this study are:
- Test the impact of the GEM intervention on weight change, and clinical and behavioral outcomes.
- Identify predictors of weight loss in the GEM intervention arm related to: a) goal-setting processes and b) intervention components
- Determine the impact of the GEM intervention on obesity-related counseling practices and attitudes in primary care providers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 18-69 years of age,
- •Body mass index of ≥30kg/m2 OR
- •Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity
- •Hypertension
- •High Cholesterol
- •Sleep Apnea
- •Osteoarthritis
- •Metabolic Syndrome
- •Prediabetes
- •Under primary care team care with at least one prior visit with their provider in the past 24 months
- •Access to a telephone, and ability to travel for in-person evaluations at baseline, 6, 12, and 24 months
排除标准
- •Patients who do not speak English or Spanish,
- •Have active psychosis or other cognitive issues,
- •Psychoactive substance use
- •Taking prescription weight-loss medication
- •Health condition that may prohibit the patient from walking or physical activity such as chest tightness, a heart condition, or severe arthritis
- •Participated in MOVE!, DPP, or another intensive weight management program (>3 sessions) in the past year,
- •Have a history of bariatric surgery,
- •Are pregnant, or become pregnant during the intervention period,
- •Metastatic cancer in the last 6 months, current chemotherapy or cancer treatment,
- •Have a provider who states they should not participate,
- •Patients who do not want to lose weight
- •Have self-reported inability to read at 5th grade level.
研究组 & 干预措施
Participants with Obesity + Enhanced Usual Care
Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will receive receive non-tailored weight management handouts by health coaches.
干预措施: Enhanced Usual Care (Behavioral)
Participants with Obesity + GEM
Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will be assigned to GEM Tool and a health coach.
干预措施: GEM (Behavioral)
结局指标
主要结局
Change in Weight From Baseline
时间窗: Baseline, Month 12
Change in Systolic Blood Pressure (SBP) From Baseline
时间窗: Baseline, Month 12
Change in Diastolic Blood Pressure (DBP) From Baseline
时间窗: Baseline, Month 12
Change in Waist Circumference From Baseline
时间窗: Baseline, Month 12
次要结局
未报告次要终点