Remote Dietary Counseling Using Web-based Tools to Promote Healthy Diet and Blood Pressure (Healthy BP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 187
- 试验地点
- 2
- 主要终点
- Change in 24-hour Systolic Blood Pressure
研究概览
简要总结
American College of Cardiology/American Heart Association (ACC/AHA) hypertension guidelines recommend lifestyle modification for patients with elevated blood pressure. While eating a Dietary Approaches to Stop Hypertension (DASH)-type diet, increasing physical activity, and weight loss have been shown to reduce blood pressure, limited resources are available in the primary care setting to help patients make these changes.
In this study, the investigators will compare the efficacy of a self-guided vs. dietitian-led approach using web-based lifestyle modification tools to reduce weight, improve dietary quality, and lower blood pressure in overweight/obese adults with elevated blood pressure.
详细描述
Goals that all participants will be instructed to target include: 1) weight loss >=3% at 3 months; 2) consume a healthier dietary pattern (high in fruits, vegetables, whole grains, low-fat dairy, vegetable/fish/poultry sources of protein, healthier sources of fat, and avoid sugar and salt); 3) reduce sodium intake to <2300 mg/d; 4) at least 180 min/wk of moderate-intensity physical activity.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •24-hour ambulatory SBP 120-160 mmHg
- •BMI ≥ 25 kg/m2
- •Access to a telephone
- •Access to a computer or smartphone with internet access
- •Complete dietary data entry for at least 5 out of 7 days during run-in period
- •Enter weight into the platform during run-in period
排除标准
- •Inability to understand English
- •Myocardial infarction, stroke, or atherosclerotic cardiovascular disease procedure within last 6 months.
- •Current treatment for malignancy
- •Planned or previous bariatric surgery
- •Pregnant, breast-feeding, or planned pregnancy prior to the end of participation
- •Self-reported average consumption of > 21 alcoholic beverages per week or binge drinking.
- •Psychiatric hospitalization in past year
- •Current symptoms of angina
- •Planning to leave the area prior to end of the study
- •Current participation in another clinical trial
- •Principal investigator discretion (i.e. concerns about safety, compliance)
研究组 & 干预措施
Self-Guided Approach
In the self-guided arm, participants will receive access to web-based tools to help achieve healthy lifestyle changes to lower their blood pressure.
The web-based tools include: 1) a web-based food frequency questionnaire (Viocare FFQ), which will provide a snapshot of participants' dietary habits in the past 6 months as well as personalized recommendations for areas to improve; 2) access to an evidence-based program (Evolve, formerly BMIQ), which includes program materials for weight loss and leading a healthy lifestyle as well as the ability for capturing dietary data entry.
干预措施: Self-Guided Approach (Behavioral)
Dietitian-led Approach
In the dietitian-led arm, dietitian will use motivational interviewing in 15-30 minute telephone calls with participants.
The web-based tools include: 1) a web-based food frequency questionnaire (Viocare FFQ), which will provide a snapshot of participants' dietary habits in the past 6 months as well as personalized recommendations for areas to improve; 2) access to an evidence-based program (Evolve, formerly BMIQ), which includes program materials for weight loss and leading a healthy lifestyle as well as the ability for capturing dietary data entry.
The web platform will be used to share participant dietary and weight data with dietitians.
干预措施: Dietitian-led Approach (Behavioral)
结局指标
主要结局
Change in 24-hour Systolic Blood Pressure
时间窗: Baseline to 12-week follow-up
Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)
次要结局
- Change in Nighttime Systolic Blood Pressure(Baseline to 12-week follow-up)
- Change in Nighttime Diastolic Blood Pressure(Baseline to 12-week follow-up)
- Change in Total Healthy Eating Index - 2015 score(Baseline to 12-week follow-up)
- Change in Waist Circumference(Baseline to 12-week follow-up)
- Change in Daytime Systolic Blood Pressure(Baseline to 12-week follow-up)
- Change in Physical Activity (metabolic equivalent of task [MET]-minute per week(Baseline to 12-week follow-up)
- Change in 24-hour diastolic blood pressure(Baseline to 12-week follow-up)
- Change in Daytime Diastolic Blood Pressure(Baseline to 12-week follow-up)
- Change in Weight(Baseline to 12-week follow-up)