Exercise and QUality Diet After Leukemia: The EQUAL Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 358
- 试验地点
- 2
- 主要终点
- Weight Loss
研究概览
简要总结
The EQUAL study has been designed for adult survivors of childhood acute lymphoblastic leukemia (ALL) who are overweight or obese. The purpose of this study is to see if diet and exercise can help people lose weight and improve other health problems. This two year study will compare two methods of informing participants about ways to lose weight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Eligibility will be confirmed via the CCSS-based medical record and by a series of questions on the EQUAL website, prior to consent.
- •Participation in the CCSS cohort
- •Diagnosed with acute lymphoblastic leukemia < 18 years of age
- •Cancer free at time of study enrollment
- •Current age ≥ 18 years
- •A body mass index (BMI) ≥ 25 kg/m2 (overweight or obese), as determined by self-reported height and weight on the most recent CCSS questionnaire
- •Internet access and a personal email account
- •Able to read and comprehend informed consent
排除标准
- •Prior history of congestive heart failure, coronary artery disease, myocardial infarction, stroke, or unstable angina;
- •Medical condition for which weight loss might be contraindicated or which would cause weight loss, such as pregnancy, anorexia or bulimia;
- •Use of prescription weight loss medication within the previous 6 months
- •History of total body irradiation (TBI)
研究组 & 干预措施
control group
Participants will receive general information brochures on healthy living and weight loss but will not have access to the Healthways at Hopkins website or counselors.
干预措施: questionnaires (Behavioral)
Intervention group
Participants will be assigned an individual diet & physical activity counselor through Healthways at Hopkins. This counselor will stay with the participant for the 24 months. The primary communication with the counselor will be via website & email. Participants will be encouraged to consume a low-calorie, low-salt diet with 7-12 daily servings of fruits, vegetables & low-fat dairy products. Calorie goals are based upon weight at study entry & whether or not the weight loss goal has been met. Participants will gradually build to ≥ 180 minutes of moderate to vigorous physical activity per week, using the activity of their own choosing & gradually adding bouts of ≥ 10 minutes in length. Monitoring & Counselor Contacts: the first 3 months, the participants are encouraged to log into the web hub on a daily basis to record weight, food intake, & physical activity. Participants who decline or drop out of the intervention program will remain on-study doing home visits & questionnaires.
干预措施: individual diet & physical activity counselor and website through Healthways at Hopkins (Behavioral)
Intervention group
Participants will be assigned an individual diet & physical activity counselor through Healthways at Hopkins. This counselor will stay with the participant for the 24 months. The primary communication with the counselor will be via website & email. Participants will be encouraged to consume a low-calorie, low-salt diet with 7-12 daily servings of fruits, vegetables & low-fat dairy products. Calorie goals are based upon weight at study entry & whether or not the weight loss goal has been met. Participants will gradually build to ≥ 180 minutes of moderate to vigorous physical activity per week, using the activity of their own choosing & gradually adding bouts of ≥ 10 minutes in length. Monitoring & Counselor Contacts: the first 3 months, the participants are encouraged to log into the web hub on a daily basis to record weight, food intake, & physical activity. Participants who decline or drop out of the intervention program will remain on-study doing home visits & questionnaires.
干预措施: questionnaires (Behavioral)
Intervention group
Participants will be assigned an individual diet & physical activity counselor through Healthways at Hopkins. This counselor will stay with the participant for the 24 months. The primary communication with the counselor will be via website & email. Participants will be encouraged to consume a low-calorie, low-salt diet with 7-12 daily servings of fruits, vegetables & low-fat dairy products. Calorie goals are based upon weight at study entry & whether or not the weight loss goal has been met. Participants will gradually build to ≥ 180 minutes of moderate to vigorous physical activity per week, using the activity of their own choosing & gradually adding bouts of ≥ 10 minutes in length. Monitoring & Counselor Contacts: the first 3 months, the participants are encouraged to log into the web hub on a daily basis to record weight, food intake, & physical activity. Participants who decline or drop out of the intervention program will remain on-study doing home visits & questionnaires.
干预措施: fasting blood draw, measurement of height, weight and waist circumference, and blood pressure (Other)
control group
Participants will receive general information brochures on healthy living and weight loss but will not have access to the Healthways at Hopkins website or counselors.
干预措施: self directed weight loss (Behavioral)
control group
Participants will receive general information brochures on healthy living and weight loss but will not have access to the Healthways at Hopkins website or counselors.
干预措施: fasting blood draw, measurement of height, weight and waist circumference, and blood pressure (Other)
结局指标
主要结局
Weight Loss
时间窗: 24 months
Weight loss will be evaluated in an intent-to-treat analysis with a linear mixed effects model with robust standard errors and an unstructured covariance matrix(50) using weight measured as the outcome modeled as a function of time, randomization arm, a history of CRT, gender, age, and race together with interaction terms between time and randomization arm.
次要结局
未报告次要终点