Pilot Tests to Optimize the Delivery of Energy Balance Interventions
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 337
- 试验地点
- 1
- 主要终点
- Change in waist circumference (Pilot II)
研究概览
简要总结
This pilot clinical trial studies different types of energy balance interventions to see how well they work in increasing the physical activity levels of breast cancer gene-positive patients, Lynch syndrome-positive patients, chronic lymphocytic leukemia (CLL) survivors or family members of cancer survivors who are at high risk for cancer. Increasing exercise and eating healthy foods may help reduce the risk of cancer. Studying how well different types of interventions work in motivating cancer survivors or high-risk family members to increase exercise and healthy food choices may help doctors plan the most effective motivational program for cancer prevention.
详细描述
PRIMARY OBJECTIVES:
I. To explore the feasibility of using the multi-phase optimization strategy (MOST) approach to optimize energy balance (EB) interventions in a sample of MD Anderson employees. (Pilot I) II. To explore the feasibility of using the MOST approach to optimize energy balance interventions in a sample of BRCA (BReast CAncer)-positive and Lynch syndrome positive individuals and their family members. (Pilot II) III. To explore the feasibility of using the MOST approach to optimize energy balance interventions in a sample of CLL (chronic lymphocytic leukemia) patients. (Pilot III)
SECONDARY OBJECTIVES:
I. To develop preliminary estimates of effect size and outcome variability for use in planning future studies. (Pilot I) II. To develop preliminary estimates of effect size and outcome variability for use in planning future studies. (Pilot II) III. To develop preliminary estimates of effect size and outcome variability for use in planning future studies. (Pilot III)
EXPLORATORY OBJECTIVES:
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
- 是
入选标准
- •PILOTS I, II AND III: Body mass index (BMI) of 25 or higher OR < 150 minutes of moderate to vigorous exercise per week OR < 5 servings of fruit and vegetables per day
- •PILOTS I, II AND III: Capable of participating in moderate-vigorous unsupervised exercise
- •PILOTS I, II AND III: Have a cellular telephone and are able and willing to send and receive text messages
- •PILOTS I, II AND III: Able to read and write English
- •PILOTS I, II AND III: Have access to internet
- •PILOT II: BRCA positive OR Lynch syndrome positive individuals
- •PILOT II (FAMILY MEMBER): Female and male biological and non-biological family members of BRCA-positive individuals OR Lynch syndrome positive individuals
- •PILOT III: CLL survivors
- •PILOT III: Has experienced fatigue within the past seven days
排除标准
- •PILOTS I, II AND III: Unable to walk without crutches, walker, cane, or other assistive device
- •PILOTS I, II AND III: Women who are pregnant (by self-report)
- •PILOTS I, II AND III: Less than 3 months post-surgery
- •PILOTS II and III: Currently receiving radiation therapy or cytotoxic chemotherapy
研究组 & 干预措施
Supportive care (energy balance interventions)
TELEPHONE COACHING VS EMAIL COACHING: Participants receive telephone coaching once per week for 16 weeks or 1 email per week for 16 weeks (with follow-up responses if the participant responds) from a coach trained in motivational interviewing.
TEXT MESSAGES: Participants receive daily text messages promoting adherence to diet and exercise recommendations daily 1-3 times per day or no text messages.
SOCIAL NETWORKING: Participants are invited to an online forum for study participants available for 16 weeks or do not receive an invitation for social networking.
SELF-MONITORING: Participants are asked to record their dietary intake 4-7 days per week or 1 day per week on a website or smartphone app.
干预措施: Dietary Intervention (Dietary Supplement)
Supportive care (energy balance interventions)
TELEPHONE COACHING VS EMAIL COACHING: Participants receive telephone coaching once per week for 16 weeks or 1 email per week for 16 weeks (with follow-up responses if the participant responds) from a coach trained in motivational interviewing.
TEXT MESSAGES: Participants receive daily text messages promoting adherence to diet and exercise recommendations daily 1-3 times per day or no text messages.
SOCIAL NETWORKING: Participants are invited to an online forum for study participants available for 16 weeks or do not receive an invitation for social networking.
SELF-MONITORING: Participants are asked to record their dietary intake 4-7 days per week or 1 day per week on a website or smartphone app.
干预措施: Internet-Based Intervention (Other)
Supportive care (energy balance interventions)
TELEPHONE COACHING VS EMAIL COACHING: Participants receive telephone coaching once per week for 16 weeks or 1 email per week for 16 weeks (with follow-up responses if the participant responds) from a coach trained in motivational interviewing.
TEXT MESSAGES: Participants receive daily text messages promoting adherence to diet and exercise recommendations daily 1-3 times per day or no text messages.
SOCIAL NETWORKING: Participants are invited to an online forum for study participants available for 16 weeks or do not receive an invitation for social networking.
SELF-MONITORING: Participants are asked to record their dietary intake 4-7 days per week or 1 day per week on a website or smartphone app.
干预措施: Laboratory Biomarker Analysis (Other)
Supportive care (energy balance interventions)
TELEPHONE COACHING VS EMAIL COACHING: Participants receive telephone coaching once per week for 16 weeks or 1 email per week for 16 weeks (with follow-up responses if the participant responds) from a coach trained in motivational interviewing.
TEXT MESSAGES: Participants receive daily text messages promoting adherence to diet and exercise recommendations daily 1-3 times per day or no text messages.
SOCIAL NETWORKING: Participants are invited to an online forum for study participants available for 16 weeks or do not receive an invitation for social networking.
SELF-MONITORING: Participants are asked to record their dietary intake 4-7 days per week or 1 day per week on a website or smartphone app.
干预措施: Questionnaire Administration (Other)
Supportive care (energy balance interventions)
TELEPHONE COACHING VS EMAIL COACHING: Participants receive telephone coaching once per week for 16 weeks or 1 email per week for 16 weeks (with follow-up responses if the participant responds) from a coach trained in motivational interviewing.
TEXT MESSAGES: Participants receive daily text messages promoting adherence to diet and exercise recommendations daily 1-3 times per day or no text messages.
SOCIAL NETWORKING: Participants are invited to an online forum for study participants available for 16 weeks or do not receive an invitation for social networking.
SELF-MONITORING: Participants are asked to record their dietary intake 4-7 days per week or 1 day per week on a website or smartphone app.
干预措施: Telephone-Based Intervention (Behavioral)
结局指标
主要结局
Change in waist circumference (Pilot II)
时间窗: Baseline to 4 months post-intervention
Expressed as the mean difference.
Change in waist circumference (Pilot I)
时间窗: Baseline to 4 months post-intervention
Expressed as the mean difference.
次要结局
未报告次要终点