A Pilot Randomized Trial of a Mobile Weight Loss Intervention for Adolescent and Young Adult Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Feasibility of interventions as measured by retention rate
研究概览
简要总结
The purpose of this study is to conduct a 6-month pilot randomized trial to determine the feasibility and acceptability of theory-based mobile weight loss interventions for survivors of adolescent and young adult cancer (AYAs). The interventions use a mobile smartphone application, previously developed for individuals at risk for type 2 diabetes and adapted for AYAs, that integrates weight and physical activity from digital devices with simplified dietary monitoring in a behavioral weight loss program.
详细描述
The purpose of this study is to conduct a 6-month pilot randomized trial to determine the feasibility and acceptability of three adapted theory-based, mobile weight loss interventions delivered via a native smartphone application among AYAs: 1) AYA Connect; 2) AYA Connect enhanced with positive psychology strategies (AYA Connect-PP); and 3) AYA Connect enhanced with positive psychology strategies plus coaching (AYA Connect-PP+).
The 3-month interventions are aimed at promoting improvements in diet quality consistent with recommendations for cancer survivors, a decrease in energy intake, an increase in energy expenditure, modest weight loss, and an increase in positive affect. The 3-month interventions will be followed by a 3-month maintenance phase (no contact). Assessments will occur at baseline, 3 (post-intervention), and 6 months (maintenance). Weight will be collected via smart scales mailed to participants. Adherence measures will include daily self-monitoring of weight (smart scale), physical activity (activity tracker), and dietary intake (food log in AYA Connect app).
Young adults (n=60), ages 18-39, diagnosed with invasive malignancy between the ages of 15-39 years, post-cancer treatment, with body mass index (BMI) of 25-50 kg/m2 will be recruited from around the United States to participate in the pilot randomized trial. Participants will be randomized into one of three conditions: 1) AYA Connect intervention; 2) AYA Connect-PP intervention; and 3) AYA Connect-PP+ intervention.
Group 1: AYA Connect Intervention: These participants will receive a smart scale, activity tracker, an individual kickoff video chat session with a health coach, and access to a mobile smartphone app that includes weekly behavioral lessons, dietary tracking log, daily weight-related behavioral goals, tailored feedback summaries, and in-app health-related messages.
Group 2: AYA Connect-PP Intervention: In addition to the intervention components Group 1 will receive, these participants will also receive lessons about positive psychology (PP) strategies, weekly goals for PP exercises, and in-app health-related messages that include reminders to practice PP exercises.
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
- None
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
- •Inclusion Criteria:
- •Currently age 18-39
- •Diagnosed with first invasive cancer between the ages of 15-39 years old
- •Within 10 years of diagnosis with no evidence of progressive disease or second primary cancers
- •Completed active cancer-directed therapy (cytotoxic chemotherapy, radiation therapy, and/or definitive surgical intervention) at least six months prior to enrollment, except maybe receiving "maintenance" therapy to prevent recurrences
- •Body Mass Index (BMI) of 25-50 kg/m2
排除标准
- •Type 1 diabetes or currently receiving medical treatment for Type 2 diabetes
- •Report a history of heart attack or stroke within the previous 6 months
- •Health problems that preclude the ability to walk for physical activity
- •Lost 5% or more of body weight (and kept it off) in the last 3 months
- •Past diagnosis of or receiving treatment for a clinically diagnosed eating disorder (anorexia nervosa or bulimia nervosa) or any compensatory behaviors within the previous 3 months
- •Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months
- •Untreated thyroid disease or any changes (type or dose) in thyroid medication in the last 6 months
- •Hospitalization for depression or other psychiatric disorder within the past 12 months
- •History of psychotic disorder or bipolar disorder
- •Currently participating in a weight loss, nutrition, or physical activity study or program or other study that would interfere with this study
- •Currently using prescription medications with known effects on appetite or weight.
- •Previous surgical procedure for weight loss or planned weight loss surgery in the next 6 months
- •Inability to speak and read English
- •Do not have an iPhone with active data and text messaging plan
- •No Internet access
- •Not willing to be randomized to either intervention arm
研究组 & 干预措施
AYA Connect
Adolescent and young adult cancer survivors receive AYA Connect intervention.
干预措施: AYA Connect intervention (Behavioral)
AYA Connect-PP
Adolescent and young adult cancer survivors receive AYA Connect-PP intervention.
干预措施: Positive Psychology (PP) intervention (Behavioral)
AYA Connect-PP
Adolescent and young adult cancer survivors receive AYA Connect-PP intervention.
干预措施: AYA Connect intervention (Behavioral)
AYA Connect-PP+
Adolescent and young adult cancer survivors receive AYA Connect-PP+ intervention.
干预措施: AYA Connect intervention (Behavioral)
AYA Connect-PP+
Adolescent and young adult cancer survivors receive AYA Connect-PP+ intervention.
干预措施: Positive Psychology (PP) intervention (Behavioral)
AYA Connect-PP+
Adolescent and young adult cancer survivors receive AYA Connect-PP+ intervention.
干预措施: Positive Psychology Plus (PP+) intervention (Behavioral)
结局指标
主要结局
Feasibility of interventions as measured by retention rate
时间窗: At 3 months
Feasibility of interventions as measured by retention rate will be calculated as the number of AYA survivor participants who completed 3-month measures divided by the number who participated.
Feasibility of interventions as measured by accrual rate
时间窗: at 3 months
Feasibility of interventions as measured by accrual rate will be calculated as the number of adolescent and young adult cancer (AYA) survivors who agreed to participate divided by the number of months of recruitment
Feasibility of interventions as measured by participation rate
时间窗: at 3 months
Feasibility of interventions as measured by participation rate will be calculated as the number of participants who agreed to participate divided by the number of eligible AYA survivors.
次要结局
- Change in weight(Up to 6 month)
- Change in Healthy Eating Index score(from the baseline to 3 and 6 month)
- Change in weekly minutes of moderate-to-vigorous activity(From baseline to 3 and 6 months)
- Change in anxiety symptoms(From baseline to 3 and 6 months)
- Retention rate at 6 months(At 6 months)
- Change in energy intake(from the baseline to 3 and 6 month)
- Adherence to self-weighing(Up to 6 month)
- Acceptability of Young Adult Cancers (AYAs) Connect(At 3 and 6 month)
- Adherence to dietary tracking(Up to 6 month)
- Adherence to physical activity monitoring(Up to 6 month)
- Change in fruit and vegetable consumption(from the baseline to 3 and 6 month)
- Change in saturated fat intake(from the baseline to 3 and 6 month)
- Change in perceived stress(From baseline to 3 and 6 months)
- Change in positive and negative affect(From baseline to 3 and 6 months)
- Change in fiber consumption(from the baseline to 3 and 6 month)
- Change in self-reported physical activity(From baseline to 3 and 6 months)
- Change in frailty index(From baseline to 3 and 6 months)
- Change in depressive symptoms(From baseline to 3 and 6 months)
- Change in steps per day(From baseline to 3 and 6 months)
- Change in health-related quality of life(From baseline to 3 and 6 months)