Using Tailored mHealth Strategies to Promote Weight Management Among Adolescent and Young Adult Cancer Survivors

Официальное название

Using Tailored mHealth Strategies to Promote Weight Management Among Adolescent and Young Adult Cancer Survivors (AYA Well)

Обзор

The AYA WELL study is a 2-arm randomized clinical trial to test the efficacy of a theory-based, mHealth weight management intervention adapted specifically for adolescent and young adult cancer survivors compared to a self-guided arm. Participants, diagnosed with cancer between ages 15-39, currently age 18-39, post-treatment at least 6 months, and who have overweight or obesity will be randomized to receive either: 1) a comprehensive mHealth weight management program (intervention) or 2) digital tools + health education + peer support (self-guided) over 12 months. Outcomes will be assessed at 3, 6, and 12 months.

Подробное описание

AYA WELL is a multi-site randomized clinical trial to test the efficacy of a 6-month theory-based, mHealth weight management intervention designed specifically for adolescent and young adult (AYA) cancer survivors, compared to a self-guided arm. The intervention is grounded in self-determination theory and designed to promote intrinsic motivation for behavior change by enhancing perceived competence, relatedness, and autonomy. The mHealth intervention includes personalized nutrition and physical activity goals, psychoeducation, evidence-based behavioral skills training, digital tools to facilitate self-monitoring (smart scale and activity tracker), tailored feedback, text messages, and access to a closed social networking group to foster peer support. The self-guided arm will receive digital tools, education, and a social networking group for peer support. The 6-month intervention will be followed by a 6-month maintenance phase (peer support only). AYA survivors (N=240, diagnosed between ages 15-39 \[current age 18-39\], posttreatment \>6 months, body mass index \[BMI\] 25-50 kg/m2) will be randomized to: 1) mHealth intervention or 2) self-guided (digital tools + education + peer support only). Randomization will be stratified by BMI, sex assigned at birth, and race/ethnicity. Assessments will occur at 0 (baseline), 3 (intervention mid-point), 6 (post-intervention), and 12 months (follow-up). Percent weight change at 6 months (primary outcome) will be assessed using a remote data collection protocol via fasted video weigh-in via smart scale to facilitate enhanced reach across the US. Secondary outcomes include frailty (frailty index), objectively measured physical activity (Fitbit), dietary intake (ASA24), and quality of life (SF-36), as well as validated surveys assessing hypothesized psychosocial mediators targeted by the intervention. A subsample of participants will complete in-person visits at each clinical site (UNC and VCU) at 0, 6, and 12 months to assess changes in body composition, waist circumference, frailty, and biomarkers of aging and cardiometabolic disease. Specific aims are:

AIM 1: To test the efficacy of a theory-based, mHealth weight management intervention compared with a self-guided control arm on percent weight change among AYA cancer survivors.

AIM 2: To determine the efficacy of the intervention compared to self-guided control on secondary outcomes.

AIM 3: To examine whether changes in putative theoretical mechanisms (competence, relatedness, autonomy) mediate the effects of the intervention on weight change.

Вмешательства

• Поведенческое AYA WELL Intervention
  Behavioral weight management intervention for adolescent and young adult cancer survivors with digital tools, smartphone web app behavioral program, text messages, and expert-guided closed social networking group for peer support.
• Поведенческое Self-Guided
  Self-guided intervention with digital tools, periodic informational support, and moderated social networking group for peer support.

Первичные конечные точки

• Weight change percent [Срок оценки: Baseline to 6 months]

Вторичные конечные точки (12)

• Weight maintenance percent [Срок оценки: 6 to 12 months]
• Body Mass Index (BMI) [Срок оценки: Baseline up to 12 months]
• Health-related quality of life [Срок оценки: Baseline up to 12 months]
• Diet quality [Срок оценки: Baseline up to 12 months]
• Device-measured physical activity [Срок оценки: Baseline up to 12 months]
• Self-reported physical activity [Срок оценки: Baseline up to 12 months]
• Frailty Index [Срок оценки: Baseline up to 12 months]
• Frailty Phenotype [Срок оценки: Baseline up to 12 months]
• p16 Expression [Срок оценки: Baseline up to 12 months]
• Biomarkers of cardiovascular disease [Срок оценки: Baseline up to 12 months]
• Blood pressure [Срок оценки: Baseline up to 12 months]
• Waist circumference [Срок оценки: Baseline up to 12 months]

Критерии участия

Критерии включения

• 18-39 years old at the time of consent.
• Diagnosed with first invasive cancer between ages 15-39 years (self-report).
• Within 10 years of diagnosis with no evidence of progressive disease or second primary cancers (self-report).
• Completed active cancer directed therapy (cytotoxic chemotherapy, radiation therapy and/or definitive surgical intervention) at least six months prior to enrollment; may be receiving "maintenance" therapy to prevent recurrences (self-report).
• Body mass index (BMI) of 25-50 kg/m2

Критерии исключения

• Type 1 diabetes or currently receiving certain medical treatments for Type 2 diabetes
• Report a history of heart attack or stroke within previous 6 months
• Health problems which preclude ability to walk for physical activity (e.g., lower limb amputation). Participants endorsing items 1-4 on the Physical Activity Readiness Questionnaire (PAR-Q) (experience of heart problems, frequent chest pains, or faintness or dizziness) will be excluded from the study.
• Lost 5% or more of body weight (and kept it off) in the last 3 months
• Lifetime history of clinical diagnosis or treatment of eating disorder (anorexia nervosa or bulimia nervosa), OR report of compensatory behaviors within the previous 3 months. If participant reports a history of compensatory behaviors, the investigators will review their information to determine eligibility.
• Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 12 months
• Untreated thyroid disease or any changes (type or dose) in thyroid medication in last 6 months
• Hospitalization for depression or other psychiatric disorder within the past 12 months.
• History of psychotic disorder or uncontrolled 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 (e.g., oral steroids, weight loss medications), with the exception of individuals on a stable dose of SSRIs for 3 months)
• Previous surgical procedure for weight loss or planned weight loss surgery in the next year
• Inability to speak and read English
• Does not reside in the United States
• Do not have mobile phone with data plan or willing to be contacted by study through text messaging
• No Internet access
• Not willing to be randomized to either intervention arm

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of North Carolina at Chapel Hill — Chapel Hill

Идентификаторы

NCT: NCT06848491 · LCCC2318 · 5R01CA270111

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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