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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 39 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 months
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

The AYA WELL study tests a 12-month weight management program using mobile tools against a self-guided program with digital tools, health lessons, and peer support. It is for cancer survivors ages 18–39 who have overweight or obesity and finished active cancer treatment at least 6 months ago. A chance process assigns each person to a group.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18–39 years old when you agree to join.
  • Your first invasive cancer—a cancer that grows into nearby tissue—was diagnosed at ages 15–39.
  • You were diagnosed within the past 10 years, with no signs of cancer getting worse or a new, separate cancer.
  • You finished active cancer treatment at least 6 months ago. You may still take treatment to help keep cancer from coming back.
  • Your body mass index (BMI), a measure based on height and weight, is 25–50.

Who can't join

  • You have type 1 diabetes, take certain treatments for type 2 diabetes, or have untreated thyroid disease. Changes to thyroid medicine in the past 6 months also exclude you.
  • You had a heart attack or stroke in the past 6 months, cannot walk for exercise, or report certain heart problems, frequent chest pain, faintness, or dizziness on the activity safety form.
  • You lost at least 5% of your weight and kept it off in the past 3 months, or were ever diagnosed or treated for anorexia or bulimia (eating disorders). Recent actions to make up for eating may also exclude you; the study team reviews this history.
  • You are pregnant, were pregnant in the past 6 months, or plan pregnancy in the next year. Past weight loss surgery, planned weight loss surgery, or other planned major surgery in the next year also exclude you.
  • You were hospitalized for a mental health condition in the past year, have a history of a psychotic disorder that affects your sense of reality, or have uncontrolled bipolar disorder, which causes major mood changes.
  • You use prescription drugs known to affect hunger or weight. SSRI antidepressants are allowed if your dose has stayed the same for 3 months.
  • You are in another weight loss, nutrition, or exercise study or program, or another study that would interfere. You must also agree to have your study group chosen by chance.
  • You cannot speak and read English, live outside the United States, lack internet access or a mobile phone with a data plan, or will not accept study text messages.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Plans for major surgery (e.g., breast reconstruction) in the next 12 months * 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

Study sites (1)

NC