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New treatment option for Obesity
Official title Using Tailored mHealth Strategies to Promote Weight Management Among Adolescent and Young Adult Cancer Survivors
ClinicalTrials.gov ID: NCT06848491
What this study is testing
- What it's testing
- 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.
- Time commitment: about 12 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 39
You may be able to join if
- 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...
- Body mass index (BMI) of 25-50 kg/m2
You likely can't join if
- 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...
- 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...
- Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 12 months
See the full eligibility 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...
- Body mass index (BMI) of 25-50 kg/m2
- 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...
- 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...
- 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 assigned by chance to either intervention arm
The study team makes the final eligibility decision.
Where it's taking place
- Chapel Hill, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 39 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chapel Hill, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.