[96a5a0]: / output / allTrials / identified / NCT06848491_identified.json

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{
"info": {
"nct_id": "NCT06848491",
"official_title": "Using Tailored mHealth Strategies to Promote Weight Management Among Adolescent and Young Adult Cancer Survivors (AYA Well)",
"inclusion_criteria": "* 18-39 years old at the time of consent.\n* Diagnosed with first invasive cancer between ages 15-39 years (self-report).\n* Within 10 years of diagnosis with no evidence of progressive disease or second primary cancers (self-report).\n* 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).\n* Body mass index (BMI) of 25-50 kg/m2\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 39 Years",
"exclusion_criteria": "* Type 1 diabetes or currently receiving certain medical treatments for Type 2 diabetes\n* Report a history of heart attack or stroke within previous 6 months\n* 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.\n* Lost 5% or more of body weight (and kept it off) in the last 3 months\n* 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\n* Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 12 months\n* Untreated thyroid disease or any changes (type or dose) in thyroid medication in last 6 months\n* Hospitalization for depression or other psychiatric disorder within the past 12 months.\n* History of psychotic disorder or uncontrolled bipolar disorder\n* Currently participating in a weight loss, nutrition, or physical activity study or program or other study that would interfere with this study\n* 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)\n* Previous surgical procedure for weight loss or planned weight loss surgery in the next year\n* Inability to speak and read English\n* Does not reside in the United States\n* Do not have mobile phone with data plan or willing to be contacted by study through text messaging\n* No Internet access\n* Not willing to be randomized to either intervention arm",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* 18-39 years old at the time of consent.",
"criterions": [
{
"exact_snippets": "18-39 years old",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 39,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "* Diagnosed with first invasive cancer between ages 15-39 years (self-report).",
"criterions": [
{
"exact_snippets": "Diagnosed with first invasive cancer",
"criterion": "first invasive cancer diagnosis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "between ages 15-39 years",
"criterion": "age at diagnosis",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 15,
"unit": "years"
},
{
"operator": "<=",
"value": 39,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "* Within 10 years of diagnosis with no evidence of progressive disease or second primary cancers (self-report).",
"criterions": [
{
"exact_snippets": "Within 10 years of diagnosis",
"criterion": "time since diagnosis",
"requirements": [
{
"requirement_type": "time",
"expected_value": {
"operator": "<=",
"value": 10,
"unit": "years"
}
}
]
},
{
"exact_snippets": "no evidence of progressive disease",
"criterion": "progressive disease",
"requirements": [
{
"requirement_type": "evidence",
"expected_value": false
}
]
},
{
"exact_snippets": "no evidence of ... second primary cancers",
"criterion": "second primary cancers",
"requirements": [
{
"requirement_type": "evidence",
"expected_value": false
}
]
}
]
},
{
"line": "* 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).",
"criterions": [
{
"exact_snippets": "Completed active cancer directed therapy (cytotoxic chemotherapy, radiation therapy and/or definitive surgical intervention) at least six months prior to enrollment",
"criterion": "completion of active cancer directed therapy",
"requirements": [
{
"requirement_type": "time since completion",
"expected_value": {
"operator": ">=",
"value": 6,
"unit": "months"
}
}
]
},
{
"exact_snippets": "may be receiving \"maintenance\" therapy to prevent recurrences (self-report)",
"criterion": "maintenance therapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Body mass index (BMI) of 25-50 kg/m2",
"criterions": [
{
"exact_snippets": "Body mass index (BMI) of 25-50 kg/m2",
"criterion": "body mass index (BMI)",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 25,
"unit": "kg/m2"
},
{
"operator": "<=",
"value": 50,
"unit": "kg/m2"
}
]
}
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
},
{
"line": "Must have maximum age of 39 Years",
"criterions": [
{
"exact_snippets": "maximum age of 39 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 39,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Type 1 diabetes or currently receiving certain medical treatments for Type 2 diabetes",
"criterions": [
{
"exact_snippets": "Type 1 diabetes",
"criterion": "Type 1 diabetes",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "currently receiving certain medical treatments for Type 2 diabetes",
"criterion": "Type 2 diabetes treatments",
"requirements": [
{
"requirement_type": "current treatment",
"expected_value": true
}
]
}
]
},
{
"line": "* Report a history of heart attack or stroke within previous 6 months",
"criterions": [
{
"exact_snippets": "history of heart attack",
"criterion": "heart attack",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
},
{
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
]
},
{
"exact_snippets": "history of ... stroke",
"criterion": "stroke",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
},
{
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
]
}
]
},
{
"line": "* 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.",
"criterions": [
{
"exact_snippets": "Health problems which preclude ability to walk for physical activity",
"criterion": "ability to walk for physical activity",
"requirements": [
{
"requirement_type": "health problems",
"expected_value": false
}
]
},
{
"exact_snippets": "lower limb amputation",
"criterion": "lower limb amputation",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "Participants endorsing items 1-4 on the Physical Activity Readiness Questionnaire (PAR-Q)",
"criterion": "endorsement of items 1-4 on the PAR-Q",
"requirements": [
{
"requirement_type": "endorsement",
"expected_value": false
}
]
},
{
"exact_snippets": "experience of heart problems",
"criterion": "heart problems",
"requirements": [
{
"requirement_type": "experience",
"expected_value": false
}
]
},
{
"exact_snippets": "frequent chest pains",
"criterion": "chest pains",
"requirements": [
{
"requirement_type": "frequency",
"expected_value": false
}
]
},
{
"exact_snippets": "faintness or dizziness",
"criterion": "faintness or dizziness",
"requirements": [
{
"requirement_type": "experience",
"expected_value": false
}
]
}
]
},
{
"line": "* Lost 5% or more of body weight (and kept it off) in the last 3 months",
"criterions": [
{
"exact_snippets": "Lost 5% or more of body weight ... in the last 3 months",
"criterion": "body weight loss",
"requirements": [
{
"requirement_type": "percentage",
"expected_value": {
"operator": ">=",
"value": 5,
"unit": "%"
}
},
{
"requirement_type": "duration",
"expected_value": "3 months"
}
]
},
{
"exact_snippets": "(and kept it off)",
"criterion": "maintained weight loss",
"requirements": [
{
"requirement_type": "duration",
"expected_value": "3 months"
}
]
}
]
},
{
"line": "* 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",
"criterions": [
{
"exact_snippets": "Lifetime history of clinical diagnosis or treatment of eating disorder (anorexia nervosa or bulimia nervosa)",
"criterion": "eating disorder",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "report of compensatory behaviors within the previous 3 months",
"criterion": "compensatory behaviors",
"requirements": [
{
"requirement_type": "time frame",
"expected_value": "within the previous 3 months"
}
]
}
]
},
{
"line": "* Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 12 months",
"criterions": [
{
"exact_snippets": "Currently pregnant",
"criterion": "pregnancy status",
"requirements": [
{
"requirement_type": "current status",
"expected_value": "pregnant"
}
]
},
{
"exact_snippets": "pregnant within the past 6 months",
"criterion": "pregnancy history",
"requirements": [
{
"requirement_type": "timeframe",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
]
},
{
"exact_snippets": "planning to become pregnant within the next 12 months",
"criterion": "pregnancy intention",
"requirements": [
{
"requirement_type": "timeframe",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 12,
"unit": "months"
}
]
}
}
]
}
]
},
{
"line": "* Untreated thyroid disease or any changes (type or dose) in thyroid medication in last 6 months",
"criterions": [
{
"exact_snippets": "Untreated thyroid disease",
"criterion": "thyroid disease",
"requirements": [
{
"requirement_type": "treatment status",
"expected_value": false
}
]
},
{
"exact_snippets": "any changes (type or dose) in thyroid medication in last 6 months",
"criterion": "thyroid medication",
"requirements": [
{
"requirement_type": "change",
"expected_value": false
},
{
"requirement_type": "time frame",
"expected_value": "last 6 months"
}
]
}
]
},
{
"line": "* Hospitalization for depression or other psychiatric disorder within the past 12 months.",
"criterions": [
{
"exact_snippets": "Hospitalization for depression",
"criterion": "hospitalization for depression",
"requirements": [
{
"requirement_type": "time frame",
"expected_value": "within the past 12 months"
}
]
},
{
"exact_snippets": "Hospitalization for ... other psychiatric disorder",
"criterion": "hospitalization for other psychiatric disorder",
"requirements": [
{
"requirement_type": "time frame",
"expected_value": "within the past 12 months"
}
]
}
]
},
{
"line": "* History of psychotic disorder or uncontrolled bipolar disorder",
"criterions": [
{
"exact_snippets": "History of psychotic disorder",
"criterion": "psychotic disorder",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "uncontrolled bipolar disorder",
"criterion": "bipolar disorder",
"requirements": [
{
"requirement_type": "control",
"expected_value": false
}
]
}
]
},
{
"line": "* Currently participating in a weight loss, nutrition, or physical activity study or program or other study that would interfere with this study",
"criterions": [
{
"exact_snippets": "Currently participating in a weight loss ... study or program",
"criterion": "participation in weight loss study or program",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Currently participating in a ... nutrition ... study or program",
"criterion": "participation in nutrition study or program",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Currently participating in a ... physical activity study or program",
"criterion": "participation in physical activity study or program",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Currently participating in a ... other study that would interfere with this study",
"criterion": "participation in other interfering study",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* 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)",
"criterions": [
{
"exact_snippets": "Currently using prescription medications with known effects on appetite or weight (e.g., oral steroids, weight loss medications)",
"criterion": "use of prescription medications affecting appetite or weight",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "with the exception of individuals on a stable dose of SSRIs for 3 months",
"criterion": "stable dose of SSRIs",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
]
}
]
},
{
"line": "* Previous surgical procedure for weight loss or planned weight loss surgery in the next year",
"criterions": [
{
"exact_snippets": "Previous surgical procedure for weight loss",
"criterion": "previous weight loss surgery",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "planned weight loss surgery in the next year",
"criterion": "planned weight loss surgery",
"requirements": [
{
"requirement_type": "time frame",
"expected_value": "in the next year"
}
]
}
]
},
{
"line": "* Inability to speak and read English",
"criterions": [
{
"exact_snippets": "Inability to speak ... English",
"criterion": "ability to speak English",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "Inability to ... read English",
"criterion": "ability to read English",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Does not reside in the United States",
"criterions": [
{
"exact_snippets": "Does not reside in the United States",
"criterion": "residence",
"requirements": [
{
"requirement_type": "location",
"expected_value": "not in the United States"
}
]
}
]
},
{
"line": "* Do not have mobile phone with data plan or willing to be contacted by study through text messaging",
"criterions": [
{
"exact_snippets": "Do not have mobile phone with data plan",
"criterion": "mobile phone with data plan",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "willing to be contacted by study through text messaging",
"criterion": "willingness to be contacted by text messaging",
"requirements": [
{
"requirement_type": "willingness",
"expected_value": true
}
]
}
]
},
{
"line": "* No Internet access",
"criterions": [
{
"exact_snippets": "No Internet access",
"criterion": "Internet access",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Not willing to be randomized to either intervention arm",
"criterions": [
{
"exact_snippets": "Not willing to be randomized to either intervention arm",
"criterion": "willingness to be randomized",
"requirements": [
{
"requirement_type": "willingness",
"expected_value": false
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}