Sleep Disorders Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged between 18 and 75 years old
• People with a body mass index (a measure of body weight relative to height) between 25 and 45
• People who have been diagnosed with any type of adult cancer within the past 10 years
• People who have finished active cancer treatment (such as surgery, radiation, or chemotherapy) with the goal of curing the cancer, at least 3 months ago but no more than 10 years ago — or people currently on active surveillance with no treatment; ongoing targeted or hormone therapies for at least 3 months, or maintenance therapy for at least 1 year, may also be acceptable (confirm with trial site for individual circumstances)
• People who already have a regular doctor (or are willing to find one before joining the study) who can address any health issues that come up and give approval to take part in a nutrition and exercise program
• People who are able and willing to take part in a supervised exercise program, as assessed by standard readiness questionnaires
• People who speak English
• People who have access to a computer or smartphone and internet to join video meetings, complete surveys, and access virtual exercise sessions
• People who live or work within 30 miles of the study centre (exceptions may be considered by the study lead on a case-by-case basis)
• People who are not planning major elective surgery, travel of more than 2 consecutive weeks, or moving home during the approximately 6-month program
• People who have not used nicotine or tobacco products in the past 6 months
• People who are willing to avoid all nutritional supplements not prescribed by a doctor for the duration of the study
• People who are willing and able to give informed consent and understand the study rules
• People who are willing to attend weekly group education sessions, monthly skills sessions, weekly group support sessions, and monthly one-on-one sessions with a registered dietitian
• People who are willing to attend up to two exercise sessions per week for the first 12 weeks (one in-person, one virtual), then one supervised session per month and one virtual session per week for the following 12 weeks
• People whose current diet or physical activity levels do not yet meet recommended healthy guidelines, as measured by standard questionnaires (exceptions may be considered by the study lead on a case-by-case basis)

Who may not be able to join:

• People with a significant decline in their ability to carry out daily activities due to their health condition, as measured by a standard cancer performance scale (confirm with trial site)
• People who are currently receiving chemotherapy, radiation, or immunotherapy aimed at curing their cancer, or who finished surgery, chemotherapy, or radiation less than 3 months ago, or who recently started targeted or hormonal therapy (unless well-tolerated and approved by the study lead)
• People who completed active or maintenance cancer treatment more than 10 years ago
• People who plan to move home within the next 6 months
• People who plan to travel for more than 2 consecutive weeks within the next 6 months
• Women who are currently pregnant or breastfeeding, were pregnant in the past 6 months, or are planning to become pregnant in the next 18 months; women of childbearing potential who are sexually active may be considered if they have had a tubal ligation or use a reliable form of contraception
• People who have had major surgery within the past 3 months or have planned elective surgery during the study period, including breast removal surgery
• People who have had treatment that significantly affects digestion or how the body processes food (for example, surgical removal of the oesophagus, stomach, or colon)
• People who have had a serious heart event (such as a heart attack, unstable chest pain, a procedure to open blocked heart arteries, stroke, or blood clot in the lungs) in the past 6 months
• People who have symptoms that may suggest heart or circulation problems, such as chest pain, shortness of breath at rest or with light activity, dizziness, or fainting
• People with uncontrolled high blood pressure or a resting heart rate above 100 beats per minute, as measured at the screening visit
• People with diabetes that is not well controlled, or whose blood sugar levels are above a certain threshold on testing — unless the diabetes is well managed with specific medications and blood sugar is within an acceptable range (confirm with trial site)
• People with an uncontrolled thyroid condition (a treated and stable thyroid condition is acceptable)
• People with very high triglyceride (a type of fat in the blood) levels above 500 mg/dL, as measured at screening
• People with very high LDL cholesterol (sometimes called "bad" cholesterol) levels above 200 mg/dL, as measured at screening
• People with other significant ongoing health conditions that could make it unsafe to take part in a diet and exercise program, such as serious heart rhythm problems, heart valve disease, significant digestive, lung, kidney, muscle or joint, neurological, blood, or psychiatric conditions
• People who have started new cholesterol-lowering, blood pressure, or blood sugar medications within the past 3 months
• People who are regularly taking prescription or over-the-counter medications known to significantly affect appetite, weight, or energy — such as weight loss drugs, appetite suppressants, lithium, stimulants, antipsychotics, or certain antidepressants (some exceptions apply — confirm with trial site)
• People who are currently using, or have used in the past 6 months, steroid medications taken throughout the body (such as prednisone), unless taken as a low-dose replacement for a specific hormonal condition
• People who have previously had weight loss surgery or a weight loss device implanted, with certain exceptions if the procedure or device removal was more than 1 year before screening (confirm with trial site for specific situations)
• People who have participated in a formal nutrition, weight loss, or physical activity program or clinical trial in the past 6 months, are currently participating in one, or plan to do so in the next 6 months
• People who have previously taken part in the BfitBwell exercise oncology program within the past 3 years (exceptions may be considered by the study lead)
• People who currently use or have used nicotine or tobacco products in the past 6 months
• People with current alcohol or substance misuse concerns, as assessed by a standard screening questionnaire
• People with a history of a clinically diagnosed eating disorder, or whose responses to eating-related questionnaires suggest a possible eating disorder — further assessment by the study doctor would be needed to determine suitability
• People with current severe depression or a history of severe depression within the past year that, in the opinion of the study doctor, would interfere with their ability to follow the program
• People with a history of other significant psychiatric conditions (such as psychosis, schizophrenia, or bipolar disorder) that, in the opinion of the study doctor, would interfere with their ability to follow the program
• People with physical limitations or medical reasons that prevent safe participation in physical activity, or who are considered high-risk based on standard exercise safety guidelines
• People who are not able to give informed consent due to cognitive difficulties

Important: Always verify eligibility with the trial site directly before applying.