Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:55 AM
Study NCT ID:
NCT07446595
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-05
First Post:
2026-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BfedBwell INSPIRE Pilot
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-03', 'studyFirstSubmitDate': '2026-02-25', 'studyFirstSubmitQcDate': '2026-02-25', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the research protocol recruitment feasibility of the augmented BfedBwell nutrition intervention', 'timeFrame': '24 weeks', 'description': 'Recruitment will be assessed as the number of adults screened and the proportion of eligible screens who enroll'}, {'measure': 'Determine the research protocol adherence feasibility of the augmented BfedBwell nutrition intervention', 'timeFrame': '24 weeks', 'description': 'Adherence will be assessed as \\[# sessions attended/# sessions provided\\]'}, {'measure': 'Determine the research protocol outcome assessment feasibility of the augmented BfedBwell nutrition intervention', 'timeFrame': '24 weeks', 'description': 'Outcome assessment rates will be assessed as \\[# completing assessments/# enrolled\\]'}, {'measure': 'Determine the research protocol retention feasibility of the augmented BfedBwell nutrition intervention', 'timeFrame': '24 weeks', 'description': 'Retention will be assessed as \\[# of participants who complete the 24-week intervention/# of participants enrolled\\]'}, {'measure': 'Determine the intervention acceptability by participants during focus groups', 'timeFrame': '24 weeks', 'description': 'Participants will be asked to participate in a 90-minute focus group to provide qualitative feedback regarding their experience and satisfaction with the intervention.'}, {'measure': 'Determine the intervention acceptability by participants using the Net Promoter Score (NPS)', 'timeFrame': '12 and 24 weeks', 'description': 'Participants will be asked to complete weekly ratings using the Net Promoter Score (NPS). Respondents are grouped as follows: 1) promoters (score 9-10) are loyal enthusiasts who will keep referring others and fueling growth, 2) passives (score 7-8) are satisfied but unenthusiastic customers who are vulnerable to competitive offerings, and 3) detractors (score 0-6) are unhappy customers who can impede growth with negative word-of-mouth. The final NPS score is calculated as % promoters - % detractors. NPS scores range from -100 to +100, with scores \\>/=0 indicating good acceptability.'}], 'secondaryOutcomes': [{'measure': 'Measure changes in self-reported sleep quality', 'timeFrame': 'Baseline and 12 and 24 weeks', 'description': 'Participants will complete the Pittsburgh Sleep Quality Index (PSQI) to evaluate perceived sleep quality. The PSQI contains 19 self-rated questions assessing several factors relating to sleep quality, and the resulting global score ranges from 0-21 points. Higher scores indicate worse sleep quality.'}, {'measure': 'Measure changes in perceived stress', 'timeFrame': 'Baseline and 12 and 24 weeks', 'description': 'Participants will complete the Perceived Stress Scale (PSS) to assess self-reported psychological stress. The PSS contains 10 questions assessing perceived stress, and the resulting total score ranges from 0-40 points. Higher scores indicate greater perceived stress.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adult Cancer Survivor', 'Lifestyle Behavior', 'Diet, food, and nutrition', 'Exercise', 'Sleep', 'Stress'], 'conditions': ['Cancer Survivorship', 'Overweight , Obesity']}, 'descriptionModule': {'briefSummary': 'This single-arm pilot study will evaluate the feasibility and acceptability of a comprehensive survivorship lifestyle intervention addressing nutrition, exercise, sleep health, and stress management. The intervention integrates the BfedBwell survivorship nutrition program with the BfitBwell clinical exercise oncology program. The augmented BfedBwell program includes: (1) a core education curriculum, (2) 1:1 counseling with a registered dietitian, (3) behavioral skills development, (4) group support, and (5) commercially available wearable technology and smart scales for self-monitoring of physical activity, sleep, and body weight.', 'detailedDescription': 'Cancer survivors with overweight/obesity who have completed active treatment will be recruited from the University of Colorado Anschutz Medical Campus for participation in a 6-month single-arm study of the augmented BfedBwell + BfitBwell interventions. Feasibility and acceptability of integrating commercially-available wearable technology and smart scales will be evaluated. The study will also explore preliminary changes in sleep quality, perceived stress, and physiological indicators of stress and immune function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-75 years\n* BMI 25-45 kg/m2\n* History of cancer within the past 10 years with a diagnosis of an adulthood cancer of any type\n* In maintenance or surveillance status, defined as completion of active cancer therapy (e.g., surgery, radiation, chemotherapy, immunotherapy) with curative intent at least 3 months and no more than 10 years prior to enrollment or active surveillance with no treatment; ongoing targeted or hormone therapies ≥3 months prior to intervention start date and/or ongoing maintenance therapy ≥1 year is permitted (exceptions to this timeframe for completion of other therapies can be made on a case-by-case basis by the PI if patients are tolerating therapy without adverse effects and will have completed active treatment or been in stable maintenance treatment prior to the intervention start date)\n* Have a primary care provider (or are willing to establish care with a primary care provider prior to study enrollment) to address medical issues which may arise during screening or study procedures/interventions and who will provide clearance to participate in a nutrition and exercise program\n* Ability and willingness to participate in a supervised exercise program; with ability assessed by the Physical Activity Readiness Questionnaire (PAR-Q+) and questions based upon National Comprehensive Cancer Network (NCCN) guidelines (note: any positive responses will trigger a required physician clearance form)\n* Speak English\n* Have access to a computer or smart phone and Internet to join Zoom meetings, complete questionnaires, and access/download the True Coach virtual exercise coaching sessions\n* Live or work within 30 miles of the AHWC (exceptions may be made at the discretion of the study PI on a case-by-case basis for highly motivated subjects)\n* Not be planning for major elective surgery, to travel for \\>2 consecutive weeks, or relocate/move during the intervention (\\~6 months)\n* No nicotine or tobacco use within previous 6 months\n* Agree to refrain from use of all nutritional supplements aside from those prescribed by a physician for the duration of the study\n* Capable and willing to give informed consent and understand exclusion criteria\n* Willing to attend weekly small group education sessions, monthly behavioral skills development sessions, weekly group support sessions, and monthly 1:1 counseling sessions with a registered dietitian (RD)\n* Willing to attend up to two BfitBwell exercise sessions (one in person supervised, one virtual unsupervised) per week for first 12 weeks then once monthly supervised and once weekly unsupervised virtual sessions for second 12 weeks\n* Not meeting dietary guidelines \\[i.e., Healthy Eating Index (HEI) score \\<80 as assessed via NCI DHQ III food frequency questionnaire\\] or physical activity guidelines \\[i.e., \\<150 minutes moderate/vigorous activity per week via self-report on Godin-Shephard Leisure-Time Physical Activity Questionnaire\\] (exceptions may be made at the discretion of the study PI on a case-by-case basis for highly motivated subjects)\n\nExclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 2 or higher\n* Actively undergoing chemotherapy, radiation, immunotherapy with curative intent or within 3 months of completion of surgery, chemotherapy, or radiation treatment or recent initiation of targeted/hormonal therapy (\\<3 months) or maintenance therapy (\\<1 year) unless well-tolerated and deemed acceptable by PI on a case-by-case basis\n* Greater than 10 years post-active or maintenance therapy\n* Plans to relocate within the next 6 months\n* Plans for extended travel (\\>2 weeks) within the next 6 months\n* For females: (1) Currently pregnant or lactating, (2) Pregnant within the past 6 months, (3) Planning to become pregnant in the next 18 months; sexually active women of childbearing potential may be enrolled if they have had a tubal ligation or use a reliable means of contraception\n* Any major surgery within the past 3 months or planned elective surgery during the intervention period, including mastectomy\n* Have completed treatment that significantly impacts digestion, metabolism, and/or food intake (e.g., surgical loss of esophagus, stomach, colon)\n* Recent (past 6 months) acute coronary event, unstable angina, coronary revascularization, stroke, or pulmonary embolism\n* Symptoms suggestive of cardiovascular disease (e.g., chest pain, shortness of breath at rest or with mild exertion, lightheadedness, syncope)\n* Uncontrolled hypertension, defined as diastolic blood pressure \\>100 mmHg, systolic blood pressure \\>160 mmHg, or resting heart rate \\>100 bpm as measured in duplicate on the screening visit after 5 minutes of rest in a seated position (if screening is needed due to lack of updated medical record within previous 12 months)\n* Diabetes (history of type 1 or type 2 diabetes, hemoglobin A1c ≥6.5%, or fasting glucose ≥126 mg/dL as measured during the screening visit if screening is needed due to lack of updated medical record within previous 12 months) unless well controlled on metformin or DPP-V inhibitor monotherapy with hemoglobin A1c \\<8%\n* History of uncontrolled thyroid disorder. History of thyroid disease or current thyroid disease treated with a stable medication regimen is acceptable\n* Triglycerides \\>500 mg/dL as measured on the screening visit (if screening is needed due to lack of updated medical record within previous 12 months)\n* LDL cholesterol \\>200 mg/dL as measured on the screening visit (if screening is needed due to lack of updated medical record within previous 12 months)\n* Presence or history of other metabolic or chronic health problems which would impact ability to safely participate in a weight loss intervention involving diet and exercise: significant cardiac arrhythmias or cardiac valvular disease, significant gastrointestinal, pulmonary, renal, musculoskeletal, neurologic, hematologic, or psychiatric disease\n* Have started lipid-lowering, hypertension, or oral hypoglycemic medication in previous 3 months\n* Sustained use of prescription or over-the-counter medications known to significantly impact appetite, weight, or energy metabolism (e.g., obesity pharmacotherapeutics agents, appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic antidepressants) with the exception of anti-endocrine or Her2 directed treatment for breast cancer and standard of care anti-emetic or anti-diarrheal agents.\n* Sustained use of systemic glucocorticoids (current or in the past 6 months) unless physiologic replacement therapy for adrenal insufficiency\n* Previous obesity treatment with surgery or weight loss device, except: (1) liposuction and/or abdominoplasty if performed \\>1 year before screening, (2) lap banding if the band has been removed \\>1 year before screening, (3) intragastric balloon if the balloon has been removed \\>1 year before screening, (4) duodenal-jejunal bypass sleeve if the sleeve has been removed \\>1 year before screening, or (5) AspireAssist or other endoscopically placed weight loss device if the device has been removed \\>1 year before screening\n* Participation within previous 6 months, current participation in, or planning to participate in any formal nutrition, weight loss, or physical activity programs or clinical trials over the next 6 months\n* Previous participation the BfitBwell exercise oncology program within the previous 3 years (exceptions may be made at the discretion of the study PI)\n* Nicotine or tobacco use (current or past 6 months)\n* Current alcohol or substance abuse as assessed by the Cut down, Annoyed, Guilty, and Eye-Opener (CAGE) questionnaire (note: study PI will follow up if screener raises any concerns of substance abuse to determine final eligibility)\n* History of clinically diagnosed eating disorders including anorexia nervosa, bulimia, binge eating disorder. Score \\>20 on the Eating Attitudes Test (EATS-26) or pattern of response on the Questionnaire of Eating and Weight Patterns (QEWP-5) suggestive of possible binge eating disorder or bulimia will require further assessment by the study MD to determine if it is appropriate for the subject to participate in the study\n* Current severe depression or history of severe depression within the previous year, based on Center for Epidemiologic Studies Depression Scale (CES-D) which in the opinion of the study MD would interfere with ability to adhere to the diet and exercise interventions and provide feedback on the interventions via questionnaires and focus groups\n* History of other significant psychiatric illness (e.g., psychosis, schizophrenia, mania, bipolar disorder) which in the opinion of the study MD would interfere with ability to adhere to the diet and exercise interventions and provide feedback on the interventions via questionnaires and focus groups\n* Have medical or physical limitations or contraindications to engaging in physical activity (e.g., severe orthopedic conditions, paralysis) or are considered high-risk based on ACSM guidelines\n* Are cognitively unable to consent'}, 'identificationModule': {'nctId': 'NCT07446595', 'briefTitle': 'BfedBwell INSPIRE Pilot', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'BfedBwell INSPIRE: Impact of an Integrated Nutrition and Exercise Program for Post-treatment Survivors on Sleep Quality, Perceived Stress, and Biomarkers of Immune Dysregulation', 'orgStudyIdInfo': {'id': '26-0077.cc'}, 'secondaryIdInfos': [{'id': 'IRC_FULL_2025_004', 'type': 'OTHER', 'domain': 'American Institute for Cancer Research'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BfedBwell INSPIRE Intervention', 'description': 'Participants will receive a 6-month comprehensive survivorship lifestyle intervention combining nutrition education and counseling with structured exercise programming. The nutrition program includes a core curriculum, 1:1 counseling, behavioral skills, group support, and the use of wearable and remote monitoring devices to support self-monitoring of physical activity, sleep, and body weight.', 'interventionNames': ['Behavioral: BfedBwell - Core Curriculum', 'Behavioral: BfedBwell - 1:1 Counseling', 'Behavioral: BfedBwell - Behavioral Skills', 'Behavioral: BfedBwell - Group Support', 'Behavioral: BfedBwell - Technology', 'Behavioral: BfitBwell - Clinical Exercise Program']}], 'interventions': [{'name': 'BfedBwell - Core Curriculum', 'type': 'BEHAVIORAL', 'description': 'Group-based education sessions based upon guidelines for nutrition and lifestyle behaviors for cancer survivorship', 'armGroupLabels': ['BfedBwell INSPIRE Intervention']}, {'name': 'BfedBwell - 1:1 Counseling', 'type': 'BEHAVIORAL', 'description': 'Individual 1:1 counseling sessions with a registered dietitian to review progress and address barriers', 'armGroupLabels': ['BfedBwell INSPIRE Intervention']}, {'name': 'BfedBwell - Behavioral Skills', 'type': 'BEHAVIORAL', 'description': 'Group-based behavioral skills development sessions and cooking demonstrations to focus on behavior change techniques (e.g., self-monitoring, goal setting) and nutrition skills (e.g., recipe development, label reading)', 'armGroupLabels': ['BfedBwell INSPIRE Intervention']}, {'name': 'BfedBwell - Group Support', 'type': 'BEHAVIORAL', 'description': 'Structured group support sessions to share experiences', 'armGroupLabels': ['BfedBwell INSPIRE Intervention']}, {'name': 'BfedBwell - Technology', 'type': 'BEHAVIORAL', 'description': 'Commercially available devices (fitness trackers, smart scales) for self-monitoring of physical activity, sleep, and body weight', 'armGroupLabels': ['BfedBwell INSPIRE Intervention']}, {'name': 'BfitBwell - Clinical Exercise Program', 'type': 'BEHAVIORAL', 'description': 'Supervised exercise program developed by a cancer exercise specialist and based upon the NCCN guidelines for physical activity during cancer survivorship and other recommendations', 'armGroupLabels': ['BfedBwell INSPIRE Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'contacts': [{'name': 'Emily Hill, PhD, RDN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Colorado Cancer Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'centralContacts': [{'name': 'Melissa Mamele, MS, RD, CSCS', 'role': 'CONTACT', 'email': 'bfedbwell@cuanschutz.edu', 'phone': '303-724-2488'}], 'overallOfficials': [{'name': 'Emily Hill, PhD, RDN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Institute for Cancer Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}