Using the Multiphase Optimization Strategy (MOST) framework, an engineering-based approach to efficiently and systematically develop, optimize, and evaluate behavioral interventions, this study will test three components: (1) 1:1 counseling with a registered dietitian, (2) behavioral skills development, and (3) group support for delivery alongside a core nutrition curriculum within a clinical exercise oncology program.
Individuals with experience in delivery of lifestyle (e.g., diet, physical activity) interventions will be recruited to deliver and evaluate the integrated BfedBwell intervention. 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 cluster-randomized 2\^3-factorial pilot optimization trial of the BfedBwell intervention. Feasibility and acceptability will be evaluated. Exploration of intervention effect on adherence to cancer survivorship guidelines, body composition, and cardiometabolic indicators of health will be used to determine a set of components that demonstrate patterns of efficacy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
74
12-week core nutrition education curriculum + 12-week tapered maintenance curriculum
Individual 1:1 counseling sessions with a registered dietitian
Group-based behavioral skills development sessions
University of Colorado Cancer Center
Aurora, Colorado, United States
RECRUITINGDetermine the research protocol recruitment feasibility of the BfedBwell nutrition intervention
Recruitment will be assessed as the number of adults screened and the proportion of eligible screens who enroll.
Time frame: 24 weeks
Determine the research protocol adherence feasibility of the BfedBwell nutrition intervention
Adherence will be assessed as \[# sessions attended/# sessions provided\] for each BfedBwell component.
Time frame: 24 weeks
Determine the research protocol outcome assessment feasibility of the BfedBwell nutrition intervention
Outcome assessment rates will be assessed as \[# completing assessments/# enrolled\].
Time frame: 24 weeks
Determine the research protocol retention feasibility of the BfedBwell nutrition intervention
Retention will be assessed as \[# of participants who complete the 24-week intervention/# of participants randomized\].
Time frame: 24 weeks
Determine the intervention acceptability by participants during focus groups
Participants will be asked to participate in a 90-minute focus group to provide qualitative feedback regarding their experience and satisfaction with the intervention.
Time frame: 24 weeks
Determine the intervention feasibility by program delivery staff using Feasibility of Intervention Measure (FIM)
Upon completion of the intervention, program delivery staff will be asked to complete the Feasibility of Intervention Measure (FIM). A Likert scale from 1 (completely disagree) to 5 (completely agree) is used for each question; higher scores indicate greater intervention feasibility.
Time frame: 12 and 24 weeks
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Structured group support sessions
Delivery and evaluation of one or more intervention components
Determine the intervention acceptability by program delivery staff using Acceptability of Intervention Measure (AIM)
Upon completion of the intervention, program delivery staff will be asked to complete the Acceptability of Intervention Measure (AIM). A Likert scale from 1 (completely disagree) to 5 (completely agree) is used for each question; higher scores indicate greater intervention acceptability.
Time frame: 12 and 24 weeks
Determine the intervention acceptability by program delivery staff using Intervention Appropriateness Measure (IAM)
Upon completion of the intervention, program delivery staff will be asked to complete the Intervention Appropriateness Measure (IAM). A Likert scale from 1 (completely disagree) to 5 (completely agree) is used for each question; higher scores indicate greater intervention appropriateness.
Time frame: 12 and 24 weeks
Determine the intervention acceptability by participants using the Net Promoter Score (NPS)
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.
Time frame: 12 and 24 weeks
Identify a set of components that demonstrate patterns of efficacy for increased adherence to lifestyle recommendations
Determine the change in adherence to cancer survivorship guidelines as measured by World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) scoring criteria. Scores range from 0 to 7 points. A higher score reflects greater adherence to the recommendations.
Time frame: 12 and 24 weeks
Identify a set of components that demonstrate patterns of efficacy for weight loss
Determine the change in weight as measured by digital scale. A lower weight indicates an improvement.
Time frame: 12 and 24 weeks
Identify a set of components that demonstrate patterns of efficacy for improvement in body composition
Determine the change in body composition as measured by dual x-ray absorptiometry (DXA). A lower body fat percentage indicates an improvement.
Time frame: 12 and 24 weeks
Measure the change in systolic blood pressure to determine improved cardiometabolic health
Systolic blood pressure will be measured at specific time points during the trial. A lower systolic blood pressure indicates an improvement.
Time frame: 12 and 24 weeks
Measure the change in diastolic blood pressure to determine improved cardiometabolic health
Diastolic blood pressure will be measured at specific time points during the trial. A lower diastolic blood pressure indicates an improvement.
Time frame: 12 and 24 weeks
Measure changes in total cholesterol to determine improved cardiometabolic health
Total cholesterol will be measured at specific time points during the trial. A lower total cholesterol indicates an improvement.
Time frame: 12 and 24 weeks
Measure changes in LDL cholesterol to determine improved cardiometabolic health
LDL cholesterol will be measured at specific time points during the trial. A lower LDL cholesterol indicates an improvement.
Time frame: 12 and 24 weeks
Measure changes in HDL cholesterol to determine improved cardiometabolic health
HDL cholesterol will be measured at specific time points during the trial. A higher HDL cholesterol indicates an improvement.
Time frame: 12 and 24 weeks
Measure changes in triglycerides to determine improved cardiometabolic health
Triglycerides will be measured at specific time points during the trial. Lower triglycerides indicate an improvement.
Time frame: 12 and 24 weeks
Measure changes in glucose to determine improved cardiometabolic health
Glucose levels will be measured at specific time points during the trial. Lower glucose levels indicate an improvement.
Time frame: 12 and 24 weeks
Measure changes in insulin to determine improved cardiometabolic health
Insulin levels will be measured at specific time points during the trial. Lower insulin levels indicate an improvement.
Time frame: 12 and 24 weeks
Intervention safety determined by number of adverse events
Overall rates of study-related mild, moderate, severe, and serious adverse events (AEs) will be tracked by study staff.
Time frame: 12 and 24 weeks