BfedBwell: Multiphase Optimization Strategy Pilot Trial of a Nutrition Intervention for Cancer Survivors With Overweight and Obesity

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

‣ For program delivery staff:

• Men and women

• Age ≥ 18 years

• Speak English

• Self-reported previous experience in the delivery of nutrition, exercise, or behavioral weight management programs

‣ For intervention participants:

• Men and women

• Age 18-75 years

• BMI 25-45 kg/m2

• History of cancer within the past 10 years with a diagnosis of an adulthood cancer of any type

• 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)

• 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

• 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)

• Speak English

• 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

⁃ 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)

⁃ Not be planning for major elective surgery, to travel for \>2 consecutive weeks, or relocate/move during the intervention (\

‣ 6 months)

⁃ No nicotine or tobacco use within previous 6 months

⁃ Agree to refrain from use of all nutritional supplements aside from those prescribed by a physician for the duration of the study

⁃ Capable and willing to give informed consent and understand exclusion criteria

⁃ Willing to attend weekly small group education sessions and some, none, or all of the following: monthly behavioral skills development sessions, weekly group support sessions and/or monthly 1:1 counseling held by a registered dietitian (RD)

⁃ Willing to attend up to two BfitBwell exercise sessions (one in person, one virtual) per week for first 12 weeks then once monthly in person and once weekly virtual sessions for second 12 weeks

⁃ 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 \[i.e., \<150 minutes moderate/vigorous activity per week via self-report on Godin-Shephard Leisure-Time Physical Activity Questionnaire\]

Locations
United States
Colorado
University of Colorado Cancer Center
RECRUITING
Aurora
Contact Information
Primary
Claudia Schaefer
bfedbwell@cuanschutz.edu
3037248489
Time Frame
Start Date: 2025-02-05
Estimated Completion Date: 2028-02
Participants
Target number of participants: 74
Treatments
Experimental: Core Curriculum
Participants will receive core curriculum
Experimental: Core Curriculum and Group Support
Participants will receive core curriculum and group support
Experimental: Core Curriculum and Behavioral Skills
Participants will receive core curriculum and behavioral skills
Experimental: Core Curriculum, Behavioral Skills, and Group Support
Participants will receive core curriculum, behavioral skills, and group support
Experimental: Core Curriculum and 1:1 Counseling
Participants will receive core curriculum and 1:1 counseling
Experimental: Core Curriculum,1:1 Counseling, and Group Support
Participants will receive core curriculum, 1:1 counseling, and group support
Experimental: Core Curriculum, 1:1 Counseling, and Behavioral Skills
Participants will receive core curriculum, 1:1 counseling, and behavioral skills
Experimental: Core Curriculum, 1:1 Counseling, Behavioral Skills, and Group Support
Participants will receive core curriculum, 1:1 counseling, behavioral skills, and group support
Experimental: Program Provider
Providers will deliver and evaluate one or more components of the diet or exercise interventions
Related Therapeutic Areas
Sponsors
Collaborators: National Cancer Institute (NCI)
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov

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