Pilot Feasibility Study of a Dyadic Culinary Nutrition Intervention
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity of Arizona
About this trial
This study will determine the feasibility and acceptability of a 12-week dyadic culinary nutrition program among Hispanic prostate cancer survivor/caregiver dyads using a randomized controlled trial design.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
History of prostate cancer diagnosis at any stage (I-IV)
Identifies as Hispanic
Completed primary curative treatment (e.g., chemotherapy, radiation, surgery) 6 weeks prior to enrollment.
Provides unpaid support for the cancer survivor
Disqualifiers
Cognitive difficulties that preclude answering the survey questions, that answering survey questions or participating in study activities, or providing informed consent.
A medical condition, movement or neurological disorder, or medication use that contraindicates participation in meal preparation.
Not co-residing (live in the separate households).
No survivor or caregiver available or willing to participate simultaneously.
Trial design
Design model
Parallel
Treatments tested in this trial
Cooking Healthy - Engaging Families (CHEF)
BehavioralThe intervention is a remote dyadic culinary nutrition program that occurs over 12-weeks with 24 total hours of intervention. The intervention includes nutrition education, cooking classes, and health coaching. All sessions are available in English and Spanish and will be held virtually through video-conferencing software and a restricted access website.
Control
BehavioralParticipants will receive written nutrition education developed for cancer survivors aligned with dietary recommendations.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: Education ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility measured by enrollment rate
Will be determined as the enrollment rate- the number of dyads enrolled out of those approached and eligible using descriptive statistics.
Time frame
Up to 12 weeks2
Appropriateness measured by retention rate
Will be determined as the retention rate- calculated as the number of dyads (survivor-caregiver pairs) completing the study versus dyads consented using descriptive statistics.
Time frame
Up to 24 weeks3
Acceptability measured by adherence rate
Acceptability will be measured by adherence rate to the intervention calculated as the total number of classes attended divided by the total possible schedule the patient could attend using descriptive statistics.
Time frame
Up to 12 weeks4
Composite measure of implementation success
Implementation success will be measured by a single composite questionnaire that will determine the extent to which the intervention is considered feasible, appropriate, and acceptable. Responses are summary scored with a possible range of 4-20; higher scores indicate greater feasibility, appropriateness, and acceptability.
Time frame
12 weeksSecondary outcomes
1
Fruit and Vegetable Servings
24-hour dietary recalls by blinded trained assessors on one weekday and one weekend day via telephone. Output is used to calculate fruit and vegetable servings.
Time frame
Baseline, 12 weeks, 24 weeks2
Concentration of Carotenoid Biomarkers
Carotenoids (beta-carotene, lutein, zeaxanthin, and lycopene) will be analyzed using blood samples obtained using a self-administered dried blood spot (DBS) collection.
Time frame
Baseline, 12 weeks, 24 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: