Web-Based Diet and Exercise Intervention for the Reduction of Obesity and Improvement of Health in Cancer Survivors and Their Partners
- Adults (age 18+) in whom at least one of the dyad members has been diagnosed and completed curative treatment for localized renal cancer, or loco-regional ovarian, colorectal, endometrial, or female breast cancer (loco-regional prostate cancer survivors are also eligible but could be on active surveillance)
- Both dyad members have no other cancers (except non-melanoma skin cancer) and/or evidence of recurrence or metastasis
- Both dyad members are likely to benefit from diet and exercise weight loss intervention, i.e., 1) overweight or obese body mass index (BMI) >= 25 kg/m^2, 2) vegetable and fruit (V&F) intake < 2.5 cups per day (day^-1), and 3) moderate-to-vigorous physical activity < 150 minutes per week (w^-1)
- Both dyad members are English-speaking and writing, and have completed the 5th grade. Many elements of our intervention and assessment will require minimal English literacy proficiency. The added expense of developing intervention and evaluative materials in languages other than English also is prohibitive (especially since many of the scales that we use have not been validated in other languages). If this trial shows repeated success, studies among non-English speakers may be justified. Representative numbers of Hispanics will be enrolled
- Both dyad members have not been told by a physician to limit their current physical activity, AND have no pre-existing medical conditions that preclude adherence to an unsupervised weight loss intervention, e.g., pregnancy, severe orthopedic conditions, impending hip or knee replacement (within 6M), end-stage renal disease, paralysis, dementia, blindness, unstable angina, untreated stage 3 hypertension, or recent history of heart attack, congestive heart failure or pulmonary conditions that required oxygen or hospitalization within 6 months. We have established a track record of safety in our home-based interventions by using these criteria
- Both dyad members are community dwelling and not residing in a skilled nursing or assisted living facility (we seek participants who are able to pursue lifestyle changes independently and not as the result of institutional control)
- Both dyad members are daily users of the internet, and own a mobile phone
- Both dyad members reside in the United States (US), Canada or Puerto Rico and within the same neighborhood (defined “as less than a 10-minute walk”) as their dyad partner
I. Determine whether dyads (comprised of an overweight/obese cancer survivor and their overweight/obese buddy) lose significantly more weight (kg) at 6-month follow-up when assigned to the eHealth intervention compared to a wait-list control.
I. Explore between-arm differences in change scores from baseline to 6-month follow-up in other key outcomes including measures of adiposity (e.g., waist circumference [WC] and body mass index [BMI]), diet quality, physical activity, systolic blood pressure (BP), health-related quality of life (QoL), and physical functioning and performance.
II. Assess the impact of the intervention on select biomarkers associated with cancer risk and progression, e.g., tumor tumor necrosis factor (TNF)alpha, insulin, and IGF-1.
III. Identify predictor variables associated with program efficacy, e.g., social support, self-efficacy, risk for depression, and dyad partner (spouse, relative, friend/neighbor).
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive a web-based diet and exercise intervention consisting of tailored text messaging and activity monitoring for 6 months.
ARM II: Participants are placed on a wait list for the web-based diet and exercise intervention and receive monthly online study newsletters for 6 months on topics unrelated to diet and exercise, but still of interest to cancer survivors and dyad members such as coping with stress, reducing exposure to radiation, sun safety, etc. to enhance retention.
Trial Phase Phase NA
Trial Type Prevention
University of Alabama at Birmingham Cancer Center
- Primary ID UAB18117
- Secondary IDs NCI-2021-00043, IRB-300003882
- Clinicaltrials.gov ID NCT04132219