This clinical trial studies the effect of a web-based diet and exercise intervention in reducing obesity and improving the health of cancer survivors and their partners. The purpose of this trial is to learn how a web-based diet and exercise intervention affects the health behaviors of cancer survivors and the people around them, as well as how it affects body weight, overall health and ability to move, quality of life, and blood markers of successful aging.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04132219.
PRIMARY OBJECTIVE:
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.
SECONDARY OBJECTIVES:
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 PhaseNo phase specified
Trial Typeprevention
Lead OrganizationUniversity of Alabama at Birmingham Cancer Center
Principal InvestigatorWendy Demark-Wahnefried