This clinical trial aims to learn better ways to help manage obesity in patients living in rural areas. Obesity increases risk for 13 types of cancer and now affects over 40% of the United States adult population. Rural Americans have higher cancer rates than those who live in urban areas and often lack access to weight control programs and resources that promote healthy lifestyles. Behavioral interventions use techniques to help patients change the way they react to environmental triggers that may cause a negative reaction. Telemedicine virtually connects patients to healthcare providers to provide, enhance, or expedite health care services, which could be particularly be beneficial for patients in rural areas with lack of local resources. Information gathered from this study will help determine if alternative ways of managing obesity in rural areas can help people reduce cancer risk by losing weight and maintaining that weight loss long-term.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05710510.
PRIMARY OBJECTIVE:
I. Test the hypothesis that team-based telemedicine (Team Care) will result in greater % weight loss at 18 months compared to Local Care +.
SECONDARY OBJECTIVES:
I. Test the hypothesis that Team Care (compared to Local Care +) will result in greater improvement in secondary outcomes, to include % weight loss at 6 and 12 months.
II. Proportion achieving >= 5% and 10% weight loss, weight change (kg), diet quality, physical activity, and quality of life at 6, 12 and 18 months.
TERTIARY OBJECTIVES:
I. Test the hypothesis that Team Care (compared to Local Care + [LC+]) will result in greater improvement in mental health, pain, sleep quality, and medical treatment process outcomes (patient activation, patient-provider communication, discussion and prescription of weight loss medications, and discussion and referral for bariatric surgery) at 6 and 18 months.
II. Evaluate the uptake of pharmacotherapy and bariatric surgery and their potential impact on the between-arm difference in % weight loss.
EXPLORATORY OBJECTIVES:
I. Explore the reach, adoption, implementation, and maintenance of the intervention according to the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) evaluation framework.
II. Investigate rural sociocultural and spatial predictors of treatment effects, including sociodemographic factors, rural identity, perceived and geographical indications (GIs)-generated food and physical activity environment, and tract/county-level measures of social disadvantage.
OUTLINE: Clinics are randomized to 1 of 2 arms.
ARM I (LC+): Patients attend quarterly clinic visits with providers per usual care that address core elements of obesity treatment guidelines on study.
ARM II (TEAM CARE): Patients participate in telemedicine group weight loss counseling sessions with a trained lifestyle coach over 24 months (36 sessions) and use educational materials, myNetDiary application (app), Fitbit activity tracker, and Aria Air smart scale on study. Patients also participate in quarterly individual sessions over 24 months (8 sessions) with a lifestyle coach to establish and review goals on study. Patients attend 3-way quarterly clinic visits over 24 months (8 sessions) with trained provider and telemedicine lifestyle coach to review progress report on study.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationUniversity of Kansas Cancer Center
Principal InvestigatorChristie Befort
