Choosing Healthy Activities and Lifestyle Management Through Portal Support — CHAMPS  

Overweight and Obesity Clinical Trial

Official title: Managing Obesity by Leveraging Health Information Technology to Lower Cancer Risk

Status Recruiting

Clinical Trial Summary

The study aims to randomize 250 participants to 1 of 2 arms: a.) an Active Intervention Group (based on the Look AHEAD* ILI) or b.) a Comparison Group (based on the Look AHEAD DSE Comparison group) to test the hypothesis that a multicomponent, multilevel behavioral weight loss intervention (Active Intervention Group) adapted for underserved groups and delivered through Health Information Technology (Health IT) tools via the Electronic Health Record (EHR) patient portal, will result in significantly greater weight loss 12 months after enrollment compared to the Comparison Group. *The Look AHEAD study was a multi-center, randomized clinical trial involving overweight and obese persons with type 2 diabetes, aimed to determine the effects on the cardiovascular outcomes of an intensive lifestyle intervention (ILI) for weight loss, in comparison to the diabetes support and education intervention (DSE).

Clinical Trial Description

This research project is a collaborative effort between the University of Tennessee Health Science Center (UTHSC) and Regional One Health, one of the largest nonprofit physician practice groups located in western Tennessee and in the surrounding rural areas - part of the Delta area with some of the highest rates of obesity in the nation. Obesity and excess body fat are associated with many diseases and adverse health consequences. Obesity is associated with an increased risk of morbidity and mortality from cancer and may worsen cancer survivorship and quality of life. Obesity also disproportionally affects underserved population groups such as racial and ethnic minorities, persons with lower socioeconomic status, and persons living in rural areas. Although numerous research studies have shown that behavioral weight loss interventions combined with dietary modification and increased physical activity are the most effective in achieving weight loss and guidelines have endorsed such interventions, there is limited literature describing behavioral weight loss strategies in real-world clinical practice settings. There are also no published studies on the effectiveness of practice-based, multicomponent behavioral interventions for weight loss in underserved populations in urban or rural settings, using Health IT and the EHR patient portal. The investigators of this study propose a practice-based clinical trial delivering the intervention via the Health IT EHR patient portal combined with supportive telephonic follow-up that specifically addresses the concerns and needs of underserved populations living in either an urban or rural area. If successful, this intervention would demonstrate an approach that could be applicable to challenging populations and would demonstrate how to develop, implement, and sustain an effective weight loss intervention integrated within a trusted healthcare system's Health IT that may prevent cancer. During Stage 1 (12 months), the investigators will refine the intervention for Health IT delivery by conducting formative research (key informant interviews and focus groups). With patients, they will seek to identify the barriers to implementing the Look AHEAD ILI behavioral weight loss intervention and adapt and modify ILI components to make them acceptable for underserved populations in both urban and rural settings and integrate those components into the EHR patient portal (Active Intervention group). The investigators will also adapt the Look AHEAD Comparison condition (DSE group) for the Comparison condition. With healthcare providers, the study team will seek to determine how a Health IT intervention integrated at the system level, can facilitate delivery of guideline concordant weight management care. During Stage 2 (years 2-5), the investigators will conduct a clinical trial and randomly assign 250 participants at the Regional One Health partner practice sites in urban and rural settings in a 1:1 ratio to either the Comparison Group or the Active Intervention Group and determine weight change (primary outcome) over time in both groups. In this study, investigators will also assess how social determinants of health are related to patient uptake and engagement with the Health IT patient portal and patient success with weight loss. ;

Related Conditions & MeSH terms

• Behavior, Health
• Obesity
• Overweight
• Overweight and Obesity
• Weight Loss

• NCT number: NCT05410353
• Study type: Interventional
• Source: University of Tennessee
• Contact: Julia Graber
• Phone: 901-448-1083
• Email: jgraber@uthsc.edu
• Status: Recruiting
• Phase: N/A
• Start date: February 24, 2023
• Completion date: January 2028