Clinical trial NCT05410353: Choosing Healthy Activities and Lifestyle Management Through Portal Support
Official title: Managing Obesity by Leveraging Health Information Technology to Lower Cancer Risk
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Weight Loss
Overweight and Obesity
Behavior, Health
Keywords: health information technology
electronic health record
patient portal
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-06-08
Enrollment: 250
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a 2-arm, parallel, randomized, controlled clinical trial. Eligible participants will be randomly assigned in a 1:1 ratio to either a behavioral weight loss intervention group delivered via Health IT with telephonic support (Active Intervention Group) or the Comparison Group. Because intervention delivery does not depend on clinic site, the study team has opted for a more powerful individual randomization over cluster randomization (but the team will potentially include clinic site as a grouping effect in the analysis).
Primary purpose: PREVENTION

Brief 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).

Detailed description: This project tests whether the adapted Look AHEAD Intensive Lifestyle Intervention (ILI) will result in significant weight loss when delivered through Health IT - EHR patient portal compared to a Comparison group (based on Look AHEAD DSE Comparison group). This project will be conducted in 2 stages: a formative assessment stage (Stage 1) and a clinical trial stage (Stage 2).

During Stage 1, we will modify the interactive technology-based Look AHEAD ILI that we already developed for the TARGIT study (Active Intervention group). We will also adapt the Look AHEAD Comparison condition (DSE group) for our Comparison condition. We will also optimize the protocol for acceptability in underserved populations and in a rural setting.

During Stage 2, we will randomly assign 250 participants to either the Comparison Group or the Active Intervention Group to address the primary aim of testing the hypothesis that a multicomponent, behavioral weight loss intervention delivered through Health IT - patient portal will lead to significantly greater weight loss 12 months after enrollment in the Active Intervention group compared with the Comparison group. Our Health IT-based intervention is potentially cost-effective and thus disseminable to any practice-based physician group with access to an EHR with a patient portal.

Eligibility criteria: Inclusion Criteria:

1. are ≥ 16 years old
2. are overweight or obese (BMI ≥ 25 kg/m2)
3. have access to the Internet via the computer or use a cellphone with a data-plan access
4. are patients at one of the participating practice sites
5. are willing to accept a random assignment, and
6. are from an underserved group (racial / ethnic minority, lower socioeconomic status, or reside in a rural location).

Exclusion Criteria:

1. coronary or cerebrovascular disease events or vascular procedures within the past 6 months
2. certain medical conditions that put participants at high risk of adverse events or preclude exercising
3. uncontrolled psychiatric disorders
4. current substance abuse, including heavy alcohol use ≥ 5 drinks on the same occasion for ≥ 5 days in the past 30 days
5. a history of amputation or bariatric surgery or are planning to have bariatric surgery within the next 12 months
6. current weight loss medication use
7. malignancy within the last 5 years (except skin cancer)
8. plans to move out of the area during the next year
9. current participation in another clinical trial
10. pregnancy or breast feeding or are planning to become pregnant within the next 12 months, and
11. instances judged by the investigators' and primary care providers' discretion.

Primary outcomes:
measure: Relative percentage change in weight
timeFrame: 12 months
Secondary outcomes:
measure: Relationship of social determinants of health (screening tool) with weight change over time
timeFrame: 12 months
measure: Relationship of social determinants of health (BRFSS) with weight change over time
timeFrame: 12 months
measure: Relationship of social determinants of health (z codes) with weight change over time
timeFrame: 12 months
Other outcomes:
Locations:
city: Memphis
country: United States
facility: University of Tennessee Health Science Center / Department of Preventive Medicine
state: Tennessee
Study officials:
affiliation: University of Tennessee
name: Karen Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References: