ACTIVE_NOT_RECRUITING

Choosing Healthy Activities and Lifestyle Management Through Portal Support

Conditions

Weight Loss Overweight and Obesity Behavior, Health health information technology electronic health record patient portal

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 different population 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).

Official Title

Managing Obesity by Leveraging Health Information Technology to Lower Cancer Risk

Quick Facts

Study Start:2023-02-24

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05410353

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 different population groups (racial / ethnic minority, lower socioeconomic status, or reside in a rural location).	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.

Inclusion Criteria

Exclusion 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 different population groups (racial / ethnic minority, lower socioeconomic status, or reside in a rural location).

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.

Contacts and Locations

Principal Investigator

Karen Johnson, MD

PRINCIPAL_INVESTIGATOR

University of Tennessee

Phyllis Richey, PhD

PRINCIPAL_INVESTIGATOR

University of Tennessee

Study Locations (Sites)

University of Tennessee Health Science Center / Department of Preventive Medicine

Memphis, Tennessee, 38105

United States

Collaborators and Investigators

Sponsor: University of Tennessee

Karen Johnson, MD, PRINCIPAL_INVESTIGATOR, University of Tennessee
Phyllis Richey, PhD, PRINCIPAL_INVESTIGATOR, University of Tennessee

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-24

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2023-02-24

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

health information technology
electronic health record
patient portal

Additional Relevant MeSH Terms

Weight Loss
Overweight and Obesity
Behavior, Health