Choosing Healthy Activities and Lifestyle Management Through Portal Support
NCT ID: NCT05410353
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
229 participants
INTERVENTIONAL
2023-02-24
2026-12-31
Brief Summary
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\*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
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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 different 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Active Intervention Group
Look AHEAD Intervention program adapted for delivery via Health IT modified for cultural and social norms applicable to different population groups
Active Intervention Group
The 3 major intervention components are diet, physical activity, and the behavioral modification curriculum. Scheduled interactions are educational podcasts (a series of audiovisual, digital media files) paired with a follow-up phone counseling session with a trained behavioral interventionist. A patient portal message will be sent to participants when a new podcast is posted. Interactive sessions will be weekly (weeks 1-16), biweekly (weeks 17-24), and monthly (weeks 25-52). The goal for weight loss is ≥ 7% of initial weight over the course of 12 months. Participants will restrict caloric intake with the goal of 1,200-1,500 kcal/day for those weighing \< 114 kg and 1,500-1,800 kcal/day for those weighing ≥ 114 kg. The physical activity goal will be for participants to gradually increase to 175-200 minutes of moderate-intensity activity per week by the 24th week. Participants will also be asked to self-monitor their dietary intake and physical activity using the "Lose It!" app.
Comparison Group
Look AHEAD DSE (Diabetes Support and Education) Comparison Group intervention adapted to be delivered via the EHR patient portal with telephonic support
Comparison Group
All participants in the Comparison Group will receive a mandatory 13 contacts per year including 3 informational sessions on nutrition, physical activity and social support and 10 contacts via patient portal or email regarding intervention topics. The Look AHEAD Comparison Group was designed to be realistic, achievable, and an acceptable intervention that encouraged optimal study retention.
Interventions
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Active Intervention Group
The 3 major intervention components are diet, physical activity, and the behavioral modification curriculum. Scheduled interactions are educational podcasts (a series of audiovisual, digital media files) paired with a follow-up phone counseling session with a trained behavioral interventionist. A patient portal message will be sent to participants when a new podcast is posted. Interactive sessions will be weekly (weeks 1-16), biweekly (weeks 17-24), and monthly (weeks 25-52). The goal for weight loss is ≥ 7% of initial weight over the course of 12 months. Participants will restrict caloric intake with the goal of 1,200-1,500 kcal/day for those weighing \< 114 kg and 1,500-1,800 kcal/day for those weighing ≥ 114 kg. The physical activity goal will be for participants to gradually increase to 175-200 minutes of moderate-intensity activity per week by the 24th week. Participants will also be asked to self-monitor their dietary intake and physical activity using the "Lose It!" app.
Comparison Group
All participants in the Comparison Group will receive a mandatory 13 contacts per year including 3 informational sessions on nutrition, physical activity and social support and 10 contacts via patient portal or email regarding intervention topics. The Look AHEAD Comparison Group was designed to be realistic, achievable, and an acceptable intervention that encouraged optimal study retention.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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).
Exclusion Criteria
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.
16 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
University of Tennessee
OTHER
Responsible Party
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Principal Investigators
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Karen Johnson, MD
Role: PRINCIPAL_INVESTIGATOR
University of Tennessee
Phyllis Richey, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Tennessee
Locations
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University of Tennessee Health Science Center / Department of Preventive Medicine
Memphis, Tennessee, United States
Countries
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Other Identifiers
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20-07328-FB
Identifier Type: -
Identifier Source: org_study_id