Clinical trial · Interventional
Choosing Healthy Activities and Lifestyle Management Through Portal Support
Managing Obesity by Leveraging Health Information Technology to Lower Cancer Risk
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Behavior, Health | — | UNRESOLVED | — |
| Overweight and Obesity | — | UNRESOLVED | — |
| Weight Loss | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active Intervention Group | Behavioral | — | UNRESOLVED |
| Comparison Group | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Active Intervention Group
- description
- Look AHEAD Intervention program adapted for delivery via Health IT modified for cultural and social norms applicable to different population groups
- interventionNames
- Behavioral: Active Intervention Group
- type
- ACTIVE_COMPARATOR
- label
- Comparison Group
- description
- Look AHEAD DSE (Diabetes Support and Education) Comparison Group intervention adapted to be delivered via the EHR patient portal with telephonic support
- interventionNames
- Behavioral: Comparison Group
Primary outcomes (1)
- measure
- Relative percentage change in weight
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
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 different population groups (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.
References
Publications (0)
Data not yet available