250 Participants Needed

Health IT-Supported Weight Loss Intervention for Obesity

(CHAMPS Trial)

JG
KJ
Overseen ByKaren Johnson, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial tests a weight loss program using online health tools and phone support for underserved groups. It aims to help people lose weight by providing easy access to diet and exercise advice through their health records. The study focuses on groups with high obesity rates who often face challenges in accessing effective weight loss programs.

Will I have to stop taking my current medications?

The trial requires that you stop using any current weight loss medications. For other medications, the protocol does not specify, so it's best to discuss with the trial team.

What data supports the effectiveness of the Health IT-Supported Weight Loss Intervention for Obesity treatment?

Research shows that Intensive Lifestyle Interventions (ILI) can lead to significant weight loss, with some studies reporting more than 5% weight reduction in patients with obesity. However, the effectiveness can vary, and while ILI can reduce some health risks, it may not improve heart-related health outcomes.12345

Is the Health IT-Supported Weight Loss Intervention for Obesity safe for humans?

The Intensive Lifestyle Intervention (ILI) has been studied for obesity and diabetes, showing some weight loss and reduced risk factors, but no improvement in heart-related health issues. There are no specific safety concerns mentioned in the studies, suggesting it is generally safe for humans.12356

How does the Intensive Lifestyle Intervention (ILI) treatment for obesity differ from other treatments?

The Intensive Lifestyle Intervention (ILI) is unique because it combines behavioral therapy and nutritional counseling to achieve weight loss, unlike standard medical treatments or surgery. While it may not be as effective as bariatric surgery, it offers a non-surgical option that can lead to significant weight loss and improvements in quality of life for some patients.12346

Research Team

KJ

Karen Johnson, MD

Principal Investigator

University of Tennessee

Eligibility Criteria

This trial is for overweight or obese individuals (BMI ≥ 25 kg/m2) who are at least 16 years old, have internet access, and belong to underserved groups. They must be patients at participating sites and willing to be randomly assigned to a group. People with certain medical conditions, uncontrolled psychiatric disorders, substance abuse issues, recent major surgeries or cancer (except skin cancer), current weight loss medication use, or plans that conflict with the study's timeline cannot join.

Inclusion Criteria

Patients are patients at one of the participating practice sites
I am 16 years old or older.
Patients are willing to accept a random assignment
See 3 more

Exclusion Criteria

I have had an amputation, bariatric surgery, or plan to within a year.
I am currently taking medication to lose weight.
I have not had heart or stroke-related health events or procedures in the last 6 months.
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Formative Assessment

Modification and optimization of the Look AHEAD ILI and DSE interventions for cultural and social norms in underserved populations

Not specified

Treatment

Participants are randomized to either the Active Intervention Group or the Comparison Group to test the weight loss intervention delivered through Health IT

12 months

Follow-up

Participants are monitored for weight change and the relationship of social determinants of health with weight change over time

12 months

Treatment Details

Interventions

  • Active Intervention Group
  • Comparison Group
Trial OverviewThe trial tests if a behavioral weight loss program delivered through Health IT tools via patient portals leads to more weight loss after one year compared to a standard support group. The Active Intervention Group receives an adapted version of the Look AHEAD intensive lifestyle intervention while the Comparison Group gets basic diabetes support education.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Active Intervention GroupExperimental Treatment1 Intervention
Look AHEAD Intervention program adapted for delivery via Health IT modified for cultural and social norms applicable to under-served population groups
Group II: Comparison GroupActive Control1 Intervention
Look AHEAD DSE (Diabetes Support and Education) Comparison Group intervention adapted to be delivered via the EHR patient portal with telephonic support

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Tennessee

Lead Sponsor

Trials
202
Recruited
146,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Regional One Health

Collaborator

Trials
5
Recruited
990+

Findings from Research

A 10-14 week inpatient intensive lifestyle intervention (ILI) for 100 severely obese individuals led to significant improvements in quality of life, including reductions in binge eating, anxiety, and depression, as well as enhancements in physical and mental health.
The study found that improvements in binge eating and physical health were directly associated with weight loss, indicating that the ILI not only helped participants lose weight but also positively impacted their overall well-being.
Beyond weight reduction: improvements in quality of life after an intensive lifestyle intervention in subjects with severe obesity.Danielsen, KK., Sundgot-Borgen, J., Mæhlum, S., et al.[2015]
Intensive Lifestyle Intervention (ILI) led to a significant weight loss of -11.58% over one year in morbidly obese patients, compared to only -0.4% in those receiving conventional obesity therapy (COT), highlighting ILI's effectiveness.
After 12 months of ILI, 42.8% of participants were no longer classified as morbidly obese, suggesting that ILI could be a viable alternative to bariatric surgery for some patients.
One year weight loss in the TRAMOMTANA study. A randomized controlled trial.Tur, JJ., Escudero, AJ., Alos, MM., et al.[2022]
Intensive lifestyle intervention (ILI) initially showed significant weight loss (over 5%) and reduced risk factors for obesity and diabetes in clinical trials, but these benefits were not sustained in a primary care setting.
The current version of ILI in primary care has resulted in less than 5% weight loss and limited health benefits, suggesting that its effectiveness has diminished and highlighting the need for a focus on prevention strategies for obesity.
[Intensive lifestyle interventions: are they effective against obesity?]de Brauw, LM.[2021]

References

Beyond weight reduction: improvements in quality of life after an intensive lifestyle intervention in subjects with severe obesity. [2015]
One year weight loss in the TRAMOMTANA study. A randomized controlled trial. [2022]
[Intensive lifestyle interventions: are they effective against obesity?] [2021]
An Intensive Lifestyle Intervention Is an Effective Treatment of Morbid Obesity: The TRAMOMTANA Study-A Two-Year Randomized Controlled Clinical Trial. [2020]
Predictors of weight loss after an intensive lifestyle intervention program in obese patients: a 1-year prospective cohort study. [2021]
Maintaining a clinical weight loss after intensive lifestyle intervention is the key to cardiometabolic health. [2022]