Health IT-Supported Weight Loss Intervention for Obesity (CHAMPS Trial)
Recruiting in Palo Alto (17 mi)
Overseen ByKaren Johnson, MD
Age: Any Age
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Tennessee
No Placebo Group
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.
12345Is 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.
12356How 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.
12346Eligibility 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
I am 16 years old or older.
My BMI is 25 or higher, indicating I am overweight or obese.
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 cancer (other than skin cancer) in the last 5 years.
Participant Groups
The 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.
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
Research locations nearbySelect from list below to view details:
University of Tennessee Health Science Center / Department of Preventive MedicineMemphis, TN
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Who is running the clinical trial?
University of TennesseeLead Sponsor
National Cancer Institute (NCI)Collaborator
Regional One HealthCollaborator
References
Beyond weight reduction: improvements in quality of life after an intensive lifestyle intervention in subjects with severe obesity. [2015]We examined the effects of 10-14 weeks of inpatient intensive lifestyle intervention (ILI), including a minimum of 90 minutes of adapted physical activity 5 days/week, with regard to changes in quality of life and associations with weight loss in subjects with severe obesity.
One year weight loss in the TRAMOMTANA study. A randomized controlled trial. [2022]Morbid obesity is a major health problem and bariatric surgery is currently the most effective therapy available to induce weight loss in these patients. This report describes 1-year changes in weight and metabolic parameters, in a trial designed to examine the effects of a nonsurgical approach, Intensive Life style Intervention (ILI) on the therapy of morbid obesity.
[Intensive lifestyle interventions: are they effective against obesity?] [2021]The intensive lifestyle intervention (ILI) has recently become part of the reimbursed care in the Netherlands. What is the value of the ILI in the treatment of obesity and diabetes? Large clinical randomized studies on the effect of ILI showed a weight loss of more than 5% in selected patients, which could be partly sustained for several years. The ILI reduced risk factors without improving cardiovascular morbidity and mortality. The expensive clinical ILI had to be translated into an accessible and affordable primary care version. With this translation the effectiveness of the ILI has disappeared. With the current ILI, the weight loss is less than 5% and the health advantages are limited. It is foreseeable that the dismal results of the ILI will not generate enthusiasm among potential participants. The impact of ILI on the obesity epidemic will be very limited. Prevention will provide the way to go.
An Intensive Lifestyle Intervention Is an Effective Treatment of Morbid Obesity: The TRAMOMTANA Study-A Two-Year Randomized Controlled Clinical Trial. [2020]Bariatric surgery is currently the most effective therapy to induce weight loss in morbidly obese patients. Objective. This controlled, clinical trial with a two-year intervention was aimed at comparing the efficacy of two nonsurgical approaches versus bariatric surgery, on body weight changes and metabolic parameters in morbidly obese patients. Methods. Patients were randomized to an Intensive Lifestyle Intervention (ILI) (n = 60) or Conventional Obesity Therapy (COT) (n = 46). The ILI group received behavioral therapy and nutritional counseling. The COT group received standard medical treatment. They were compared with a third group, Surgical Obesity Group (SOG) (n = 37). Results. Patients who received ILI had a greater percentage of weight loss than patients receiving COT (-11.3% versus -1.6%; p
Predictors of weight loss after an intensive lifestyle intervention program in obese patients: a 1-year prospective cohort study. [2021]Studies of lifestyle intervention programs in morbid obesity report large variations in weight loss outcomes. This is reported not only between but also within standardized programs. Such reports point to participants' characteristics as possible predictors of this outcome. The aim of this prospective cohort study was to identify predictors of weight loss after a 1-year partly residential intensive lifestyle intervention program (ILI).
Maintaining a clinical weight loss after intensive lifestyle intervention is the key to cardiometabolic health. [2022]Intensive lifestyle interventions (ILI) are criticised for ineffective obesity treatment because weight loss over time is modest and thus of limited clinical relevance. However, a subgroup (5-30%) maintains a clinical weight loss >10%, but it is not clear if cardiometabolic health follows this pattern. The aim was to study the effect of different magnitudes of weight loss maintenance after ILI on cardiometabolic health.