Health IT-Supported Weight Loss Intervention for Obesity

(CHAMPS Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Karen Johnson, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Tennessee

Must not be taking: Weight loss medications

Disqualifiers: Coronary disease, Uncontrolled psychiatric, Substance abuse, others

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. ^{1 2 3 4 5}

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. ^{1 2 3 5 6}

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. ^{1 2 3 4 6}

Research Team

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

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.

Trial 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 (Behavioural Intervention)
• Comparison Group (Behavioural Intervention)

Trial Overview 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.

Participant Groups

Group I: Active Intervention Group Experimental Treatment 1 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 Group Active Control 1 Intervention

Look AHEAD DSE (Diabetes Support and Education) Comparison Group intervention adapted to be delivered via the EHR patient portal with telephonic support

Who Is Running the Clinical Trial?

University of Tennessee

Lead Sponsor

Trials

202

Recruited

146,000+

Larry Dillaha

University of Tennessee

Chief Executive Officer since 2021

MD from the University of Tennessee, Memphis

Robert Elfont

University of Tennessee

Chief Medical Officer since 2021

MD, PhD

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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) led to a significant weight loss of -11.3% over two years in morbidly obese patients, compared to only -1.6% in the Conventional Obesity Therapy (COT) group, suggesting ILI is more effective than standard medical treatment.

While bariatric surgery resulted in a greater weight loss of -29.6%, ILI showed promising results, with 44.4% of participants no longer classified as morbidly obese after 24 months, indicating it could be a viable alternative for those not eligible for surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Intensive Lifestyle Intervention Is an Effective Treatment of Morbid Obesity: The TRAMOMTANA Study-A Two-Year Randomized Controlled Clinical Trial. Burguera, B., Jesús Tur, J., Escudero, AJ., et al.[2020]

In a study of 199 morbidly obese patients undergoing a 1-year intensive lifestyle intervention, the average weight loss was 10 kg, with significant predictors of weight loss including the amount lost at 12 weeks, age, and occupational status.

Factors such as adherence to a weight loss diary, absence of type 2 diabetes, and regular follow-ups with general practitioners positively influenced weight loss outcomes at the 12-week mark, which in turn predicted greater weight loss after one year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of weight loss after an intensive lifestyle intervention program in obese patients: a 1-year prospective cohort study. Karlsen, TI., Søhagen, M., Hjelmesæth, J.[2021]

Participants who maintained a weight loss of over 10% after an intensive lifestyle intervention showed significantly better cardiometabolic health outcomes compared to those with moderate weight loss or weight regain, including lower BMI, reduced fat composition, and improved blood markers like triglycerides and glucose levels.

The study involved 80 participants from a larger group of 2420, and it demonstrated that maintaining substantial weight loss is associated with enhanced metabolic health, suggesting that intensive lifestyle interventions can have meaningful long-term benefits for a subset of individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maintaining a clinical weight loss after intensive lifestyle intervention is the key to cardiometabolic health. Dandanell, S., Skovborg, C., Præst, CB., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Beyond weight reduction: improvements in quality of life after an intensive lifestyle intervention in subjects with severe obesity. [2015]

2. England pubmed.ncbi.nlm.nih.gov

One year weight loss in the TRAMOMTANA study. A randomized controlled trial. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

[Intensive lifestyle interventions: are they effective against obesity?] [2021]

4. Egypt pubmed.ncbi.nlm.nih.gov

An Intensive Lifestyle Intervention Is an Effective Treatment of Morbid Obesity: The TRAMOMTANA Study-A Two-Year Randomized Controlled Clinical Trial. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Predictors of weight loss after an intensive lifestyle intervention program in obese patients: a 1-year prospective cohort study. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Maintaining a clinical weight loss after intensive lifestyle intervention is the key to cardiometabolic health. [2022]