Health IT-Supported Weight Loss Intervention for Obesity

(CHAMPS Trial)

Overseen By Karen Johnson, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Tennessee

Must not be taking: Weight loss medications

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to help people lose weight using Health Information Technology, such as online tools through a patient portal. Participants will join one of two groups: one receives a tailored weight loss plan (Active Intervention Group, also known as Intensive Lifestyle Intervention or Behavioral Weight Loss Intervention), while the other receives standard diabetes support and education. The goal is to determine if the personalized plan results in greater weight loss after a year. Ideal candidates are overweight or obese individuals with reliable internet access who are willing to participate in a diverse study group. This trial may suit those seeking to lose weight and improve health through technology. As an unphased trial, it offers a unique opportunity to explore innovative weight loss methods, potentially benefiting participants' health journeys.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that lifestyle programs for weight loss are generally safe and easy to follow. Studies have found that these programs can help people lose weight without major side effects. For example, a review of short-term programs found that combining exercise and healthy eating helps adults with obesity lose weight effectively, with no serious problems reported.

This trial uses a program similar to the Look AHEAD study, which focused on weight loss in people with type 2 diabetes and did not report major safety issues. Participants in the Look AHEAD study made significant lifestyle changes, and the program was considered safe for long-term use.

Overall, evidence suggests that the program being tested is safe for participants, with no significant risks reported in past studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this weight loss intervention because it leverages Health IT to deliver personalized support tailored to cultural and social norms, making it more inclusive than many one-size-fits-all programs. Unlike traditional treatments that often rely on in-person meetings or generic advice, this intervention uses technology to adapt the Look AHEAD program for diverse populations, potentially increasing engagement and effectiveness. By integrating with electronic health records and offering telephonic support, it aims to provide continuous, accessible care, which could lead to better long-term weight management outcomes.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that the Active Intervention Group, one of the treatment arms in this trial, is based on the Look AHEAD study and can help people with obesity lose a significant amount of weight. On average, participants lose about 8 kilograms, or 8% of their starting weight, which is a notable reduction. The Look AHEAD study found that 50% of participants lost at least 5% of their body weight over eight years. This weight loss was linked to better health, including improved blood sugar, cholesterol levels, and blood pressure. The program is now being adapted to use Health IT tools, potentially making it easier and more effective for a wide range of people. Meanwhile, the Comparison Group in this trial will receive the Look AHEAD DSE (Diabetes Support and Education) intervention, adapted for delivery via the EHR patient portal with telephonic support. ^{2 6 7 8 9}

Who Is on the Research Team?

Karen Johnson, MD

Principal Investigator

University of Tennessee

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Active Intervention Group
• Comparison Group

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.

How Is the Trial Designed?

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 different 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+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Regional One Health

Collaborator

Trials

5

Recruited

990+

Published Research Related to This Trial

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Intensive lifestyle interventions: are they effective against obesity?] de Brauw, LM.[2021]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3904491/

Eight-Year Weight Losses with an Intensive Lifestyle ... Look AHEAD's ILI produced clinically meaningful weight loss (≥5%) at year 8 in 50% of patients with type 2 diabetes and can be used to manage other obesity- ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06321809

Intensive Lifestyle Interventions to Overweight and Obese ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

3. gastrojournal.org gastrojournal.org/article/S0016-5085(17)30139-7/fulltext

Intensive Lifestyle Intervention for Obesity Persons with obesity typically lose approximately 8 kg (approximately 8% of initial weight) with this approach, accompanied by improvements in health and ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2212267215002592

Lifestyle Weight-Loss Intervention Outcomes in Overweight ... For overweight or obese individuals with type 2 diabetes, a weight loss of at least 5% improved glucose, lipids, and blood pressure control over 12 months.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12530373/

Intensive weight loss intervention versus usual care in adults ... Total diet replacements (TDRs) and weight loss medications (WLMs) have proven effective in producing substantial weight loss for individuals ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5503454/

Behavioral Lifestyle Interventions for Moderate and Severe ... This study reviews evidence of behavioral lifestyle interventions for weight loss in this population.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11493725/

Effects of health at every size based interventions on ... This study aims to provide rapid and up-to-date evidence on the effectiveness of Health at Every Size (HAES) interventions compared to ...

8. cdc.gov cdc.gov/pcd/issues/2024/23_0347.htm

Weight Loss in Short-Term Interventions for Physical ... Short-term multicomponent interventions involving physical activity and nutrition can achieve weight loss for adults with overweight or obesity.

9. cms.gov cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?&NcaName=Intensive%20Behavioral%20Therapy%20for%20Obesity&NCAId=253

Decision Memo - Intensive Behavioral Therapy for Obesity Orlistat plus behavioral intervention resulted in 3-kg (6.6-lb) more weight loss than did placebo after 12 months. Metformin resulted in less ...