Intensive Lifestyle Intervention for Weight Loss

(PROPEL-IT Trial)

Overseen By Peter T Katzmarzyk, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pennington Biomedical Research Center

Must not be taking: Weight loss medications

Disqualifiers: Recent weight loss, Pregnancy, Bariatric surgery, Life-threatening disease, others

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

Compensation: Varies

Number of Visits: 6

Duration: 24 months

352 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, it does exclude those currently using weight loss medication.

What data supports the effectiveness of the treatment Intensive Lifestyle Intervention for weight loss?

Research shows that intensive lifestyle interventions, which include a reduced-calorie diet, increased physical activity, and behavior therapy, can lead to significant weight loss and improvements in health and quality of life for people with obesity. Participants typically lose about 8% of their initial weight, and these interventions are effective for both obesity and type 2 diabetes. ^{1 2 3 4 5}

Is Intensive Lifestyle Intervention generally safe for humans?

Intensive Lifestyle Interventions (ILI) for weight loss, which include a reduced-calorie diet, increased physical activity, and behavior therapy, are generally safe and can lead to improvements in health and quality of life. These interventions have been shown to improve weight loss and cardiovascular risk factors in various studies. ^{5 6 7 8 9}

How is the Intensive Lifestyle Intervention treatment for weight loss different from other treatments?

The Intensive Lifestyle Intervention for weight loss is unique because it combines a reduced-calorie diet, increased physical activity, and behavior therapy over a minimum of 6 months, with a focus on long-term maintenance through regular counseling. Unlike other treatments, it emphasizes sustained lifestyle changes and can be delivered in-person or through digital platforms, although in-person interventions tend to be more effective. ^{4 5 10 11 12}

What is the purpose of this trial?

The primary aim is to test the effectiveness of an innovative 24-month pragmatic and scalable weight-loss centric approach using a collaborative care model that connects patients with a non-Primary Care Practitioner (PCP) health coach who delivers care remotely to patients through the patient portal of an electronic medical record (EMR).

Research Team

Peter T Katzmarzyk, PhD

Principal Investigator

Pennington Biomedical Research Center

Eligibility Criteria

This trial is for Black/African American residents of Louisiana aged 40-70 with Type II diabetes or pre-diabetes, obesity (BMI 30.0-50.0 kg/m2), and internet access. Participants must be willing to change their diet/activity and not be pregnant, in a weight loss program, have life-threatening diseases, past bariatric surgery, or recent significant weight loss.

Inclusion Criteria

I am between 40 and 70 years old.

My BMI is between 30.0 and 50.0.

Have weight measured at an Ochsner clinic within 4 weeks of screening

Exclusion Criteria

I have had bariatric surgery or plan to within 2 years.

You plan to move away from the area within the next 2 years.

My condition can worsen with exercise or weight loss.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a comprehensive, 'high-intensity' program delivered remotely using eHealth technology, with weekly sessions in the first six months followed by monthly sessions for the remaining 18 months

24 months

Weekly sessions for 6 months, then monthly sessions for 18 months

Follow-up

Participants are monitored for changes in various health metrics such as body weight, cholesterol levels, and blood pressure

4 weeks

Treatment Details

Interventions

• Intensive Lifestyle Intervention

Trial Overview The study tests a remote intensive lifestyle intervention over 24 months for weight loss in primary care using technology. A health coach will guide patients through changes in diet and physical activity via an electronic medical record patient portal.

Participant Groups

Group I: Intensive Lifestyle Intervention Experimental Treatment 1 Intervention

The intervention arm receives a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Obesity Guidelines, delivered remotely using eHealth technology, by trained health coaches embedded in the Digital Medicine Group in the Ochsner Health System. The intervention includes remote sessions with the health coach using evidence-based components such as the use of portion control and various behavioral strategies .Patients in the Intervention arm attend weekly sessions in the first six months, followed by monthly sessions for the remaining 18 months.

Group II: Usual Care Active Control 1 Intervention

Patients in the usual care arm will receive their normal, usual care from their primary care team.

Who Is Running the Clinical Trial?

Pennington Biomedical Research Center

Lead Sponsor

Trials

314

Recruited

183,000+

Ochsner Health System

Collaborator

Trials

97

Recruited

91,900+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Findings from Research

Both in-person and telephone group lifestyle interventions (LI) led to significantly greater weight loss compared to medical nutrition therapy (MNT) in patients with type 2 diabetes, with mean weight loss of 5.6% and 4.6% respectively at 6 months.

The cost-effectiveness of in-person LI was better than telephone LI, with an incremental cost of $789 per kilogram lost compared to $1223 for telephone LI, indicating that in-person programs may provide a more economical option for achieving weight loss in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Lifestyle Intervention for Type 2 Diabetes in Primary Care: the REAL HEALTH-Diabetes Randomized Clinical Trial. Delahanty, LM., Levy, DE., Chang, Y., et al.[2022]

A new mathematical model was developed to predict weight changes based on dietary energy intake, using data from 8 longitudinal studies with 157 participants, which showed strong accuracy in its predictions (R² values of 0.83 and 0.91).

This model can help obese patients and their doctors set realistic long-term weight maintenance goals by calculating the necessary dietary changes, making it a practical tool for weight management professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modeling weight-loss maintenance to help prevent body weight regain. Hall, KD., Jordan, PN.[2023]

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]

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]

In the Look AHEAD trial, severely obese participants (BMI ≥40 kg/m²) who underwent an intensive lifestyle intervention (ILI) lost an average of 9.04% of their initial body weight after one year, which was significantly more than the 7.43% weight loss in overweight participants, showing that ILI is effective for severe obesity.

All groups, including severely obese participants, showed similar improvements in cardiovascular disease risk factors such as fitness, LDL cholesterol, and blood pressure, indicating that intensive lifestyle changes can benefit individuals regardless of their initial weight category.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of lifestyle interventions for individuals with severe obesity and type 2 diabetes: results from the Look AHEAD trial. Unick, JL., Beavers, D., Jakicic, JM., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Lifestyle Intervention for Type 2 Diabetes in Primary Care: the REAL HEALTH-Diabetes Randomized Clinical Trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Modeling weight-loss maintenance to help prevent body weight regain. [2023]

3. 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]

4. 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]

5. United States pubmed.ncbi.nlm.nih.gov

Intensive Lifestyle Intervention for Obesity: Principles, Practices, and Results. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Primary care delivery of behavioral weight loss services for adults with cardiovascular risk factors: development of pragmatic implementation strategies and results of a randomized feasibility trial. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of lifestyle interventions for individuals with severe obesity and type 2 diabetes: results from the Look AHEAD trial. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Primary care delivery of behavioral weight loss services for adults with cardiovascular risk factors: development of pragmatic practice components and results of a randomized feasibility trial. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Answers to Clinical Questions in the Primary Care Management of People with Obesity: Lifestyle Management. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Differences in weight loss across different BMI classes: a meta-analysis of the effects of interventions with diet and exercise. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Fifty Years of Behavioral/Lifestyle Interventions for Overweight and Obesity: Where Have We Been and Where Are We Going? [2022]