Lifestyle Intervention for Obesity

Overseen By Morgan Meyer

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Must not be taking: Weight loss, Anti-inflammatory

Disqualifiers: Pregnancy, Diabetes, Heart conditions, others

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

Compensation: Varies

Number of Visits: 8

Duration: 12 months

32 Participants Needed

Trial Summary

What is the purpose of this trial?

Emerging adulthood (18-25 years of age) is a critical developmental window to promote weight management and cardiometabolic health, particularly for emerging adult women. The primary purpose of this study is to test the preliminary efficacy of the intensive lifestyle intervention for EA women in reducing adiposity, as well as improving biomarkers of inflammation and metabolic risk over 12 months compared with a traditional behavioral weight loss intervention. This treatment program will be tested in emerging adult (EA) women ages 18-25 years old with a BMI of 25-50 kg/m\^2.

Will I have to stop taking my current medications?

The trial requires that you have not used medications that may impact weight or metabolic function, or anti-inflammatory medications, in the past 3 months. If you are currently taking these types of medications, you would need to stop before participating.

What data supports the effectiveness of the treatment Integrated Lifestyle Intervention (ILI) for obesity?

Research shows that intensive lifestyle interventions (ILIs) can lead to weight loss and improve quality of life in people with severe obesity. These interventions are also considered effective for preventing type 2 diabetes and other health issues related to obesity. ^{1 2 3 4 5}

Is the lifestyle intervention for obesity safe for humans?

The research on intensive lifestyle interventions (ILI) for obesity, including those with type 2 diabetes and cardiovascular risk factors, does not report any specific safety concerns, suggesting it is generally safe for humans. ^{3 6 7 8 9}

How is the Integrated Lifestyle Intervention (ILI) treatment for obesity different from other treatments?

The Integrated Lifestyle Intervention (ILI) is unique because it focuses on intensive lifestyle changes, including regular physical activity and dietary adjustments, rather than medication or surgery. It aims to achieve sustainable weight loss and improve quality of life, although its effectiveness can vary and may not significantly impact long-term health outcomes compared to other treatments. ^{2 4 5 9 10}

Research Team

Jessica LaRose

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

This trial is for young women aged 18-25 with a BMI of 25-50, not currently pregnant or breastfeeding, without severe medical conditions affecting weight or inflammation. Participants must not be on weight loss programs or medications that affect weight/metabolism and should wear an activity tracker for at least 8 hours a day.

Inclusion Criteria

BMI 25-50 kg/m2

I am female.

Must wear the Actigraph for >8 hours/day for 4 days

Exclusion Criteria

Pregnant or lactating

I have a condition affecting my hormone regulation.

I have not been hospitalized for depression or any psychiatric disorder in the last year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Integrated Lifestyle Intervention or Behavioral Weight Loss program, including digital tools for self-monitoring, group sessions, and e-coaching over 12 months

12 months

8 weekly group sessions, 4 bi-weekly sessions, monthly boosters

Follow-up

Participants are monitored for changes in adiposity, inflammation, and cardiometabolic risk factors

4 weeks

Treatment Details

Interventions

• Integrated Lifestyle Intervention (ILI)
• Monitoring with digital tools

Trial Overview The study tests how monitoring health with digital tools and an Integrated Lifestyle Intervention (ILI) can impact obesity-related inflammation in young adult women. It aims to improve cardiometabolic health by reducing chronic low-level inflammation.

Participant Groups

Group I: Integrated Lifestyle Intervention (ILI) Experimental Treatment 1 Intervention

ILI participants will receive training in empirically supported strategies to improve psychological function (e.g., restructuring negative thoughts, distress tolerance), with a focus on changing discrete behaviors linked to inflammation (e.g., sleep, processed foods, physical activity), all intertwined with BWL content adapted to meet the needs of EAs. All participants will receive digital tools to facilitate self-monitoring-the initial 4-month program will consist of group sessions via Zoom (8 weekly, 4 bi-weekly) with weekly tailored e-coaching, followed by monthly boosters through 12 months.

Group II: Behavioral Weight Loss (BWL) Experimental Treatment 2 Interventions

All participants will receive digital tools to facilitate self-monitoring-the initial 4-month program will consist of group sessions via Zoom (8 weekly, 4 bi-weekly) with weekly tailored e-coaching, followed by monthly boosters through 12 months.

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

Comprehensive lifestyle modification programs delivered in person can lead to an average weight loss of about 10% over 16-26 weeks, while web-based interventions typically result in around 5% weight loss, highlighting the effectiveness of in-person support.

Combining lifestyle changes with long-term medication use may enhance initial weight loss and help maintain weight loss over time, suggesting a multi-faceted approach could be beneficial for obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior therapy for obesity: where are we now? Sarwer, DB., von Sydow Green, A., Vetter, ML., et al.[2022]

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]

The Intensive Lifestyle Intervention (ILI) led to a significant weight loss of 7.19 kg at 12 months compared to usual care (UC) in a study involving 803 underserved patients with obesity, indicating its efficacy in promoting weight loss.

Several factors, including improvements in eating behaviors and physical activity, partially explained the weight loss during the ILI, but the ILI group experienced some weight regain by month 24, suggesting the need for ongoing support to maintain weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mediators of weight change in underserved patients with obesity: exploratory analyses from the Promoting Successful Weight Loss in Primary Care in Louisiana (PROPEL) cluster-randomized trial. Dorling, JL., Martin, CK., Yu, Q., et al.[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 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]

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]

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]

References

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

Behavior therapy for obesity: where are we now? [2022]

2. 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]

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

Mediators of weight change in underserved patients with obesity: exploratory analyses from the Promoting Successful Weight Loss in Primary Care in Louisiana (PROPEL) cluster-randomized trial. [2023]

4. 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]

5. 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]

6. 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]

7. 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]

8. 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]

9. Netherlands pubmed.ncbi.nlm.nih.gov

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

10. Netherlands pubmed.ncbi.nlm.nih.gov

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