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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new lifestyle program designed to help young women manage their weight and improve health markers related to inflammation and metabolism over a year. Participants will follow either a traditional weight loss plan or an Integrated Lifestyle Intervention (ILI) that also emphasizes mental well-being and specific behaviors, such as improving sleep and reducing processed food intake. Women aged 18-25 with a BMI between 25 and 50, who are not currently in a weight loss program or using weight loss medications, may find this trial suitable. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance weight management strategies for young women.

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 prior data suggests that this lifestyle intervention is safe for emerging adult women?

Research has shown that lifestyle changes can be safe and effective for weight loss. One study found that participants in an Intensive Lifestyle Intervention (ILI) lost an average of 8.6% of their starting weight after 12 months. Changes such as healthier eating and increased activity are generally safe and well-tolerated by most people.

Digital tools used in these programs also help individuals stay on track. Studies indicate that digital self-monitoring can boost motivation and accountability. These tools provide quick feedback, which encourages adherence to goals.

Overall, lifestyle changes combined with digital tools have demonstrated positive results without major safety concerns. However, consulting a healthcare provider before starting any new program is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Integrated Lifestyle Intervention (ILI) for obesity because it combines behavioral weight loss strategies with psychological training to tackle inflammation-related behaviors like poor sleep and eating processed foods. Unlike standard treatments that often focus solely on diet and exercise, ILI also includes digital tools for self-monitoring and personalized e-coaching, offering a more holistic approach to weight management. This comprehensive method aims to improve not just weight loss but overall psychological well-being, setting it apart from traditional options.

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

Research has shown that intensive lifestyle changes can lead to significant weight loss. For example, one study found that half of the participants with type 2 diabetes maintained at least a 5% reduction in body weight after eight years. These changes typically involve consuming fewer calories and increasing physical activity.

In this trial, participants will join different treatment arms. The Integrated Lifestyle Intervention (ILI) arm will train participants in strategies to enhance psychological function and modify behaviors linked to inflammation, alongside behavioral weight loss content. Meanwhile, the Behavioral Weight Loss (BWL) arm will offer digital tools for self-monitoring and structured support through group sessions and e-coaching. Both methods emphasize structured support and progress tracking to aid in weight management. ^{6 7 8 9 10}

Who Is on the Research Team?

Jessica LaRose

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

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

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

I am female.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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/PMC3258572/

Cognitive-Behavioral Therapy, Behavioral Weight Loss ... Remission from binge-eating was associated with significantly greater percent BMI loss. Findings support BWL as an alternative treatment option to CBT for BED.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7647951/

The Effects of Behavioral Weight Loss and ... Attendance in BWL classes and setting a weight loss goal results in greater weight loss than either not attending BWL or not setting a weight loss goal.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2352578921002010

Effectiveness of profile by Sanford behavioral weight loss ... This study showed that participants enrolled in the Profile BWL program lost significantly more weight than those in the matched control group who received ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2837210

Regulation of Cues vs Cognitive Behavioral Therapy for ... Although ROC+BWL resulted in greater weight loss compared with CBT during treatment, these differences were not maintained.

5. mhealth.jmir.org mhealth.jmir.org/2023/1/e45057

Patterns and Predictors of Engagement With Digital Self ... Background: Long-term self-monitoring (SM) of weight, diet, and exercise is commonly recommended by behavioral weight loss (BWL) treatments.

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

Eight-Year Weight Losses with an Intensive Lifestyle ... The lifestyle intervention's strengths are offset by findings that 32% of ILI participants did not lose at least 5% of initial weight in the first year, and ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0016508517301397

Intensive Lifestyle Intervention for Obesity The Guidelines recommend a minimum of 6 months of high-intensity, comprehensive lifestyle intervention, consisting of a reduced-calorie diet, increased physical ...

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

Intensive Lifestyle Intervention for Obesity At month 12, the ILI produced a mean loss of 8.6% of their initial weight, and 68.0% of participants lost ≥5% of their initial weight. Participants in the DSE ...

9. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/226013

Long-term Effects of a Lifestyle Intervention on Weight and ... This report examines the changes in weight, fitness, glycemic control, and CVD risk factors during a 4-year period for 5145 overweight or obese ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2613279/

The Look AHEAD Study: A Description of the Lifestyle ... This article describes the lifestyle intervention and the empirical evidence to support it. The two principal intervention goals are to induce a mean loss ≥ 7% ...