Integrated Lifestyle Intervention for Obesity

Overseen By Danielle M Ostendorf, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Appetite suppressants, Antipsychotics, Tricyclic antidepressants, others

Disqualifiers: Cardiovascular disease, Diabetes, Renal disease, others

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

Compensation: Varies

Number of Visits: 12

Duration: 26 weeks

64 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how effectively an Integrated Lifestyle Intervention (a structured lifestyle program) can manage weight when combined with physical activity support. It tests various combinations, including group classes, one-on-one sessions, fitness app memberships, and mental imagery exercises. The target participants are individuals with a BMI between 25 and 45 who have engaged in less than 150 minutes of moderate exercise weekly for the past three months. This trial is designed for those interested in a structured weight management plan without enrolling in other programs. As an unphased trial, it offers a unique opportunity to participate in innovative weight management strategies.

Will I have to stop taking my current medications?

The trial requires that participants do not regularly use medications that significantly impact appetite, weight, sleep, or energy metabolism, such as appetite suppressants, lithium, stimulants, anti-psychotics, and tricyclic antidepressants. If you are taking any of these, you may need to stop before joining the study.

What prior data suggests that this integrated lifestyle intervention is safe?

Research has shown that lifestyle changes, like those in this study, are generally safe. Studies have found that programs involving diet changes, exercise, and support can help people lose weight and improve health. Most participants find them easy to follow without issues.

These programs often lead to moderate weight loss and a decrease in body mass index (BMI), indicating effectiveness without harm. Overall, participants in similar programs have not reported serious side effects, making these lifestyle changes a safe option for managing obesity. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Integrated Lifestyle Intervention for Obesity because it combines several innovative approaches to weight management. Unlike standard treatments that often focus solely on diet or exercise, this intervention integrates a structured lifestyle program with group classes led by a registered dietitian, personalized one-on-one support, and mental imagery techniques to enhance motivation and engagement. Additionally, some treatment arms include access to the Peloton fitness app, which offers a flexible and engaging way to stay active. This comprehensive strategy not only addresses physical health but also the psychological aspects of weight management, potentially leading to more sustainable results.

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

Research has shown that combining diet, exercise, and behavior changes can lead to significant weight loss. In this trial, participants will join different treatment arms, each incorporating elements such as group classes, personal coaching, fitness memberships, and mental imagery. For example, some studies have found that people can lose about 4.19 kilograms on average, and 40.3% may lose at least 5% of their body weight. These programs often include support like group classes and personal coaching, which help individuals make and maintain healthy changes over time. Additionally, more than half of the participants in certain studies achieved weight loss that significantly improved their health. Overall, these combined lifestyle approaches effectively reduce obesity. ^{1 3 4 6 7}

Who Is on the Research Team?

Danielle Ostendorf, PhD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for English-speaking men and women aged 18-65 who are overweight or obese with a BMI of 25-45 kg/m2, lead a sedentary lifestyle (exercising less than 150 minutes per week), and have not been in any weight loss or exercise programs recently. They must have access to technology like computers or smartphones with Wi-Fi, and be willing to attend program sessions.

Inclusion Criteria

You have not participated in moderate intensity exercise for at least 150 minutes per week during the preceding 3 months.

You are a provider participant.

You have more than one year of experience in providing interventions to modify dietary and/or exercise habits.

Exclusion Criteria

- Nicotine use (current or past 6 months)

- History of clinically diagnosed eating disorders including anorexia nervosa, bulimia, binge eating disorder. Score >20 on the Eating Attitudes Test (EATS-26) or pattern of response on the Questionnaire on Eating and Weight Patterns-5 (QEWP-5) suggestive of possible binge eating disorder or bulimia will require further assessment by the Study MD to determine if it is appropriate for the subject to participate in the study.

I have heart, blood vessel, or stroke-related conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 6-month lifestyle weight management program integrated with the Move group-based classes, including weekly and biweekly virtual sessions

26 weeks

12 weekly visits, 7 biweekly visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Integrated Lifestyle Intervention

Trial Overview The study is testing the integration of the Move physical activity support program into an existing lifestyle intervention. Participants will receive various supports such as one-on-one coaching, mental imagery techniques, fitness memberships, group-based classes, and Prevent T2 strategies to encourage healthier living habits.

How Is the Trial Designed?

Group I: PreventT2 + Move group-based classes + Move 1:1 Support Experimental Treatment 3 Interventions

Participants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum (formally known as the National Diabetes Prevention Program), integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian from the Colorado Nutrition Obesity Research Center Clinical Intervention and Translation (CIT) Core. Participants will also receive Move individualized support sessions. The 1:1 support sessions are designed to help participants adopt the physical activity messages from each Move group-based class into their daily lives.

Group II: PreventT2 + Move group-based classes + Mental Imagery + Move 1:1 Support Experimental Treatment 4 Interventions

Participants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum (formally known as the National Diabetes Prevention Program), integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian from the Colorado Nutrition Obesity Research Center Clinical Intervention and Translation (CIT) Core. Participants will also receive Move individualized support sessions. The 1:1 support sessions are designed to help participants adopt the physical activity messages from each Move group-based class into their daily lives. In addition, participants will receive access to online mental guided imagery sessions. Guided positive exercise imagery scripts were developed based on work from Williams et al. and prompt several sensory and emotional experiences.

Group III: PreventT2 + Move group-based classes + Mental Imagery + Fitness Membership Experimental Treatment 4 Interventions

Participants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum (formally known as the National Diabetes Prevention Program), integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian from the Colorado Nutrition Obesity Research Center Clinical Intervention and Translation (CIT) Core. Participants will also receive a 6-month membership to the Peloton fitness app. In addition, participants will receive access to online mental guided imagery sessions. Guided positive exercise imagery scripts were developed based on work from Williams et al. and prompt several sensory and emotional experiences.

Group IV: PreventT2 + Move group-based classes + Mental Imagery Experimental Treatment 3 Interventions

Participants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum (formally known as the National Diabetes Prevention Program), integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian from the Colorado Nutrition Obesity Research Center Clinical Intervention and Translation (CIT) Core. In addition, participants will receive access to online mental guided imagery sessions. Guided positive exercise imagery scripts were developed based on work from Williams et al. and prompt several sensory and emotional experiences.

Group V: PreventT2 + Move group-based classes + Fitness Membership + Move 1:1 Support Experimental Treatment 4 Interventions

Participants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum (formally known as the National Diabetes Prevention Program), integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian from the Colorado Nutrition Obesity Research Center Clinical Intervention and Translation (CIT) Core. Participants will also receive a 6-month membership to the Peloton fitness app. Participants will also receive Move individualized support sessions. The 1:1 support sessions are designed to help participants adopt the physical activity messages from each Move group-based class into their daily lives.

Group VI: PreventT2 + Move group-based classes + Fitness Membership + Mental Imagery + Move 1:1 Support Experimental Treatment 5 Interventions

Participants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum, integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian. Participants will also receive a 6-month membership to the Peloton fitness app. Participants will also receive Move individualized support sessions. In addition, participants will receive access to online mental guided imagery sessions.

Group VII: PreventT2 + Move group-based classes + Fitness Membership Experimental Treatment 3 Interventions

Participants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum (formally known as the National Diabetes Prevention Program), integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian from the Colorado Nutrition Obesity Research Center Clinical Intervention and Translation (CIT) Core. Participants will also receive a 6-month membership to the Peloton fitness app.

Group VIII: PreventT2 + Move group-based classes Experimental Treatment 2 Interventions

Participants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum (formally known as the National Diabetes Prevention Program), integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian from the Colorado Nutrition Obesity Research Center Clinical Intervention and Translation (CIT) Core.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

A lifestyle intervention program combining diet, exercise, and psychological support significantly improved lifestyle-related behaviors in 60 overweight and obese patients over 6 months, as evidenced by better scores in dietary caloric intake, physical activity, and healthy eating.

The program also led to positive changes in body composition parameters, indicating that such comprehensive interventions can effectively support weight management in a primary healthcare setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness of a program for treatment of overweight and nonmorbid obesity in primary healthcare and its influence lifestyle modification]. Arrebola Vivas, E., Gómez-Candela, C., Fernández Fernández, C., et al.[2015]

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]

A 12-month study involving 147 obese patients with type 2 diabetes showed that a lifestyle intervention program led by dietitians resulted in significantly greater weight loss (3.0 kg) and reduced waist circumference (-4.2 cm) compared to usual care.

Participants in the lifestyle case management group also experienced improved HbA1c levels, reduced use of diabetes medications by 0.8 medications per day, and enhanced health-related quality of life across multiple domains, indicating the program's effectiveness in managing diabetes and obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating lifestyle intervention to practice in obese patients with type 2 diabetes: Improving Control with Activity and Nutrition (ICAN) study. Wolf, AM., Conaway, MR., Crowther, JQ., et al.[2019]

A comprehensive lifestyle modification program can lead to a significant weight loss of about 10% of initial body weight within 16 to 26 weeks, especially when delivered through group or individual on-site treatments.

Long-term weight control is enhanced by ongoing contact with healthcare providers, high physical activity levels, and the use of medications alongside lifestyle changes, which also help in reducing cardiovascular risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle modification for the management of obesity. Wadden, TA., Butryn, ML., Wilson, C.[2022]

Individuals with severe obesity experience a complex and dynamic process of maintaining lifestyle changes three years after intervention, characterized by ups and downs in their daily lives.

Support from healthcare providers and a collaborative, humanized approach are crucial for helping these individuals navigate the challenges of sustaining healthy living and making ongoing adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ups and downs of lifestyle modification: An existential journey among persons with severe obesity. Toft, BS., Hörberg, U., Rasmussen, B.[2022]

An obesity management ontology was successfully developed, focusing on enhancing client participation in weight control through tailored interventions, with a high evaluation score of 4.5 out of 5.

The ontology includes 127 concepts related to obesity management, such as behavioral interventions and dietary advice, and was implemented in a prototype Android application to facilitate effective client engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an obesity management ontology based on the nursing process for the mobile-device domain. Kim, HY., Park, HA., Min, YH., et al.[2021]

Lifestyle modification therapy can lead to a significant weight loss of 8-10% over approximately 30 weeks for overweight and obese patients, combining diet, exercise, and behavioral strategies.

To enhance the effectiveness and sustainability of this therapy, new strategies such as individualized treatment, remote delivery via phone or internet, and integration with community programs or bariatric surgery have shown promising results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle modification in the management of obesity: achievements and challenges. Dalle Grave, R., Calugi, S., El Ghoch, M.[2022]

The Electronic Cardio-Metabolic Program (eCMP) was found to be a feasible and well-accepted intervention for high-risk adults, with a high retention rate of 93% at 3 months and 86% at 6 months.

Participants in the eCMP experienced significant weight loss and reductions in waist circumference, along with decreased anxiety and perceived stress, indicating potential benefits in cardiometabolic risk factors despite no significant change in overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Electronic CardioMetabolic Program (eCMP) for Patients With Cardiometabolic Risk: A Randomized Controlled Trial. Azar, KM., Koliwad, S., Poon, T., et al.[2019]

A 16-week group-based lifestyle education program for overweight and obese adults with metabolic syndrome led to significant improvements in body composition and cardio-metabolic health, demonstrating effectiveness similar to more intensive individual programs.

Participants found practical components like food-label reading and cooking sessions particularly helpful, and the program's peer support structure enhanced motivation and engagement, suggesting that social support is crucial for successful lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management for obesity and cardio-metabolic fitness: description and evaluation of the lifestyle modification program of a randomised controlled trial. Pettman, TL., Misan, GM., Owen, K., et al.[2018]

A randomized clinical trial involving 445 participants showed that individual telephone counseling for obesity management significantly reduced weight regain compared to an email education control, with a posterior probability greater than 99%.

Participants receiving individual telephone counseling were more likely to achieve at least a 10% weight reduction (31.5%) compared to those in the control group (19.1%), indicating that personalized support can enhance long-term weight loss maintenance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Telehealth Extended Care for Maintenance of Weight Loss in Rural US Communities: A Randomized Clinical Trial. Perri, MG., Shankar, MN., Daniels, MJ., et al.[2020]

Lifestyle interventions that combine dietary changes, physical activity support, and weight management education are the first-line treatment for obesity, emphasizing their importance in addressing the global obesity epidemic.

The chapter highlights the need for personalized weight management programs to enhance effectiveness and long-term adherence, given the significant health risks associated with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Loss Strategies. Roberts, SB., Anton, S., Dao, MC.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7027681/

Lifestyle Modification Approaches for the Treatment of ... This article reviews the principal components of comprehensive lifestyle modification, which include diet, physical activity, and behavior therapy.

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

Behavioral Lifestyle Interventions for Moderate and Severe ... Among the 25 behavioral interventions in the 12 studies, 18 reported percent of participants achieving clinically significant weight loss up to 12 months (32–97 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0090825825007279

Integration of a lifestyle modification intervention for women ... Moreover, the LMI was found to be effective in helping patients lose a mean of 4.19 kgs during the intervention, with 40.3 % of patients losing at least 5 % of ...

4. ahajournals.org ahajournals.org/doi/10.1161/circulationaha.111.039453

Lifestyle Modification for Obesity | Circulation Lifestyle modification, also referred to as behavioral weight control, includes 3 primary components: diet, exercise, and behavior therapy.

5. nyaspubs.onlinelibrary.wiley.com nyaspubs.onlinelibrary.wiley.com/doi/full/10.1111/nyas.15278

Behavior‐change lifestyle interventions for the treatment of ... Summary of findings​​ Most behavior-change lifestyle interventions had moderate effects in reducing obesity outcomes (e.g., body weight, BMI, and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3313649/

Lifestyle Modification for Obesity: New Developments in Diet ... Lifestyle modification, also referred to as behavioral weight control, includes 3 primary components: diet, exercise, and behavior therapy.

7. nature.com nature.com/articles/s41366-024-01499-2

Structured lifestyle modification as an adjunct to obesity ... There is strong evidence that structured lifestyle modification programmes improve health in patients with obesity and related disorders.