Integrated Lifestyle Intervention for Obesity

Recruiting in Palo Alto (17 mi)

Overseen by Danielle Ostendorf, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Trial Summary

What is the purpose of this trial?

This study plans to learn more about the feasibility and acceptability of integrating the Move physical activity support program within an existing lifestyle intervention program.

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 data supports the effectiveness of the Integrated Lifestyle Intervention treatment for obesity?

Research shows that lifestyle modification programs, which include diet, exercise, and behavior changes, can lead to a weight loss of about 8-10% over 30 weeks. These programs are effective in managing obesity and can also help reduce cardiovascular risk factors.

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Is the Integrated Lifestyle Intervention safe for humans?

Lifestyle interventions, which include changes in diet, exercise, and psychological support, have been used safely in various programs for managing obesity and related health risks. These programs are generally well-accepted and focus on sustainable, healthy changes without significant safety concerns.

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How is the Integrated Lifestyle Intervention treatment different from other obesity treatments?

The Integrated Lifestyle Intervention treatment is unique because it combines diet, exercise, and psychological support to help manage obesity, focusing on lifestyle changes rather than medication. This approach aims to improve long-term adherence and is tailored to individual needs, making it different from standard treatments that may not address all these aspects together.

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Eligibility Criteria

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.

Trial Timeline

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

Participant Groups

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.

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Colorado Anschutz Medical Campus Aurora, CO

Who Is Running the Clinical Trial?

University of Colorado, Denver Lead Sponsor

National Heart, Lung, and Blood Institute (NHLBI) Collaborator

References

1. Sweden pubmed.ncbi.nlm.nih.gov

The ups and downs of lifestyle modification: An existential journey among persons with severe obesity. [2022] Maintaining a healthy living after the end of a lifestyle intervention is a challenge for persons with severe obesity. Measurable outcomes are often emphasised, but there is a need for understanding the process of lifestyle change and the long-term perspectives among persons with severe obesity.

2. Germany pubmed.ncbi.nlm.nih.gov

Lifestyle modification in the management of obesity: achievements and challenges. [2022] Lifestyle modification therapy for overweight and obese patients combines specific recommendations on diet and exercise with behavioral and cognitive procedures and strategies. In completers it produces a mean weight loss of 8-10 % in about 30 weeks of treatment. However, two main issues still to be resolved are how to improve dissemination of this approach, and how to help patients maintain the healthy behavioral changes and avoid weight gain in the long term. In recent years, several strategies for promoting and maintaining lifestyle modification have been evaluated, and promising results have been achieved by individualising the treatment, delivering the intervention by phone and internet or in a community setting, and combining lifestyle modification programs with residential treatment and bariatric surgery. These new strategies raise optimistic expectations for the effective management of obesity through lifestyle modification.

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

Lifestyle modification for the management of obesity. [2022] Several expert panels have recommended that obese individuals attempt to lose 10% of their initial body weight through a combination of diet, physical activity, and behavior therapy (frequently referred to as lifestyle modification). This article reviews the short-and long-term results of lifestyle modification and methods to improve them. Randomized controlled trials were examined that compared different diet and activity interventions for inducing and maintaining weight loss. Studies that compared different methods of providing lifestyle modification, including on-site vs. Internet-based delivery, also were examined. A comprehensive lifestyle modification program was found to induce a loss of approximately 10% of initial weight in 16 to 26 weeks of group or individual treatment, delivered on-site. Comprehensive Internet-based programs induced a loss of approximately half this size. Patients' consumption of portion-controlled diets, including liquid meal replacements, was associated with significantly greater short-term weight loss than was the consumption of isocaloric diets comprised of conventional foods. Factors associated with long-term weight control included continued patient-practitioner contact (whether on-site or by e-mail), high levels of physical activity, and the long-term use of pharmacotherapy combined with lifestyle modification. In summary, lifestyle modification induces clinically significant weight loss that is associated with the prevention or amelioration of cardiovascular risk factors.

4. United States 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. [2019] To assess the efficacy of a lifestyle intervention program that can be readily translated into clinical practice for obese patients with type 2 diabetes.

5. Canada pubmed.ncbi.nlm.nih.gov

Development of an obesity management ontology based on the nursing process for the mobile-device domain. [2021] Lifestyle modification is the most important factor in the management of obesity. It is therefore essential to enhance client participation in voluntary and continuous weight control.

6. Canada pubmed.ncbi.nlm.nih.gov

The Electronic CardioMetabolic Program (eCMP) for Patients With Cardiometabolic Risk: A Randomized Controlled Trial. [2019] Effective lifestyle interventions targeting high-risk adults that are both practical for use in ambulatory care settings and scalable at a population management level are needed.

7. England pubmed.ncbi.nlm.nih.gov

Behavior therapy for obesity: where are we now? [2022] To describe the short-term and long-term results of lifestyle modification for obesity.

8. England 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. [2018] Sustainable lifestyle modification strategies are needed to address obesity and cardiovascular risk factors. Intensive, individualised programs have been successful, but are limited by time and resources. We have formulated a group-based lifestyle education program based upon national diet and physical activity (PA) recommendations to manage obesity and cardio-metabolic risk factors. This article describes the content and delivery of this program, with information on compliance and acceptability.

9. Spain pubmed.ncbi.nlm.nih.gov

[Effectiveness of a program for treatment of overweight and nonmorbid obesity in primary healthcare and its influence lifestyle modification]. [2015] Lifestyle intervention is fundamental for obesity treatment. The aim of this study was to evaluate the effects of a program focused on diet, exercise and psychological support on Lifestyle Modification in overweight and obese patients treated in Primary Health Care setting.

10. Germany pubmed.ncbi.nlm.nih.gov

Weight Loss Strategies. [2022] Lifestyle interventions for weight loss combine support for changing diet and physical activity with weight management education and are considered the first line treatment for obesity. A variety of diet-focused interventions including time-restricted eating are also increasingly being promoted for weight management. This chapter reviews different types of interventions for weight management, their underlying health behavior change models, and effectiveness to date in randomized trials. The results justify increasing efforts to improve program effectiveness generally, and to personalize interventions to support long-term adherence. The high prevalence of obesity worldwide, combined with the known increase in risk of non-communicable diseases with duration of excess weight, provides a compelling justification for routine delivery of effective weight management interventions in the community and in clinical care.

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

Effect of Telehealth Extended Care for Maintenance of Weight Loss in Rural US Communities: A Randomized Clinical Trial. [2020] Lifestyle interventions for obesity produce reductions in body weight that can decrease risk for diabetes and cardiovascular disease but are limited by suboptimal maintenance of lost weight and inadequate dissemination in low-resource communities.