Stepped Care for Obesity

Overseen By Ariana M Chao, PhD, CRNP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Serious medical, psychiatric, pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to help people maintain weight loss after losing at least 5% of their initial weight. Participants will first complete a 16-week program focused on lifestyle changes and meal replacements to lose weight. Successful participants will then join one of three groups for a year: one group receives monthly educational emails, another uses digital tools like a smart scale and activity tracker (known as SELF, a Digital Health Intervention for Weight Loss Maintenance), and the third follows a step-by-step program called STEP (Skills to Enhance Positivity) that adjusts based on progress. Ideal participants are adults with a body mass index (BMI) of 30 or higher, or 27 with a related health issue, who have access to a smartphone and home internet. As an unphased trial, this study offers participants the chance to explore innovative weight maintenance strategies that could improve their long-term health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you recently started or changed the dosage of a medication that can cause significant weight change, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that digital health tools for weight loss, such as the SELF program, are effective and safe. These tools, which include wearable devices and personalized text messages, perform as well as in-person weight loss programs. They typically lack serious side effects, making them a suitable option for many individuals.

The STEP program is newer, so less information is available about its safety. However, it employs a method that adjusts based on individual progress, aiming to provide safe and personalized support. More research is needed to confirm its safety, but the goal is to help maintain weight loss in a manageable way.

Both programs aim to support weight loss journeys with minimal risk, though individual experiences may vary. Consulting a healthcare provider about available options is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Stepped Care (STEP) approach for obesity because it offers a personalized way to tackle weight management. Unlike traditional options that often focus solely on lifestyle changes or medication, STEP combines different strategies, adjusting the intensity of interventions based on individual progress. This adaptability allows for a more tailored approach, potentially leading to better long-term results. Additionally, the use of digital tools and text-message interventions in the SELF arm offers a modern, tech-savvy way to engage patients, making it easier for them to stick with healthy habits. This blend of personalized care and digital support could transform how we approach obesity treatment.

What evidence suggests that this trial's treatments could be effective for weight loss maintenance?

This trial will compare different approaches to weight management, including a text-message intervention with digital tools (SELF) and a stepped care approach (STEP). Studies have shown that digital health tools, such as text messages and activity trackers, can aid weight loss, with users often losing about 2–2.5 kg more than those who don't use these tools. Research also indicates that these digital tools effectively help people maintain weight loss over time.

In the stepped care approach tested in this trial, research suggests that gradually increasing support levels can aid weight management. One study found that people using this method lost weight and maintained their weight loss better than with some other methods. By adjusting support based on individual progress, this approach may lead to better long-term results. ^{1 2 3 6 7}

Who Is on the Research Team?

Ariana M Chao, PhD, CRNP

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with obesity, defined as a BMI of at least 30 or at least 27 with an obesity-related complication. Participants must have lost at least 5% of their initial weight during the first phase of the study, be able to exercise, own a smartphone and have home wireless access.

Inclusion Criteria

My BMI is 30 or higher, or it's 27 or higher with an obesity-related health issue.

Completion of baseline assessment tasks

Ability to engage in physical activity

Exclusion Criteria

Serious medical condition or psychiatric condition that may pose a risk to the participant during intervention, cause a change in weight, or limit ability to adhere to the behavioral recommendations of the program

Pregnant or planning pregnancy in the next 1.5 years

I recently started or changed the dose of a medication that can affect my weight.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in

16-week behavioral weight loss treatment with weekly-group lifestyle counseling and a partial meal replacement diet

16 weeks

Weekly group sessions

Randomized Treatment

52-week randomized trial of 3 weight loss maintenance strategies: Usual Care, SELF, and STEP

52 weeks

Monthly educational modules (Usual Care), daily text messages and digital tools (SELF), progressive steps based on response (STEP)

Follow-up

Participants are monitored for weight maintenance and other health metrics after the treatment phase

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SELF
• STEP
• Usual care

Trial Overview The trial tests three strategies for maintaining weight loss over a year after an initial successful dieting phase. Usual Care involves monthly educational emails; SELF includes smart scales, activity trackers, and daily texts; STEP has four escalating steps based on individual progress.

How Is the Trial Designed?

Group I: Text-message intervention with digital tools (SELF) Experimental Treatment 1 Intervention

Text-message intervention

Group II: Stepped Care (STEP) Experimental Treatment 1 Intervention

Stepped care

Group III: Usual care Active Control 1 Intervention

Usual care

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

An interdisciplinary comprehensive weight loss program, combined with a biweekly behavioral maintenance program, helped participants maintain 83% of their initial weight loss after 18 months.

This multi-disciplinary approach, which includes social support and aerobic exercise, is considered the best current treatment for obesity, providing significant long-term health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current treatment of obesity: a behavioral medicine perspective. Pera, V., Clark, MM., Abrams, DB.[2005]

A randomized controlled trial involving 80 overweight/obese women showed that both a skill-based intervention (SBI) and counseling-based intervention (CBI) led to significant weight loss at 6 months, with participants maintaining some weight loss at 24 months.

The SBI group demonstrated a significant reduction in dietary fat intake, suggesting that this intervention may positively influence eating habits, although the long-term weight loss differences between SBI and CBI were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical skills for weight loss: 2-y follow-up results of a randomized trial. Yeh, MC., Rodriguez, E., Nawaz, H., et al.[2016]

The 'Steps to Growing Up Healthy' trial is testing a brief motivational counseling (BMC) intervention for preventing obesity in Latino and Black children aged 2-4 years, with a target of 150 mother-child dyads over 12 months.

The study aims to determine if adding monthly contact from community health workers (CHWs) enhances the effectiveness of BMC in reducing children's BMI percentiles, potentially providing a scalable approach to obesity prevention in high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Steps to Growing Up Healthy: a pediatric primary care based obesity prevention program for young children. Gorin, AA., Wiley, J., Ohannessian, CM., et al.[2022]

Obesity is linked to various serious health issues, such as cardiovascular disease and type 2 diabetes, as well as significant psychosocial challenges that affect daily functioning.

The article highlights the importance of assessing psychosocial functioning in patients with obesity, especially those undergoing bariatric surgery, as weight loss can lead to notable psychological improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Psychosocial Burden of Obesity. Sarwer, DB., Polonsky, HM.[2022]

After implementing a structured approach to obesity management in a primary care office, providers improved their assessment and management of patients with obesity, aligning more closely with clinical practice guidelines.

Despite these improvements, less than 40% of patients had their readiness for change documented, indicating that further efforts are needed to enhance the prevention and management of obesity in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a clinical practice guideline in a primary care setting for the prevention and management of obesity in adults. Rust, C., Prior, RM., Stec, M.[2021]

A randomized controlled trial involving 467 obesity rehabilitation patients showed that a combined planning and telephone aftercare intervention significantly increased physical activity levels after 12 months, with participants engaging in 58 more minutes of activity per week compared to the control group.

Despite the increase in physical activity, the intervention did not lead to a significant reduction in body weight compared to standard care, suggesting that enhancing physical activity alone may still help reduce health risks for obese patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A combined planning and telephone aftercare intervention for obese patients: effects on physical activity and body weight after one year. Ströbl, V., Knisel, W., Landgraf, U., et al.[2014]

Obesity is linked to various health issues, and while BMI is commonly used for diagnosis, it may not accurately reflect body fat in all cases, prompting the need for more comprehensive risk assessment tools like the Edmonton and Kings Obesity Staging Criteria.

Effective obesity management requires a multi-disciplinary approach involving various healthcare professionals, and it is crucial to use supportive communication strategies while avoiding weight-stigmatizing language to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of patients living with obesity. Dobbie, LJ., Coelho, C., Crane, J., et al.[2023]

The STOP Obesity Alliance developed a new standard of care for treating adult obesity through collaborative roundtable discussions, aiming to create clear guidelines for clinical providers and community settings.

This standard includes practices for various treatment settings and addresses coverage and payment policies, serving as a foundational step to enhance existing obesity care guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Proposed Standard of Obesity Care for All Providers and Payers. Dietz, WH., Gallagher, C.[2020]

The study identified eight key interpersonal processes during clinical consultations that help patients with obesity make meaningful health changes, including compassion, understanding root causes, and action planning.

By focusing on personalized care and fostering empathetic relationships, the approach led to improved patient activation and better physical and psychological health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalizing obesity assessment and care planning in primary care: patient experience and outcomes in everyday life and health. Luig, T., Anderson, R., Sharma, AM., et al.[2020]

A 2.5-day interactive workshop significantly improved the knowledge and competence of 63 resident and fellow physicians in managing obesity, with an average increase of 110% in their understanding of obesity-related topics.

Participants reported enhanced confidence and improved patient care practices six months after the workshop, indicating that immersive training can lead to meaningful changes in clinical practice regarding obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and outcomes of an immersive obesity summit workshop for medical resident and fellow education. Velazquez, A., Robinson, KJH., Frederick, JL., et al.[2021]

Citations

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2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10145832/

Digital Health Solutions for Weight Loss and Obesity The matched-pair control group gained 1.81% total body weight (TBW) without Vida coaching and lost −2.47% with Vida, whilst the total intervention group lost ...

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Five-year follow-up of a randomized weight loss trial on ... A meta-analysis showed that digital interventions may be more effective in weight loss than a non-digital intervention in the short-term [7].

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Efficacy of in-person versus digital enhanced lifestyle ... Digitally enhanced lifestyle interventions are associated with superior weight loss outcomes and higher achievement rates of weight loss clinical milestones ...

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Digital behaviour change intervention for weight loss ... This mixed methods study aims to evaluate user experiences, system use, and preliminary efficacy of eCHANGE, an application based self-management intervention ...

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Optimizing Self-Monitoring in a Digital Weight Loss ... Self-monitoring is a well-established behavioral strategy for facilitating weight loss among adults with overweight or obesity. [20-22]. It ...

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Implementation of a digital behavior change intervention ... Based on the development and implementation process of eCHANGE, an evidence-informed application-based self-management intervention for weight loss maintenance.