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

Trial Summary

What is the purpose of this trial?

This study is a 3-group, parallel design, randomized controlled trial (RCT) in approximately 258 adults with obesity that will investigate whether a 16-week behavioral weight loss treatment and a 52-week stepped-care digital health intervention can improve the maintenance of a ≥ 5% weight loss. 16-week run-in (Phase 1). To qualify for randomization, participants must lose ≥ 5% of initial weight in the 16-week run-in. This loss will be achieved with the provision of weekly-group lifestyle counseling, which includes a partial meal replacement diet. 52-week randomized trial of 3 weight loss maintenance strategies (Phase 2): Participants who have achieved ≥ 5% weight loss during Phase 1 will be randomly assigned to 1 of 3 groups: 1. Participants in the Usual Care group will be emailed monthly educational modules with information on maintaining weight loss. 2. Participants in the SELF group will receive a wireless "smart" body weight scale and a wearable physical activity tracker, and daily text messages with tailored feedback to assist in weight loss maintenance. 3. Participants in the STEP group will be enrolled in an intervention that consists of 4 steps that are progressive and based on response to treatment. After 13 weeks at each step, participants who do not maintain a ≥5% weight loss or regain 2 percentage points of weight from the participants randomization value will move to a higher intensity step. Participants who maintain weight loss will stay at the same step.

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.

What data supports the effectiveness of the Stepped Care for Obesity treatment?

Research shows that personalized care planning, which includes understanding personal root causes and fostering positive provider-patient communication, can help patients with obesity make manageable changes to improve their health. Additionally, implementing clinical practice guidelines in primary care settings has been shown to improve the management of obesity by setting goals and assessing readiness for change. ^{1 2 3 4 5}

What makes the STEP treatment for obesity unique compared to other treatments?

The STEP treatment, or Skills to Enhance Positivity, is unique because it focuses on enhancing positive skills and behaviors, which may differ from traditional obesity treatments that often emphasize diet and exercise alone. This approach could potentially address the psychological and behavioral aspects of obesity, offering a more holistic treatment option. ^{6 7 8 9 10}

Research Team

Ariana M Chao, PhD, CRNP

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

Weight > 440 lbs

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2021]

2. Sweden 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. [2014]

3. Italy pubmed.ncbi.nlm.nih.gov

Clinical evaluation of patients living with obesity. [2023]

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

A Proposed Standard of Obesity Care for All Providers and Payers. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Personalizing obesity assessment and care planning in primary care: patient experience and outcomes in everyday life and health. [2020]

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

Current treatment of obesity: a behavioral medicine perspective. [2005]

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

Steps to Growing Up Healthy: a pediatric primary care based obesity prevention program for young children. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Technical skills for weight loss: 2-y follow-up results of a randomized trial. [2016]

9. England pubmed.ncbi.nlm.nih.gov

Development and outcomes of an immersive obesity summit workshop for medical resident and fellow education. [2021]

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

The Psychosocial Burden of Obesity. [2022]