Stepped Care for Obesity
Recruiting in Palo Alto (17 mi)
Overseen byAriana M Chao, PhD, CRNP
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Johns Hopkins University
Disqualifiers: Serious medical, psychiatric, pregnancy, others
No Placebo Group
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.
12345What 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.
678910Eligibility 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.
I am between 18 and 70 years old.
Completion of baseline assessment tasks
+4 more
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
+5 more
Trial 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
Participant Groups
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.
3Treatment groups
Experimental Treatment
Active Control
Group I: Text-message intervention with digital tools (SELF)Experimental Treatment1 Intervention
Text-message intervention
Group II: Stepped Care (STEP)Experimental Treatment1 Intervention
Stepped care
Group III: Usual careActive Control1 Intervention
Usual care
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Johns Hopkins UniversityBaltimore, MD
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Who Is Running the Clinical Trial?
Johns Hopkins UniversityLead Sponsor
National Institute of Nursing Research (NINR)Collaborator
References
Implementation of a clinical practice guideline in a primary care setting for the prevention and management of obesity in adults. [2021]Over two-thirds of American adults have obesity or overweight, increasing the risk of comorbidities, mortality, and healthcare costs. Despite this growing issue, screening and counseling for an unhealthy weight are not common in primary care and clinical practice guidelines (CPGs) for prevention and management of obesity are underutilized. Following the stepwise approach outlined in the Registered Nurses' Association of Ontario Toolkit: Implementation of Best Practice Guidelines, the Institute for Clinical Systems Improvement: Prevention and Management of Obesity for Adults were implemented in a primary care office in Lexington, KY. Education was implemented with providers and staff. An assessment of readiness for change was completed at check-in and customizable phrases were built into the electronic health record. After a 12-week implementation, providers were consistently assessing for comorbidities, setting goals, and managing weight in those with obesity using evidence-based strategies. Readiness for change was being documented in less than 40% of those patients. For those with overweight providers were assessing readiness for change in only 30% of patients and were setting goals in just over 40% of patients. After the implementation, care more closely followed the CPG but additional steps are necessary to improve the prevention and management of obesity in this population.
A combined planning and telephone aftercare intervention for obese patients: effects on physical activity and body weight after one year. [2014]Obese patients require sustained lifestyle changes to reduce their health risks. We therefore developed a combined planning and telephone aftercare intervention based on the Health Action Process Approach to enhance physical activity after inpatient rehabilitation for obesity.
Clinical evaluation of patients living with obesity. [2023]Obesity is a significant public health concern which is implicated in cardiometabolic disease, mechanical complications and psychiatric sequelae. BMI is currently used for diagnosis; however, it has limited sensitivity for adiposity in certain circumstances. This has led to the development of risk stratification tools like the Edmonton Staging criteria and the Kings Obesity Staging Criteria: these facilitate and guide comprehensive obesity-related complication assessment. Healthcare professionals working within obesity clinics should adopt evidence-based communication strategies, including shared decision-making, motivational interviewing, and realistic goal setting. It is also vital to avoid weight-stigmatising terminology in all aspects of care, as this can negatively impact patients. Primary care plays an essential part in obesity care and should work to promptly identify cases, initiate treatment and forward on to specialist services where appropriate. Clinical evaluation of the patient living with obesity should take a holistic approach and involve input from bariatric physicians, dietitians, psychologists, and bariatric surgeons, wider members of the multi-disciplinary team should be involved where needed. Clinicians should take a detailed history, examination and order laboratory tests to investigate for complications. Overall, with appropriate evaluation, these assessments can guide patient management and facilitate long-term improvement in health.
A Proposed Standard of Obesity Care for All Providers and Payers. [2020]The aim of this work is to develop a practical, tangible, measurable, and simple standard of care for the treatment of adult obesity that provides guidance for both clinical providers and community settings.
Personalizing obesity assessment and care planning in primary care: patient experience and outcomes in everyday life and health. [2020]Obesity is a complex, chronic disease, frequently associated with multiple comorbidities. Its management is hampered by a lack of translation of evidence on chronicity and pathophysiology into clinical practice. Also, it is not well understood how to support effective provider-patient communication that adequately addresses patients' personal root causes and barriers and helps them feel capable to take action for their health. This study examined interpersonal processes during clinical consultations, their impacts, and outcomes with the aim to develop an approach to personalized obesity assessment and care planning. We used a qualitative, explorative design with 20 participants with obesity, sampling for maximum variation, to examine video-recorded consultations, patient interviews at three time points, provider interviews and patient journals. Analysis was grounded in a dialogic interactional perspective and found eight key processes that supported patients in making changes to improve health: compassion and listening; making sense of root causes and contextual factors in the patient's story; recognizing strengths; reframing misconceptions about obesity; focusing on whole-person health; action planning; fostering reflection and experimenting. Patient outcomes include activation, improved physical and psychological health. The proposed approach fosters emphatic care relationships and sensible care plans that support patients in making manageable changes to improve health.
Current treatment of obesity: a behavioral medicine perspective. [2005]Obesity is a complex biopsychosocial phenomenon. It has a profound effect on patients' physical and psychological health. Due to the complexity of the problem and the recidivism following treatment, it is recommended that obese patients receive in-depth interdisciplinary evaluation to match them appropriately to comprehensive treatment. Participation in an interdisciplinary comprehensive active weight loss treatment program followed by participation in a professionally led biweekly behavioral maintenance program that included social influence and aerobic exercise has generated maintenance of 83% of initial weight loss at an 18-month follow up. This comprehensive multi-disciplinary treatment approach, best offered in a behavioral medicine center setting, represents state-of-the-art treatment at this time and can result in long-term medical and psychological benefits for the obese patient.
Steps to Growing Up Healthy: a pediatric primary care based obesity prevention program for young children. [2022]Leading medical organizations have called on primary care pediatricians to take a central role in the prevention of childhood obesity. Weight counseling typically has not been incorporated into routine pediatric practice due to time and training constraints. Brief interventions with simple behavior change messages are needed to reach high-risk children, particularly Latino and Black children who are disproportionately affected by obesity and related comorbidities. Steps to Growing Up Healthy (Added Value) is a randomized controlled trial testing the efficacy of brief motivational counseling (BMC) delivered by primary care clinicians and the added value of supplementing BMC with monthly contact by community health workers (CHW) in the prevention/reversal of obesity in Latino and Black children ages 2-4 years old.
Technical skills for weight loss: 2-y follow-up results of a randomized trial. [2016]To investigate the sustained effectiveness of a novel skill-based intervention for weight loss.
Development and outcomes of an immersive obesity summit workshop for medical resident and fellow education. [2021]Physicians need better training to manage patients with obesity. Our study capitalized on the intimate nature of an extracurricular obesity workshop, creating an interactive educational programme. We assessed the short- and long-term impact of the workshop on trainees' knowledge, competence and confidence in caring for patients with obesity in an outpatient setting. This is a cross-sectional study, involving regionally diverse mix of resident and fellow physicians. A live 2.5-day continuing medical education summit was held 11 to 13 March 2016. Obesity-related topics were reviewed using state-of-the art pedagogical techniques. Pre-/post-levels of knowledge, competence and clinical practice strategies were analysed. Sixty-three candidates interested in additional obesity medicine training were nominated by US residency and fellowship programme directors and selected to attend the summit. On average, learners experienced a 110% relative increase in knowledge and competence. The overall effect size was 0.95, with participants being ~54% more knowledgeable about the management of patients with obesity. All participants self-reported that this activity increased their knowledge about the subject matter, improving their performance in caring for patients when asked about their practice in a follow-up survey 6 months following the workshop. This immersive summit promoted robust gains in knowledge and confidence, ultimately translating to reported practice improvements at the individual and health system levels. Future research is warranted on the sustainability of gained skills.
The Psychosocial Burden of Obesity. [2022]Obesity is associated with several comorbidities, including cardiovascular disease, type 2 diabetes, sleep apnea, osteoarthritis, and several forms of cancer. Obesity and its comorbidities also come with a significant psychosocial burden, impacting numerous areas of psychosocial functioning. The evaluation of psychosocial functioning is an important part of the assessment and treatment planning for the patient with obesity. This article provides an overview of the psychosocial burden of obesity. The article also describes the psychological changes typically seen with weight loss. A particular focus is on the psychosocial functioning of individuals with extreme obesity who present for and undergo bariatric surgery.