Patient Coach Support for Obesity

Overseen By Shenbagam Dewar, MD, ABOM

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Active mental health disorder, cognitive impairment, mobility limited

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a personal coach in helping people adhere to a weight management plan. The coach collaborates with participants to overcome challenges and maintain motivation on their health journey. The trial seeks individuals with a BMI of 35 or higher who face weight-related health issues such as high blood pressure or diabetes. Participants should be able to move around a room and have an interest in managing their weight. As an unphased trial, this study provides a unique opportunity for participants to receive personalized support in their weight management journey.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this patient coaching is safe for weight loss?

Research shows that coaching for weight management is generally manageable for patients. Studies have found that a peer coach can aid weight loss in primary care settings and encourage participation in weight management programs. One study found that patients who met with both a coach and a doctor lost a significant amount of weight over 24 weeks.

Overall, health coaching empowers patients with the knowledge and skills to actively participate in their care. Reports of major negative effects from these coaching methods have not emerged, suggesting that patient coaching is a safe way to support weight management goals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Patient Coach Support is unique because it offers a personalized, human-centered approach to tackling obesity, unlike the standard options like medications or surgical interventions. This method focuses on behavioral change through regular, supportive interactions, which can lead to more sustainable weight loss and lifestyle improvements. Researchers are excited about this approach because it empowers patients by giving them the tools and motivation to manage their condition in a more holistic and long-term way.

What evidence suggests that patient coach support is effective for obesity?

Research has shown that health coaching, which participants in this trial will receive, can help obese adults lose weight. One study found that health coaching led to significant weight loss. Another study showed that peer coaching helped many participants lose at least 5% of their body weight. Additionally, combining health coaching with self-monitoring tools improved weight and lifestyle habits. These findings suggest that having a coach can help people adhere to their weight management plans and achieve better weight loss results. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for older adults who are dealing with obesity. Participants should be willing to follow a weight and lifestyle plan (OHWL Clinic Activities) and work with a coach who will support them outside of the clinic setting. Specific eligibility criteria were not provided, so it's important to contact the study organizers for detailed requirements.

Inclusion Criteria

Body Mass Index (BMI) equal to or greater than 35

Interest in weight management

I can walk across a room with or without help from a device.

Exclusion Criteria

Active mental health disorder, such as major depression

I have significant memory or thinking problems.

I am unable to leave my bed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive support from a patient coach to adhere to the Optimal Health Weight and Lifestyle (OHWL) Clinic plan, including attending physical therapy and nutritional consultations.

6 months

Regular visits as needed for coaching and consultations

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in PROMIS-29 and NHATS scores.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Patient Coach Support

Trial Overview

The study is testing if adding a personal coach to standard obesity treatment helps older adults stick to their health plans better. The coaches operate independently from the clinic, supported by research funds, and their effectiveness will be evaluated through patient data, performance measures, and interviews.

How Is the Trial Designed?

Group I: Study Participants Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

A randomized control trial involving 60 obese students showed that a self-empowerment-based coaching program significantly reduced total body fat and improved healthy behavior habits compared to a control group.

The intervention group also reported greater improvements in satisfaction related to hobbies, exercise, sleep, and spiritual well-being, indicating a holistic benefit of the coaching approach in managing obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of self-empowerment-based patient-centered care for obese students in primary services: A randomized controlled trial. Dewi, DK., Sekartini, R., Sunardi, D., et al.[2023]

A randomized controlled trial involving 340 participants showed that a digital lifestyle coaching program led to a significant weight loss of 4.5 kg over 12 months compared to only 1.5 kg in the usual care group, indicating the efficacy of digital coaching for obesity management.

Both groups experienced reductions in hemoglobin A1c levels, suggesting improvements in blood sugar control, but there was no significant difference between the groups, highlighting that while weight loss was greater in the intervention group, blood sugar improvements were similar for both.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Weight Loss in a Primary Care-Anchored eHealth Lifestyle Coaching Program: Randomized Controlled Trial. Hesseldal, L., Christensen, JR., Olesen, TB., et al.[2022]

A study involving 225 nurse practitioner students revealed that they observed significant differences in how preceptors managed obesity, with many preceptors demonstrating positive, unbiased interactions with patients.

Despite concerns in existing literature about weight bias, NP students reported that their preceptors often displayed warmth and support when treating patients with obesity, suggesting a need for continued education on effective and compassionate obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse practitioner students' observations of preceptor engagement in obesity management and weight bias: A mixed-methods approach. Hauff, C., Fruh, SM., Sims, BM., et al.[2022]

A systematic review of 22 studies on coaching for obesity treatment found that these interventions were effective, achieving a 51% success rate in reducing weight and improving physical activity and eating habits.

Most studies had moderate quality, with 46% being randomized controlled trials, and interventions typically lasted between 2 to 19 months, primarily targeting adults in both private and public settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Coaching for the treatment of obesity and overweight: a systematic review]. Cordella, P., Costa-Cordella, S., Lecumberri, M., et al.[2022]

The study involved ten previously hospitalized patients living with obesity and used qualitative interviews to explore their experiences, revealing that timely access to appropriate equipment and better hospital infrastructure are crucial for meeting their care needs.

Participants highlighted the importance of positive interpersonal interactions with healthcare professionals, expressing a need for improved communication and awareness of weight bias, which could enhance their overall hospital experience and support weight loss efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The lived experience of patients with obesity at a metropolitan public health setting. Pazsa, FM., Said, CM., Haines, KJ., et al.[2022]

Integrating the Get Healthy Service, a telephone-delivered coaching program, with standard multidisciplinary care led to significant weight loss and improvements in body mass index for participants, with the intervention group losing an average of 12.6 kg over 6 months.

Both the control and intervention groups showed similar health improvements, indicating that the telephone coaching service is a viable adjunct to obesity treatment, with high patient satisfaction reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Telephone Health Coaching Integration with Standard Multidisciplinary Care for Adults with Obesity Attending a Weight Management Service: A Pilot Study. Driscoll, S., Meyerowitz-Katz, G., Ahlenstiel, G., et al.[2022]

In a 6-month weight loss program involving 1432 participants, those who attended more expert coaching sessions, live weekly classes, and received regular feedback on their food logs experienced significant weight loss, averaging 5.14% of their baseline weight.

Specifically, attending 80% of coaching sessions, 60% of live classes, and receiving at least one feedback day per week were identified as key factors that contributed to clinically significant weight loss outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expert Coaching in Weight Loss: Retrospective Analysis. Painter, SL., Ahmed, R., Kushner, RF., et al.[2019]

A new approach to weight loss emphasizes client responsibility, encouraging individuals to take charge of their own weight management rather than relying solely on health providers.

The study introduces a guiding instrument that helps clients plan, execute, and evaluate their weight loss actions, aiming to foster independence and improve long-term success in weight reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting the management of weight reduction. Whitman, NA.[2019]

In a study of 225 participants in a telephonic health coaching program, those who engaged in at least 6 coaching sessions experienced a significant average weight loss of -3.5%, compared to a modest overall weight change of -2.1% for the group.

Despite the focus on weight management, the study found no significant changes in healthcare utilization or costs associated with program engagement, suggesting that while coaching can aid weight loss, it may not impact healthcare visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating an insurer-based health coaching program: Impact of program engagement on healthcare utilization and weight loss. Reid, N., Bennett, W., Coughlin, J., et al.[2020]

In a pilot study involving 33 predominantly African American participants with obesity and diabetes or prediabetes, a weight loss intervention combining group visits and peer coaching led to a significant average weight loss of 4.5 kg, with 27% of participants losing at least 5% of their initial body weight.

Participants found the program acceptable, completing about 50% of group visits and 40% of peer coaching calls, indicating that this novel approach to weight management in primary care is feasible and well-received.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study evaluating the feasibility and initial outcomes of a primary care weight loss intervention with peer coaches. Dutton, GR., Phillips, JM., Kukkamalla, M., et al.[2018]

This trial will assess the effectiveness of a weight loss intervention involving peer coaches over 18 months, with 375 adults with obesity participating from 10 primary care practices, aiming to improve body weight and patient-centered outcomes.

If successful, the peer coach model could provide a sustainable and practical approach to weight management in primary care, potentially enhancing clinical outcomes and reducing healthcare costs related to obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A weight loss intervention delivered by peer coaches in primary care: Rationale and study design of the PROMISE trial. Dutton, GR., Lewis, CE., Cherrington, A., et al.[2023]

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Health Coaching: Help Patients Take Charge of Their Health

Health coaching is a team-based approach that helps patients gain the knowledge, skills, and confidence to become active participants in their care.