Lifestyle and Health Coaching Strategies for Obesity

(WISE Health Trial)

Overseen By Chelsi Reynolds

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Structured lifestyle intervention, others

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

Compensation: Varies

Number of Visits: 2

60 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It involves lifestyle and health coaching, and if needed, enhanced medical management in partnership with your primary care provider.

What data supports the effectiveness of the treatment Augment with enhanced medical management, Intensify lifestyle approach, Weight-focused health coaching, Weight Loss Coaching, Behavioral Weight Management, Biobehavioral Interventions, Weight-neutral health coaching, Weight-neutral health coaching, Weight-neutral biobehavioral intervention for obesity?

Research shows that coaching approaches, including self-empowerment and regular contact, can help maintain weight loss by boosting motivation and adherence to healthy behaviors. Additionally, engaging in at least six coaching sessions has been linked to greater weight loss success. ^{1 2 3 4 5}

Is health coaching for weight management safe for humans?

The research does not specifically address safety concerns, but health coaching for weight management is generally considered safe as it focuses on lifestyle changes like diet and exercise, which are typically low-risk. ^{2 3 4 5 6}

How is the treatment 'Weight-focused and Weight-neutral health coaching' for obesity different from other treatments?

This treatment is unique because it uses a personalized and integrative coaching approach, considering individual needs and systemic factors, rather than just focusing on diet and exercise. It also incorporates a novel method of personalizing interventions based on traditional Chinese medicine symptoms, aiming for long-term sustainable results. ^{1 3 4 7 8}

What is the purpose of this trial?

The proposed 6-month pilot Sequential Multiple Assignment Randomize Trial (SMART) has two aims. The first and primary aim is to determine the feasibility of conducting a full-scale SMART to compare weight-focused (i.e., weight loss) and weight-neutral (i.e., weight loss is not an explicit goal) adaptive biobehavioral interventions for improving cardiometabolic health in Black adults with overweight or obesity (BMI ≥27 kg/m2) plus at least one weight-related cardiometabolic condition (high blood pressure, prediabetes or diabetes, and/or high cholesterol). Biobehavioral interventions are treatment strategies that combine lifestyle-based behavioral interventions such as eating a healthy diet and exercise with medications. In this study, participants will be randomly assigned to receive either weight-focused or weight-neutral health coaching for 7 weeks. At week 8, participants will be identified as either "responders" or "nonresponders" to the initial interventions. The threshold for response in the weight-focused condition is greater than or equal to 3% weight loss. The threshold for response in the weight-neutral condition is engaging in greater than or equal to 150 minutes of moderate physical activity for the 7 days prior to the week 8 study visit. Responders to the initial interventions will continue with health coaching on a biweekly basis for weeks 9-26 of the intervention. Nonresponders will be re-randomized to either intensify the lifestyle-based intervention by receiving a membership to the YMCA and enrolling in group fitness classes or augmenting the health coaching with enhanced medical management in partnership with their established primary care provider. The second aim is to use clinical data from the pilot SMART to estimate treatment effects and the between-person variability in these effects. Because this is a pilot study, these estimates will not be used to make comparisons or draw conclusions on the comparative effectiveness of intervention conditions. Rather, these data will be used to generate preliminary effect sizes that can be used to estimate the sample size required for a full-scale trial. Clinical trial feasibility data will be collected on an ongoing basis throughout the study and clinical data will be collected prior to initiating the intervention (baseline) and at week 8 (response visit) and week 26 (post-intervention visit).

Research Team

Drew Sayer, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for Black adults over 18 with obesity or overweight and at least one condition like high blood pressure, prediabetes/diabetes, or high cholesterol. Participants must speak English, be open to any intervention offered, have internet access and a device to use it on, and a primary care provider willing to join the study if needed.

Inclusion Criteria

I am Black or African American.

I have high blood pressure or it's slightly elevated.

I have prediabetes or type 2 diabetes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants receive either weight-focused or weight-neutral health coaching for 7 weeks

7 weeks

Weekly visits (in-person or virtual)

Response Assessment

Participants are assessed for response to initial interventions at week 8

1 week

1 visit (in-person)

Continued Treatment

Responders continue with biweekly health coaching; nonresponders are re-randomized to intensified lifestyle or enhanced medical management

18 weeks

Biweekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Augment with enhanced medical management
• Intensify lifestyle approach
• Weight-focused health coaching
• Weight-neutral health coaching

Trial Overview The study tests two approaches: weight-focused health coaching aiming for weight loss and weight-neutral coaching focusing on physical activity without targeting weight loss. Nonresponders after initial weeks may get intensified lifestyle changes or enhanced medical management in partnership with their doctors.

Participant Groups

Group I: Weight-Neutral Health Coaching with Intensified Lifestyle Approach for Nonresponders Experimental Treatment 2 Interventions

Participants will start with weight-neutral health coaching for 7 weeks and individuals achieving \<150 minutes of moderate physical activity will be given a 4-month membership to the YMCA and enrolled in group fitness classes.

Group II: Weight-Neutral Health Coaching with Enhanced Medical Management Experimental Treatment 2 Interventions

Participants will start with weight-neutral health coaching for 7 weeks and individuals achieving \<150 minutes of moderate physical activity will meet with their primary care provider and health coach to consider additional or revised medication plans to address their weight and weight-related chronic conditions.

Group III: Weight-Focused Health Coaching with Intensified Lifestyle Approach for Nonresponders Experimental Treatment 2 Interventions

Participants will start with weight-focused health coaching for 7 weeks and individuals achieving \<3% weight loss will be given a 4-month membership to the YMCA and enrolled in group fitness classes.

Group IV: Weight-Focused Health Coaching with Enhanced Medical Management Experimental Treatment 2 Interventions

Participants will start with weight-focused health coaching for 7 weeks and individuals achieving \<3% weight loss will meet with their primary care provider and health coach to consider additional or revised medication plans to address their weight and weight-related chronic conditions.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Findings from Research

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]

Participants who received ongoing coaching after a behavioral weight loss program showed the highest adherence to dietary self-monitoring immediately following their coaching calls, indicating that these interactions boost motivation and commitment to weight loss behaviors.

While adherence to dietary self-monitoring decreased over time, the likelihood of self-weighing increased in the days following the coaching call, suggesting that different weight management behaviors may be influenced differently by coach contact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do monthly coaching calls influence proximal participant adherence in a behavioral weight loss program? Butryn, ML., Kerrigan, S., Hagerman, CJ., et al.[2023]

The ASPIRE Coaching Fidelity Checklist (ACFC) is a newly developed and validated tool designed to assess the fidelity of coaching in weight loss programs, consisting of 19 items across two domains and five subscales.

The ACFC demonstrated strong internal consistency and was positively associated with weight loss outcomes in group-based coaching, indicating its effectiveness in guiding coaching practices, although it showed variable reliability for phone-based coaching.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validation of the ASPIRE-VA coaching fidelity checklist (ACFC): a tool to help ensure delivery of high-quality weight management interventions. Damschroder, LJ., Goodrich, DE., Kim, HM., et al.[2022]

Lifestyle interventions that combine dietary changes, physical activity support, and weight management education are the first-line treatment for obesity, emphasizing their importance in addressing the global obesity epidemic.

The chapter highlights the need for personalized weight management programs to enhance effectiveness and long-term adherence, given the significant health risks associated with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Loss Strategies. Roberts, SB., Anton, S., Dao, MC.[2022]

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]

A systematic review of 38 studies on self-reported health coaching for weight loss found very low quality evidence and a high risk of bias, indicating that the effectiveness of this intervention is unclear.

While there was a slight positive effect of health coaching compared to usual care, the effect size was trivial and not significant when only high-quality studies were considered, suggesting that self-reported health coaching may not be a reliable method for weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Coaching Strategies for Weight Loss: A Systematic Review and Meta-Analysis. Sieczkowska, SM., de Lima, AP., Swinton, PA., et al.[2023]

A new personalized and dynamic approach to obesity management was developed through a five-year integrative coaching program, involving collaboration among various health professionals and experts in systems thinking.

The program utilized a systems health model to identify key factors influencing obesity and incorporated participant subtyping based on traditional Chinese medicine, allowing for tailored interventions that adapt to individual needs and goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Personalized Integrative Obesity-Coaching Program: A Systems Health Perspective. Brink, SM., Wortelboer, HM., Emmelot, CH., et al.[2022]

The current obesity treatment model in America focuses on individual responsibility for weight loss through specific exercise and dietary goals, but this approach is not effective and may contribute to the obesity problem.

A new model is needed that emphasizes societal responsibility, functional activity, and food-based diets rather than strict nutritional guidelines to better address obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The emperor's tailors: the failure of the medical weight loss paradigm and its causal role in the obesity of America. Puterbaugh, JS.[2009]

References

1. India pubmed.ncbi.nlm.nih.gov

The effectiveness of self-empowerment-based patient-centered care for obese students in primary services: A randomized controlled trial. [2023]

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

Do monthly coaching calls influence proximal participant adherence in a behavioral weight loss program? [2023]

3. England pubmed.ncbi.nlm.nih.gov

Development and validation of the ASPIRE-VA coaching fidelity checklist (ACFC): a tool to help ensure delivery of high-quality weight management interventions. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Weight Loss Strategies. [2022]

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

Evaluating an insurer-based health coaching program: Impact of program engagement on healthcare utilization and weight loss. [2020]

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

Health Coaching Strategies for Weight Loss: A Systematic Review and Meta-Analysis. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Developing a Personalized Integrative Obesity-Coaching Program: A Systems Health Perspective. [2022]

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

The emperor's tailors: the failure of the medical weight loss paradigm and its causal role in the obesity of America. [2009]