60 Participants Needed

Lifestyle and Health Coaching Strategies for Obesity

(WISE Health Trial)

DS
CR
Overseen ByChelsi Reynolds
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores different health coaching strategies to improve heart and metabolic health in Black adults who are overweight or obese and have conditions like high blood pressure, diabetes, or high cholesterol. Participants will follow either a weight-focused health coaching plan, aiming for weight loss, or a weight-neutral plan, emphasizing healthy habits without focusing on weight loss. If the initial plan proves ineffective, participants may receive more intensive lifestyle support or enhanced medical management. This trial suits Black adults with a BMI of 27 or higher, a related health condition, and reliable internet access. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance health strategies for the community.

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.

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

A previous study found weight-focused health coaching to be generally safe and well-tolerated by participants. Specifically, when combined with portion-controlled meals, this approach led to weight loss over 24 weeks, with no major negative effects reported. This indicates the method's safety for participants.

For weight-neutral health coaching, research shows these methods are also safe. These strategies aim to improve overall health without emphasizing weight loss. Studies have shown that techniques like mindful eating and body acceptance are well-received and usually don't cause negative side effects.

Overall, both weight-focused and weight-neutral health coaching methods have demonstrated safety in trials. Participants can feel confident about the safety of these health coaching methods.12345

Why are researchers excited about this trial?

Researchers are excited about these health coaching strategies for obesity because they explore new approaches beyond traditional weight loss methods like diets and medication. The weight-focused coaching aims to enhance results with additional support like fitness classes or medical management for those who don't initially succeed, offering a personalized, intensified approach. Meanwhile, the weight-neutral coaching shifts the focus from weight loss to increased physical activity and overall health, which can be more sustainable and less stressful for some individuals. These strategies could provide more flexible and supportive options for managing obesity, catering to diverse needs and preferences.

What evidence suggests that this trial's treatments could be effective for obesity?

This trial will compare different health coaching strategies for obesity. Research has shown that weight-focused health coaching, one approach in this trial, can help obese adults lose weight. Studies have found it can lead to better eating habits and less weight gain over time, especially when combined with methods like portion control.

Meanwhile, weight-neutral health coaching, another approach tested in this trial, can still improve overall health. This method promotes a healthy lifestyle and physical activity, which can help manage conditions like high blood pressure and diabetes. Both approaches have encouraged healthier habits and improved heart and metabolic health.26789

Who Is on the Research Team?

DS

Drew Sayer, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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.
My primary care doctor agrees to work closely with the trial team.
See 6 more

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Weight-Neutral Health Coaching with Intensified Lifestyle Approach for NonrespondersExperimental Treatment2 Interventions
Group II: Weight-Neutral Health Coaching with Enhanced Medical ManagementExperimental Treatment2 Interventions
Group III: Weight-Focused Health Coaching with Intensified Lifestyle Approach for NonrespondersExperimental Treatment2 Interventions
Group IV: Weight-Focused Health Coaching with Enhanced Medical ManagementExperimental Treatment2 Interventions

Find a Clinic Near You

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+

Published Research Related to This Trial

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.
Developing a Personalized Integrative Obesity-Coaching Program: A Systems Health Perspective.Brink, SM., Wortelboer, HM., Emmelot, CH., et al.[2022]
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.
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]
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.
Do monthly coaching calls influence proximal participant adherence in a behavioral weight loss program?Butryn, ML., Kerrigan, S., Hagerman, CJ., et al.[2023]

Citations

The impact of behavioral weight management interventions on ...We found evidence to suggest that interventions improved uncontrolled eating, external eating, susceptibility to hunger, restraint and intuitive eating at ...
The Impact of Health Coaching on Weight and Physical ...Health coaching is an effective approach for weight loss in obese adults. The results of this study support the consideration of HC as a treatment option.
Health Coaching Strategies for Weight Loss: A Systematic ...We conducted a systematic review and meta-analysis to synthesize and evaluate the quality of evidence supporting the use of self-reported health coaching for ...
Behavioral Weight Loss Interventions to Prevent Obesity ...The USPSTF found adequate evidence that behavior-based weight loss maintenance interventions are associated with less weight gain after the ...
Obesity medicine provider-directed health coaching in a ...This proof-of-concept project found that Obesity Medicine Physician-directed, portion-controlled meals and HWC can improve weight reduction across a 24-week ...
Peer Coaching to Support Weight Management in Primary ...This randomized clinical trial assesses the effect of a health-coaching intervention on weight loss among veterans at a Veteran Affairs health
Behavioral Weight Management Coach | Obesity - AMA Ed HubThis course provides a comprehensive understanding of weight management and interventions. Learners will explore the multifaceted aspects of obesity.
Commercial weight-loss programs in the management of ...National Diabetes Prevention Program, WW, Jenny Craig, Medifast, and OPTIFAST have shown 12-month weight-loss efficacy and safety.
Behavioral Weight Management Coach | Self-PacedThis course covers weight management, obesity, behavioral strategies, dietary and physical activity recommendations, and using technology for coaching.
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