Lifestyle Coaching for Obesity

(FireFit Trial)

Overseen By Stefanos N Kales, MD

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: Cambridge Health Alliance

Must not be taking: Anti-obesity drugs

Disqualifiers: Females, BMI < 30, CVD, cancer, others

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

Compensation: Varies

Number of Visits: 3

Duration: 9 months

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of lifestyle coaching in improving body composition and overall health. Participants will receive either personalized coaching focused on healthy habits or standard written health advice. The trial seeks male firefighters with a BMI of 30 or higher who live or work in the Boston metro area and wish to improve their body composition and quality of life. The study will measure changes in body composition, physical activity, and overall well-being. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance health strategies for others.

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 are using anti-obesity drugs, you must have stopped them at least 6 months before joining the trial.

What prior data suggests that lifestyle coaching is safe for participants?

Studies have shown that lifestyle coaching is generally safe and manageable. Research indicates that participants in these programs often experience positive changes without major side effects. Specifically, weight management programs with coaching have helped individuals lose weight and improve their health over time.

These studies have found no serious negative effects linked to lifestyle coaching. Instead, participants often report better eating habits, increased exercise, and an overall improved quality of life. These findings suggest that lifestyle coaching is a safe choice for those seeking to improve their health with structured support and guidance. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about lifestyle coaching for obesity because it offers a holistic approach that targets multiple aspects of a person’s life. Unlike standard options like medication or surgery, this treatment emphasizes personal and group coaching to improve diet, increase physical activity, enhance sleep quality, manage stress, and foster positive social connections. The integration of these lifestyle changes, based on the six pillars of lifestyle medicine, is what sets it apart and may lead to sustainable, long-term health benefits without the need for invasive procedures or pharmaceuticals.

What evidence suggests that lifestyle coaching might be an effective treatment for obesity?

Research has shown that lifestyle coaching, which participants in this trial may receive, can aid in weight loss and improve health. Studies have found that people in health coaching programs often lose weight and experience reductions in blood pressure and cholesterol. For instance, one study found that many participants lost at least 5% of their starting weight. Another study noted improved body health when people engaged in both one-on-one and group coaching. In short, lifestyle coaching can help manage obesity by promoting healthier eating, increased exercise, and better daily habits. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for obese firefighters looking to improve their health. Participants should be willing to undergo a 9-month lifestyle coaching program, which includes both individual and group sessions. They must be open to having their body composition, metabolic health, exercise capacity, and quality of life assessed.

Inclusion Criteria

Express interest in participating in a study of clinical interventions aimed at improving body composition (weight loss), metabolic status, and quality of life

Recruitment from Massachusetts, Rhode Island, and Southern New Hampshire, which are part of the Boston metro area

BMI of 30 kg/m² or greater based on self-reported height and weight

Exclusion Criteria

I haven't taken any weight loss drugs in the last 6 months.

BMI less than 30 kg/m² based on self-reported height and weight

Active psychosis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a baseline health assessment including lifestyle scores, body composition, metabolic/hormonal indices, physical fitness, and behavioral health screens

1 week

Treatment

Participants receive either general health instructions or individual and group lifestyle coaching interventions for 9 months

9 months

3 visits (in-person) at 3, 6, and 9 months

Follow-up

Participants are monitored for changes in body composition, metabolic health, and lifestyle behaviors

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lifestyle Coaching

Trial Overview The study tests if lifestyle coaching can help obese firefighters lose weight and get healthier compared to just getting written instructions. It looks at changes in body fat and muscle, metabolic issues, fitness levels (like push-ups), activity habits, diet quality, sleep patterns over nine months.

How Is the Trial Designed?

Group I: Control/ General Written Health Instructions Active Control 1 Intervention

Participants will receive standard lifestyle recommendations, consisting of two pages of written information summarized from the American Heart Association's 'Healthy for Good' webpages for the general public. These will include guidance on healthy diets, physical activity, healthy sleep, stress reduction, and avoiding tobacco, excess alcohol, and other harmful substances.

Group II: Individual & Group Lifestyle Medicine-based Coaching Active Control 1 Intervention

This group will receive personal and group coaching sessions based on the six pillars of lifestyle medicine: 1) a plant- predominant eating pattern (consistent with the AIH "Full Plate Living" program); 2) physical movement; 3) restorative sleep; 4) management of stress; 5) avoidance of risky substances; and 6) positive social connections. Target goals for the participants assigned to Lifestyle Coaching will include the following: improving diet quality together with moderate caloric restriction; engaging in more physical activity with a goal of 150 minutes or more per week of at least moderate intensity (e.g. brisk walking); getting 7-8 hours of sleep nightly when possible and using short naps when work or other conditions interfere with getting at least 7 hours of sleep; increasing resilience and using positive social/family connections to manage/decrease stress.

Who Is Running the Clinical Trial?

Cambridge Health Alliance

Lead Sponsor

Trials

65

Recruited

22,400+

Ardmore Institute of Health

Collaborator

Trials

6

Recruited

96,200+

Published Research Related to This Trial

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]

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]

The CooL intervention, a combined lifestyle program in the Netherlands, was found to be accessible and effective in helping obese individuals adopt healthier lifestyles, as evaluated by both participants and stakeholders.

Despite its positive reception, the program's success relies on increasing the recognition and integration of lifestyle coaches within the healthcare system, highlighting the need for better networking and communication about their role.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The implementation of the coaching on lifestyle (CooL) intervention: lessons learnt. van Rinsum, C., Gerards, S., Rutten, G., et al.[2020]

An online lifestyle intervention coaching protocol was developed based on the Diabetes Prevention Program, aiming to provide effective obesity treatment in primary care settings.

This e-counseling approach allows for high-quality lifestyle advice to be accessible to patients who cannot attend in-person sessions due to scheduling or geographic limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an online diabetes prevention lifestyle intervention coaching protocol for use in primary care practice. Simkin-Silverman, LR., Conroy, MB., Bhargava, T., et al.[2018]

The Coaching on Lifestyle programme (CooL) effectively helped adults achieve sustained improvements in motivation, lifestyle behaviors, quality of life, and weight over an 18-month period.

While adults showed significant positive changes, the program had mixed results for children and their parents, indicating that different strategies may be needed to engage younger participants effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Coaching on Lifestyle (CooL) Intervention for Overweight and Obesity: A Longitudinal Study into Participants' Lifestyle Changes. van Rinsum, C., Gerards, S., Rutten, G., et al.[2019]

In a study of Kaiser Permanente Northern California patients, 70% of those who completed two or more telephonic health coaching sessions reported satisfaction with the program, indicating a positive patient experience.

73% of participants who engaged in multiple sessions felt that the coaching helped them achieve their weight-related goals, highlighting the efficacy of telephonic coaching in promoting healthy lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient satisfaction and perceived success with a telephonic health coaching program: the Natural Experiments for Translation in Diabetes (NEXT-D) Study, Northern California, 2011. Adams, SR., Goler, NC., Sanna, RS., et al.[2021]

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]

Participants in the Get Healthy Information and Coaching Service (GHS) maintained significant improvements in weight, waist circumference, and BMI six months after completing a 6-month coaching program, indicating the program's effectiveness in promoting long-term lifestyle changes.

While improvements in fruit and vegetable consumption were sustained, the increase in physical activity levels observed at the end of the program did not persist at the 12-month follow-up, suggesting a need for ongoing support in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Australia's Get Healthy Information and Coaching Service: maintenance of self-reported anthropometric and behavioural changes after program completion. O'Hara, BJ., Phongsavan, P., Eakin, EG., et al.[2021]

A telephonic lifestyle coaching intervention for psychiatric outpatients led to significant weight loss and improved health over 12 months, with 46% of participants losing 5% or more of their baseline weight.

The study found that having support from a caregiver reduced dropout rates, highlighting the importance of social support in maintaining participation in lifestyle interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evaluation of a telephonic wellness coaching intervention for weight reduction and wellness improvement in a community-based cohort of persons with serious mental illness. Temmingh, H., Claassen, A., van Zyl, S., et al.[2022]

Over 60% of US adults are overweight or obese, which increases their risk for chronic diseases like cardiovascular disease, highlighting the urgent need for effective weight management strategies.

Even small changes in physical activity and diet can lead to significant weight loss and help maintain a healthy body composition, yet many patients do not receive adequate guidance from healthcare providers on how to achieve these changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet, exercise, and the challenge of combating obesity in primary care. McInnis, KJ.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6125027/

Clinical Effectiveness of Lifestyle Health Coaching The LHC program is effective in modifying multiple behaviors and improving risk factors, including blood pressure, cholesterol, and weight, in diverse ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2838318

Peer Coaching to Support Weight Management in Primary ... Secondary clinical outcomes included mean (SE) weight change in percentage, proportion of patients achieving 5% or higher weight loss, and waist ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2667368124000482

Obesity medicine provider-directed health coaching in a ... The results convey that weight reduction significantly improved across the 24-week program while meeting both with a coach and obesity medicine physician and ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06890975?cond=COACH%20syndrome%20OR%20%22cerebellar%20vermis%20hypoplasia-oligophrenia-congenital%20ataxia-coloboma-hepatic%20fibrosis%22%20OR%20%22%20gentile%20syndrome%22%20OR%20%22%20Joubert%20syndrome%20with%20congenital%20hepatic%20fibrosis%22%20OR%20%22%20Joubert%20syndrome%20with%20hepatic%20defect%22%20OR%20%22%20JS-H%22&aggFilters=status:not%20rec&viewType=Table&rank=5

"F!reF!ghterF!t": Lifestyle Coaching Interventions for Obese ... Our goal is to explore the effectiveness of 9- month lifestyle medicine based coaching intervention (individual and group coaching) versus control (usual ...

5. cureus.com cureus.com/articles/316668-the-effect-of-lifestyle-coaching-design-on-patient-engagement-and-weight-loss-in-non-diabetic-patients-of-a-semaglutide-supported-digital-obesity-program-in-the-uk-a-comparative-retrospective-cohort-study

The Effect of Lifestyle Coaching Design on Patient ... The analysis also found no statistically significant difference in the weight-loss outcomes of the reactive and proactive coaching groups.

6. mdpi.com mdpi.com/2072-6643/17/14/2382

Lifestyle Medicine for Obesity in the Era of Highly Effective ... Efficacy and safety of liraglutide 3.0 mg for weight management are similar across races: Subgroup analysis across the SCALE and phase II randomized trials ...

7. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/articles/10.1186/s12913-024-11876-2

Exploring successes, barriers, and enablers in the one-year ... We examined how healthcare professionals perceive patient success in a one-year web-based weight management program, the Healthy Weight Coaching.