50 Participants Needed

Lifestyle Coaching for Obesity

(FireFit Trial)

SN
Overseen ByStefanos N Kales, MD
Age: 18 - 65
Sex: Male
Trial Phase: Academic
Sponsor: Cambridge Health Alliance
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment Lifestyle Coaching for obesity?

Research shows that lifestyle coaching, like the CooL program, can help adults with obesity make lasting changes in their lifestyle, leading to weight loss and improved quality of life. Additionally, telephonic lifestyle coaching has been effective in reducing weight and improving health in people with serious mental illness.12345

Is lifestyle coaching safe for humans?

Lifestyle coaching, used for obesity and other conditions, generally appears safe for humans. Studies have shown it can help improve weight, physical activity, and eating habits without mentioning any significant safety concerns.12567

How does lifestyle coaching differ from other treatments for obesity?

Lifestyle coaching for obesity is unique because it focuses on personalized support to help individuals change their diet and physical activity habits, often using remote methods like online or telephone coaching. This approach can be more accessible and flexible compared to traditional in-person treatments, and it emphasizes long-term behavior change rather than just short-term weight loss.168910

What is the purpose of this trial?

Our goal is to explore the effectiveness of 9- month lifestyle medicine based coaching intervention (individual and group coaching) versus control (usual care/ written health instructions). The primary study outcomes will be mean changes in body composition metrics . Secondary outcomes will be the prevalence of metabolic abnormities, progression/regression of Metabolic Syndrome, push-up \& sit/stand capacity, self-reported physical activity, and quality of life/diet/sleep measures.

Eligibility Criteria

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
See 1 more

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
See 6 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Active Control
Group I: Control/ General Written Health InstructionsActive Control1 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 CoachingActive Control1 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.

Find a Clinic Near You

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+

Findings from Research

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.
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.
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.
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]

References

Development of an online diabetes prevention lifestyle intervention coaching protocol for use in primary care practice. [2018]
The Coaching on Lifestyle (CooL) Intervention for Overweight and Obesity: A Longitudinal Study into Participants' Lifestyle Changes. [2019]
Patient satisfaction and perceived success with a telephonic health coaching program: the Natural Experiments for Translation in Diabetes (NEXT-D) Study, Northern California, 2011. [2021]
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. [2022]
The implementation of the coaching on lifestyle (CooL) intervention: lessons learnt. [2020]
[Coaching for the treatment of obesity and overweight: a systematic review]. [2022]
Effectiveness of Australia's Get Healthy Information and Coaching Service: maintenance of self-reported anthropometric and behavioural changes after program completion. [2021]
Efficacy of Telephone Health Coaching Integration with Standard Multidisciplinary Care for Adults with Obesity Attending a Weight Management Service: A Pilot Study. [2022]
Weight Loss Strategies. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Diet, exercise, and the challenge of combating obesity in primary care. [2019]
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