269 Participants Needed

Lifestyle Coaching for Weight Loss

(MAINTAIN PRIME Trial)

MB
KK
Overseen ByKensaku Kawamoto, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Utah
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 information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment MAINTAIN PRIME Lifestyle Coaching for weight loss?

Research shows that lifestyle coaching programs can lead to modest weight loss, especially when participants engage in at least six sessions. A study found that participants who met this engagement benchmark achieved significantly greater weight loss, suggesting that consistent participation in lifestyle coaching can be effective for weight management.12345

Is lifestyle coaching for weight loss safe for humans?

Lifestyle coaching for weight loss, which includes diet, physical activity, and behavior therapy, is generally considered safe for humans. Studies have shown that such programs can lead to weight loss and improvements in health without significant safety concerns.26789

How does the MAINTAIN PRIME Lifestyle Coaching treatment differ from other weight loss treatments?

MAINTAIN PRIME Lifestyle Coaching is unique because it focuses on personalized lifestyle changes and engagement, with an emphasis on maintaining weight loss through sustained behavior changes rather than just initial weight reduction. Unlike many treatments that may not provide long-term solutions, this approach aims to prevent weight regain by setting realistic goals and encouraging consistent participation in coaching sessions.1371011

What is the purpose of this trial?

Many people struggle not only to lose weight through changes in diet and physical activity, but also to maintain weight loss once they have achieved it. In a previous study, our team designed and deployed a weight maintenance intervention that was delivered through the patient portal of an electronic health record (EHR) and found that patients who tracked their weight, diet, and physical activity and also received coaching had better success with maintaining recent intentional weight loss than patients who tracked but did not receive coaching. The investigators propose to repeat the intervention in a new health care system and train routine health care staff (e.g., medical assistants and nurses) to be coaches, a more sustainable model that will allow ongoing intervention delivery after the proposed study ends.This is a pragmatic randomized clinical Trial with percent weight change at 24 months as the primary outcome. This will be a 2-arm randomized trial that compares the MAINTAIN PRIME lifestyle coaching intervention to a control tracking intervention.

Eligibility Criteria

This trial is for adults aged 18-75 with a BMI of ≥25 who have lost at least 5% body weight in the past two years and want to maintain it. Participants must be able to use the Epic MyHealth patient portal and plan to stay with a participating primary care practice. Those with conditions causing unintended weight loss, poor computer skills, or inability to follow study procedures are excluded.

Inclusion Criteria

You have lost at least 5% of your body weight on purpose in the last 24 months and have been able to keep it off.
Have or be willing to get an account with the Epic MyHealth patient portal embedded in the electronic health record (EHR)
Plan to maintain a University of Utah Health relationship in one of the participating primary care practices
See 1 more

Exclusion Criteria

Current or planned pregnancy in the next 3 years
I do not have conditions like cancer or thyroid disease causing weight loss.
My doctor thinks I can't safely do activities like brisk walking for 30 minutes.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the MAINTAIN PRIME lifestyle coaching intervention or control tracking intervention

24 months

Follow-up

Participants are monitored for weight maintenance and intervention sustainability

4 weeks

Treatment Details

Interventions

  • Control tracking
  • MAINTAIN PRIME Lifestyle Coaching
Trial Overview The study tests if lifestyle coaching (MAINTAIN PRIME) helps people keep off weight better than just tracking their own diet and activity. It's a practical trial where health staff like nurses become coaches. Participants will either get this coaching or control tracking, decided randomly, and results are measured after two years.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Lifestyle coachingExperimental Treatment1 Intervention
Group II: Control trackingActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials
1,169
Recruited
1,623,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Findings from Research

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.
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 comprehensive lifestyle modification program can lead to a significant weight loss of about 10% of initial body weight within 16 to 26 weeks, especially when delivered through group or individual on-site treatments.
Long-term weight control is enhanced by ongoing contact with healthcare providers, high physical activity levels, and the use of medications alongside lifestyle changes, which also help in reducing cardiovascular risk factors.
Lifestyle modification for the management of obesity.Wadden, TA., Butryn, ML., Wilson, C.[2022]
A new mathematical model was developed to predict weight changes based on dietary energy intake, using data from 8 longitudinal studies with 157 participants, which showed strong accuracy in its predictions (R² values of 0.83 and 0.91).
This model can help obese patients and their doctors set realistic long-term weight maintenance goals by calculating the necessary dietary changes, making it a practical tool for weight management professionals.
Modeling weight-loss maintenance to help prevent body weight regain.Hall, KD., Jordan, PN.[2023]

References

Evaluating an insurer-based health coaching program: Impact of program engagement on healthcare utilization and weight loss. [2020]
Lifestyle modification for the management of obesity. [2022]
Modeling weight-loss maintenance to help prevent body weight regain. [2023]
Retention rates and weight loss in a commercial weight loss program. [2022]
Development of an online diabetes prevention lifestyle intervention coaching protocol for use in primary care practice. [2018]
The future of obesity reduction: beyond weight loss. [2021]
The LIFE program: a wellness approach to weight loss. [2022]
A descriptive study of individuals successful at long-term maintenance of substantial weight loss. [2022]
Weight loss maintenance in severely obese adults after an intensive lifestyle intervention: 2- to 4-year follow-up. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Diet, exercise, and the challenge of combating obesity in primary care. [2019]
Hormonal regulatory mechanisms in obese children and adolescents after previous weight reduction with a lifestyle intervention: maintain - paediatric part - a RCT from 2009-15. [2020]
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