Lifestyle Coaching for Weight Loss

(MAINTAIN PRIME Trial)

Overseen By Kensaku Kawamoto, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Cancer, Thyroid disease, Heart failure, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people maintain their weight loss by comparing two approaches: MAINTAIN PRIME Lifestyle Coaching and simple tracking. Participants will receive coaching from trained healthcare staff to determine its effectiveness in maintaining weight loss. The trial seeks individuals who have intentionally lost at least 5% of their body weight in the last two years and plan to continue using the University of Utah Health system. As an unphased trial, this study offers a unique opportunity to explore effective weight maintenance strategies with professional support.

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 prior data suggests that this lifestyle coaching intervention is safe?

Research has shown that lifestyle coaching, such as in the MAINTAIN PRIME program, is generally safe for participants. In past studies, individuals who received coaching through an electronic health record (EHR) system maintained weight loss more successfully than those who only tracked their weight and activities. No specific reports of negative effects from the coaching itself have emerged, suggesting it is well-tolerated by participants.

The program offers diet and exercise advice from trained healthcare staff. As it does not involve medications or medical procedures, the risks remain very low. Participants can expect a supportive experience aimed at helping them maintain their weight loss. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MAINTAIN PRIME Lifestyle Coaching because it offers a personalized approach to weight loss, focusing on sustainable lifestyle changes rather than quick fixes. Unlike traditional methods that often center around restrictive diets or medications, this coaching emphasizes behavior modification, goal setting, and ongoing support, which can lead to lasting weight management. Additionally, the program is designed to be adaptable, catering to the unique needs and circumstances of each individual, which can enhance motivation and adherence to healthy habits over time.

What evidence suggests that the MAINTAIN PRIME lifestyle coaching intervention could be effective for weight loss?

Research has shown that the MAINTAIN PRIME lifestyle coaching program, which participants in this trial may receive, helps people maintain weight loss more effectively than just tracking weight and activities. In earlier studies, participants using this coaching program lost an average of 10.7% of their body weight. In this trial, some participants will receive coaching along with tracking, while others will only track their weight and activities. Specifically, those who had coaching along with tracking were more successful at maintaining their weight loss compared to those who only tracked. This suggests that having a coach can significantly aid in keeping the weight off. The program employs regular healthcare staff as coaches, facilitating ongoing support. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Lifestyle coaching Experimental Treatment 1 Intervention

Group II: Control tracking Active Control 1 Intervention

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle modification for the management of obesity. Wadden, TA., Butryn, ML., Wilson, C.[2022]

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]

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]

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]

A lifestyle-modification program that includes increased physical activity and a balanced diet can significantly reduce obesity-related health risks, even if there is minimal or no weight loss.

Such lifestyle changes can lead to improvements in abdominal obesity, visceral fat, and cardiometabolic risk factors, as well as increases in muscle mass and cardiorespiratory fitness, highlighting the importance of focusing on health improvements rather than just weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The future of obesity reduction: beyond weight loss. Ross, R., Bradshaw, AJ.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modeling weight-loss maintenance to help prevent body weight regain. Hall, KD., Jordan, PN.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11781796/

Baseline results from the MAINTAIN PRIME trial - PMC

Average weight and BMI at baseline were 205.0 (SD 48.9) lbs and 33.2 (6.8) kg/m2, respectively. Participants lost an average of 10.7% (SD 5.2) of their body ...

2.

ahajournals.org

ahajournals.org/doi/10.1161/cir.151.suppl_1.P2015

Abstract P2015: Perceptions of Health Coaching for Weight ...

Methods: Participants in MAINTAIN PRIME were primary care patients with BMI ≥25 before intentional weight loss of ≥5%, randomized to health ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39298682/

Scalable and successful patient portal lifestyle coaching ...

Our previous research demonstrated that coaching alongside self-monitoring improves weight maintenance compared to monitoring alone. Integrating ...

4.

ahajournals.org

ahajournals.org/doi/10.1161/circ.149.suppl_1.P119

Abstract P119: Patient Evaluation of Technology and ...

Results: Out of 163 participants completing 12 months in MAINTAIN PRIME, 65 (40 in coaching and 25 in tracking groups, 39.9% response rate) ...

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1551714424001034

Implementing weight maintenance with existing staff and ...

Average weight and BMI at baseline were 205.0 (SD 48.9) lbs. and 33.2 (6.8) kg/m2, respectively. Participants lost an average of 10.7% (SD 5.2) of their body ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11568843/

Scalable and successful patient portal lifestyle coaching ...

MAINTAIN PRIME is an RCT comparing EHR-based coaching plus tracking vs. tracking alone for primary care patients with recent weight loss.

7.

ahajournals.org

ahajournals.org/doi/10.1161/circ.145.suppl_1.P098

Abstract P098: Feasibility Of Training Primary Care Staff To ...

Methods: MAINTAIN PRIME is an RCT comparing EHR-based coaching plus tracking vs tracking alone for primary care patients with recent weight loss ...

8.

researchgate.net

researchgate.net/publication/337196969_Effect_of_Electronic_Health_Record-Based_Coaching_on_Weight_Maintenance_A_Randomized_Trial

Effect of Electronic Health Record-Based Coaching on ...

The components of MAINTAIN PRIME have been validated in a prior randomized controlled trial (RCT) called MAINTAIN-pc. 29, 30 While MAINTAINpc used experienced ...

9.

jmir.org

jmir.org/2022/9/e39741/

Long-term Weight Loss in a Primary Care–Anchored ...

Compared to usual care, digital lifestyle coaching can induce significant weight loss for people living with obesity, both with and without type 2 diabetes, ...