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Lifestyle Coaching
Lifestyle Coaching for Weight Loss (MAINTAIN PRIME Trial)
N/A
Waitlist Available
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults aged 18-75
Be older than 18 years old
Must not have
Unable to attend the orientation/baseline visit or comply with the protocol procedures
Edematous state that interferes with bodyweight assessment (e.g., severe congestive heart failure, end-stage renal disease, or ascites)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Summary
This trial will test whether a weight-loss intervention delivered through a patient portal by health care staff can help people maintain their weight loss.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves lifestyle changes rather than medication, side effects may include typical responses to diet change or increased physical activity such as muscle soreness or digestive adjustments but no medical side effects from drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I can attend all required visits and follow the study rules.
Select...
I have swelling that makes it hard to measure my weight accurately.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in body weight
Secondary outcome measures
Change in BMI percentage
Change in blood pressure
Change in dietary habits as measured by grams of fat
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Lifestyle coachingExperimental Treatment1 Intervention
Group II: Control trackingActive Control1 Intervention
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Who is running the clinical trial?
University of UtahLead Sponsor
1,110 Previous Clinical Trials
1,788,287 Total Patients Enrolled
2 Trials studying Weight Loss
113 Patients Enrolled for Weight Loss
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,381 Previous Clinical Trials
4,314,833 Total Patients Enrolled
101 Trials studying Weight Loss
18,588 Patients Enrolled for Weight Loss
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.I can attend all required visits and follow the study rules.I have had weight loss surgery in the past 2 years or plan to in the next 3 years.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.I have swelling that makes it hard to measure my weight accurately.You have a body mass index (BMI) of 25 or higher before trying to lose weight.I am between 18 and 75 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Lifestyle coaching
- Group 2: Control tracking
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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