- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02201069
My Health Coach Study
Study Overview
Detailed Description
The aim of the study is to determine whether medical assistants (MAs) can assist primary care providers to achieve healthier lifestyles via better sleep, food choices, weight loss and/or increased physical activity in their patients. The hypothesis driving this research is that health coaching can be done by existing medical support staff to facilitate healthy lifestyles in a primary care setting. Coaching can maximize the health of the patient population in a cost-effective way if the coaching service is integrated into primary care clinics with minimal capital investment at the outset. A major focus will be on behaviors associated with weight management since this is the most common health issue in the U.S. today. This method, if successful, should be easily adaptable to other health behaviors and in most any medical practice that seeks to improve the health of its patient base in a cost-effective way.
In order to achieve a change in health behaviors, and especially weight loss, regular follow-up contacts are needed. Previous research has shown health coaching to be effective, but this has utilized programs that "add on" to the existing clinic structure. This type of coaching model is difficult to sustain. Utilizing existing staff for health coaching is a method we propose to more fully integrate this service into primary care clinics.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48108
- Briarwood Family Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- adults age 21 and over
- referred by primary care physician for health coaching
- have telephone for follow-up
- English speaking
Exclusion Criteria:
- pregnant or trying to become pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: health coaching
12 weeks of health coaching using weekly contact in the first month and biweekly contacts in months 2-3.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Weight loss
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diet quality
Time Frame: 12 weeks
|
adherence to USDA recommendations
|
12 weeks
|
|
Physical activity
Time Frame: 12 weeks
|
adherence to physical activity recommendations of 30 min/day of at least moderate activity.
|
12 weeks
|
|
Sleep
Time Frame: 12 weeks
|
Better sleep habits
|
12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life
Time Frame: 12 weeks
|
stress, fatigue, self-efficacy, motivation
|
12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HUM00087322
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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