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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02201069
Other study ID # HUM00087322
Secondary ID
Status Completed
Phase N/A
First received July 24, 2014
Last updated August 18, 2016
Start date August 2014
Est. completion date August 2016

Study information

Verified date August 2016
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The "My Health Coach Study" seeks to determine if health coaching by a medical assistant can help patients have better sleep, a better diet, be more physically active or lose weight, according to the recommendation of their health care provider.


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.


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years to 100 Years
Eligibility 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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Behavioral:
health coaching


Locations

Country Name City State
United States Briarwood Family Medicine Ann Arbor Michigan

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Quality of Life stress, fatigue, self-efficacy, motivation 12 weeks No
Primary Weight loss 12 weeks No
Secondary Diet quality adherence to USDA recommendations 12 weeks No
Secondary Physical activity adherence to physical activity recommendations of 30 min/day of at least moderate activity. 12 weeks No
Secondary Sleep Better sleep habits 12 weeks Yes
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