Habit-focused health coaching for Metabolic Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Metabolic Syndrome+1 More
Habit-focused health coaching - Behavioral
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

A randomized controlled trial will be conducted to evaluate the effectiveness of the Habit Design (HD) approach in a corporate health context over the course of one year in subjects with metabolic syndrome. All subjects will be coached to increase physical activity. Additionally, subjects will choose and be coached to achieve a goal of either increasing fruit and vegetable intake or substituting water for sugar-sweetened beverages. Subjects will be randomly assigned to receive either standard coaching (control condition) or HD-enhanced coaching (experimental condition).

Eligible Conditions
  • Metabolic Syndrome

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Metabolic Syndrome

Study Objectives

3 Primary · 18 Secondary · Reporting Duration: 48 weeks

16 weeks
Change from baseline average daily step count at 16 weeks
Change in baseline blood pressure at 16 weeks
Change in baseline fasting blood glucose at 16 weeks
Change in baseline triglycerides at 16 weeks
Waist Circumference
Change in frequency consuming fruits and vegetables in the past 4 months at 16 weeks
Change in frequency consuming water in the past 4 months at 16 weeks
32 weeks
Change from baseline average daily step count at 32 weeks
Change in baseline blood pressure at 32 weeks
Change in baseline fasting blood glucose at 32 weeks
Change in baseline triglycerides at 32 weeks
Change in baseline waist circumference at 32 weeks
Change in frequency consuming fruits and vegetables in the past 4 months at 32 weeks
Change in frequency consuming water in the past 4 months at 32 weeks
48 weeks
Change from baseline average daily step count at 48 weeks
Change in baseline blood pressure at 48 weeks
Change in baseline fasting blood glucose at 48 weeks
Change in baseline triglycerides at 48 weeks
Change in baseline waist circumference at 48 weeks
Change in frequency consuming fruits and vegetables in the past 4 months at 48 weeks
Change in frequency consuming water in the past 4 months at 48 weeks

Trial Safety

Safety Progress

1 of 3

Other trials for Metabolic Syndrome

Trial Design

2 Treatment Groups

Standard health coaching
1 of 2
Habit-focused health coaching
1 of 2
Active Control
Experimental Treatment

424 Total Participants · 2 Treatment Groups

Primary Treatment: Habit-focused health coaching · No Placebo Group · N/A

Habit-focused health coaching
Behavioral
Experimental Group · 1 Intervention: Habit-focused health coaching · Intervention Types: Behavioral
Standard health coaching
Behavioral
ActiveComparator Group · 1 Intervention: Standard health coaching · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 48 weeks

Who is running the clinical trial?

University of WashingtonOTHER
1,583 Previous Clinical Trials
1,565,562 Total Patients Enrolled
8 Trials studying Metabolic Syndrome
314 Patients Enrolled for Metabolic Syndrome
TriHealth Inc.OTHER
90 Previous Clinical Trials
50,013 Total Patients Enrolled
Habit DesignLead Sponsor
Susan Stoner, PhDPrincipal InvestigatorUniversity of Washington
Scott Woods, MDPrincipal InvestigatorTriHealth Inc.
2 Previous Clinical Trials
395 Total Patients Enrolled
Michael Kim, MBAPrincipal InvestigatorHabit Design

Eligibility Criteria

Age 18 - 65 · All Participants · 8 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 16th, 2021

Last Reviewed: October 24th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.