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Health Coaching for Metabolic Syndrome

N/A
Recruiting
Led By Michael Kim, MBA
Research Sponsored by Habit Design
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Meet at least 3/5 criteria for metabolic syndrome: elevated triglycerides (≥150 mg/dL), insufficient high-density lipoprotein cholesterol (<40 mg/dL in males and <50 mg/dL in females), elevated blood pressure (systolic ≥130 and/or diastolic ≥85 mm Hg), elevated fasting blood glucose (≥100 mg/dl), above-threshold waist circumference (≥102 cm in males and ≥80 cm in females)
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trialwill explore if a coaching approach focusing on habits can help people with metabolic syndrome improve their health over the course of one year.

Who is the study for?
This trial is for individuals with metabolic syndrome who are part of TriHealth's Corporate Wellness Program and have completed a health assessment. Participants must meet at least three criteria for metabolic syndrome, own a smartphone, and be interested in increasing physical activity and healthy eating or drinking habits.
What is being tested?
The study compares two types of health coaching over one year: standard coaching versus Habit Design-enhanced coaching. Both groups will work on increasing physical activity and either fruit/vegetable intake or water consumption instead of sugary drinks.
What are the potential side effects?
Since the interventions involve lifestyle changes like diet modification and increased exercise, potential side effects may include muscle soreness from new physical activities or digestive changes due to dietary adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I meet at least three criteria for metabolic syndrome.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline average daily step count at 16 weeks
Change from baseline average daily step count at 32 weeks
Change from baseline average daily step count at 48 weeks
Secondary study objectives
Change in baseline blood pressure at 16 weeks
Change in baseline blood pressure at 32 weeks
Change in baseline blood pressure at 48 weeks
+15 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Habit-focused health coachingExperimental Treatment1 Intervention
Health coaching enhanced with a focus on habit formation using a mobile application called Habit Design
Group II: Standard health coachingActive Control1 Intervention
Standard health coaching to increase health behaviors

Find a Location

Who is running the clinical trial?

Habit DesignLead Sponsor
University of WashingtonOTHER
1,817 Previous Clinical Trials
1,913,958 Total Patients Enrolled
8 Trials studying Metabolic Syndrome
314 Patients Enrolled for Metabolic Syndrome
TriHealth Inc.OTHER
99 Previous Clinical Trials
53,367 Total Patients Enrolled

Media Library

Habit-focused health coaching Clinical Trial Eligibility Overview. Trial Name: NCT04262401 — N/A
Metabolic Syndrome Research Study Groups: Standard health coaching, Habit-focused health coaching
Metabolic Syndrome Clinical Trial 2023: Habit-focused health coaching Highlights & Side Effects. Trial Name: NCT04262401 — N/A
Habit-focused health coaching 2023 Treatment Timeline for Medical Study. Trial Name: NCT04262401 — N/A
~86 spots leftby Nov 2025
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