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Health Coaching for Metabolic Syndrome

Q: May I be considered a participant in this experiment?

The prerequisites for this clinical trial are metabolic syndrome and being between 18-60 years of age. The number of participants sought is approximately 424 people.

Q: Is it still possible to partake in this trial as a participant?

Affirmative, according to the information accessible on clinicaltrials.gov this investigation is presently accepting participants. It was initially posted November 23rd 2020 and its most recent revision was made in early November 2022. Approximately 424 patients need to be enrolled from 1 designated site.

Q: How many individuals are actively engaging in this clinical experiment?

Affirmative. According to clinicaltrials.gov, this research venture is currently searching for 424 individuals at one site and was first posted on November 23rd 2020 with the most recent update occurring on November 7th 2022.

Q: What are the key goals of this research endeavor?

This 32-week long trial will be monitored in order to detect a change from average daily step count at 16 weeks. The secondary outcomes which shall also be evaluated include: waist circumference, frequency of water intake over the past four months and fasting blood glucose levels after 48 weeks.

Q: Does the age limit for participation in this experiment exceed 85 years?

This medical trial has an age restriction, with a minimum of 18 and maximum of 60 years old for potential enrollees.

N/A

Recruiting

Led By Susan Stoner, PhD

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Habit DesignLead Sponsor

University of WashingtonOTHER

1,741 Previous Clinical Trials

1,847,342 Total Patients Enrolled

8 Trials studying Metabolic Syndrome

314 Patients Enrolled for Metabolic Syndrome

TriHealth Inc.OTHER

97 Previous Clinical Trials

53,164 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

May I be considered a participant in this experiment?

"The prerequisites for this clinical trial are metabolic syndrome and being between 18-60 years of age. The number of participants sought is approximately 424 people."

Answered by AI

Is it still possible to partake in this trial as a participant?

"Affirmative, according to the information accessible on clinicaltrials.gov this investigation is presently accepting participants. It was initially posted November 23rd 2020 and its most recent revision was made in early November 2022. Approximately 424 patients need to be enrolled from 1 designated site."

Answered by AI

How many individuals are actively engaging in this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this research venture is currently searching for 424 individuals at one site and was first posted on November 23rd 2020 with the most recent update occurring on November 7th 2022."

Answered by AI

What are the key goals of this research endeavor?

"This 32-week long trial will be monitored in order to detect a change from average daily step count at 16 weeks. The secondary outcomes which shall also be evaluated include: waist circumference, frequency of water intake over the past four months and fasting blood glucose levels after 48 weeks."

Answered by AI