- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04262401
Promoting Healthy Habits in Metabolic Syndrome
November 7, 2022 updated by: Habit Design
Habit Design: Testing a Novel Behavioral Approach to Corporate Wellness in the Context of Metabolic Syndrome
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).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
To evaluate the effectiveness of the Habit Design approach, the investigators will conduct a randomized controlled trial with 424 corporate health program participants over the course of one year.
Study subjects will be employees of TriHealth or their spouses who have completed a health screening as part of their corporate wellness program and identified as having metabolic syndrome.
All subjects will be coached to increase physical activity, which will be monitored with a Fitbit and Fitabase software.
Additionally, prior to randomization, subjects will choose a goal of 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).
Conditions will be stratified/balanced by choice of goal and gender using urn randomization.
In both conditions coaching will be manualized, monitored for fidelity, and delivered via telephone in 12 weekly active coaching sessions followed by 4 monthly maintenance coaching sessions.
Coaching sessions will last 15-30 minutes.
The primary outcome will be average daily step count measured with Fitbit over the course of at least one week at baseline, 16 weeks, 32 weeks, and 48 weeks.
The secondary outcomes will be indices of fruit/vegetable intake or water intake, according to the participant's choice.
Tertiary outcomes will consist of fasting blood glucose, triglycerides, high density lipoprotein, blood pressure, waist circumference, and body mass index, measured at each time point.
Additionally, self-reported physical activity; junk food, and sugar-sweetened beverage consumption; automaticity of exercise and fruit, vegetable, and water consumption; self-efficacy and social support for target behaviors; and health-related quality of life will be assessed over time.
Ratings of usability and satisfaction and app usage metrics will also be examined.
Analyses will be intent-to-treat and assume 15% loss to follow-up.
Study Type
Interventional
Enrollment (Anticipated)
424
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Susan Stoner, PhD
- Phone Number: 2065434520
- Email: sastoner@uw.edu
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45212
- Recruiting
- TriHealth
-
Contact:
- Shannon Ricca, MA
- Phone Number: 513-977-0081
- Email: Shannon_Ricca@trihealth.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participant in TriHealth's Corporate Wellness Program completing voluntary Personal Health Assessment, including screening for metabolic syndrome.
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)
- Interested in increasing physical activity and fruit/vegetable or water intake
- Own a compatible smartphone (iOS or Android) and willing/able to use it for the study
Exclusion Criteria:
- Have medical or other contraindications to increasing physical activity or fruit/vegetable/water intake
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Standard health coaching
Standard health coaching to increase health behaviors
|
12 weekly sessions of standard health coaching followed by 4 monthly sessions
|
EXPERIMENTAL: Habit-focused health coaching
Health coaching enhanced with a focus on habit formation using a mobile application called Habit Design
|
12 weekly sessions of standard health coaching followed by 4 monthly sessions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline average daily step count at 16 weeks
Time Frame: 16 weeks
|
Fitbit data will be monitored using the Fitabase platform.
|
16 weeks
|
Change from baseline average daily step count at 32 weeks
Time Frame: 32 weeks
|
Fitbit data will be monitored using the Fitabase platform.
|
32 weeks
|
Change from baseline average daily step count at 48 weeks
Time Frame: 48 weeks
|
Fitbit data will be monitored using the Fitabase platform.
|
48 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in frequency consuming fruits and vegetables in the past 4 months at 16 weeks
Time Frame: 16 weeks
|
Self-reported food frequency data derived from the Diet History Questionnaire-III.
Fifteen items for fruits and fifteen items for vegetables will be rated on a scale from 0-9 and a sum of the item scores will be computed.
Minimum: 0, Maximum: 270.
Higher numbers are better.
|
16 weeks
|
Change in frequency consuming fruits and vegetables in the past 4 months at 32 weeks
Time Frame: 32 weeks
|
Self-reported food frequency data derived from the Diet History Questionnaire-III.
Fifteen items for fruits and fifteen items for vegetables will be rated on a scale from 0-9 and a sum of the item scores will be computed.
Minimum: 0, Maximum: 270.
Higher numbers are better.
|
32 weeks
|
Change in frequency consuming fruits and vegetables in the past 4 months at 48 weeks
Time Frame: 48 weeks
|
Self-reported food frequency data derived from the Diet History Questionnaire-III.
Fifteen items for fruits and fifteen items for vegetables will be rated on a scale from 0-9 and a sum of the item scores will be computed.
Minimum: 0, Maximum: 270.
Higher numbers are better.
|
48 weeks
|
Change in frequency consuming water in the past 4 months at 16 weeks
Time Frame: 16 weeks
|
Self-reported food frequency data derived from the Diet History Questionnaire-III.
Two items for water will be rated on a scale from 0-9 and a sum of the item scores will be computed.
Minimum: 0, Maximum: 18. Higher numbers are better.
|
16 weeks
|
Change in frequency consuming water in the past 4 months at 32 weeks
Time Frame: 32 weeks
|
Self-reported food frequency data derived from the Diet History Questionnaire-III.
Two items for water will be rated on a scale from 0-9 and a sum of the item scores will be computed.
Minimum: 0, Maximum: 18. Higher numbers are better.
|
32 weeks
|
Change in frequency consuming water in the past 4 months at 48 weeks
Time Frame: 48 weeks
|
Self-reported food frequency data derived from the Diet History Questionnaire-III.
Two items for water will be rated on a scale from 0-9 and a sum of the item scores will be computed.
Minimum: 0, Maximum: 18. Higher numbers are better.
|
48 weeks
|
Change in baseline triglycerides at 16 weeks
Time Frame: 16 weeks
|
Triglycerides will be measured using standard laboratory procedures.
|
16 weeks
|
Change in baseline triglycerides at 32 weeks
Time Frame: 32 weeks
|
Triglycerides will be measured using standard laboratory procedures.
|
32 weeks
|
Change in baseline triglycerides at 48 weeks
Time Frame: 48 weeks
|
Triglycerides will be measured using standard laboratory procedures.
|
48 weeks
|
Change in baseline fasting blood glucose at 16 weeks
Time Frame: 16 weeks
|
Fasting blood glucose will be measured using standard laboratory procedures.
|
16 weeks
|
Change in baseline fasting blood glucose at 32 weeks
Time Frame: 32 weeks
|
Fasting blood glucose will be measured using standard laboratory procedures.
|
32 weeks
|
Change in baseline fasting blood glucose at 48 weeks
Time Frame: 48 weeks
|
Fasting blood glucose will be measured using standard laboratory procedures.
|
48 weeks
|
Change in baseline blood pressure at 16 weeks
Time Frame: 16 weeks
|
Systolic and diastolic blood pressure will be measured using standard procedures.
|
16 weeks
|
Change in baseline blood pressure at 32 weeks
Time Frame: 32 weeks
|
Systolic and diastolic blood pressure will be measured using standard procedures.
|
32 weeks
|
Change in baseline blood pressure at 48 weeks
Time Frame: 48 weeks
|
Systolic and diastolic blood pressure will be measured using standard procedures.
|
48 weeks
|
Change in baseline waist circumference at 16 weeks
Time Frame: 16 weeks
|
Waist circumference will be measured using standard procedures.
|
16 weeks
|
Change in baseline waist circumference at 32 weeks
Time Frame: 32 weeks
|
Waist circumference will be measured using standard procedures.
|
32 weeks
|
Change in baseline waist circumference at 48 weeks
Time Frame: 48 weeks
|
Waist circumference will be measured using standard procedures.
|
48 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael Kim, MBA, Habit Design
- Principal Investigator: Susan Stoner, PhD, University of Washington
- Principal Investigator: Scott Woods, MD, TriHealth Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 23, 2020
Primary Completion (ANTICIPATED)
April 1, 2024
Study Completion (ANTICIPATED)
December 1, 2024
Study Registration Dates
First Submitted
February 4, 2020
First Submitted That Met QC Criteria
February 6, 2020
First Posted (ACTUAL)
February 10, 2020
Study Record Updates
Last Update Posted (ACTUAL)
November 10, 2022
Last Update Submitted That Met QC Criteria
November 7, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R44HL142328 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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