Promoting Healthy Habits in Metabolic Syndrome
Primary Purpose
Metabolic Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard health coaching
Habit-focused health coaching
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome
Eligibility Criteria
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
Sites / Locations
- TriHealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard health coaching
Habit-focused health coaching
Arm Description
Standard health coaching to increase health behaviors
Health coaching enhanced with a focus on habit formation using a mobile application called Habit Design
Outcomes
Primary Outcome Measures
Change from baseline average daily step count at 16 weeks
Fitbit data will be monitored using the Fitabase platform.
Change from baseline average daily step count at 32 weeks
Fitbit data will be monitored using the Fitabase platform.
Change from baseline average daily step count at 48 weeks
Fitbit data will be monitored using the Fitabase platform.
Secondary Outcome Measures
Change in frequency consuming fruits and vegetables in the past 4 months at 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.
Change in frequency consuming fruits and vegetables in the past 4 months at 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.
Change in frequency consuming fruits and vegetables in the past 4 months at 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.
Change in frequency consuming water in the past 4 months at 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.
Change in frequency consuming water in the past 4 months at 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.
Change in frequency consuming water in the past 4 months at 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.
Change in baseline triglycerides at 16 weeks
Triglycerides will be measured using standard laboratory procedures.
Change in baseline triglycerides at 32 weeks
Triglycerides will be measured using standard laboratory procedures.
Change in baseline triglycerides at 48 weeks
Triglycerides will be measured using standard laboratory procedures.
Change in baseline fasting blood glucose at 16 weeks
Fasting blood glucose will be measured using standard laboratory procedures.
Change in baseline fasting blood glucose at 32 weeks
Fasting blood glucose will be measured using standard laboratory procedures.
Change in baseline fasting blood glucose at 48 weeks
Fasting blood glucose will be measured using standard laboratory procedures.
Change in baseline blood pressure at 16 weeks
Systolic and diastolic blood pressure will be measured using standard procedures.
Change in baseline blood pressure at 32 weeks
Systolic and diastolic blood pressure will be measured using standard procedures.
Change in baseline blood pressure at 48 weeks
Systolic and diastolic blood pressure will be measured using standard procedures.
Change in baseline waist circumference at 16 weeks
Waist circumference will be measured using standard procedures.
Change in baseline waist circumference at 32 weeks
Waist circumference will be measured using standard procedures.
Change in baseline waist circumference at 48 weeks
Waist circumference will be measured using standard procedures.
Full Information
NCT ID
NCT04262401
First Posted
February 4, 2020
Last Updated
November 7, 2022
Sponsor
Habit Design
Collaborators
University of Washington, TriHealth Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04262401
Brief Title
Promoting Healthy Habits in Metabolic Syndrome
Official Title
Habit Design: Testing a Novel Behavioral Approach to Corporate Wellness in the Context of Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 23, 2020 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Habit Design
Collaborators
University of Washington, TriHealth Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
424 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard health coaching
Arm Type
Active Comparator
Arm Description
Standard health coaching to increase health behaviors
Arm Title
Habit-focused health coaching
Arm Type
Experimental
Arm Description
Health coaching enhanced with a focus on habit formation using a mobile application called Habit Design
Intervention Type
Behavioral
Intervention Name(s)
Standard health coaching
Intervention Description
12 weekly sessions of standard health coaching followed by 4 monthly sessions
Intervention Type
Behavioral
Intervention Name(s)
Habit-focused health coaching
Intervention Description
12 weekly sessions of standard health coaching followed by 4 monthly sessions
Primary Outcome Measure Information:
Title
Change from baseline average daily step count at 16 weeks
Description
Fitbit data will be monitored using the Fitabase platform.
Time Frame
16 weeks
Title
Change from baseline average daily step count at 32 weeks
Description
Fitbit data will be monitored using the Fitabase platform.
Time Frame
32 weeks
Title
Change from baseline average daily step count at 48 weeks
Description
Fitbit data will be monitored using the Fitabase platform.
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Change in frequency consuming fruits and vegetables in the past 4 months at 16 weeks
Description
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.
Time Frame
16 weeks
Title
Change in frequency consuming fruits and vegetables in the past 4 months at 32 weeks
Description
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.
Time Frame
32 weeks
Title
Change in frequency consuming fruits and vegetables in the past 4 months at 48 weeks
Description
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.
Time Frame
48 weeks
Title
Change in frequency consuming water in the past 4 months at 16 weeks
Description
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.
Time Frame
16 weeks
Title
Change in frequency consuming water in the past 4 months at 32 weeks
Description
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.
Time Frame
32 weeks
Title
Change in frequency consuming water in the past 4 months at 48 weeks
Description
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.
Time Frame
48 weeks
Title
Change in baseline triglycerides at 16 weeks
Description
Triglycerides will be measured using standard laboratory procedures.
Time Frame
16 weeks
Title
Change in baseline triglycerides at 32 weeks
Description
Triglycerides will be measured using standard laboratory procedures.
Time Frame
32 weeks
Title
Change in baseline triglycerides at 48 weeks
Description
Triglycerides will be measured using standard laboratory procedures.
Time Frame
48 weeks
Title
Change in baseline fasting blood glucose at 16 weeks
Description
Fasting blood glucose will be measured using standard laboratory procedures.
Time Frame
16 weeks
Title
Change in baseline fasting blood glucose at 32 weeks
Description
Fasting blood glucose will be measured using standard laboratory procedures.
Time Frame
32 weeks
Title
Change in baseline fasting blood glucose at 48 weeks
Description
Fasting blood glucose will be measured using standard laboratory procedures.
Time Frame
48 weeks
Title
Change in baseline blood pressure at 16 weeks
Description
Systolic and diastolic blood pressure will be measured using standard procedures.
Time Frame
16 weeks
Title
Change in baseline blood pressure at 32 weeks
Description
Systolic and diastolic blood pressure will be measured using standard procedures.
Time Frame
32 weeks
Title
Change in baseline blood pressure at 48 weeks
Description
Systolic and diastolic blood pressure will be measured using standard procedures.
Time Frame
48 weeks
Title
Change in baseline waist circumference at 16 weeks
Description
Waist circumference will be measured using standard procedures.
Time Frame
16 weeks
Title
Change in baseline waist circumference at 32 weeks
Description
Waist circumference will be measured using standard procedures.
Time Frame
32 weeks
Title
Change in baseline waist circumference at 48 weeks
Description
Waist circumference will be measured using standard procedures.
Time Frame
48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susan Stoner, PhD
Phone
2065434520
Email
sastoner@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Kim, MBA
Organizational Affiliation
Habit Design
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susan Stoner, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Scott Woods, MD
Organizational Affiliation
TriHealth Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
TriHealth
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon Ricca, MA
Phone
513-977-0081
Email
Shannon_Ricca@trihealth.com
First Name & Middle Initial & Last Name & Degree
Scott Woods, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Promoting Healthy Habits in Metabolic Syndrome
We'll reach out to this number within 24 hrs