Metabolic SyndromeNCT04262401
Promoting Healthy Habits in Metabolic Syndrome
A study testing Standard health coaching and Habit-focused health coaching in people with Metabolic Syndrome, run by Habit Design at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Standard health coaching and Habit-focused health coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 424 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Nov 2020to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- Have medical or other contraindications to increasing physical activity or fruit/vegetable/water intake
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
TriHealth
Cincinnati, Ohio, 45212
Shannon Ricca, MA, 513-977-0081, Shannon_Ricca@trihealth.com
Scott Woods, MD
About this study
Official title: 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).
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- Standard health coaching, Habit-focused health coaching
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard health coachingBehavioural
12 weekly sessions of standard health coaching followed by 4 monthly sessions
Habit-focused health coachingBehavioural
12 weekly sessions of standard health coaching followed by 4 monthly sessions
| Study group | Role | What they receive |
|---|---|---|
| Standard health coaching | Active comparator | Standard health coaching to increase health behaviors Receives: Behavioral: Standard health coaching |
| Habit-focused health coaching | Experimental | Health coaching enhanced with a focus on habit formation using a mobile application called Habit Design Receives: Behavioral: Habit-focused health coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline average daily step count at 16 weeks
Fitbit data will be monitored using the Fitabase platform.
Measured: 16 weeks
Change from baseline average daily step count at 32 weeks
Fitbit data will be monitored using the Fitabase platform.
Measured: 32 weeks
Change from baseline average daily step count at 48 weeks
Fitbit data will be monitored using the Fitabase platform.
Measured: 48 weeks
Secondary outcomes (18)
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.
Measured: 16 weeks
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.
Measured: 32 weeks
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.
Measured: 48 weeks
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.
Measured: 16 weeks
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.
Measured: 32 weeks
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.
Measured: 48 weeks
Change in baseline triglycerides at 16 weeks
Triglycerides will be measured using standard laboratory procedures.
Measured: 16 weeks
Change in baseline triglycerides at 32 weeks
Triglycerides will be measured using standard laboratory procedures.
Measured: 32 weeks
Change in baseline triglycerides at 48 weeks
Triglycerides will be measured using standard laboratory procedures.
Measured: 48 weeks
Change in baseline fasting blood glucose at 16 weeks
Fasting blood glucose will be measured using standard laboratory procedures.
Measured: 16 weeks
Change in baseline fasting blood glucose at 32 weeks
Fasting blood glucose will be measured using standard laboratory procedures.
Measured: 32 weeks
Change in baseline fasting blood glucose at 48 weeks
Fasting blood glucose will be measured using standard laboratory procedures.
Measured: 48 weeks
Change in baseline blood pressure at 16 weeks
Systolic and diastolic blood pressure will be measured using standard procedures.
Measured: 16 weeks
Change in baseline blood pressure at 32 weeks
Systolic and diastolic blood pressure will be measured using standard procedures.
Measured: 32 weeks
Change in baseline blood pressure at 48 weeks
Systolic and diastolic blood pressure will be measured using standard procedures.
Measured: 48 weeks
Change in baseline waist circumference at 16 weeks
Waist circumference will be measured using standard procedures.
Measured: 16 weeks
Change in baseline waist circumference at 32 weeks
Waist circumference will be measured using standard procedures.
Measured: 32 weeks
Change in baseline waist circumference at 48 weeks
Waist circumference will be measured using standard procedures.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start23 Nov 2020
- Primary completionApr 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 424 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Habit Design
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Washington, TriHealth Inc.
- Responsible party
- Sponsor
- Investigators
- Michael Kim, MBA, Principal investigator, Habit DesignSusan Stoner, PhD, Principal investigator, University of WashingtonScott Woods, MD, Principal investigator, TriHealth Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262401
- Sponsor's protocol ID
- R44HL142328
- Status last verified
- Nov 2022
- First submitted
- 4 Feb 2020
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Habit Design: Testing a Novel Behavioral Approach to Corporate Wellness in the Context of Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT04262401
- Acronym / sponsor ID
- R44HL142328
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 424 participants (estimated)
- Lead sponsor
- Habit DesignIndustry (pharma, biotech, devices)
- Collaborators
- University of Washington, TriHealth Inc.
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 10 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard health coaching | Active comparator | Behavioral: Standard health coachingStandard health coaching to increase health behaviors |
| Habit-focused health coaching | Experimental | Behavioral: Habit-focused health coachingHealth coaching enhanced with a focus on habit formation using a mobile application called Habit Design |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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:
- 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
Key exclusion criteria (1 listed)
- Have medical or other contraindications to increasing physical activity or fruit/vegetable/water intake
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard health coaching12 weekly sessions of standard health coaching followed by 4 monthly sessions | Behavioural | Standard health coaching |
| Habit-focused health coaching12 weekly sessions of standard health coaching followed by 4 monthly sessions | Behavioural | Habit-focused health coaching |
Primary outcome
Change from baseline average daily step count at 16 weeks
Time frame: 16 weeks
Fitbit data will be monitored using the Fitabase platform.
Change from baseline average daily step count at 32 weeks
Time frame: 32 weeks
Fitbit data will be monitored using the Fitabase platform.
Change from baseline average daily step count at 48 weeks
Time frame: 48 weeks
Fitbit data will be monitored using the Fitabase platform.
18 secondary outcomes
Change in frequency consuming fruits and vegetables in the past 4 months at 16 weeks
Time frame: 16 weeks
Change in frequency consuming fruits and vegetables in the past 4 months at 32 weeks
Time frame: 32 weeks
Change in frequency consuming fruits and vegetables in the past 4 months at 48 weeks
Time frame: 48 weeks
Change in frequency consuming water in the past 4 months at 16 weeks
Time frame: 16 weeks
Change in frequency consuming water in the past 4 months at 32 weeks
Time frame: 32 weeks
Change in frequency consuming water in the past 4 months at 48 weeks
Time frame: 48 weeks
Change in baseline triglycerides at 16 weeks
Time frame: 16 weeks
Change in baseline triglycerides at 32 weeks
Time frame: 32 weeks
Change in baseline triglycerides at 48 weeks
Time frame: 48 weeks
Change in baseline fasting blood glucose at 16 weeks
Time frame: 16 weeks
Change in baseline fasting blood glucose at 32 weeks
Time frame: 32 weeks
Change in baseline fasting blood glucose at 48 weeks
Time frame: 48 weeks
Change in baseline blood pressure at 16 weeks
Time frame: 16 weeks
Change in baseline blood pressure at 32 weeks
Time frame: 32 weeks
Change in baseline blood pressure at 48 weeks
Time frame: 48 weeks
Change in baseline waist circumference at 16 weeks
Time frame: 16 weeks
Change in baseline waist circumference at 32 weeks
Time frame: 32 weeks
Change in baseline waist circumference at 48 weeks
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kim, MBA principal investigator
Habit Design
Susan Stoner, PhD principal investigator
University of Washington
Scott Woods, MD principal investigator
TriHealth Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard health coaching and Habit-focused health coaching in people with Metabolic Syndrome, run by Habit Design at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susan Stoner, PhD (2065434520, sastoner@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline average daily step count at 16 weeks (time frame: 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.