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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
424

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Participant in TriHealth's Corporate Wellness Program completing voluntary Personal Health Assessment, including screening for metabolic syndrome.

  2. 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)
  3. Interested in increasing physical activity and fruit/vegetable or water intake
  4. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Standard health coaching
Standard health coaching to increase health behaviors
Behavioral: Standard health coaching
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
Behavioral: Habit-focused health coaching
12 weekly sessions of standard health coaching followed by 4 monthly sessions

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Habit Design

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Washington
TriHealth Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 23, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2024

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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