Promoting Healthy Habits in Metabolic Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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Habit Design: Testing a Novel Behavioral Approach to Corporate Wellness in the Context of Metabolic Syndrome

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Behavioral: Standard health coaching
* Behavioral: Habit-focused health coaching


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard health coaching<br>Standard health coaching to increase health behaviors | Behavioral: Standard health coaching<br>* 12 weekly sessions of standard health coaching followed by 4 monthly sessions<br>|
| Experimental: Habit-focused health coaching<br>Health coaching enhanced with a focus on habit formation using a mobile application called Habit Design | Behavioral: Habit-focused health coaching<br>* 12 weekly sessions of standard health coaching followed by 4 monthly sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline average daily step count at 16 weeks | Fitbit data will be monitored using the Fitabase platform. | 16 weeks | 
| Change from baseline average daily step count at 32 weeks | Fitbit data will be monitored using the Fitabase platform. | 32 weeks | 
| Change from baseline average daily step count at 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 | 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 | 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 | 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 | 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 | 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 | 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 | Triglycerides will be measured using standard laboratory procedures. | 16 weeks | 
| Change in baseline triglycerides at 32 weeks | Triglycerides will be measured using standard laboratory procedures. | 32 weeks | 
| Change in baseline triglycerides at 48 weeks | Triglycerides will be measured using standard laboratory procedures. | 48 weeks | 
| Change in baseline fasting blood glucose at 16 weeks | Fasting blood glucose will be measured using standard laboratory procedures. | 16 weeks | 
| Change in baseline fasting blood glucose at 32 weeks | Fasting blood glucose will be measured using standard laboratory procedures. | 32 weeks | 
| Change in baseline fasting blood glucose at 48 weeks | Fasting blood glucose will be measured using standard laboratory procedures. | 48 weeks | 
| Change in baseline blood pressure at 16 weeks | Systolic and diastolic blood pressure will be measured using standard procedures. | 16 weeks | 
| Change in baseline blood pressure at 32 weeks | Systolic and diastolic blood pressure will be measured using standard procedures. | 32 weeks | 
| Change in baseline blood pressure at 48 weeks | Systolic and diastolic blood pressure will be measured using standard procedures. | 48 weeks | 
| Change in baseline waist circumference at 16 weeks | Waist circumference will be measured using standard procedures. | 16 weeks | 
| Change in baseline waist circumference at 32 weeks | Waist circumference will be measured using standard procedures. | 32 weeks | 
| Change in baseline waist circumference at 48 weeks | Waist circumference will be measured using standard procedures. | 48 weeks |