Clinical trial NCT04262401: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Habit Design
Sponsor class: INDUSTRY
Collaborators: name: University of Washington
name: TriHealth Inc.
First posted: 2020-02-10
Enrollment: 424
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline average daily step count at 16 weeks
timeFrame: 16 weeks
measure: Change from baseline average daily step count at 32 weeks
timeFrame: 32 weeks
measure: Change from baseline average daily step count at 48 weeks
timeFrame: 48 weeks
Secondary outcomes:
measure: Change in frequency consuming fruits and vegetables in the past 4 months at 16 weeks
timeFrame: 16 weeks
measure: Change in frequency consuming fruits and vegetables in the past 4 months at 32 weeks
timeFrame: 32 weeks
measure: Change in frequency consuming fruits and vegetables in the past 4 months at 48 weeks
timeFrame: 48 weeks
measure: Change in frequency consuming water in the past 4 months at 16 weeks
timeFrame: 16 weeks
measure: Change in frequency consuming water in the past 4 months at 32 weeks
timeFrame: 32 weeks
measure: Change in frequency consuming water in the past 4 months at 48 weeks
timeFrame: 48 weeks
measure: Change in baseline triglycerides at 16 weeks
timeFrame: 16 weeks
measure: Change in baseline triglycerides at 32 weeks
timeFrame: 32 weeks
measure: Change in baseline triglycerides at 48 weeks
timeFrame: 48 weeks
measure: Change in baseline fasting blood glucose at 16 weeks
timeFrame: 16 weeks
measure: Change in baseline fasting blood glucose at 32 weeks
timeFrame: 32 weeks
measure: Change in baseline fasting blood glucose at 48 weeks
timeFrame: 48 weeks
measure: Change in baseline blood pressure at 16 weeks
timeFrame: 16 weeks
measure: Change in baseline blood pressure at 32 weeks
timeFrame: 32 weeks
measure: Change in baseline blood pressure at 48 weeks
timeFrame: 48 weeks
measure: Change in baseline waist circumference at 16 weeks
timeFrame: 16 weeks
measure: Change in baseline waist circumference at 32 weeks
timeFrame: 32 weeks
measure: Change in baseline waist circumference at 48 weeks
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: TriHealth
state: Ohio
Study officials:
affiliation: Habit Design
name: Michael Kim, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Susan Stoner, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: TriHealth Inc.
name: Scott Woods, MD
role: PRINCIPAL_INVESTIGATOR
References: