Promoting Healthy Habits in Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04262401
• Other study ID #: R44HL142328
• Status: Recruiting
• Phase: N/A
• Start date: November 23, 2020
• Est. completion date: December 2024

Study information

• Verified date: November 2022
• Source: Habit Design
• Contact: Susan Stoner, PhD
• Phone: 2065434520
• Email: sastoner[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 424
• Est. completion date: December 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Behavioral:
• Standard health coaching
12 weekly sessions of standard health coaching followed by 4 monthly sessions
• Habit-focused health coaching
12 weekly sessions of standard health coaching followed by 4 monthly sessions

Locations

Country	Name	City	State
United States	TriHealth	Cincinnati	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Habit Design	TriHealth Inc., University of Washington

Country where clinical trial is conducted

United States, 

Outcome

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