Promoting Healthy Habits in Metabolic Syndrome

NCT ID: NCT04262401

Last Updated: 2022-11-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 424 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-23
• Study Completion Date: 2024-12-31

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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard health coaching

Standard health coaching to increase health behaviors

Group Type: ACTIVE_COMPARATOR

Standard health coaching

Intervention Type: BEHAVIORAL

12 weekly sessions of standard health coaching followed by 4 monthly sessions

Habit-focused health coaching

Health coaching enhanced with a focus on habit formation using a mobile application called Habit Design

Group Type: EXPERIMENTAL

Habit-focused health coaching

Intervention Type: BEHAVIORAL

12 weekly sessions of standard health coaching followed by 4 monthly sessions

Interventions

Standard health coaching

12 weekly sessions of standard health coaching followed by 4 monthly sessions

Intervention Type: BEHAVIORAL

Habit-focused health coaching

12 weekly sessions of standard health coaching followed by 4 monthly sessions

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: collaborator

TriHealth Inc.

OTHER

Sponsor Role: collaborator

Habit Design

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Kim, MBA

Role: PRINCIPAL_INVESTIGATOR

Habit Design

Susan Stoner, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Scott Woods, MD

Role: PRINCIPAL_INVESTIGATOR

TriHealth Inc.

Locations

TriHealth

Cincinnati, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Susan Stoner, PhD

Role: CONTACT

sastoner@uw.edu

2065434520

Facility Contacts

Shannon Ricca, MA

Role: primary

Shannon_Ricca@trihealth.com

513-977-0081

Other Identifiers

R44HL142328

Identifier Type: NIH

Identifier Source: org_study_id

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