Promoting Healthy Habits in Metabolic Syndrome

Phase

N/A

Condition

Metabolic Syndrome

High Cholesterol (Hyperlipidemia)

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT04262401

R44HL142328

Ages 18-60
All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

Participant in TriHealth's Corporate Wellness Program completing voluntary PersonalHealth 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 <50mg/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

Exclusion Criteria:

Have medical or other contraindications to increasing physical activity orfruit/vegetable/water intake

Study Design

November 23, 2020

December 31, 2024

Study 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.

Connect with a study center

TriHealth
Cincinnati, Ohio 45212
United States
Active - Recruiting

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