Promoting Healthy Habits in Metabolic Syndrome

NCT04262401 | Unknown DMC

• 1 other identifier: R44HL142328
• Study Type: interventional
• Target: 424
• Locations: 1 country
• Sites: 1

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).

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (18)

• Change in frequency consuming fruits and vegetables in the past 4 months at 16 weeks

  16 weeks

• Change in frequency consuming fruits and vegetables in the past 4 months at 32 weeks

  32 weeks

• Change in frequency consuming fruits and vegetables in the past 4 months at 48 weeks

  48 weeks

• Change in frequency consuming water in the past 4 months at 16 weeks

  16 weeks

• Change in frequency consuming water in the past 4 months at 32 weeks

  32 weeks

Study Arms (2)

Standard health coaching

ACTIVE COMPARATOR

Standard health coaching to increase health behaviors

Behavioral: Standard health coaching

Habit-focused health coaching

EXPERIMENTAL

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

Behavioral: Habit-focused health coaching

Interventions

Standard health coaching BEHAVIORAL

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

Standard health coaching

Habit-focused health coaching BEHAVIORAL

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

Habit-focused health coaching

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Habit Design: lead
• University of Washington: collaborator
• TriHealth Inc.: collaborator

Study Sites (1)

TriHealth

Cincinnati, Ohio, 45212, United States

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Michael Kim, MBA

  Habit Design

  PRINCIPAL INVESTIGATOR

• Susan Stoner, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Scott Woods, MD

  TriHealth Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Stoner, PhD

CONTACT

2065434520; sastoner@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 10, 2020
• Study Start: November 23, 2020
• Primary Completion: April 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)