Recruiting

Healthy Habits

Sponsor:

Habit Design

Code:

NCT04262401

Conditions

Metabolic Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Standard health coaching

Habit-focused health coaching

Study Details

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

Study ID

NCT04262401

Start date

Nov 23, 2020

Status verified date

Nov, 2022

Completion date

Dec, 2024

Anticipated

Primary completion date

Apr, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

424 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard health coaching

Standard health coaching to increase health behaviors

experimental: Habit-focused health coaching

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

Interventions

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

Primary outcome measure

  • Change from baseline average daily step count at 16 weeks [ Time Frame: 16 weeks ]
  • Change from baseline average daily step count at 32 weeks [ Time Frame: 32 weeks ]
  • Change from baseline average daily step count at 48 weeks [ Time Frame: 48 weeks ]

Central Contacts and Locations

Central contacts

Susan Stoner, PhD

2065434520sastoner@uw.edu

Locations

TriHealth

Recruiting

Cincinnati, Ohio, United States, 45212

Contacts

Shannon Ricca, MA

513-977-0081Shannon_Ricca@trihealth.com

Principal Investigator:

Scott Woods, MD

More Information

Sponsor

Habit Design

Last update posted

Nov 10, 2022

Last verified

Nov, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Habit Design on 2022-11-10.