Skip to main content
OpenTrials
Completed

NCT Number: NCT01299051

Steps to Health: Targeting Obesity in the Health Care Workplace

The proposal of this study is to compare the effectiveness of two worksite weight management programs at Duke: Steps to Health (STH) ('usual standard of care') and the more extensive Steps to Health Plus! (STH+). We have added an additional follow-up, by invitation only, for participants in the study who agreed to be contacted for future research.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obese Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Dept. of Community and Family Medicine

Durham, North Carolina, 27710, United States

About this study

Steps to Health and Steps to Health Plus! aim to help Duke employees achieve weight loss and maintain healthy weights. We will be following participants in these programs over a two year period. These two groups will be compared with an observational comparison group of employees who meet eligibility criteria but do not take part in the randomized controlled trial. We will assess whether the two programs decrease obesity-related injuries in the workplace and estimate the net costs of the two programs relative to their effectiveness more broadly.

In the additional follow-up, we will be assessing factors that may be related to program success. This will include a survey as well as some focus group data.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Completion of a Health Risk Assessment
  • BMI ≥ 30
  • Able to read and understand study materials which are presented in English
  • No plans to leave Duke in the next year
  • Enrolled in one of the Duke health plans
  • Not currently pregnant

Exclusion criteria

  • Enrolled in the other available individual intervention programs (hypertension, cholesterol or pre-diabetes)
  • Enrolling in one of the LFL weight management programs in order to qualify for bariatric surgery

Treatment and study plan

Steps to Health

Behavioral

Steps to Health (STH): The STH curriculum is a 12-month educational program targeting obese employees for healthy lifestyle changes for weight loss. The program includes:

  • Face-to-face visit with counselor during Month 1 to set specific health goals.
  • Telephone counseling at 6 and 12 months, coupled with biometric feedback sessions.
  • Monthly generic health education materials sent via e-mail.
  • Incentives (up to 1,000 STH dollars [$100]) to take part in the program assessments.

Other names: STH

Steps to Health Plus!

Behavioral

The STH+ intervention is an intensive 12-month behavioral intervention targeting obese employees. It is stage-based and works with the participant at his/her level of readiness to change using counseling based on motivational interviewing. STH+ includes:

  • Face-to-face visit with counselor at Month 1
  • Meeting with exercise physiologist in Month 2
  • Monthly counseling sessions (in-person in Months 3, 6, 9 and 12, others via telephone)
  • Meeting with exercise physiologist during Month 5
  • Quarterly biometric feedback (Months 3, 6, 9, and 12)
  • Incentives (up to 1,000 STH dollars [$100]) to take part in the program assessments.

Other names: STH+, PTC

Primary outcomes

  1. Weight loss

    Time frame: ~1-2 years post baseline

    Determine whether employees participating in STH+ will lose significantly more body mass than participants in STH.

Secondary outcomes

  1. Improvement in level of physical activity

    Time frame: ~1-2 years post baseline.

    Determine whether employees participating in STH+ will experience greater improvements level or amount of physical activity than employees in STH.

  2. Relative impact of the different programs

    Time frame: ~1-2 years post baseline

    Determine the relative impact of STH+ and STH on 1) reduction in workplace injuries and associated costs, 2) health care utilization and health claim reimbursements, and 3) absenteeism and presenteeism.

  3. Relative cost of different programs

    Time frame: ~1-3 years post baseline

    Determine the overall relative impact of STH+ and STH on net program costs.

  4. Improvement in nutrition

    Time frame: ~1-2 years post baseline

    Determine whether employees participating in STH+ will experience greater improvements in diet, as measured by amount of calories consumed from fat and amount of fruits and vegetables consumed than employees in STH.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2016
First posted
Feb 18, 2011
Registry last updated
Mar 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.