Worksite Wellness Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Quality of Life; Obesity; Overweight
• Interventions: Behavioral: The iDiet® (also called Healthy Weight for Living when used as a not-for-profit intervention) with Voucher; Behavioral: Human Performance Institute©; Behavioral: The iDiet® (also called Healthy Weight for Living when used as a not-for-profit intervention) with Food

• Registration Number: NCT02593240
• Lead Sponsor: Tufts University

Brief Summary

Worksites offer attractive locations for reducing the national prevalence of overweight and obesity. Interventions that are both effective and sustainable for producing long-term changes in health and employee wellness are urgently needed. In an 18-month worksite randomized controlled trial in 12 worksites, this study will test two lifestyle approaches designed to facilitate behavior modification for achieving long-term improvements in health and quality of life. Worksites randomized to the immediate intervention arm will receive the two on-site wellness programs and the randomized control sites will participate in outcomes assessments for the initial 6-month period, after which participants will receive vouchers to participate in the program of their choice. The primary focus of the worksite wellness study is to identify ways to improve health-related quality of life, with a particular focus on a decrease in cardiometabolic risk factors, including weight, improved weight-related wellness, and improved energy level in work and life. The two interventions will be separately tested against the control condition in intention-to-treat models and with a completers analysis.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-10-21
• Study First Submitted QC: 2015-10-29
• Study First Posted: 2015-11-01
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-24
• Last Update Posted: 2020-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 554

Inclusion Criteria

1. Willingness to sign an informed consent form
2. Willingness to provide release from his/her physician before starting the intervention program-a requirement for each of the 3 wellness programs
3. Willingness to provide email identification (ID) and contact information to the commercial program facilitators to receive program materials and other feedback related to program progress
4. Willingness to complete outcome assessments and self-monitoring in order to track intervention effectiveness
5. BMI ≥ 20 kg/m2 and < 50 kg/m2 at screening, if participant opts into the HPI arm
6. BMI ≥ 25 kg/m2 and < 50 kg/m2 at screening, if participant opts into the weight loss arm

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Exclusion Criteria

1. Employees who are temporary contract workers or employees who work remotely most of the time

2. < 21 years of age

3. Participation in a weight loss program or intensive wellbeing program at time of enrollment

4. Pregnant or lactating (per self-reports, now or intended during study)

5. Prior weight loss surgery or a medical complication that would prevent full participation

6. Multiple severe dietary intolerances (e.g. gluten combined with dairy or meat) which would reduce intervention adherence

7. Non-English speaking

8. Individuals who have lost > 15 pounds in the past 6 months

9. Mobility limitations (inhibiting the ability to stand on one's own or get on and off of the scale)

10. Major diseases including active cancer or cardiovascular disease

11. BMI < 25 kg/m2 or ≥ 50 kg/m2 at screening, for those that opt-in to the weight-loss group

12. BMI <20 kg/m2 or ≥ 50 kg/m2 at screening, for those that opt-in to the HPI group

    For those interested in the weight loss intervention, additional exclusion criteria are as follows:

13. Any condition that influences the ability to absorb food (e.g. inflammatory bowel disease or celiac disease)

14. Very active individuals (> 2 hours/day or >14 hours/week of vigorous activity).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
The iDiet® with Voucher	The iDiet® (also called Healthy Weight for Living when used as a not-for-profit intervention) with Voucher	These participants will be part of the intervention sites and will receive the iDiet® with Voucher for the duration of the study (18 months).
Human Performance Institute©	Human Performance Institute©	These participants will be part of the intervention sites and will receive the Human Performance Institute© intervention for the duration of the study (18 months).
The iDiet® with Food	The iDiet® (also called Healthy Weight for Living when used as a not-for-profit intervention) with Food	These participants will be part of the intervention sites and will receive the iDiet® with Food for the duration of the study (18 months).

Primary Outcome Measures

Name	Time	Method
Weight (iDiet/Healthy Weight for Living arms)	1.5 years	Fasted measurements of weight obtained in duplicate to ±0.1 kg at baseline, 6, 12, and 18 months using the TANITA TBF-300A.
Quality of Life (HPI arm)	1.5 years	Assessed by the RAND Short Form 36 Health Survey (SF-36) at baseline, 6, 12, and 18 months.

Secondary Outcome Measures

Name	Time	Method
Blood pressure	1.5 years	Systolic and diastolic blood pressure (mm Hg) measured to the nearest 1 mm Hg at baseline, 6, 12, and 18 months using a validated automated monitor (3 fasted measurements, 5 minutes apart, after 5 minutes of quiet sitting).
Eating behavior (Three-Factor Eating)	1.5 years	Assessed by the Three-Factor Eating Questionnaire (self-administered) at baseline, 6, 12, and 18 months.
Eating behavior (Food Cravings)	1.5 years	Assessed by the Food Cravings Questionnaire - Trait (self-administered) at baseline, 6, 12, and 18 months.
Productivity	1.5 years	Assessed by the Work Productivity and Impairment scale (self-administered) at baseline, 6, 12, and 18 months.
Sleep	1.5 years	Assessed by the Medical Outcomes Study Sleep Questionnaire (self-administered) at baseline, 6, 12, and 18 months.
Depression	1.5 years	Assessed by the Center for Epidemiological Studies Depression Scale (self-administered) at baseline, 6, 12, and 18 months.
Cholesterol	1.5 years	Total cholesterol, high-density lipoprotein, and low-density lipoprotein measured at baseline, 6, 12, and 18 months using the Alere Cholestech LDX® System, which requires 40 microliters of blood (fasted lipid panel).
Triglycerides	1.5 years	Triglycerides measured at baseline, 6, 12, and 18 months using the Alere Cholestech LDX® System (fasted lipid panel).
Mood	1.5 years	Assessed by the Profile of Mood States (self-administered) at baseline, 6, 12, and 18 months. Variables include anger-hostility, depression-dejection, fatigue-inertia, and vigor-activity.
Well-being	1.5 years	Assessed by the Ryff Purpose in Life scale (self-administered) at baseline, 6, 12, and 18 months.
Eating behavior (Food Preferences)	1.5 years	Assessed by the Food Preferences Questionnaire (self-administered) at baseline, 6, 12, and 18 months.
Glucose	1.5 years	Fasting blood glucose measured at baseline, 6, 12, and 18 months using the Alere Cholestech LDX® System.
Hemoglobin A1c	1.5 years	HbA1c measured at baseline, 6, 12, and 18 months using the Siemens DCA Vantage, which requires 1 microliter of blood (fasted measurement).
Physical Activity	1.5 years	Assessed by the International Physical Activity Questionnaire (self-administered) at baseline, 6, 12, and 18 months.

Trial Locations

Locations (1)

Tufts University Human Nutrition Research Center on Aging; 🇺🇸 Boston, Massachusetts, United States