Back to resultsWorksite Wellness Randomized Controlled Trial
Primary Purpose
Obesity, Overweight, Quality of Life
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The iDiet® (also called Healthy Weight for Living when used as a not-for-profit intervention) with Food
The iDiet® (also called Healthy Weight for Living when used as a not-for-profit intervention) with Voucher
Human Performance Institute©
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Energy, Presenteeism, Absenteeism, Cardiometabolic health, Obesity, Overweight, Weight Loss, Quality of Life, Weight Control, Eating Behavior, Food Cravings, Hunger, Worksite Wellness
Eligibility Criteria
Inclusion Criteria:
- Willingness to sign an informed consent form
- Willingness to provide release from his/her physician before starting the intervention program-a requirement for each of the 3 wellness programs
- 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
- Willingness to complete outcome assessments and self-monitoring in order to track intervention effectiveness
- BMI ≥ 20 kg/m2 and < 50 kg/m2 at screening, if participant opts into the HPI arm
- BMI ≥ 25 kg/m2 and < 50 kg/m2 at screening, if participant opts into the weight loss arm
Exclusion Criteria:
- Employees who are temporary contract workers or employees who work remotely most of the time
- < 21 years of age
- Participation in a weight loss program or intensive wellbeing program at time of enrollment
- Pregnant or lactating (per self-reports, now or intended during study)
- Prior weight loss surgery or a medical complication that would prevent full participation
- Multiple severe dietary intolerances (e.g. gluten combined with dairy or meat) which would reduce intervention adherence
- Non-English speaking
- Individuals who have lost > 15 pounds in the past 6 months
- Mobility limitations (inhibiting the ability to stand on one's own or get on and off of the scale)
- Major diseases including active cancer or cardiovascular disease
- BMI < 25 kg/m2 or ≥ 50 kg/m2 at screening, for those that opt-in to the weight-loss group
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:
- Any condition that influences the ability to absorb food (e.g. inflammatory bowel disease or celiac disease)
- Very active individuals (> 2 hours/day or >14 hours/week of vigorous activity).
Sites / Locations
- Tufts University Human Nutrition Research Center on Aging
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
Human Performance Institute©
The iDiet® with Voucher
The iDiet® with Food
Wait-listed control
Arm Description
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).
These participants will be part of the intervention sites and will receive the iDiet® with Voucher for the duration of the study (18 months).
These participants will be part of the intervention sites and will receive the iDiet® with Food for the duration of the study (18 months).
These participants will be part of the control sites and will participate in outcome assessments for a 6-month period only.
Outcomes
Primary Outcome Measures
Weight (iDiet/Healthy Weight for Living arms)
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)
Assessed by the RAND Short Form 36 Health Survey (SF-36) at baseline, 6, 12, and 18 months.
Secondary Outcome Measures
Blood pressure
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).
Cholesterol
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
Triglycerides measured at baseline, 6, 12, and 18 months using the Alere Cholestech LDX® System (fasted lipid panel).
Glucose
Fasting blood glucose measured at baseline, 6, 12, and 18 months using the Alere Cholestech LDX® System.
Hemoglobin A1c
HbA1c measured at baseline, 6, 12, and 18 months using the Siemens DCA Vantage, which requires 1 microliter of blood (fasted measurement).
Eating behavior (Food Preferences)
Assessed by the Food Preferences Questionnaire (self-administered) at baseline, 6, 12, and 18 months.
Eating behavior (Three-Factor Eating)
Assessed by the Three-Factor Eating Questionnaire (self-administered) at baseline, 6, 12, and 18 months.
Eating behavior (Food Cravings)
Assessed by the Food Cravings Questionnaire - Trait (self-administered) at baseline, 6, 12, and 18 months.
Depression
Assessed by the Center for Epidemiological Studies Depression Scale (self-administered) at baseline, 6, 12, and 18 months.
Mood
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.
Physical Activity
Assessed by the International Physical Activity Questionnaire (self-administered) at baseline, 6, 12, and 18 months.
Well-being
Assessed by the Ryff Purpose in Life scale (self-administered) at baseline, 6, 12, and 18 months.
Productivity
Assessed by the Work Productivity and Impairment scale (self-administered) at baseline, 6, 12, and 18 months.
Sleep
Assessed by the Medical Outcomes Study Sleep Questionnaire (self-administered) at baseline, 6, 12, and 18 months.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02593240
Brief Title
Worksite Wellness Randomized Controlled Trial
Official Title
Worksite Wellness Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tufts University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight, Quality of Life
Keywords
Energy, Presenteeism, Absenteeism, Cardiometabolic health, Obesity, Overweight, Weight Loss, Quality of Life, Weight Control, Eating Behavior, Food Cravings, Hunger, Worksite Wellness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
554 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Human Performance Institute©
Arm Type
Experimental
Arm Description
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).
Arm Title
The iDiet® with Voucher
Arm Type
Experimental
Arm Description
These participants will be part of the intervention sites and will receive the iDiet® with Voucher for the duration of the study (18 months).
Arm Title
The iDiet® with Food
Arm Type
Experimental
Arm Description
These participants will be part of the intervention sites and will receive the iDiet® with Food for the duration of the study (18 months).
Arm Title
Wait-listed control
Arm Type
No Intervention
Arm Description
These participants will be part of the control sites and will participate in outcome assessments for a 6-month period only.
Intervention Type
Behavioral
Intervention Name(s)
The iDiet® (also called Healthy Weight for Living when used as a not-for-profit intervention) with Food
Intervention Description
The intensive iDiet® group behavioral weight loss program will be delivered in person at the worksite or by videoconference and with support of the program's web platform. This intervention will be delivered by trained group leaders and will initially include weekly 1-hour support and education meetings of 20 participants/group with a message board for group communication and individual communication with the group leader. Over time support will be provided online rather than in live meetings. The intervention involves a weight loss behavioral program with particular emphasis on hunger reduction and craving control for both weight loss and prevention of weight regain. Half of the participants per worksite receiving the iDiet® intervention will be randomized to receive commercial dried food products (partial supply) from Yevo Intl., which are designed to help with weight control and health.
Intervention Type
Behavioral
Intervention Name(s)
The iDiet® (also called Healthy Weight for Living when used as a not-for-profit intervention) with Voucher
Intervention Description
The intensive iDiet® group behavioral weight loss program delivered in person at the worksite or by videoconference and with support of the program's web platform. This intervention will be delivered by trained group leaders and will initially include weekly 1-hour support and education meetings of 20 participants/group with a message board for group communication and individual communication with the group leader. Over time support will be provided online rather than in live meetings. The intervention involves a weight loss behavioral program with particular emphasis on hunger reduction and craving control for both weight loss and prevention of weight regain. Half of the participants per worksite receiving the Diet® intervention will be randomized to receive gift cards monthly for the first 6 months to purchase foods at their local grocery store (partial costs).
Intervention Type
Behavioral
Intervention Name(s)
Human Performance Institute©
Intervention Description
The Human Performance Institute© (HPI) training workshop is a comprehensive individual development training program that focuses on the concept of energy management. The primary aim of this program is to help individuals develop attitudes, habits, and behaviors that increase their levels of daily energy, life satisfaction, and overall functioning. The course is delivered at an off-site location over 2.5 days, by 3 coaches, in a group format of 25 - 32 participants (with employees from more than one worksite per group).
Primary Outcome Measure Information:
Title
Weight (iDiet/Healthy Weight for Living arms)
Description
Fasted measurements of weight obtained in duplicate to ±0.1 kg at baseline, 6, 12, and 18 months using the TANITA TBF-300A.
Time Frame
1.5 years
Title
Quality of Life (HPI arm)
Description
Assessed by the RAND Short Form 36 Health Survey (SF-36) at baseline, 6, 12, and 18 months.
Time Frame
1.5 years
Secondary Outcome Measure Information:
Title
Blood pressure
Description
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).
Time Frame
1.5 years
Title
Cholesterol
Description
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).
Time Frame
1.5 years
Title
Triglycerides
Description
Triglycerides measured at baseline, 6, 12, and 18 months using the Alere Cholestech LDX® System (fasted lipid panel).
Time Frame
1.5 years
Title
Glucose
Description
Fasting blood glucose measured at baseline, 6, 12, and 18 months using the Alere Cholestech LDX® System.
Time Frame
1.5 years
Title
Hemoglobin A1c
Description
HbA1c measured at baseline, 6, 12, and 18 months using the Siemens DCA Vantage, which requires 1 microliter of blood (fasted measurement).
Time Frame
1.5 years
Title
Eating behavior (Food Preferences)
Description
Assessed by the Food Preferences Questionnaire (self-administered) at baseline, 6, 12, and 18 months.
Time Frame
1.5 years
Title
Eating behavior (Three-Factor Eating)
Description
Assessed by the Three-Factor Eating Questionnaire (self-administered) at baseline, 6, 12, and 18 months.
Time Frame
1.5 years
Title
Eating behavior (Food Cravings)
Description
Assessed by the Food Cravings Questionnaire - Trait (self-administered) at baseline, 6, 12, and 18 months.
Time Frame
1.5 years
Title
Depression
Description
Assessed by the Center for Epidemiological Studies Depression Scale (self-administered) at baseline, 6, 12, and 18 months.
Time Frame
1.5 years
Title
Mood
Description
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.
Time Frame
1.5 years
Title
Physical Activity
Description
Assessed by the International Physical Activity Questionnaire (self-administered) at baseline, 6, 12, and 18 months.
Time Frame
1.5 years
Title
Well-being
Description
Assessed by the Ryff Purpose in Life scale (self-administered) at baseline, 6, 12, and 18 months.
Time Frame
1.5 years
Title
Productivity
Description
Assessed by the Work Productivity and Impairment scale (self-administered) at baseline, 6, 12, and 18 months.
Time Frame
1.5 years
Title
Sleep
Description
Assessed by the Medical Outcomes Study Sleep Questionnaire (self-administered) at baseline, 6, 12, and 18 months.
Time Frame
1.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Willingness to sign an informed consent form
Willingness to provide release from his/her physician before starting the intervention program-a requirement for each of the 3 wellness programs
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
Willingness to complete outcome assessments and self-monitoring in order to track intervention effectiveness
BMI ≥ 20 kg/m2 and < 50 kg/m2 at screening, if participant opts into the HPI arm
BMI ≥ 25 kg/m2 and < 50 kg/m2 at screening, if participant opts into the weight loss arm
Exclusion Criteria:
Employees who are temporary contract workers or employees who work remotely most of the time
< 21 years of age
Participation in a weight loss program or intensive wellbeing program at time of enrollment
Pregnant or lactating (per self-reports, now or intended during study)
Prior weight loss surgery or a medical complication that would prevent full participation
Multiple severe dietary intolerances (e.g. gluten combined with dairy or meat) which would reduce intervention adherence
Non-English speaking
Individuals who have lost > 15 pounds in the past 6 months
Mobility limitations (inhibiting the ability to stand on one's own or get on and off of the scale)
Major diseases including active cancer or cardiovascular disease
BMI < 25 kg/m2 or ≥ 50 kg/m2 at screening, for those that opt-in to the weight-loss group
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:
Any condition that influences the ability to absorb food (e.g. inflammatory bowel disease or celiac disease)
Very active individuals (> 2 hours/day or >14 hours/week of vigorous activity).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sai Krupa Das, PhD
Organizational Affiliation
Tufts University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susan B Roberts, PhD
Organizational Affiliation
Tufts University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts University Human Nutrition Research Center on Aging
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
12. IPD Sharing Statement
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Worksite Wellness Randomized Controlled Trial
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