ObesityNCT02593240

Worksite Wellness Randomized Controlled Trial

A study testing 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 and Human Performance Institute© in people with Obesity and Overweight, run by Tufts University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for: Obesity, Overweight, Quality of Life
What is being tested?: 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 and Human Performance Institute©
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 554 participants
Where: 1 siteUnited States
Study dates: Sep 2015to Mar 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 15Show fewer

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).

Trial locations and contacts

1 site in 1 country.

United States1 site

Tufts University Human Nutrition Research Center on Aging
Boston, Massachusetts, 02111

Other trials in United States

About this study

Official title: Worksite Wellness Study

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.

Conditions: Obesity, Overweight, Quality of Life
Being tested: 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©
Keywords: Energy, Presenteeism, Absenteeism, Cardiometabolic health, Obesity, Overweight, Weight Loss, Quality of Life, Weight Control, Eating Behavior, Food Cravings, Hunger, Worksite Wellness
Medical subject headings: Obesity, Overweight, Weight Loss, Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

The iDiet® (also called Healthy Weight for Living when used as a not-for-profit intervention) with FoodBehavioural
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.
The iDiet® (also called Healthy Weight for Living when used as a not-for-profit intervention) with VoucherBehavioural
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).
Human Performance Institute©Behavioural
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).

Study groups in NCT02593240
Study group	Role	What they receive
Human Performance Institute©	Experimental	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). Receives: Behavioral: Human Performance Institute©
The iDiet® with Voucher	Experimental	These participants will be part of the intervention sites and will receive the iDiet® with Voucher for the duration of the study (18 months). Receives: Behavioral: The iDiet® (also called Healthy Weight for Living when used as a not-for-profit intervention) with Voucher
The iDiet® with Food	Experimental	These participants will be part of the intervention sites and will receive the iDiet® with Food for the duration of the study (18 months). Receives: Behavioral: The iDiet® (also called Healthy Weight for Living when used as a not-for-profit intervention) with Food
Wait-listed control	No intervention	These participants will be part of the control sites and will participate in outcome assessments for a 6-month period only.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1.5 years
Quality of Life (HPI arm)
Assessed by the RAND Short Form 36 Health Survey (SF-36) at baseline, 6, 12, and 18 months.
Measured: 1.5 years

Secondary outcomes (14)

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).
Measured: 1.5 years
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).
Measured: 1.5 years
Triglycerides
Triglycerides measured at baseline, 6, 12, and 18 months using the Alere Cholestech LDX® System (fasted lipid panel).
Measured: 1.5 years
Glucose
Fasting blood glucose measured at baseline, 6, 12, and 18 months using the Alere Cholestech LDX® System.
Measured: 1.5 years
Hemoglobin A1c
HbA1c measured at baseline, 6, 12, and 18 months using the Siemens DCA Vantage, which requires 1 microliter of blood (fasted measurement).
Measured: 1.5 years
Eating behavior (Food Preferences)
Assessed by the Food Preferences Questionnaire (self-administered) at baseline, 6, 12, and 18 months.
Measured: 1.5 years
Eating behavior (Three-Factor Eating)
Assessed by the Three-Factor Eating Questionnaire (self-administered) at baseline, 6, 12, and 18 months.
Measured: 1.5 years
Eating behavior (Food Cravings)
Assessed by the Food Cravings Questionnaire - Trait (self-administered) at baseline, 6, 12, and 18 months.
Measured: 1.5 years
Depression
Assessed by the Center for Epidemiological Studies Depression Scale (self-administered) at baseline, 6, 12, and 18 months.
Measured: 1.5 years
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.
Measured: 1.5 years
Physical Activity
Assessed by the International Physical Activity Questionnaire (self-administered) at baseline, 6, 12, and 18 months.
Measured: 1.5 years
Well-being
Assessed by the Ryff Purpose in Life scale (self-administered) at baseline, 6, 12, and 18 months.
Measured: 1.5 years
Productivity
Assessed by the Work Productivity and Impairment scale (self-administered) at baseline, 6, 12, and 18 months.
Measured: 1.5 years
Sleep
Assessed by the Medical Outcomes Study Sleep Questionnaire (self-administered) at baseline, 6, 12, and 18 months.
Measured: 1.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2015Mar 2018

First posted2 Nov 2015 (estimated)
Study startSep 2015
Primary completionMar 2018
Study completionMar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 554 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02593240
Sponsor's protocol ID: 11768
Status last verified: Aug 2020
First submitted: 21 Oct 2015
Last updated: 27 Aug 2020
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Worksite Wellness Study
ClinicalTrials.gov ID: NCT02593240
Acronym / sponsor ID: 11768
Conditions: Obesity, Overweight, Quality of Life
Keywords: Energy, Presenteeism, Absenteeism, Cardiometabolic health, Obesity, Overweight, Weight Loss, Quality of Life
Study type: Interventional
Recruitment status: Completed
Enrolment: 554 participants (actual)
Lead sponsor: Tufts UniversityUniversity, hospital or other
Study start: Sep 2015 (actual)
Primary completion: Mar 2018 (actual)
Study completion: Mar 2018 (actual)
First posted: 2 Nov 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Human Performance Institute©	Experimental	Behavioral: 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 Voucher	Experimental	Behavioral: The iDiet® (also called Healthy Weight for Living when used as a not-for-profit intervention) with VoucherThese participants will be part of the intervention sites and will receive the iDiet® with Voucher for the duration of the study (18 months).
The iDiet® with Food	Experimental	Behavioral: The iDiet® (also called Healthy Weight for Living when used as a not-for-profit intervention) with FoodThese participants will be part of the intervention sites and will receive the iDiet® with Food for the duration of the study (18 months).
Wait-listed control	No intervention	–These participants will be part of the control sites and will participate in outcome assessments for a 6-month period only.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
The iDiet® (also called Healthy Weight for Living when used as a not-for-profit intervention) with FoodThe 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.	Behavioural	The iDiet® with Food
The iDiet® (also called Healthy Weight for Living when used as a not-for-profit intervention) with VoucherThe 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).	Behavioural	The iDiet® with Voucher
Human Performance Institute©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).	Behavioural	Human Performance Institute©

Primary outcome

Weight (iDiet/Healthy Weight for Living arms)
Time frame: 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)
Time frame: 1.5 years
Assessed by the RAND Short Form 36 Health Survey (SF-36) at baseline, 6, 12, and 18 months.

14 secondary outcomes

Blood pressure
Time frame: 1.5 years
Cholesterol
Time frame: 1.5 years
Triglycerides
Time frame: 1.5 years
Glucose
Time frame: 1.5 years
Hemoglobin A1c
Time frame: 1.5 years
Eating behavior (Food Preferences)
Time frame: 1.5 years
Eating behavior (Three-Factor Eating)
Time frame: 1.5 years
Eating behavior (Food Cravings)
Time frame: 1.5 years
Depression
Time frame: 1.5 years
Mood
Time frame: 1.5 years
Physical Activity
Time frame: 1.5 years
Well-being
Time frame: 1.5 years
Productivity
Time frame: 1.5 years
Sleep
Time frame: 1.5 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.

Related trials for Obesity

RecruitingPhase 4
Translational Health Research Into Vascular and Neurocognitive Effects of Weight Loss
Class I/II Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
A Phase 1/2a Study of WVE-007 in Adults Living With Overweight or Obesity
Overweight and Obesity
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
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Not yet recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sai Krupa Das, PhD principal investigator

Tufts University

Susan B Roberts, PhD principal investigator

Tufts University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight (iDiet/Healthy Weight for Living arms) (time frame: 1.5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02593240.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2020.