Clinical trial NCT01208350: Testing Strategies to Encourage Weight Loss in an Employer Setting
Official title: Testing Strategies to Encourage Weight Loss in an Employer Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Keywords: Weight Loss
Motivation
Workplace
Web platform
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
name: incentaHEALTH
name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
First posted: 2010-09-23
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 3-arm pilot randomized controlled trial to evaluate the effectiveness of two novel ways of structuring financial incentives to motivate and sustain long-term weight loss. The study will recruit eligible employees at Children's Hospital of Philadelphia (CHOP) to participate in a 6-month weight loss program and an additional 3-month follow-up period. The primary outcome measure in this randomized control trial will be pounds of weight lost between baseline and 6 months. The goal of this study is to evaluate whether a novel financial incentive program delivered through a workplace can effectively encourage sustained weight loss among obese employees.

The study hypotheses are 1) mean weight loss will be greater in all the intervention groups compared to the control group by the end of the 24-week intervention period; and 2) individuals in the intervention groups will have a lower mean weight at the end of the 12-week follow-up period than individuals in the control group.


Eligibility criteria: Inclusion Criteria:

* Aged 18 to 70 (inclusive)
* BMI between 30 and 40 (inclusive)

Exclusion Criteria:

* Inability to consent
* Illiteracy and/or inability to speak, read, and write English
* Participation in another research study
* Current treatment for drug or alcohol use
* Consumption of ≥ 5 alcoholic drinks per day
* Myocardial infarction or stroke within the past 6 months
* Current addiction to prescription medicines or street drugs
* Serious psychiatric diagnoses (e.g., severe major depressive disorder, bipolar disorder, schizophrenia)
* Pregnant or currently breastfeeding
* Diabetic and using any medicine besides metformin to control blood glucose
* Metastatic cancer
* Unstable medical conditions that would likely prevent the subject from completing the study
* Previous diagnosis of an eating disorder
* History of unsafe weight loss behaviors such as binging or the use of laxatives

Primary outcomes:
measure: Change in weight between baseline and six months
timeFrame: 24 weeks
Secondary outcomes:
measure: usability of a newly developed web portal and its feasibility for future randomized clinical trials aimed at changing health-related behaviors
timeFrame: end of study
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Kevin Volpp, MD, PhD
role: STUDY_CHAIR
affiliation: University of Pennsylvania
name: Jeffrey T Kullgren, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kullgren JT, Troxel AB, Loewenstein G, Asch DA, Norton LA, Wesby L, Tao Y, Zhu J, Volpp KG. Individual- versus group-based financial incentives for weight loss: a randomized, controlled trial. Ann Intern Med. 2013 Apr 2;158(7):505-14. doi: 10.7326/0003-4819-158-7-201304020-00002.