NCT01208350

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

September 8, 2014

Status Verified

September 1, 2012

Enrollment Period

10 months

First QC Date

September 22, 2010

Last Update Submit

September 4, 2014

Conditions

Weight Loss

Keywords

Weight LossMotivationWorkplaceWeb platform

Outcome Measures

Primary Outcomes (1)

  • Change in weight between baseline and six months

    24 weeks

Secondary Outcomes (1)

  • usability of a newly developed web portal and its feasibility for future randomized clinical trials aimed at changing health-related behaviors

    end of study

Study Arms (3)

1

EXPERIMENTAL
Behavioral: Individual payout

2

EXPERIMENTAL
Behavioral: Group-based payout

3

ACTIVE COMPARATOR
Behavioral: No intervention

Interventions

No interventionBEHAVIORAL

Monthly weigh-ins for 6 months without financial incentives associated with weight loss, and follow-up weigh-in at 9 months

3
Group-based payoutBEHAVIORAL

Monthly weigh-ins for 6 months where five sequential participants, randomized to this condition, will be joined into virtual groups where individual rewards for weight loss are dependent on the weight loss of others in the group, with follow-up weigh in at 9 months

2
Individual payoutBEHAVIORAL

Monthly weigh-ins for 6 months and if monthly goals are met, participants receive payout at the end of the month, with follow-up weigh-in at 9 months

1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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.

    PMID: 23546562DERIVED

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kevin Volpp, MD, PhD

    University of Pennsylvania

    STUDY CHAIR

  • Jeffrey T Kullgren, MD, MPH

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2010

First Posted

September 23, 2010

Study Start

March 1, 2011

Primary Completion

January 1, 2012

Study Completion

August 1, 2014

Last Updated

September 8, 2014

Record last verified: 2012-09

Locations

US(1)