A Randomized Incentive-Based Weight Loss Trial in Singapore

January 3, 2016 updated by: Eric A. Finkelstein, Duke-NUS Graduate Medical School
The purpose of this study is to test the extent to which incentives, when combined with an existing evidence-based weight loss program, improve weight loss and weight loss maintenance. It will also compare the cost-effectiveness of the incentive-based weight loss programs to the basic program without incentives.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Globally, the rise in obesity rates has reached epidemic proportions, and in Singapore 53% of adults have a body mass index (BMI) great than 23.0 kg/m2, a level that increases risk for chronic disease among Asians. This study aims to test the extent to which traditional or behavioural economic incentives, when combined with an existing evidence-based weight loss program, improve weight loss and weight loss maintenance. Data will be collected through a two-arm (basic weight loss program, basic program plus traditional or behavioural economic incentives) randomized controlled trial (RCT) where key outcome variables are defined as weight loss (kilograms) at 8 months when the incentive program concludes, and at 12 months, after a 4 month period in which no additional incentives are provided. We hypothesize that at both 8 and 12 months, weight loss will be greater in the incentive arm than in the arm without incentives. The growing obesity epidemic, the high costs of obesity to employers, insurers and governments across Asia, and the fact that the incentive program is designed to be close to cost neutral, suggest that this research has high potential to have a significant public health impact, both in Singapore and the region.

Study Type

Interventional

Enrollment (Actual)

161

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 169608
        • Singapore General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed informed consent
  • Age 21+
  • BMI 25+
  • Willing to be randomized into 1 of the 2 study arms
  • Willing to pay the $399 entry fee
  • Stated willingness to commit to participating in all assessments regardless of weight change or study arm

Exclusion Criteria:

  • Current pregnancy/lactation (women who become pregnant during the study will be withdrawn)
  • Type 1 diabetes
  • Type 2 diabetes on medication other than Metformin
  • End-stage Renal Disease
  • Ischemic Heart Disease requiring intervention in the past 6 months
  • Thyroid disease that has yet to stabilize
  • Changes in weight of greater than 3% in the past 6 months
  • Use of weight loss medication in the past 6 months
  • Malignancy requiring chemotherapy/radiation in the past 5 years
  • Acute medical problems requiring 3+ days of missed work during previous 4 week period
  • Any serious hospitalization or surgery in the past 6 months
  • Use of corticosteroids in the past 6 months
  • Answer 'YES' to any of the PAR-Q questions
  • Unable to obtain MD consent from a physician giving permission to participate in the study
  • Evidence of clinical depression (as assessed by the Beck Depression Inventory)
  • Currently on medications for a mental health or substance abuse condition
  • Evidence of binge eating based on the Binge Eating Disorders Scale (BEDS)
  • Unable to communicate in English
  • Additional concerns in which the clinical investigator deems problematic for participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Control participants will attend a 4-month structured weight-loss program and attend subsequent follow-ups at 4-month intervals upon completion of the program.
Experimental: Incentives
Incentive arm participants will be offered an additional program (in addition to the COMM program) where they can earn incentives for meeting specified weight loss targets or step goals. They will be offered a choice between traditional (payments with certainty) and behavioral(payments paid via lottery) incentives.
Other: Financial Incentives
Incentive arm participants will be able to earn incentives for meeting specified weight loss targets or step goals. They will be offered a choice between traditional (payments with certainty) and behavioral(payments paid via lottery) incentives.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight change
Time Frame: Baseline, 4 months, 8 months and 12 months
Baseline, 4 months, 8 months and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent body fat
Time Frame: Baseline, 4 months, 8 months, 12 months
Baseline, 4 months, 8 months, 12 months
Self-reported physical activity
Time Frame: Baseline, 4 months, 8 months, 12 months
Baseline, 4 months, 8 months, 12 months
Steps, aerobic steps and minutes of physical activity
Time Frame: Monthly through month 8 (in incentive arms)
Monthly through month 8 (in incentive arms)
Intrinsic and Extrinsic motivation
Time Frame: Baseline
Baseline
Sociodemographics
Time Frame: Baseline
Baseline
Health-related quality of life
Time Frame: Baseline, 4 months, 8 months, 12 months
Baseline, 4 months, 8 months, 12 months
Intervention costs
Time Frame: Baseline through month 8
Baseline through month 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke-NUS Graduate Medical School

Collaborators

Singapore General Hospital

Investigators

  • Principal Investigator: Eric A. Finkelstein, PhD, MHA, Duke-NUS Graduate Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

February 12, 2012

First Submitted That Met QC Criteria

February 14, 2012

First Posted (Estimate)

February 15, 2012

Study Record Updates

Last Update Posted (Estimate)

January 5, 2016

Last Update Submitted That Met QC Criteria

January 3, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0742_001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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