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A Randomized Incentive-Based Weight Loss Trial in Singapore

Primary Purpose

Obesity, Incentives

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Financial Incentives
Sponsored by
Duke-NUS Graduate Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Obesity focused on measuring Obesity, Weight loss, Incentives, Motivation

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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  • Current pregnancy/lactation (women who become pregnant during the study will be withdrawn)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

Sites / Locations

  • Singapore General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Incentives

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Weight change

Secondary Outcome Measures

Percent body fat
Self-reported physical activity
Steps, aerobic steps and minutes of physical activity
Intrinsic and Extrinsic motivation
Sociodemographics
Health-related quality of life
Intervention costs

Full Information

First Posted
February 12, 2012
Last Updated
January 3, 2016
Sponsor
Duke-NUS Graduate Medical School
Collaborators
Singapore General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01533454
Brief Title
A Randomized Incentive-Based Weight Loss Trial in Singapore
Official Title
A Randomized Incentive-Based Weight Loss Trial in Singapore
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Duke-NUS Graduate Medical School
Collaborators
Singapore General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Incentives
Keywords
Obesity, Weight loss, Incentives, Motivation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
161 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Incentives
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Financial Incentives
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight change
Time Frame
Baseline, 4 months, 8 months and 12 months
Secondary Outcome Measure Information:
Title
Percent body fat
Time Frame
Baseline, 4 months, 8 months, 12 months
Title
Self-reported physical activity
Time Frame
Baseline, 4 months, 8 months, 12 months
Title
Steps, aerobic steps and minutes of physical activity
Time Frame
Monthly through month 8 (in incentive arms)
Title
Intrinsic and Extrinsic motivation
Time Frame
Baseline
Title
Sociodemographics
Time Frame
Baseline
Title
Health-related quality of life
Time Frame
Baseline, 4 months, 8 months, 12 months
Title
Intervention costs
Time Frame
Baseline through month 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric A. Finkelstein, PhD, MHA
Organizational Affiliation
Duke-NUS Graduate Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore

12. IPD Sharing Statement

Citations:
PubMed Identifier
28554160
Citation
Finkelstein EA, Tham KW, Haaland BA, Sahasranaman A. Applying economic incentives to increase effectiveness of an outpatient weight loss program (TRIO) - A randomized controlled trial. Soc Sci Med. 2017 Jul;185:63-70. doi: 10.1016/j.socscimed.2017.05.030. Epub 2017 May 15.
Results Reference
derived

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A Randomized Incentive-Based Weight Loss Trial in Singapore

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