NCT03534336

Brief Summary

The objective of this project is to design a Behavioral Economics Based Online Lifestyle Balance Program that employs behavioral economics to engage and motivate adherence to an Internet-based program. The investigators compare the effects of two financial incentives on inducing weight loss: a direct financial incentive for weight loss and a financial incentive for health literacy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
710

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 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

Study Start

First participant enrolled

October 12, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2016

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 23, 2018

Completed
Last Updated

August 22, 2018

Status Verified

August 1, 2018

Enrollment Period

8 months

First QC Date

May 11, 2018

Last Update Submit

August 20, 2018

Conditions

Keywords

Weight ReductionHealth LiteracyFinancial IncentivesLifestyle Change

Outcome Measures

Primary Outcomes (1)

  • Weight Loss at the end of the weight loss program (at Week 13)

    Weight measured at the Week 13 weigh-in session. Weight measurements are taken by trained research assistants using digital scales.

    At week 13 of the RCT.

Secondary Outcomes (1)

  • Weight Loss at the end of the post-intervention period (Week 25)

    At week 25 of the RCT.

Study Arms (3)

Control

NO INTERVENTION

Participants are enrolled in a 12-week, self-administered online weight loss program. The program is delivered through 12 weekly sessions; each includes educational videos and a health literacy quiz. Each quiz contains 10 questions, and a quiz is considered "passed" when at least 7 questions are answered correctly. All participants are encouraged to follow the program, take the quizzes, and lose 5% of their baseline body weight by the end of the program. No financial incentives are given for losing weight or passing quizzes.

Incentive for Education

EXPERIMENTAL

Same 12-week, self-administered online weight loss program as in the Control arm. Each participant is also given a $150 "Incentive for Education" for passing at least nine quizzes by the end of the program.

Behavioral: Incentive for Education

Incentive for Weight Loss

EXPERIMENTAL

Same 12-week, self-administered online weight loss program as in the Control arm. Each participant is also given a $150 "Incentive for Weight Loss" for losing 5% of their baseline body weight.

Behavioral: Incentive for Weight Loss

Interventions

A $150 "Incentive for Education" is given to the participants for passing at least nine quizzes by the end of the program

Incentive for Education

A $150 "Incentive for Weight Loss" is given to the participants for losing at least 5% of baseline weight by the end of the program

Incentive for Weight Loss

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI between 23 and 33
  • Age between 40 and 60 years old

You may not qualify if:

  • History of diabetes
  • History of significant cardiovascular disease
  • Family history of atherosclerosis
  • High blood pressure
  • Significant lung disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University of Singapore

Singapore, 119077, Singapore

Location

MeSH Terms

Conditions

Weight LossBehavior

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
A participant knows only the information that is specific to his/her arm.
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: 3-arm RCT (Control, Incentive for Weight Loss, Incentive for Education) stratified by Gender.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 11, 2018

First Posted

May 23, 2018

Study Start

October 12, 2015

Primary Completion

June 22, 2016

Study Completion

June 22, 2016

Last Updated

August 22, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in the research, after de-identification (text, tables, figures, and appendices).

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Beginning 3 months and ending 5 years following article publication.
Access Criteria
Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.

Locations