NCT01533454

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
161

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable obesity

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 15, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

January 5, 2016

Status Verified

January 1, 2016

Enrollment Period

3.1 years

First QC Date

February 12, 2012

Last Update Submit

January 3, 2016

Conditions

ObesityIncentives

Keywords

ObesityWeight lossIncentivesMotivation

Outcome Measures

Primary Outcomes (1)

  • Weight change

    Baseline, 4 months, 8 months and 12 months

Secondary Outcomes (7)

  • Percent body fat

    Baseline, 4 months, 8 months, 12 months

  • Self-reported physical activity

    Baseline, 4 months, 8 months, 12 months

  • Steps, aerobic steps and minutes of physical activity

    Monthly through month 8 (in incentive arms)

  • Intrinsic and Extrinsic motivation

    Baseline

  • Sociodemographics

    Baseline

  • +2 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

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.

Incentives

EXPERIMENTAL

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

Interventions

Financial IncentivesOTHER

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.

Incentives

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

Related Publications (1)

  • 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.

    PMID: 28554160DERIVED

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Eric A. Finkelstein, PhD, MHA

    Duke-NUS Graduate Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 12, 2012

First Posted

February 15, 2012

Study Start

September 1, 2012

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

January 5, 2016

Record last verified: 2016-01

Locations

SG(1)