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Completed

NCT Number: NCT01533454

A Randomized Incentive-Based Weight Loss Trial in Singapore

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.

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Singapore General Hospital

Singapore, 169608

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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  • Current pregnancy/lactation (women who become pregnant during the study will be withdrawn)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

Treatment and study plan

Financial Incentives

Other

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 outcomes

  1. Weight change

    Time frame: Baseline, 4 months, 8 months and 12 months

Secondary outcomes

  1. Percent body fat

    Time frame: Baseline, 4 months, 8 months, 12 months

  2. Self-reported physical activity

    Time frame: Baseline, 4 months, 8 months, 12 months

  3. Steps, aerobic steps and minutes of physical activity

    Time frame: Monthly through month 8 (in incentive arms)

  4. Intrinsic and Extrinsic motivation

    Time frame: Baseline

  5. Sociodemographics

    Time frame: Baseline

  6. Health-related quality of life

    Time frame: Baseline, 4 months, 8 months, 12 months

  7. Intervention costs

    Time frame: Baseline through month 8

Sponsors and collaborators

Lead sponsor

Duke-NUS Graduate Medical School

Other

Collaborators

  • Singapore General Hospital

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Feb 15, 2012
Registry last updated
Jan 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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