Clinical trial NCT01533454: A Randomized Incentive-Based Weight Loss Trial in Singapore
Official title: A Randomized Incentive-Based Weight Loss Trial in Singapore
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Incentives
Keywords: Obesity
Weight loss
Incentives
Motivation
Lead sponsor: Duke-NUS Graduate Medical School
Sponsor class: OTHER
Collaborators: name: Singapore General Hospital
First posted: 2012-02-15
Enrollment: 161
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Weight change
timeFrame: Baseline, 4 months, 8 months and 12 months
Secondary outcomes:
measure: Percent body fat
timeFrame: Baseline, 4 months, 8 months, 12 months
measure: Self-reported physical activity
timeFrame: Baseline, 4 months, 8 months, 12 months
measure: Steps, aerobic steps and minutes of physical activity
timeFrame: Monthly through month 8 (in incentive arms)
measure: Intrinsic and Extrinsic motivation
timeFrame: Baseline
measure: Sociodemographics
timeFrame: Baseline
measure: Health-related quality of life
timeFrame: Baseline, 4 months, 8 months, 12 months
measure: Intervention costs
timeFrame: Baseline through month 8
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Duke-NUS Graduate Medical School
name: Eric A. Finkelstein, PhD, MHA
role: PRINCIPAL_INVESTIGATOR
References:
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.