A Randomized Incentive-Based Weight Loss Trial in Singapore

Obesity Clinical Trial

Official title:

A Randomized Incentive-Based Weight Loss Trial in Singapore

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01533454
• Other study ID #: 0742_001
• Status: Completed
• Phase: N/A
• First received: February 12, 2012
• Last updated: January 3, 2016
• Start date: September 2012
• Est. completion date: October 2015

Study information

• Verified date: January 2016
• Source: Duke-NUS Graduate Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Incentives
• Obesity
• Weight Loss

Intervention

Other:
• Financial Incentives
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.

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Duke-NUS Graduate Medical School	Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight change		Baseline, 4 months, 8 months and 12 months	No
Secondary	Percent body fat		Baseline, 4 months, 8 months, 12 months	No
Secondary	Self-reported physical activity		Baseline, 4 months, 8 months, 12 months	No
Secondary	Steps, aerobic steps and minutes of physical activity		Monthly through month 8 (in incentive arms)	No
Secondary	Intrinsic and Extrinsic motivation		Baseline	No
Secondary	Sociodemographics		Baseline	No
Secondary	Health-related quality of life		Baseline, 4 months, 8 months, 12 months	No
Secondary	Intervention costs		Baseline through month 8	No