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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01533454
Other study ID # 0742_001
Secondary ID
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


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
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