NCT02008474

Brief Summary

The purpose of this study is to examine different types of monetary incentive paradigms for weight loss.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P25-P50 for phase_3 obesity

Timeline
Completed

Started Jan 2014

Typical duration for phase_3 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

December 6, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
21 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

2.4 years

First QC Date

December 6, 2013

Last Update Submit

August 29, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • weight change from initial assessment to the 3-month follow-up assessment measured on a digital scale to the nearest 0.1-kilogram

    0 to 3 months

Secondary Outcomes (2)

  • weight change from the initial assessment to the 12 month assessment measured on a digital scale to the nearest 0.1-kilogram

    0 to 12 months

  • Weight change from the 3 month assessment to the 12 month assessment measured on a digital scale to the nearest 0.1-kilogram

    3 to 12 months

Study Arms (4)

Online weight loss + Incentives for behavior 3 months

ACTIVE COMPARATOR
Behavioral: Online weight loss + incentives for behavior 3 months

Online weight loss + Incentives for weight loss 3 months

ACTIVE COMPARATOR
Behavioral: Online weight loss + incentives for weight loss at month 3

Online weight loss + Incentives for behavior 12 months

ACTIVE COMPARATOR
Behavioral: Online weight loss + Incentives for behavior 12 months

Online weight loss + Incentives for weight loss 12 months

ACTIVE COMPARATOR
Behavioral: Online weight loss + Incentives for weight loss 12 months

Interventions

Participants will receive monetary incentives for submitting their behavior change information into a study website

Online weight loss + Incentives for behavior 3 months

Participants will receive an incentive for meeting their weight loss goal at month 3.

Online weight loss + Incentives for weight loss 3 months

Participants will receive incentives for submitting behavior change information over the course of 12 months.

Online weight loss + Incentives for behavior 12 months

Participants will be receive monetary incentives for reaching their weight loss goal at months 3 and 12.

Online weight loss + Incentives for weight loss 12 months

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \>=25kg/m2
  • English speaking
  • Age 18-70

You may not qualify if:

  • Health problems that make weight loss or unsupervised exercise unsafe
  • Current pregnancy or plan to become pregnant int he next 12 months
  • Planned relocation
  • Current participation in weight loss research study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miriam Hospital's Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rena Wing, PhD

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR
  • Tricia M Leahey, PhD

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2013

First Posted

December 11, 2013

Study Start

January 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 30, 2016

Record last verified: 2016-08

Locations