NCT02008071

Brief Summary

The purpose of this study is to conduct a pilot randomized controlled trial, to determine whether providing financial incentives for meeting daily step goals (a) increases the daily step counts of participants, (b) increases compliance with the overall program (including diet recommendations), and (c) increases weight loss.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2013

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
Last Updated

July 22, 2015

Status Verified

December 1, 2013

Enrollment Period

4 months

First QC Date

November 13, 2013

Last Update Submit

July 21, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Daily Step Count

    Change in steps/day from week 1 to week 12.

    Change from week 1 to week 12

Secondary Outcomes (1)

  • Program Compliance

    Change from week 1 to week 12

Other Outcomes (1)

  • Weight Loss

    Change from week 1 to week 12. There will also be measures taken 3 months following week 12

Study Arms (2)

Daily step goal financial incentive

EXPERIMENTAL
Behavioral: Daily step goal financial incentive

Control, Standard of Care

ACTIVE COMPARATOR
Behavioral: Standard of Care

Interventions

Participants' daily activity was incentivized. Reaching a predetermined/individualized step goal each day resulted in 1.00 per day.

Daily step goal financial incentive

Standard payment of 70.00 at the beginning of the study. Participants' daily activity was not incentivized.

Control, Standard of Care

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • required to be able to read.
  • required to have access to a computer.
  • required to have a body mass index between 27 and 45 kg.m-2.
  • required to take fewer than 7,000 steps per day at baseline (as determined by a pedometer, averaged across 4-7 days).

You may not qualify if:

  • Individuals who report having an injury or physical limitation that renders them unable to walk ¼ mile without difficulty.
  • Uncontrolled cardiovascular or metabolic condition determined by health history questionnaire.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tennessee

Knoxville, Tennessee, 37996, United States

Location

MeSH Terms

Conditions

Weight Loss

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2013

First Posted

December 11, 2013

Study Start

March 1, 2013

Primary Completion

July 1, 2013

Study Completion

August 1, 2013

Last Updated

July 22, 2015

Record last verified: 2013-12

Locations