Effects of a Minimal-Contact Lifestyle Intervention on Physical Activity, Diet, and Body Weight (STEP)

July 21, 2015 updated by: University of Tennessee
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Knoxville, Tennessee, United States, 37996
        • University of Tennessee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Daily step goal financial incentive
Behavioral: Daily step goal financial incentive
Participants' daily activity was incentivized. Reaching a predetermined/individualized step goal each day resulted in 1.00 per day.
Active Comparator: Control, Standard of Care
Behavioral: Standard of Care
Standard payment of 70.00 at the beginning of the study. Participants' daily activity was not incentivized.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily Step Count
Time Frame: Change from week 1 to week 12
Change in steps/day from week 1 to week 12.
Change from week 1 to week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Program Compliance
Time Frame: Change from week 1 to week 12
Compliance with the physical activity prescription, means meeting or exceeding the step goal for that day. Participants' compliance was assessed by totaling the number of days they met their step goal and dividing it by the total number of days of the intervention. Thus, providing investigators the percentage of days that each participant complied with their physical activity prescription.
Change from week 1 to week 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight Loss
Time Frame: Change from week 1 to week 12. There will also be measures taken 3 months following week 12
Change in weight, waist circumference, and hip circumference from week 1 to week 12. There will also be measures taken 3 months following week 12. This will be defined as the follow-up data.
Change from week 1 to week 12. There will also be measures taken 3 months following week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tennessee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

November 13, 2013

First Submitted That Met QC Criteria

December 5, 2013

First Posted (Estimate)

December 11, 2013

Study Record Updates

Last Update Posted (Estimate)

July 22, 2015

Last Update Submitted That Met QC Criteria

July 21, 2015

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UTK-123

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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