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

Primary Purpose

Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Daily step goal financial incentive
Standard of Care
Sponsored by
University of Tennessee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Tennessee

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Daily step goal financial incentive

Control, Standard of Care

Arm Description

Outcomes

Primary Outcome Measures

Daily Step Count
Change in steps/day from week 1 to week 12.

Secondary Outcome Measures

Program Compliance
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.

Full Information

First Posted
November 13, 2013
Last Updated
July 21, 2015
Sponsor
University of Tennessee
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1. Study Identification

Unique Protocol Identification Number
NCT02008071
Brief Title
Effects of a Minimal-Contact Lifestyle Intervention on Physical Activity, Diet, and Body Weight
Acronym
STEP
Official Title
Effects of a Minimal-Contact Lifestyle Intervention on Physical Activity, Diet, and Body Weight
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Tennessee

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Daily step goal financial incentive
Arm Type
Experimental
Arm Title
Control, Standard of Care
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Daily step goal financial incentive
Intervention Description
Participants' daily activity was incentivized. Reaching a predetermined/individualized step goal each day resulted in 1.00 per day.
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care
Intervention Description
Standard payment of 70.00 at the beginning of the study. Participants' daily activity was not incentivized.
Primary Outcome Measure Information:
Title
Daily Step Count
Description
Change in steps/day from week 1 to week 12.
Time Frame
Change from week 1 to week 12
Secondary Outcome Measure Information:
Title
Program Compliance
Description
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.
Time Frame
Change from week 1 to week 12
Other Pre-specified Outcome Measures:
Title
Weight Loss
Description
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.
Time Frame
Change from week 1 to week 12. There will also be measures taken 3 months following week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Tennessee
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37996
Country
United States

12. IPD Sharing Statement

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

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