Effects of a Minimal-Contact Lifestyle Intervention on Physical Activity, Diet, and Body Weight
STEP
1 other identifier
interventional
57
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2013
Shorter than P25 for not_applicable
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 13, 2013
CompletedFirst Posted
Study publicly available on registry
December 11, 2013
CompletedJuly 22, 2015
December 1, 2013
4 months
November 13, 2013
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
EXPERIMENTALControl, Standard of Care
ACTIVE COMPARATORInterventions
Participants' daily activity was incentivized. Reaching a predetermined/individualized step goal each day resulted in 1.00 per day.
Standard payment of 70.00 at the beginning of the study. Participants' daily activity was not incentivized.
Eligibility Criteria
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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