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OpenTrials
Completed

NCT Number: NCT02008071

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

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.

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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Tennessee

Knoxville, Tennessee, 37996, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Daily step goal financial incentive

Behavioral

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

Standard of Care

Behavioral

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

Primary outcomes

  1. Daily Step Count

    Time frame: Change from week 1 to week 12

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

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Tennessee

Other

Registry information

Acronym: STEP

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Dec 11, 2013
Registry last updated
Jul 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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