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

Weight Loss Clinical Trial

— STEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02008071
• Other study ID #: UTK-123
• Status: Completed
• Phase: N/A
• First received: November 13, 2013
• Last updated: July 21, 2015
• Start date: March 2013
• Est. completion date: August 2013

Study information

• Verified date: December 2013
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
United States	University of Tennessee	Knoxville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Weight Loss	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	No
Primary	Daily Step Count	Change in steps/day from week 1 to week 12.	Change from week 1 to week 12	No
Secondary	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.	Change from week 1 to week 12	No