Weight LossSTEPNCT02008071
Effects of a Minimal-Contact Lifestyle Intervention on Physical Activity, Diet, and Body Weight
A study testing Daily step goal financial incentive in people with Weight Loss, run by University of Tennessee at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- Daily step goal financial incentive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Weight Loss
- Being tested
- Daily step goal financial incentive, Standard of Care
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily step goal financial incentiveBehavioural
Participants' daily activity was incentivized. Reaching a predetermined/individualized step goal each day resulted in 1.00 per day.
Standard of CareBehavioural
Standard payment of 70.00 at the beginning of the study. Participants' daily activity was not incentivized.
| Study group | Role | What they receive |
|---|---|---|
| Daily step goal financial incentive | Experimental | Not described Receives: Behavioral: Daily step goal financial incentive |
| Control, Standard of Care | Active comparator | Not described Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Step Count
Change in steps/day from week 1 to week 12.
Measured: Change from week 1 to week 12
Secondary outcomes (1)
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.
Measured: Change from week 1 to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startMar 2013
- Primary completionJul 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008071
- Sponsor's protocol ID
- UTK-123
- Acronym
- STEP
- Status last verified
- Dec 2013
- First submitted
- 13 Nov 2013
- Last updated
- 22 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Minimal-Contact Lifestyle Intervention on Physical Activity, Diet, and Body Weight
- ClinicalTrials.gov ID
- NCT02008071
- Acronym / sponsor ID
- STEP / UTK-123
- Conditions
- Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily step goal financial incentive | Experimental | Behavioral: Daily step goal financial incentive |
| Control, Standard of Care | Active comparator | Behavioral: Standard of Care |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily step goal financial incentiveParticipants' daily activity was incentivized. Reaching a predetermined/individualized step goal each day resulted in 1.00 per day. | Behavioural | Daily step goal financial incentive |
| Standard of CareStandard payment of 70.00 at the beginning of the study. Participants' daily activity was not incentivized. | Behavioural | Control, Standard of Care |
Primary outcome
Daily Step Count
Time frame: Change from week 1 to week 12
Change in steps/day from week 1 to week 12.
1 secondary outcome
Program Compliance
Time frame: Change from week 1 to week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily step goal financial incentive in people with Weight Loss, run by University of Tennessee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Step Count (time frame: Change from week 1 to week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2015.