Insulin ResistanceMOVENCT01848353

Financial Incentives to Exercise for Adolescents

A study testing Exercise training in people with Insulin Resistance and Obesity, run by University of Oklahoma at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 11 to 20 yearsHealthy volunteers can take part
Conditions the study is for: Insulin Resistance, Obesity, Sedentary Lifestyle
What is being tested?: Exercise training
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 142 participants
Where: 2 sitesUnited States
Study dates: May 2013to May 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 11 to 20 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

11.0-20.9 years old
overweight or obese
family history of diabetes (primary or secondary relative)
not in sports or exercise program (3 or fewer days per week of moderate-to-vigorous intensity physical activity, MVPA) for prior 3 months
Tanner stage 2 or above
11.0-20.9 years old

Show all 10Show fewer

normal weight
For low physical activity subgroup: not in sports or exercise program (3 or fewer days per week of MVPA) for prior 3 months
For high physical activity subgroup: >30 minutes of structured MVPA on >3 days/week over the preceding 3 months
Tanner stage 2 or above

Who cannot join

metabolic, endocrine, cardiovascular, kidney disease
orthopedic problems that limit physical activity
medications or treatments that would interfere with the outcomes and interpretations
smoking or tobacco use
alcohol or illicit drug use
pregnancy

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Choctaw Nation of Oklahoma Healthcare
Hugo, Oklahoma, 74743
Choctaw Nation Diabetes Wellness Center
Talihina, Oklahoma, 74571

Other trials in United States

About this study

Official title: Incentivizing Behavior: Promoting More Physical Activity in American Indian Youth

Among youth populations, American Indians have the highest prevalence of diabetes in the United States. This study will use exercise as the principal lifestyle modification approach to reduce the risk of diabetes in this population. The Choctaw Nation of Oklahoma has several excellent, but underutilized wellness facilities in their Health Services Area in rural Southeast Oklahoma, a low socioeconomic region. It has been established that exercise lowers diabetes risk, and many overweight/obese, insulin resistant American Indian youth who live in this region would benefit from an increase in regular exercise. The challenge is to modify behavior so that routine exercise is established and maintained. The proposed study will test whether monetary incentives can elicit greater frequency and duration of exercise in American Indian youth when transportation and access barriers are reduced.

Read the detailed description

Study participants in the intervention arm of the study will be asked to exercise on 3 days per week for 48 weeks. Clinical and physical assessments will be performed at baseline and after 16, 32 and 48 weeks. Participants will be randomized into one of two groups. Each group will receive payment for exercise sessions completed but one group will be on a fixed schedule of compensation and the other will have a schedule that incentivizes frequency or duration of exercise. In addition, two reference groups of age-matched participants who are normal weight and subclassified as having either low or high levels of physical activity and fitness will be tested. The reference groups will complete baseline tests and will not enter the exercise intervention program.

Conditions: Insulin Resistance, Obesity, Sedentary Lifestyle
Being tested: Exercise training
Medical subject headings: Insulin Resistance, Obesity, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Exercise trainingBehavioural
All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.

Study groups in NCT01848353
Study group	Role	What they receive
Standard payment, phase 1	Active comparator	All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior. Receives: Behavioral: Exercise training
Standard payment, phase 2	Active comparator	All participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 17-32 (phase 2). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior. Receives: Behavioral: Exercise training
Ramp-down payment, phase 3	Active comparator	All participants will perform exercise training. This phase will last from weeks 33-48 (phase 3). Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes, but the value of the payments will decrease weekly (ramp-down) until reaching zero in week 41. All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior. Receives: Behavioral: Exercise training
Incentivized payment, phase 1	Experimental	All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they increase exercise frequency (number of days) during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior Receives: Behavioral: Exercise training
Incentivized payment, phase 2	Experimental	All participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they exercise for longer than 20 minutes per session during weeks 17-32 (phase 2). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior Receives: Behavioral: Exercise training
Raffle payment, phase 3	Experimental	All participants will perform exercise training. In weeks 33-48 (phase 3)participants in this arm will receive fewer financial incentives than in the prior 32 weeks but they will be delivered through a raffle system to utilize a variable reinforcement approach. All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior. Receives: Behavioral: Exercise training
Normal weight, low activity group	No intervention	This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have low physical activity and fitness like the intervention group. Therefore differences in their results with the intervention group will reflect the effects of overweight/obesity on the variables of interest.
Normal weight, high activity group	No intervention	This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have higher physical activity and fitness than the intervention group. They will therefore serve as a healthy reference group and differences in their results with the intervention group will reflect the effects of both overweight/obesity and physical activity on the variables of interest.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Volume of Exercise (Total Time)
Frequency and duration of moderate-to-vigorous physical activity will be measured using heart rate monitors. The monitors will be worn each exercise session. Participants are asked to complete 3 exercise sessions per week throughout the 48-week period of enrollment. The primary comparison between the experimental and active comparator groups will be the volume of exercise (total time) accumulated. Comparisons will be made for accumulated exercise volume at 16, 32, and 48 weeks and the change from baseline (week 0).
Measured: at baseline (week 0) and weeks 16, 32, and 48.

Secondary outcomes (3)

Insulin Resistance
Fasting blood glucose and insulin concentration will be measured and used to calculate the homeostatic model of assessment for insulin resistance (iHOMA2, %S). Testing will be performed at baseline (week 0) and weeks 16, 32, and 48. Data analysis will focus on the change from baseline and whether that change differs between groups.
Measured: at baseline (week 0) and weeks 16, 32, and 48.
Exercise Fitness
Peak oxygen uptake (VO2max) during a progressive intensity bicycle test to fatigue. Testing will be performed at baseline (week 0) and weeks 16, 32, and 48. Data analysis will focus on the change from baseline and whether that change differs between groups.
Measured: at baseline (week 0) and weeks 16, 32, and 48.
Body Composition
Body fat content. Testing will be performed at baseline (week 0) and weeks 16, 32, and 48. Data analysis will focus on the change from baseline and whether that change differs between groups.
Measured: at baseline (week 0) and weeks 16, 32, and 48.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2013May 2017

First posted7 May 2013 (estimated)
Study startMay 2013
Primary completionApr 2017
Study completionMay 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Insulin ResistanceStudies of the same condition, open and under way.
More trials run by University of OklahomaThe sponsor's other registered studies.
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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 142 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01848353
Sponsor's protocol ID: P20 MD000528-RP2
Other IDs: P20MD000528
Acronym: MOVE
Status last verified: Mar 2019
First submitted: 25 Apr 2013
Last updated: 3 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Short KR, Chadwick JQ, Cannady TK, Branam DE, Wharton DF, Tullier MA, Thompson DM, Copeland KC. Using financial incentives to promote physical activity in American Indian adolescents: A randomized controlled trial. PLoS One. 2018 Jun 1;13(6):e0198390. doi: 10.1371/journal.pone.0198390. eCollection 2018.
PubMed 29856832

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Insulin Resistance trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Incentivizing Behavior: Promoting More Physical Activity in American Indian Youth
ClinicalTrials.gov ID: NCT01848353
Acronym / sponsor ID: MOVE / P20 MD000528-RP2
Conditions: Insulin Resistance, Obesity, Sedentary Lifestyle
Study type: Interventional
Recruitment status: Completed
Enrolment: 142 participants (actual)
Lead sponsor: University of OklahomaUniversity, hospital or other
Study start: May 2013 (actual)
Primary completion: Apr 2017 (actual)
Study completion: May 2017 (actual)
First posted: 7 May 2013 (estimated)
Results: Posted 14 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
Standard payment, phase 1	Active comparator	Behavioral: Exercise trainingAll participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.
Standard payment, phase 2	Active comparator	Behavioral: Exercise trainingAll participants will perform exercise training. Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes during weeks 17-32 (phase 2). All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.
Ramp-down payment, phase 3	Active comparator	Behavioral: Exercise trainingAll participants will perform exercise training. This phase will last from weeks 33-48 (phase 3). Participants in this arm will receive a fixed amount of money for exercise session lasting at least 20 minutes, but the value of the payments will decrease weekly (ramp-down) until reaching zero in week 41. All exercise recommendations and outcome tests will be same for this group as the experimental group so that the two groups differ only in the financial incentives they receive for exercise behavior.
Incentivized payment, phase 1	Experimental	Behavioral: Exercise trainingAll participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they increase exercise frequency (number of days) during weeks 1-16 (phase 1). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior
Incentivized payment, phase 2	Experimental	Behavioral: Exercise trainingAll participants will perform exercise training. Participants in this arm will receive an increasing amount of money when they exercise for longer than 20 minutes per session during weeks 17-32 (phase 2). All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior
Raffle payment, phase 3	Experimental	Behavioral: Exercise trainingAll participants will perform exercise training. In weeks 33-48 (phase 3)participants in this arm will receive fewer financial incentives than in the prior 32 weeks but they will be delivered through a raffle system to utilize a variable reinforcement approach. All exercise recommendations and outcome tests will be same for this group as the active comparator group so that the two groups differ only in the financial incentives they receive for exercise behavior.
Normal weight, low activity group	No intervention	–This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have low physical activity and fitness like the intervention group. Therefore differences in their results with the intervention group will reflect the effects of overweight/obesity on the variables of interest.
Normal weight, high activity group	No intervention	–This group of participants will complete only the baseline tests and assessments and will serve as a reference group. They will be selected to have higher physical activity and fitness than the intervention group. They will therefore serve as a healthy reference group and differences in their results with the intervention group will reflect the effects of both overweight/obesity and physical activity on the variables of interest.

Who may qualify

Ages: 11 to 20 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (10 listed)

11.0-20.9 years old
overweight or obese
family history of diabetes (primary or secondary relative)
not in sports or exercise program (3 or fewer days per week of moderate-to-vigorous intensity physical activity, MVPA) for prior 3 months
Tanner stage 2 or above

Key exclusion criteria (6 listed)

metabolic, endocrine, cardiovascular, kidney disease
orthopedic problems that limit physical activity
medications or treatments that would interfere with the outcomes and interpretations
smoking or tobacco use
alcohol or illicit drug use

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
Exercise trainingAll participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.	Behavioural	Incentivized payment, phase 1, Incentivized payment, phase 2, Raffle payment, phase 3, Ramp-down payment, phase 3, Standard payment, phase 1, Standard payment, phase 2

Primary outcome

Change From Baseline in Volume of Exercise (Total Time)
Time frame: at baseline (week 0) and weeks 16, 32, and 48.
Frequency and duration of moderate-to-vigorous physical activity will be measured using heart rate monitors. The monitors will be worn each exercise session. Participants are asked to complete 3 exercise sessions per week throughout the 48-week period of enrollment. The primary comparison between the experimental and active comparator groups will be the volume of exercise (total time) accumulated. Comparisons will be made for accumulated exercise volume at 16, 32, and 48 weeks and the change from baseline (week 0).

3 secondary outcomes

Insulin Resistance
Time frame: at baseline (week 0) and weeks 16, 32, and 48.
Exercise Fitness
Time frame: at baseline (week 0) and weeks 16, 32, and 48.
Body Composition
Time frame: at baseline (week 0) and weeks 16, 32, and 48.

Results and safety

Results posted to the registry on 14 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Payment	38	35
Incentivized Payment	43	42
Normal Weight, Low Activity Group	20	20
Normal Weight, High Activity Group	19	19

Primary outcome: Change From Baseline in Volume of Exercise (Total Time)

Time frame: at baseline (week 0) and weeks 16, 32, and 48.. Mean (Standard Deviation). Unit: hours

Measure	Standard Payment, Phase 1 n = 35	Incentivized Payment, Phase 1 n = 42	Standard Payment, Phase 2 n = 20	Incentivized Payment, Phase 2 n = 26	Ramp-down Payment, Phase 3 n = 4	Raffle Payment, Phase 3 n = 9
Value	15.2 (10.1)	15.0 (8.1)	8.0 (5.5)	12.4 (11.1)	10.2 (3.8)	8.8 (4.7)

Population analysed: In Phase 1, 81 people were randomized, but 4 withdrew after assignment so 77 people had exercise behavior data for analyses. In Phase 2, 51 were randomized, but 5 withdrew after assignment, leaving 46 for behavior analyses. In Phase 3, 15 were randomized, 2 withdrew after assignment, leaving 13 for behavior analyses.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were monitored for each participant for as long as they were actively enrolled in the study, a period of up to 48 weeks for the exercise intervention group.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Payment, Phase 1	0 of 38 (0%)	0 of 38 (0%)	0 of 38
Incentivized Payment, Phase 1	0 of 43 (0%)	0 of 43 (0%)	0 of 43
Standard Payment, Phase 2	0 of 23 (0%)	0 of 23 (0%)	0 of 23
Incentivized Payment, Phase 2	0 of 28 (0%)	0 of 28 (0%)	0 of 28
Ramp-down Payment, Phase 3	0 of 5 (0%)	0 of 5 (0%)	0 of 5
Raffle Payment, Phase 3	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Normal Weight, Low Activity Group	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Normal Weight, High Activity Group	0 of 19 (0%)	0 of 19 (0%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29856832Short KR, Chadwick JQ, Cannady TK, Branam DE, Wharton DF, Tullier MA, Thompson DM, Copeland KC. Using financial incentives to promote physical activity in American Indian adolescents: A randomized controlled trial. PLoS One. 2018 Jun 1;13(6):e0198390. doi: 10.1371/journal.pone.0198390. eCollection 2018.

Related trials for Insulin Resistance

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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.

Kevin R Short, PhD principal investigator

University of Oklahoma

Kenneth C Copeland, MD principal investigator

University of Oklahoma

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Exercise training in people with Insulin Resistance and Obesity, run by University of Oklahoma at 2 sites 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 10 inclusion and 6 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 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 14 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Volume of Exercise (Total Time) (time frame: at baseline (week 0) and weeks 16, 32, and 48.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01848353, which also lists 1 linked publication.

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 3 Apr 2019.