NCT01848353

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2013

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

March 14, 2019

Completed
Last Updated

April 3, 2019

Status Verified

March 1, 2019

Enrollment Period

3.9 years

First QC Date

April 25, 2013

Results QC Date

April 10, 2018

Last Update Submit

March 25, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    at baseline (week 0) and weeks 16, 32, and 48.

Secondary Outcomes (3)

  • Insulin Resistance

    at baseline (week 0) and weeks 16, 32, and 48.

  • Exercise Fitness

    at baseline (week 0) and weeks 16, 32, and 48.

  • Body Composition

    at baseline (week 0) and weeks 16, 32, and 48.

Other Outcomes (2)

  • Physical Activity

    at baseline (week 0) and weeks 16, 32, and 48.

  • Blood Lipids

    at baseline (week 0) and weeks 16, 32, and 48.

Study Arms (8)

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.

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.

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.

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

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

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.

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.

Interventions

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

Incentivized payment, phase 1Incentivized payment, phase 2Raffle payment, phase 3Ramp-down payment, phase 3Standard payment, phase 1Standard payment, phase 2

Eligibility Criteria

Age11 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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
  • years old
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Choctaw Nation of Oklahoma Healthcare

Hugo, Oklahoma, 74743, United States

Location

Choctaw Nation Diabetes Wellness Center

Talihina, Oklahoma, 74571, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Insulin ResistanceObesitySedentary Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Kevin Short, PhD, Associate Professor
Organization
University of Oklahoma Health Sciences Center

Study Officials

  • Kevin R Short, PhD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR
  • Kenneth C Copeland, MD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2013

First Posted

May 7, 2013

Study Start

May 1, 2013

Primary Completion

April 1, 2017

Study Completion

May 1, 2017

Last Updated

April 3, 2019

Results First Posted

March 14, 2019

Record last verified: 2019-03

Locations