Financial Incentives to Exercise for Adolescents

Incentivizing Behavior: Promoting More Physical Activity in American Indian Youth

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01848353

Acronym

MOVE

Enrollment

142

Registered

2013-05-07

Start date

2013-05-31

Completion date

2017-05-31

Last updated

2019-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance, Obesity, Sedentary Lifestyle

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.

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.

Interventions

BEHAVIORALExercise training

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

11 Years to 20 Years

Healthy volunteers

Yes

Inclusion criteria

for exercise intervention cohort: * 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 Inclusion Criteria for reference group cohort: * 11.0-20.9 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

Exclusion criteria

for all participants: * 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

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Volume of Exercise (Total Time)	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).

Secondary

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

Other

Measure	Time frame	Description
Physical Activity	at baseline (week 0) and weeks 16, 32, and 48.	Daily step counts measured with accelerometers. 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.
Blood Lipids	at baseline (week 0) and weeks 16, 32, and 48.	Standard assessment of fasting triglycerides. 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.

Countries

United States

Participant flow

Recruitment details

Recruitment for the exercise intervention was July 2013 - April 2016. Recruitment for the reference group was July 2015 - April 2017. All participants were were recruited from medical clinics, schools, or community settings in Southeast Oklahoma.

Pre-assignment details

142 people enrolled (completed informed consent). During screening, 4 OW/Ob and 8 NW people were disqualified, and 5 OW/Ob and 5 NW people voluntarily withdrew. Baseline data were thus available for 120 people. After baseline testing was complete, 81 OW/Ob participants were randomly assigned to either standard pay or incentive group for Phase 1.

Participants by arm

Arm	Count
Standard Payment, Phase 1 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. Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.	38
Incentivized Payment, Phase 1 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 Exercise training: All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.	43
Normal Weight, Low Activity Group 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.	20
Normal Weight, High Activity Group 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.	19
Total	120

Withdrawals & dropouts

Period	Reason	FG000	FG001
Phase 1	Withdrawal by Subject	3	1
Phase 2	Withdrawal by Subject	3	2
Phase 3	Withdrawal by Subject	1	1

Baseline characteristics

Characteristic	Standard Payment, Phase 1	Incentivized Payment, Phase 1	Normal Weight, Low Activity Group	Normal Weight, High Activity Group	Total
Age, Continuous	13.8 years STANDARD_DEVIATION 2.2	14.2 years STANDARD_DEVIATION 2.2	14.6 years STANDARD_DEVIATION 2.3	14.3 years STANDARD_DEVIATION 1.9	14.4 years STANDARD_DEVIATION 2.3
Body mass index	33.4 kg/m^2 STANDARD_DEVIATION 7	34.8 kg/m^2 STANDARD_DEVIATION 6.1	20.8 kg/m^2 STANDARD_DEVIATION 1.9	20.1 kg/m^2 STANDARD_DEVIATION 2.4	30.1 kg/m^2 STANDARD_DEVIATION 9
Race (NIH/OMB) American Indian or Alaska Native	38 Participants	43 Participants	20 Participants	19 Participants	120 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Region of Enrollment United States	38 participants	43 participants	20 participants	19 participants	186 participants
Sex: Female, Male Female	21 Participants	25 Participants	11 Participants	7 Participants	64 Participants
Sex: Female, Male Male	17 Participants	18 Participants	9 Participants	12 Participants	56 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk
deaths Total, all-cause mortality	0 / 38	0 / 43	0 / 23	0 / 28	0 / 5	0 / 10	0 / 20	0 / 19
other Total, other adverse events	0 / 38	0 / 43	0 / 23	0 / 28	0 / 5	0 / 10	0 / 20	0 / 19
serious Total, serious adverse events	0 / 38	0 / 43	0 / 23	0 / 28	0 / 5	0 / 10	0 / 20	0 / 19

Outcome results

Primary

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).