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Financial Incentives to Exercise for Adolescents (MOVE)

25. mars 2019 oppdatert av: University of Oklahoma

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

142

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

11 år til 20 år (Barn, Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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.
Atferdsmessig: Exercise training
All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
Aktiv komparator: Standard payment, phase 2
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.
Atferdsmessig: Exercise training
All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
Aktiv komparator: Ramp-down payment, phase 3
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.
Atferdsmessig: Exercise training
All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
Eksperimentell: 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
Atferdsmessig: Exercise training
All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
Eksperimentell: Incentivized payment, phase 2
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
Atferdsmessig: Exercise training
All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
Eksperimentell: Raffle payment, phase 3
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.
Atferdsmessig: Exercise training
All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
Ingen inngripen: 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.
Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Volume of Exercise (Total Time)
Tidsramme: 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).
at baseline (week 0) and weeks 16, 32, and 48.

Sekundære resultatmål

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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Physical Activity
Tidsramme: 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.
at baseline (week 0) and weeks 16, 32, and 48.
Blood Lipids
Tidsramme: 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.
at baseline (week 0) and weeks 16, 32, and 48.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Oklahoma

Etterforskere

  • Hovedetterforsker: Kevin R Short, PhD, University of Oklahoma
  • Hovedetterforsker: Kenneth C Copeland, MD, University of Oklahoma

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mai 2013

Primær fullføring (Faktiske)

1. april 2017

Studiet fullført (Faktiske)

1. mai 2017

Datoer for studieregistrering

Først innsendt

25. april 2013

Først innsendt som oppfylte QC-kriteriene

6. mai 2013

Først lagt ut (Anslag)

7. mai 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. april 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. mars 2019

Sist bekreftet

1. mars 2019

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • P20 MD000528-RP2

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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