Træningseffekter på neurobiologien bag stressrelateret spiseadfærd hos veteraner
The purpose of this study is to learn more about how common lifestyle interventions, such as exercise, affect how our brains respond to performing thinking tasks and to viewing pictures of foods and various other objects. The investigators are also interested in how changes in hormones that might be different in men and women could affect how lifestyle interventions change these brain responses.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The purpose of this study is to learn more about how common lifestyle interventions, such as exercise, affect how our brains respond to performing thinking tasks and to viewing pictures of foods and various other objects. The investigators are also interested in how changes in hormones that might be different in men and women could affect how lifestyle interventions change these brain responses. This will help us to better understand how different lifestyle interventions affect the brain and how this might relate to various behaviors. Eligible participants will be asked to complete 2 study days before and again after a 12-week intervention period, during which they will either continue with usual activities or be asked to complete exercise sessions four times per week. They will be randomly assigned to one of these conditions (exercise or not) and will not be able to choose their group assignment.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Kristina T Legget, PhD
- Telefonnummer: (720) 724-5809
- E-mail: kristina.legget@va.gov
Studiesteder
-
-
Colorado
-
Aurora, Colorado, Forenede Stater, 80045-7211
- Rekruttering
- Rocky Mountain Regional VA Medical Center, Aurora, CO
-
Kontakt:
- Kristina T Legget, PhD
- Telefonnummer: (720) 724-5809
- E-mail: kristina.legget@va.gov
-
Ledende efterforsker:
- Kristina T. Legget, PhD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Veteran
- Body mass index (BMI) of 25 or greater
- Physically inactive
- Able to attend study visits in person in Aurora, CO
Exclusion Criteria:
- Currently pregnant
- History of bariatric surgery
- Current eating disorder
- Current treatment with appetite-altering medications (e.g., glucagon-like peptide-1 (GLP-1) agonists)
- Contraindication to MRI (weight > 500 pounds (lbs); claustrophobia; metal or electronic devices in the body)
- Cardiovascular disease, chronic kidney disease, pulmonary disease, or diabetes
- Unable to exercise due to cardiac, pulmonary, neurologic, or orthopedic reasons
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Exercise
Participants will complete 4 aerobic exercise training sessions per week for 12 weeks. The exercise program will begin at 15 minutes per session and duration will be gradually increased by 5 minutes each week until participants reach 30 minutes per session (with 5 min warm-up and cool-down). Exercise will be performed at a "moderate" intensity, which will be about 60-70% of your predicted maximal level. Participants will meet with study personnel once per week. |
12 weeks of aerobic exercise, with 4 sessions per week. |
|
Ingen indgriben: Usual activity
Participants will keep doing what they usually do for the 12-week intervention period. They will be asked not to change their usual physical activity levels during this period. They will meet with study personnel once per week |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percent change in blood oxygen level dependent (BOLD) response to visual food cues as measured by functional magnetic resonance imaging (fMRI)
Tidsramme: Baseline, 12 weeks
|
Percent change in blood oxygen level dependent (BOLD) response from baseline to after the 12-week intervention period while viewing visual food cues. The primary contrast of interest is the comparison of high-calorie food images to nonfood object images. |
Baseline, 12 weeks
|
|
Change in serum cortisol response to counting task
Tidsramme: Baseline, 12 weeks
|
Change from baseline to after the 12-week intervention period in serum cortisol levels (micrograms per deciliter (mcg/dL)) throughout a counting task involving mental math (measured as area under the curve). |
Baseline, 12 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in heart rate response to counting task
Tidsramme: Baseline, 12 weeks
|
Change from baseline to after the 12-week intervention period in heart rate (measured by photoplethysmograph; aggregated in 1 min intervals) throughout a counting task involving mental math (measured as area under the curve). |
Baseline, 12 weeks
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in percent body fat
Tidsramme: Baseline, 12 weeks
|
Change in percent body fat, as measured by dual-energy x-ray absorptiometry, from baseline to after the 12-week intervention period. |
Baseline, 12 weeks
|
|
Percent change in body weight
Tidsramme: Baseline, 12 weeks
|
Percent change in body weight (kilograms) from baseline to after the 12-week intervention period. |
Baseline, 12 weeks
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Kristina T. Legget, PhD, Rocky Mountain Regional VA Medical Center, Aurora, CO
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ENDA-009-24S
- I01CX002752 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
As some journals now require authors to provide access to data, de-identified, anonymized data sets will be created after study results are published, and made available upon request for general research purposes, based on availability of resources. No proprietary data will be made publicly available. Sufficient data and descriptors will be made available to confirm conclusions in resulting publications and duplicate statistical analyses.
IPD-delingstidsramme
Data will become available after publication of study results and be available at least 3 years beyond the completion of the study.
IPD-delingsadgangskriterier
Data will be made available upon request for general research purposes, based on availability of resources.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
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