- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03129048
Mediterranean Diet, Weight Loss, and Cognition in Obese Older Adults
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Illinois
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Chicago, Illinois, Vereinigte Staaten, 60608
- University of Illinois at Chicago
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Men and women ≥ 55 years of age],
- BMI 30.0-50.0 kg/m2,
- English speaking
- Have access to a phone
- Plan to reside in the Chicago area for the following 14 months
- Minimal levels of cognitive impairment as determined by the Montreal Cognitive Assessment (MoCA) < 19.
Exclusion Criteria:
- The exclusion criteria ensure that participants can safely participate in the trial.
- renal disease
- autoimmune disorder
- immunodeficiency
- malabsorptive disorder
- gastrointestinal and hepatic diseases
- severe ischemic heart disease
- severe pulmonary disease
- bariatric surgery
- alcohol abuse (> 50 grams/day) or illicit drug abuse
- uncontrolled diabetes based on capillary hemoglobin A1c (HbA1c) > 9.0%
- schizophrenia or bipolar disorder
- cancer treatment within the past 12 months
- weight > 450 lbs. (due to the weight limitation of the DXA scanner)
- diagnosed sleep apnea and regularly using a cpap machine
- currently adhering to a MedDiet, Montreal Cognitive Assessment (MoCA) < 19,(161) -
- currently on a weight-loss diet or actively involved in a formal weight loss program (e.g., Weight Watchers.)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: MedDiet-WL
MedDiet-WL group, advice and exchange lists will be designed to promote a 1-2 lb. per week weight loss (approximately 30% caloric restriction or a reduction of about 600 calories per day) for an end goal of a 7% weight loss from baseline.
|
Research subjects will be randomly assigned to one of three intervention groups. The MedDiet-A group will learn about and how to adhere to the Mediterranean Diet. Over the course of 8 months, they will receive twenty-two classes 60-minute in length. The MedDiet-WL group will learn about the Mediterranean Diet, how to adhere to is and engage in lifestyle choices like exercising and eating fewer calories so that they will loose weight. Over the course of 8 months they will receive 22 classes, each 90 minutes in length. The Typical Diet Control group will be asked to maintain current eating and activity patterns over the course of the 14 month study. |
Experimental: MedDiet-A
For the MedDiet-A group, dietary advice and corresponding exchange lists will be given within the context of promoting weight stability.
|
Research subjects will be randomly assigned to one of three intervention groups. The MedDiet-A group will learn about and how to adhere to the Mediterranean Diet. Over the course of 8 months, they will receive twenty-two classes 60-minute in length. The MedDiet-WL group will learn about the Mediterranean Diet, how to adhere to is and engage in lifestyle choices like exercising and eating fewer calories so that they will loose weight. Over the course of 8 months they will receive 22 classes, each 90 minutes in length. The Typical Diet Control group will be asked to maintain current eating and activity patterns over the course of the 14 month study. |
Sonstiges: Typical Diet Control (TDC)
Typical Diet Control (TDC) will maintain current eating and activity patterns and weight over 14 months.
|
Research subjects will be randomly assigned to one of three intervention groups. The MedDiet-A group will learn about and how to adhere to the Mediterranean Diet. Over the course of 8 months, they will receive twenty-two classes 60-minute in length. The MedDiet-WL group will learn about the Mediterranean Diet, how to adhere to is and engage in lifestyle choices like exercising and eating fewer calories so that they will loose weight. Over the course of 8 months they will receive 22 classes, each 90 minutes in length. The Typical Diet Control group will be asked to maintain current eating and activity patterns over the course of the 14 month study. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Assessing change in Attention between time periods
Zeitfenster: 14 months
|
Baseline, 8-month (first intervention), and 14-month assessments will include Digit Symbol test.
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14 months
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Assessing change in Executive Function between time periods
Zeitfenster: 14 months
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Baseline, 8-month (first intervention), and 14-month assessments will include the Trail Making Test Part B.
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14 months
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Assessing change in Memory between time periods
Zeitfenster: 14 months
|
Baseline, 8-month (first intervention), and 14-month assessments will include tests of memory including the delayed free recall from the Hopkins Verbal Learning Test.
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14 months
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Marian Fitzgibbon, PhD, UIC
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Fitzgibbon M, Blumstein L, Schiffer L, Antonic MA, McLeod A, Dakers R, Restrepo L, Boots EA, Sanchez-Flack JC, Tussing-Humphreys L, Lamar M. Adapting to the COVID-19 pandemic on Building Research in Diet and Cognition (BRIDGE) trial. Trials. 2021 Jul 16;22(1):459. doi: 10.1186/s13063-021-05383-6.
- Fitzgibbon M, Blumstein L, Schiffer L, Antonic MA, McLeod A, Dakers R, Restrepo L, Boots EA, Sanchez-Flack JC, Tussing-Humphreys L, Lamar M. Adapting to the impact of the COVID-19 pandemic on a randomized controlled trial examining lifestyle behaviors on cognitive functioning in obese African American adults: Building Research in Diet and Cognition (BRIDGE). Res Sq. 2021 Apr 26:rs.3.rs-290482. doi: 10.21203/rs.3.rs-290482/v1. Preprint.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2016-0258
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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