- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03843190
Healthy Me: Ein Programm für ältere Frauen
Veränderungen des Gewichts und der körperlichen Funktion bei älteren afroamerikanischen Frauen in einem nationalen, gemeinnützigen, gemeinschaftsbasierten, Peer-geführten Gewichtsverlustprogramm
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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North Carolina
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Durham, North Carolina, Vereinigte Staaten, 27707
- Duke University
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Beschreibung
Einschlusskriterien:
- Afroamerikanische Frauen im Alter von ≥60
- BMI ≥30 kg/m2
- verminderte körperliche Funktionsfähigkeit (d. h. diejenigen, die bei der Short Physical Performance Battery [SPPB] zwischen 4 und 10 [von 12] Punkten erzielen)
- Stabiles Körpergewicht (± 2 kg für 6 Monate vor der Studie)
- Sitzend (nicht mehr als 1 Stunde pro Woche trainieren)
Bedingte Einschlusskriterien:
Teilnehmer mit Typ-2-Diabetes unter Insulin oder Sulfonylharnstoffen dürfen nur dann an der Studie teilnehmen, wenn ihre Anbieter sich bereit erklären, die sich ändernden Medikamentenanforderungen im Zusammenhang mit einer möglichen Gewichtsabnahme zu bewältigen, indem sie ein Formular „Erlaubnis zur Teilnahme“ unterzeichnen. Es ist wichtig, Typ-2-Diabetiker auf Insulin und Sulfonylharnstoffe einzubeziehen, da diese Teilnehmer stark von einer Gewichtsabnahme profitieren können.
Ausschlusskriterien:
- Typ-2-Diabetiker auf Insulin oder Sulfonylharnstoffen ohne Genehmigung des Anbieters
- aktuelle Krebsdiagnose
- Einnahme von Medikamenten, von denen angenommen wird, dass sie den Stoffwechsel, das Körpergewicht, den Energieverbrauch oder den Appetit beeinflussen
- schwere psychiatrische Störung
- aktuelle mittelschwere bis schwere Symptome einer Depression
- Demenz
- neurologische Erkrankungen, die Funktionseinschränkungen verursachen
- instabile medizinische Erkrankung wie instabile Angina pectoris, frischer Myokardinfarkt oder dekompensierte Herzinsuffizienz Klasse III-IV
- unheilbare Erkrankungen
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Pfunde vernünftig abnehmen (TOPS)
Diese Gruppe erhält zu Beginn der Studie eine TOPS-Intervention.
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Dietitian-facilitated classes
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Sonstiges: Wartelistenkontrolle
Diese Gruppe wird 6 Monate lang die Kontrollgruppe sein.
Nach Abschluss der Studie erhalten sie Gutscheine für die Teilnahme an TOPS-Chaptern in der Community.
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Am Ende des Studiums wird die Teilnahme an von Gleichaltrigen geleiteten Kursen angeboten.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Weight Change
Zeitfenster: Baseline to 6 months
|
Percent of body weight change over 6 months
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Baseline to 6 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Systolic Blood Pressure (BP)
Zeitfenster: Baseline, 3 months, 6 months
|
A measure of cardiovascular disease (CVD) risk.
|
Baseline, 3 months, 6 months
|
|
Diastolic Blood Pressure (BP)
Zeitfenster: Baseline, 3 months, 6 months
|
A measure of cardiovascular disease (CVD) risk.
|
Baseline, 3 months, 6 months
|
|
Waist Circumference (WC)
Zeitfenster: Baseline, 3 months, 6 months
|
A measure of cardiovascular disease (CVD) risk.
|
Baseline, 3 months, 6 months
|
|
Hemoglobin A1c (HA1c)
Zeitfenster: Baseline, 3 months, 6 months
|
Percentage of hemoglobin that is coated with glucose.
A measure of cardiovascular disease (CVD) risk.
|
Baseline, 3 months, 6 months
|
|
HDL (High-Density Lipoprotein) Cholesterol
Zeitfenster: Baseline, 3 months, 6 months
|
A measure of cardiovascular disease (CVD) risk.
|
Baseline, 3 months, 6 months
|
|
LDL (Low-Density Lipoprotein) Cholesterol, Calculated
Zeitfenster: Baseline, 3 months, 6 months
|
A measure of cardiovascular disease (CVD) risk.
|
Baseline, 3 months, 6 months
|
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LDL (Low-Density Lipoprotein) Cholesterol, Direct
Zeitfenster: Baseline, 3 months, 6 months
|
A measure of cardiovascular disease (CVD) risk.
|
Baseline, 3 months, 6 months
|
|
Triglycerides
Zeitfenster: Baseline, 3 months, 6 months
|
A measure of cardiovascular disease (CVD) risk.
|
Baseline, 3 months, 6 months
|
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Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - General Health
Zeitfenster: Baseline, 3 months, 6 months
|
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower the score the more disability.
The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
|
Baseline, 3 months, 6 months
|
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Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Physical Functioning
Zeitfenster: Baseline, 3 months, 6 months
|
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower the score the more disability.
The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
|
Baseline, 3 months, 6 months
|
|
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Role Functioning/Physical
Zeitfenster: Baseline, 3 months, 6 months
|
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower the score the more disability.
The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
|
Baseline, 3 months, 6 months
|
|
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Role Functioning/Emotional
Zeitfenster: Baseline, 3 months, 6 months
|
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower the score the more disability.
The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
|
Baseline, 3 months, 6 months
|
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Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Energy/Fatigue
Zeitfenster: Baseline, 3 months, 6 months
|
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower the score the more disability.
The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
|
Baseline, 3 months, 6 months
|
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Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Emotional Well-being
Zeitfenster: Baseline, 3 months, 6 months
|
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower the score the more disability.
The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
|
Baseline, 3 months, 6 months
|
|
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Social Functioning
Zeitfenster: Baseline, 3 months, 6 months
|
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower the score the more disability.
The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
|
Baseline, 3 months, 6 months
|
|
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Pain
Zeitfenster: Baseline, 3 months, 6 months
|
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower the score the more disability.
The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
|
Baseline, 3 months, 6 months
|
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Healthcare Utilization as Measured by Number of Primary Care Visits
Zeitfenster: Baseline, 3 months, 6 months
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Number of primary care visits reported by participant in last month (baseline) or since last study visit (3 and 6 months).
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Baseline, 3 months, 6 months
|
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Healthcare Utilization as Measured by Number of Participants With Emergency Department Visits
Zeitfenster: Baseline, 3 months, 6 months
|
Number of participants reporting emergency department visit(s) in last month (baseline) or since last study visit (3 and 6 months).
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Baseline, 3 months, 6 months
|
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Healthcare Utilization as Measured by Number of Participants With Hospitalizations
Zeitfenster: Baseline, 3 months, 6 months
|
Number of participants reporting hospitalization(s) in last month (baseline) or since last study visit (3 and 6 months).
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Baseline, 3 months, 6 months
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Physical Function as Measured by Short Physical Performance Battery (SPPB)
Zeitfenster: Baseline, 3 months, 6 months
|
The Short Physical Performance Battery (SPPB) is an objective measurement instrument of balance, lower extremity strength, and functional capacity in older adults.
Scores range from zero to 12 possible points.
Lower scores are associated with lower function.
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Baseline, 3 months, 6 months
|
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Physical Function as Measured by 8-ft Up and Go
Zeitfenster: Baseline, 3 months, 6 months
|
The 8-foot up-and-go test is a timed test that measures balance, agility, and speed while walking or moving.
Higher times are associated with worse physical function.
|
Baseline, 3 months, 6 months
|
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Physical Function as Measured by Isometric Hand Grip, Right Hand
Zeitfenster: Baseline, 3 months, 6 months
|
Decreased grip strength is a predictor of adverse outcomes in older adults.
|
Baseline, 3 months, 6 months
|
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Physical Function as Measured by Isometric Hand Grip, Left Hand
Zeitfenster: Baseline, 3 months, 6 months
|
Decreased grip strength is a predictor of adverse outcomes in older adults.
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Baseline, 3 months, 6 months
|
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Physical Function as Measured by 30 Second Chair Stands
Zeitfenster: Baseline, 3 months, 6 months
|
Counts the number of times a participant goes from sitting to standing in 30 seconds.
Tests leg strength and endurance.
Higher number associated with higher leg strength and endurance.
|
Baseline, 3 months, 6 months
|
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Physical Function as Measured by 6 Minute Walk Test
Zeitfenster: Baseline, 3 months, 6 months
|
Measures distance walked in 6 minutes and assesses aerobic capacity and endurance.
Higher number indicates higher aerobic capacity and endurance.
|
Baseline, 3 months, 6 months
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Nia S Mitchell, MD, MPH, Duke University
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
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Pro00100588
- R01AG058725 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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