Garden-fresh Produce and Exercise Reduce Colon Cancer Risk (GFPE)
4. Juni 2019 aktualisiert von: William J. McCarthy, Ph.D., University of California, Los Angeles
Garden-fresh Produce and Exercise Reduce Colon Cancer Risk by Reducing Central Obesity and Increasing Stool Quality
The investigators propose a church-based health promotion program designed to reduce colon cancer risk in a mostly African American community served by the Lincoln Memorial Church in South Los Angeles.
The investigators propose involving 20 overweight/obese community members in a 10-session health promotion program featuring weekly cooking classes, didactic nutrition instruction and brief bouts of exercise.
Behavioral aim is to increase participants' fiber intake from commonly consumed plant foods and reduce their intake of pro-inflammatory foods.
They will be followed for 3 months from time of enrollment.
Intervention is expected to increase participants' mean stool weight and improve their Bristol Stool Chart score.
Intervention is expected to reduce waist circumference and systolic blood pressure of participants.
These effects are expected to be accompanied by self-reports of increased fiber intake and reduced intake of saturated fat and refined sugar as well as evidence of increased physical activity.
Studienübersicht
Status
Unbekannt
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
The investigators propose a church-based health promotion program designed to reduce colon cancer risk in a mostly African American community served by the Lincoln Memorial Church in South Los Angeles.
The Los Angeles County of Public Health has divided the county into nine service planning areas (SPAs), of which South LA is one.
Of all the SPAs, the South LA SPA has the highest prevalence of obesity and the lowest adherence to federal nutrition recommendations.
With seed grant funds from a cooperative NIH grant shared by the Drew School of Medicine and University of California-Los Angeles (UCLA), the Lincoln Memorial Church of Los Angeles is sponsoring a behavioral intervention featuring 10 weekly sessions composed of cooking demonstrations, brief didactic nutrition education and 10-minute exercise bouts.
All sessions will take place in the church kitchen and meeting room.
Participants are expected to be 20 mostly African American, overweight/obese community members.
The behavioral goal of the health promotion sessions is to encourage participants to eat more fiber-rich plant foods, minimally processed, to consume fewer pro-inflammatory foods including foods rich in saturated fat, sodium and refined sugar, and to engage in federally recommended amounts of physical activity.
If research resources become available to enable blood chemistry results and/or fecal metagenomic results, the investigators would predict that 3 months after participant enrollment in the study, participants would experience a reduction in their high-sensitivity-C-reactive protein concentration and an increase in the relative abundance of obligate anaerobic bacteria relative to other bacteria in fecal samples.
As seems likely, however, results will be limited to evaluating the weight and form of participant stool samples using the Bristol Stool Chart and evaluating participants' waist circumference and systolic blood pressure.
The 3 month follow-up assessment is expected to show increased stool weight, improved Bristol Stool Chart score, decreased waist circumference, decreased systolic blood pressure, reduced intake of saturated fat and refined sugar, and increased weekly physical activity.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
21
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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California
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Los Angeles, California, Vereinigte Staaten, 90095-6900
- UCLA Center for Cancer Prevention & Control Research
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- body mass index > 25 > 40.
- must reside within 5 miles of the Lincoln Memorial Congregational Church
- must understand English
Exclusion Criteria:
- Crohns disease, ulcerative colitis or irritable bowel syndrome
- currently taking any prescription medication likely to cause weight gain or weight loss
- Currently taking medication for diabetes (e.g., metformin, insulin)
- Had a heart attack in the last 12 months
- Ever had bariatric surgery (weight loss surgery)
- Have been hospitalized for a mental health problem in the last 12 months
- Are currently pregnant or breastfeeding
- Currently use tobacco products such as cigarettes, electronic cigarettes
- Currently use marijuana products, including edibles
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Garden-fresh produce and exercise (GFPE)
Participants are encouraged to double their consumption of minimally processed fiber-rich plant foods, especially garden-fresh produce from the church community garden.
Participants are also encouraged to limit pro-inflammatory foods rich in saturated fat, sodium and added sugar.
Participants are also encouraged to engage in 150 minutes of moderate to vigorous physical activity per week, most likely in the form of brisk walking.
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The Garden-fresh produce and exercise (GFPE) health promotion intervention features 10 weekly sessions that take place after Sunday services in the Lincoln Memorial Church kitchen/meeting space.
Each session includes a cooking demonstration focused on how to prepare and cook a meal composed of fiber-rich plant foods minimally processed.
Each session also includes brief, didactic nutrition instruction and a 10-minute bout of physical activity.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Stool weight
Zeitfenster: At baseline and 3 months post-enrollment
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Mean stool weight of single bowel evacuation using precision digital scale
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At baseline and 3 months post-enrollment
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Bristol Stool Chart score
Zeitfenster: At baseline and 3 months post-enrollment
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Bristol Stool Chart score ranges from 1 (hard lumps) to 7 (soft, diarrhea, liquid)
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At baseline and 3 months post-enrollment
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Waist circumference
Zeitfenster: At baseline and 3 months post-enrollment
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Waist circumference measured over light clothing using tensioner-equipped waist circumference measuring device
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At baseline and 3 months post-enrollment
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Systolic blood pressure
Zeitfenster: At baseline and 3 months post-enrollment
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Resting blood pressure assessed in participant seated quietly at a table with legs uncrossed
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At baseline and 3 months post-enrollment
|
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Ratio of fruit and vegetable fiber intake to total solid food intake
Zeitfenster: At baseline and 3 months post-enrollment
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The ratio of fruit and vegetable fiber intake relative to total gram weight of foods consumed per day based on data from Block Food Frequency questionnaire.
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At baseline and 3 months post-enrollment
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Saturated fat intake
Zeitfenster: At baseline and 3 months post-enrollment
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Mean grams (g) of saturated fat intake consumed daily based on retrospective food consumption data obtained from administration of the Block Food Frequency questionnaire.
The Daily Value for saturated fat is less than 20 g per day, based on a 2,000 calorie diet.
Meat-eating Americans generally consume more than 20 g per day but usually don't exceed 80 g per day.
Humans make all the saturated fat that they need, so consuming zero g of saturated fat per day is consistent with good health.
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At baseline and 3 months post-enrollment
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Sugary beverage intake
Zeitfenster: At baseline and 3 months post-enrollment
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Percent of daily calorie intake attributable to sugary beverage intake
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At baseline and 3 months post-enrollment
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Mitarbeiter
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
17. März 2019
Primärer Abschluss (Voraussichtlich)
30. Juli 2019
Studienabschluss (Voraussichtlich)
30. August 2019
Studienanmeldedaten
Zuerst eingereicht
1. Juni 2019
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
4. Juni 2019
Zuerst gepostet (Tatsächlich)
6. Juni 2019
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
6. Juni 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
4. Juni 2019
Zuletzt verifiziert
1. Juni 2019
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- U54CA14393009
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
Because the pilot study sample is small (N=20), the likelihood of deductive disclosure of identity is high even if the shared data were de-identified.
Hence, there will be no sharing of individual level data with other researchers not originally comprising the investigative team.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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