Garden-fresh Produce and Exercise Reduce Colon Cancer Risk (GFPE)
4 giugno 2019 aggiornato da: 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.
Panoramica dello studio
Stato
Sconosciuto
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
21
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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California
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Los Angeles, California, Stati Uniti, 90095-6900
- UCLA Center for Cancer Prevention & Control Research
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Stool weight
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Bristol Stool Chart score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
17 marzo 2019
Completamento primario (Anticipato)
30 luglio 2019
Completamento dello studio (Anticipato)
30 agosto 2019
Date di iscrizione allo studio
Primo inviato
1 giugno 2019
Primo inviato che soddisfa i criteri di controllo qualità
4 giugno 2019
Primo Inserito (Effettivo)
6 giugno 2019
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
6 giugno 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
4 giugno 2019
Ultimo verificato
1 giugno 2019
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- U54CA14393009
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
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.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .