Garden-fresh Produce and Exercise Reduce Colon Cancer Risk (GFPE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03976284|
Recruitment Status : Active, not recruiting
First Posted : June 6, 2019
Last Update Posted : June 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Garden-fresh Produce and Exercise (GFPE)||Behavioral: Garden-fresh produce and exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Participants will participate in 10 weekly health promotion sessions featuring cooking instruction, brief didactic nutrition instruction and 10-minute bouts of physical activity all taking place in the church kitchen/meeting room.|
|Masking:||None (Open Label)|
|Official Title:||Garden-fresh Produce and Exercise Reduce Colon Cancer Risk by Reducing Central Obesity and Increasing Stool Quality|
|Actual Study Start Date :||March 17, 2019|
|Estimated Primary Completion Date :||July 30, 2019|
|Estimated Study Completion Date :||August 30, 2019|
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.
Behavioral: Garden-fresh produce and exercise
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.
Other Name: GFPE
- Stool weight [ Time Frame: At baseline and 3 months post-enrollment ]Mean stool weight of single bowel evacuation using precision digital scale
- Bristol Stool Chart score [ Time Frame: At baseline and 3 months post-enrollment ]Bristol Stool Chart score ranges from 1 (hard lumps) to 7 (soft, diarrhea, liquid)
- Waist circumference [ Time Frame: At baseline and 3 months post-enrollment ]Waist circumference measured over light clothing using tensioner-equipped waist circumference measuring device
- Systolic blood pressure [ Time Frame: At baseline and 3 months post-enrollment ]Resting blood pressure assessed in participant seated quietly at a table with legs uncrossed
- Ratio of fruit and vegetable fiber intake to total solid food intake [ Time Frame: At baseline and 3 months post-enrollment ]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.
- Saturated fat intake [ Time Frame: At baseline and 3 months post-enrollment ]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.
- Sugary beverage intake [ Time Frame: At baseline and 3 months post-enrollment ]Percent of daily calorie intake attributable to sugary beverage intake
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03976284
|United States, California|
|UCLA Center for Cancer Prevention & Control Research|
|Los Angeles, California, United States, 90095-6900|