Garden-fresh Produce and Exercise Reduce Colon Cancer Risk (GFPE)
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ClinicalTrials.gov Identifier: NCT03976284 |
Recruitment Status :
Active, not recruiting
First Posted : June 6, 2019
Last Update Posted : June 6, 2019
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Condition or disease | Intervention/treatment | Phase |
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Garden-fresh Produce and Exercise (GFPE) | Behavioral: Garden-fresh produce and exercise | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 21 participants |
Allocation: | N/A |
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) |
Primary Purpose: | Prevention |
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 |

Arm | Intervention/treatment |
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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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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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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 |
Responsible Party: | William J. McCarthy, Ph.D., Principal Investigator, University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT03976284 |
Other Study ID Numbers: |
U54CA14393009 |
First Posted: | June 6, 2019 Key Record Dates |
Last Update Posted: | June 6, 2019 |
Last Verified: | June 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | 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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Colonic Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases |