- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03976284
Garden-fresh Produce and Exercise Reduce Colon Cancer Risk (GFPE)
June 4, 2019 updated by: 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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095-6900
- UCLA Center for Cancer Prevention & Control Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stool weight
Time Frame: At baseline and 3 months post-enrollment
|
Mean stool weight of single bowel evacuation using precision digital scale
|
At baseline and 3 months post-enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
At baseline and 3 months post-enrollment
|
Waist circumference
Time Frame: At baseline and 3 months post-enrollment
|
Waist circumference measured over light clothing using tensioner-equipped waist circumference measuring device
|
At baseline and 3 months post-enrollment
|
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
|
At baseline and 3 months post-enrollment
|
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.
|
At baseline and 3 months post-enrollment
|
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.
|
At baseline and 3 months post-enrollment
|
Sugary beverage intake
Time Frame: At baseline and 3 months post-enrollment
|
Percent of daily calorie intake attributable to sugary beverage intake
|
At baseline and 3 months post-enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 17, 2019
Primary Completion (Anticipated)
July 30, 2019
Study Completion (Anticipated)
August 30, 2019
Study Registration Dates
First Submitted
June 1, 2019
First Submitted That Met QC Criteria
June 4, 2019
First Posted (Actual)
June 6, 2019
Study Record Updates
Last Update Posted (Actual)
June 6, 2019
Last Update Submitted That Met QC Criteria
June 4, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- U54CA14393009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD 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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Garden-fresh produce and exercise
-
Boston Medical CenterPatient-Centered Outcomes Research Institute; United States Department of Agriculture... and other collaboratorsCompleted
-
Harvard School of Public Health (HSPH)Africa Academy for Public Health; University of DodomaCompleted
-
North Carolina State UniversityCompletedPediatric Obesity | Sedentary BehaviorUnited States
-
Groupe Hospitalier de la Rochelle Ré AunisUllo WorldCompletedChild Behavior DisordersFrance
-
University of PennsylvaniaCompleted
-
University of Texas at AustinBoys and Girls Club of AustinCompleted
-
Akron General Medical CenterThe Cleveland Clinic; The University of AkronActive, not recruitingHypertension | Obesity | Type 2 Diabetes | Pre-diabetesUnited States
-
Tufts UniversityHealth Care District of Palm Beach County; South Florida Hunger Coalition; Jupiter... and other collaboratorsCompleted
-
McMaster UniversitySt. Joseph's Healthcare Hamilton; Hamilton Health Sciences Corporation; Queen... and other collaboratorsCompletedClostridium Difficile InfectionCanada