Garden-fresh Produce and Exercise Reduce Colon Cancer Risk

Garden-fresh Produce and Exercise (GFPE) Clinical Trial

— GFPE  

Official title:

Garden-fresh Produce and Exercise Reduce Colon Cancer Risk by Reducing Central Obesity and Increasing Stool Quality

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03976284
• Other study ID #: U54CA14393009
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 17, 2019
• Est. completion date: August 30, 2019

Study information

• Verified date: June 2019
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21
• Est. completion date: August 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Neoplasms
• Garden-fresh Produce and Exercise (GFPE)

Intervention

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.

Locations

Country	Name	City	State
United States	UCLA Center for Cancer Prevention & Control Research	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Charles Drew University of Medicine and Science

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stool weight	Mean stool weight of single bowel evacuation using precision digital scale	At baseline and 3 months post-enrollment
Secondary	Bristol Stool Chart score	Bristol Stool Chart score ranges from 1 (hard lumps) to 7 (soft, diarrhea, liquid)	At baseline and 3 months post-enrollment
Secondary	Waist circumference	Waist circumference measured over light clothing using tensioner-equipped waist circumference measuring device	At baseline and 3 months post-enrollment
Secondary	Systolic blood pressure	Resting blood pressure assessed in participant seated quietly at a table with legs uncrossed	At baseline and 3 months post-enrollment
Secondary	Ratio of fruit and vegetable fiber intake to total solid food intake	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
Secondary	Saturated fat intake	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
Secondary	Sugary beverage intake	Percent of daily calorie intake attributable to sugary beverage intake	At baseline and 3 months post-enrollment