Clinical trial NCT03976284: Garden-fresh Produce and Exercise Reduce Colon Cancer Risk
Official title: Garden-fresh Produce and Exercise Reduce Colon Cancer Risk by Reducing Central Obesity and Increasing Stool Quality
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Garden-fresh Produce and Exercise (GFPE)
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Charles Drew University of Medicine and Science
First posted: 2019-06-06
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Stool weight
timeFrame: At baseline and 3 months post-enrollment
Secondary outcomes:
measure: Bristol Stool Chart score
timeFrame: At baseline and 3 months post-enrollment
measure: Waist circumference
timeFrame: At baseline and 3 months post-enrollment
measure: Systolic blood pressure
timeFrame: At baseline and 3 months post-enrollment
measure: Ratio of fruit and vegetable fiber intake to total solid food intake
timeFrame: At baseline and 3 months post-enrollment
measure: Saturated fat intake
timeFrame: At baseline and 3 months post-enrollment
measure: Sugary beverage intake
timeFrame: At baseline and 3 months post-enrollment
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Center for Cancer Prevention & Control Research
state: California
Study officials:
References: