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Garden-fresh Produce and Exercise Reduce Colon Cancer Risk

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03976284
Acronym
GFPE
Enrollment
21
Registered
2019-06-06
Start date
2019-03-17
Completion date
2019-08-30
Last updated
2019-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Garden-fresh Produce and Exercise (GFPE)

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.

Interventions

BEHAVIORALGarden-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.

Sponsors

Charles Drew University of Medicine and Science
CollaboratorOTHER
University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Stool weightAt baseline and 3 months post-enrollmentMean stool weight of single bowel evacuation using precision digital scale

Secondary

MeasureTime frameDescription
Waist circumferenceAt baseline and 3 months post-enrollmentWaist circumference measured over light clothing using tensioner-equipped waist circumference measuring device
Systolic blood pressureAt baseline and 3 months post-enrollmentResting blood pressure assessed in participant seated quietly at a table with legs uncrossed
Bristol Stool Chart scoreAt baseline and 3 months post-enrollmentBristol Stool Chart score ranges from 1 (hard lumps) to 7 (soft, diarrhea, liquid)
Saturated fat intakeAt baseline and 3 months post-enrollmentMean 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 intakeAt baseline and 3 months post-enrollmentPercent of daily calorie intake attributable to sugary beverage intake
Ratio of fruit and vegetable fiber intake to total solid food intakeAt baseline and 3 months post-enrollmentThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026