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Garden-fresh Produce and Exercise Reduce Colon Cancer Risk (GFPE)

Primary Purpose

Garden-fresh Produce and Exercise (GFPE)

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Garden-fresh produce and exercise
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Garden-fresh Produce and Exercise (GFPE)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UCLA Center for Cancer Prevention & Control Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Garden-fresh produce and exercise (GFPE)

Arm Description

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.

Outcomes

Primary Outcome Measures

Stool weight
Mean stool weight of single bowel evacuation using precision digital scale

Secondary Outcome Measures

Bristol Stool Chart score
Bristol Stool Chart score ranges from 1 (hard lumps) to 7 (soft, diarrhea, liquid)
Waist circumference
Waist circumference measured over light clothing using tensioner-equipped waist circumference measuring device
Systolic blood pressure
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
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
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
Percent of daily calorie intake attributable to sugary beverage intake

Full Information

First Posted
June 1, 2019
Last Updated
June 4, 2019
Sponsor
University of California, Los Angeles
Collaborators
Charles Drew University of Medicine and Science
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1. Study Identification

Unique Protocol Identification Number
NCT03976284
Brief Title
Garden-fresh Produce and Exercise Reduce Colon Cancer Risk
Acronym
GFPE
Official Title
Garden-fresh Produce and Exercise Reduce Colon Cancer Risk by Reducing Central Obesity and Increasing Stool Quality
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 17, 2019 (Actual)
Primary Completion Date
July 30, 2019 (Anticipated)
Study Completion Date
August 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Charles Drew University of Medicine and Science

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Garden-fresh Produce and Exercise (GFPE)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
UCLA Center for Cancer Prevention & Control Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-6900
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

Garden-fresh Produce and Exercise Reduce Colon Cancer Risk

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