Neoplasms

Digestive System Diseases

All Conditions

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Reproductive Control Agents

All Drugs and Chemicals

Herbal and Botanical

Dinoprostone

Cola

Healthy People 2010 Diet using an exchange list

Mediterranean Diet using an exchange list

1 Healthy Eating

2 Mediterranean

Zora Djuric, Ph.D.

The purpose of this study is to help develop diets for colon cancer prevention. This study will compare the Mediterranean diet to the Healthy People 2010 diet in 120 subjects with increased risk for colorectal cancer.

There is substantial epidemiological evidence that dietary patterns influence colorectal cancer risk. The associations of any particular nutrient with increased or decreased risks, however, may not be due to that nutrient per se but to the whole foods that are rich in that nutrient. Simultaneously, reducing intakes of foods associated with increased risk while increasing foods identified in preventive diets may be the best approach for prevention. The Cretan-Mediterranean diet in particular appears to hold great promise for cancer prevention. The major components of the traditional Cretan diet have been associated with decreased colon cancer. Relative to the American diet, this diet has lower n-6/n-3 and n-6/n-9 fatty acid ratios, lower polyunsaturated fatty acid intake, lower red meat intake, and higher intakes of plant-based foods and monounsaturated fatty acids.

The hypothesis of this study is that adherence to a Mediterranean type of diet will result in a decrease in n-6 fatty acids and increased n-3 and n-9 fatty acids in human colorectal mucosa. This together with aspects of the diet such as increased intakes of fruits and vegetables, is expected to modulate eicosanoid metabolism and epithelial proliferation in normal mucosa. 120 persons, with an increased risk for colorectal cancer, will be randomized to a modified Mediterranean diet or a Healthy People 2010 diet for six months.

Healthy Eating for Colon Cancer Prevention

A Mediterranean Diet in Colon Cancer Prevention

Percentage of participants who met 70% of diet goals as outlined in the exchange list

University of Michigan

Research Professor

Healthy People 2010 Diet

Healthy People 2010 Diet through dietary counseling: 6 months telephone counseling

Mediterranean Diet

Mediterranean Diet through dietary counseling: 6 months telephone counseling

Healthy People 2010 Diet using an exchange list

1 Healthy Eating: 6 months telephone counseling

Mediterranean Diet using an exchange list

2 Mediterranean: 6 months telephone counseling

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Zora Djuric

Adherence to Dietary Goals

Overall Study

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Rare Diseases

Obesity

Body Weight

Body Weight Changes

Weight Gain

Chronic Graft Versus Host Disease

Participants randomized to the HH/HF study intervention will work with a coach through phone calls and text messages for 12 weeks to set goals targeting home-based environmental determinants of dietary behaviors.

Participants in the control condition will receive two mailings which focus on the same dietary outcomes as the HH/HF intervention but without the home environment emphasis.

The HH/HF Intervention involves coaching calls, text messages and intervention materials that are designed to increase behavioral capability, self-efficacy and behavioral intention to improve the home food environment for healthy eating and weight gain prevention. The intervention is delivered over a 12 week period.

Health Homes/Healthy Families (HH/HF) Intervention

Participants in the control condition will receive two mailings on healthy eating, the first from the "Dietary Guidelines For Americans 2015-2020, 8th Edition" and the second from "Choose MyPlate". Additionally, both mailings will include a food diary from the Centers for Disease Control and Prevention. Mailings will be sent to participants one and six-weeks post-baseline. These materials focus on the same dietary outcomes being targeted in the HH/HF intervention, but without the home environment emphasis. Control group participants will receive their home environment profile with a list of healthy actions upon completion of the study.

Control

Michelle Kegler, DrPH/MPH

This trial will evaluate a healthy eating and weight gain prevention intervention for delivery through calls to the 2-1-1 number.

It is now well-established that obesity and excess weight increase the risk of cancer (i.e., colorectal and post-menopausal breast cancer), as well as other chronic diseases including diabetes, stroke, coronary heart disease, and arthritis. The World Cancer Research Fund and the American Institute for Cancer Research state "maintenance of a healthy weight throughout life may be one of the most important ways to protect against cancer". Unfortunately, adults generally gain weight as they age.

Healthy Homes/Healthy Families (HH/HF) Intervention involves a tailored home environment profile and a health coach working with participants to select and implement a series of healthy actions to create a home environment more supportive of healthy eating and physical activity.

The Federal Communications Commission (FCC) designated 2-1-1 as the 3-digit number to call for information and referrals to social services and other assistance in the United States. This study will evaluate a healthy eating and weight gain prevention intervention for delivery through 2-1-1 calls.

Healthy Homes/Healthy Families (HH/HF) Intervention in 2-1-1 Callers

A Hybrid Effectiveness-Implementation Study on Weight Gain Prevention Among 2-1-1 Callers

Individual participant data that underlie the results, after de-identification will be shared

The USDA HEI measures diet quality and is calculated from two telephone administered 24-hr dietary recalls (one weekday, one weekend day). The HEI evaluates foods with a scoring system using 13 components for different food groups and the key recommendations of the 2015-2020 "Dietary Guidelines for Americans". Scores range from 0 to 100 where a score of 100 is an ideal score indicating that a diet follows the key recommendations of the 2015-2020 "Dietary Guidelines for Americans".

Kcal per day will be calculated and recorded. The most recent version of the Automated Self-Administered 24-hour dietary recall (ASA24) program prompts for food description details and automatically codes and calculates nutrient intakes using the USDA Food and Nutrient Database for Dietary Studies. The average of one weekday and one weekend day will be used to estimate Kcal per day at each time point.

Participants will self-report weight in pounds each time point

A home environment survey will be administered via telephone at each time point to assess household food inventory, food preparation methods, meals/snacks with the television on, use of non-home food sources for family meals, and frequency of shopping for fruits and vegetables.

Centers for Disease Control and Prevention

Emory University

Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

This is a single arm pilot study of group base exercise

The BE-BALANCED program will run for 12-weeks, with participants attending group-based virtual supervised exercise sessions twice weekly. Participants will complete an individual in-person assessment at baseline and again at end of intervention to collect physical outcome measures and will complete questionnaires electronically using REDCap, (or mailed version). Follow-up assessments will be administered electronically to each participant using REDCap at 3-months after program completion (24 weeks post-baseline).

Be-Balanced

Kelly Mackenzie

Kelly P Lab

Kristin L Campbell

This study will explore the feasibility (suitability), efficacy (research-setting outcomes), and participant satisfaction of a virtually-supervised 12-week exercise and diet intervention for women with ovarian cancer. It will include exercise, behavior change strategies, and guidance around healthy eating. Participants will be instructed and supervised virtually in two exercise sessions weekly for 12 weeks by a professional trained to deliver the program. An additional 1 exercise session per week, completed independently, will be added from weeks 4-12 of the program. Finally participants will participate in two separate virtual group nutrition sessions. Assessments will occur at baseline, end-of-intervention, and 6 months post-baseline.

Purpose: To assess the feasibility, preliminary efficacy, and patient perspectives of a 12-week supervised, virtually-delivered exercise and healthy eating program for women living with and beyond ovarian cancer.

Hypothesis: The investigators hypothesize that the program will be feasible and will demonstrate efficacy, and that patient perspectives will be overall positive and in support of the program.

Justification: Women living with and beyond ovarian cancer exercise at levels below the general population, and are at an increased risk for falls. Exercise and healthy eating programming is not a part of routine care. This project has the potential to demonstrate a feasible and relatively low-cost option for offering such programming.

Objectives: the objectives of this program are: 1) Primary Objective: To measure the feasibility of delivering the BE-BALANCED program from a virtual (i.e. live video) setting. Feasibility will be evaluated per individual item based on a priori targets; 2) Secondary Objective: To evaluate the preliminary efficacy of the BE-BALANCED program; 3) Tertiary Objective: To evaluate patient satisfaction (post-intervention only)

Research Design: This study is a prospective single-arm feasibility study.

Statistical Analysis: The primary aim is feasibility. This will be evaluated using descriptive statistics, focusing on the program recruitment, attendance, attrition, and fidelity. For secondary and tertiary/exploratory aims, a repeated measures ANOVA will be performed for each measure to evaluate the change in outcomes from baseline and end of intervention (12-weeks) and 3-month follow-up. In addition to the RM-ANOVA, an effect size for each measure will be calculated based on the same time-frame comparisons. SPSS will be used to process data.

Targeted Physical Activity to Improve Mobility and Falls Risk in Women Living With Ovarian Cancer

Targeted Physical Activity to Improve Mobility and Falls Risk in Women Living With Ovarian Cancer (The BE-BALANCED Study)

Overall satisfaction; measured on scale 0-7 with higher score meaning higher satisfaction.

Assessed by meeting accrual targets (number recruited)

Assessed as number of supervised virtual sessions that a participant attended, out of a total of 24 group exercise sessions, and number of self-directed sessions completed, out of a total of 9 sessions.

Assessed as number of drop-outs during the 12-week program.

Group Belonging Scale (0-20; higher is better)

Measured by the gait speed portion of The Short Physical Performance Battery. Measured in seconds.

Measured by 8 foot timed up and go (Seniors Fitness Test). Measured by distance in seconds.

Measured by 30-second chair stand (Seniors Fitness Test). Measured in repetitions completed.

Measured by 30-second biceps curl (Seniors Fitness Test). Measured in repetitions completed.

Measured by Functional Reach Test. Measured in centimeters.

Measured by the Six Minute Walk test. Measured in meters.

Measured using stadiometer. Measured in meters

Measured using a scale. Measured in kilograms

Aggregated measure of height and weight, reported in kilograms/meter\^2

Measured by 36-item Short Form Health Survey; Norm-based 0-100, higher score represents better health

Measured by Hospital Anxiety and Depression Scale; Score range 0-21, higher score is higher depression and anxiety.

Measured by Modified Godin Leisure Time Physical Activity questionnaire; Scoring range 0 - no specified maximum. Scoring \< 14 units "insufficiently Active" ; 14-23 is "moderately active" and \>=24 is "active".

Measured by standard falls calendar for the duration of the study as number of falls.

British Columbia Cancer Agency

University of British Columbia

Uterine Cervical Neoplasms

Uterine Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Mothers participated in educational/behavior change sessions to promote HPV vaccination among their 9-12 year old daughters

Mothers and daughters participated in educational/behavior change sessions to promote healthy eating and appropriate nutrition label interpretation

Mothers assigned to this arm participated in educational/behavior change sessions to promote HPV vaccination among their unvaccinated 9-12 year old daughters

HPV Vaccination

Mothers and daughters assigned to this arm received education on healthy eating and how to appropriately interpret nutrition labels

Healthy Eating

The overall goal of this study to promote HPV vaccine uptake among daughters of Latina immigrants between the ages of 9 and 12.

Objective: Implementation and examination of the efficacy of a culturally relevant, community-based HPV vaccination intervention among daughters of Latina immigrants 9-12 years of age in Alabama.

Methods: Group-randomized controlled trial evaluating two interventions: 1) promotion of HPV vaccination and 2) promotion of healthy eating using "place of residence" as the unit of randomization. Between May 2013 and October 2017, forty locations with 317 mother-daughter dyads were enrolled.

HPV Vaccination Among Daughters of Latina Immigrants

Daughters of mothers assigned to the HPV vaccination arm will more likely to complete the recommended HPV doses at 7-month follow-up than daughters of mothers assigned to the healthy eating arm.

Mothers and daughters assigned to the healthy eating arm will be more likely to eat fried food less than once per week, consume at least three portions of fruit/vegetables per day and have less than one sweetened beverage per day at 7-months than mothers and daughters assigned to the HPV vaccination arm

Mothers and daughters assigned to the healthy eating arm will be more likely to read nutrition labels sometimes/always and correctly interpret nutrition labels than mothers and daughters assigned to the HPV vaccination arm

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Healthy Eating for Colon Cancer Prevention	NCT00475722	Colon Cancer	1 Healthy Eatin... 2 Mediterranean	21 Years -	University of Michigan
Healthy Homes/Healthy Families (HH/HF) Intervention in 2-1-1 Callers	NCT04373434	Weight Change, ...	Health Homes/He... Control	18 Years - 70 Years	Emory University
Healthy Eating for Colon Cancer Prevention	NCT00475722	Colon Cancer	1 Healthy Eatin... 2 Mediterranean	21 Years -	University of Michigan
Healthy Eating for Colon Cancer Prevention	NCT00475722	Colon Cancer	1 Healthy Eatin... 2 Mediterranean	21 Years -	University of Michigan
Healthy Homes/Healthy Families (HH/HF) Intervention in 2-1-1 Callers	NCT04373434	Weight Change, ...	Health Homes/He... Control	18 Years - 70 Years	Emory University
Targeted Physical Activity to Improve Mobility and Falls Risk in Women Living With Ovarian Cancer	NCT04911114	Ovarian Cancer	Be-Balanced	50 Years - 75 Years	University of British Columbia
HPV Vaccination Among Daughters of Latina Immigrants	NCT04154319	Cervical Cancer Healthy Diet	HPV Vaccination Healthy Eating	18 Years -	University of Alabama at Birmingham
Targeted Physical Activity to Improve Mobility and Falls Risk in Women Living With Ovarian Cancer	NCT04911114	Ovarian Cancer	Be-Balanced	50 Years - 75 Years	University of British Columbia

Spots Global Cancer Trial Database for healthy eating