Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

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

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Intervention program including in-person instruction and counseling about exercise and diet, exercise practice sessions, and telephone counseling. Packet of questionnaires will be completed.

Packet of questionnaires will be completed.

Intervention program including in-person instruction and counseling about exercise and diet, exercise practice sessions, and telephone counseling.

Weight Gain Prevention Program

Questionnaire

Karen Basen-Engquist, PhD

The specific aims of this study are:

1. To test the feasibility of a randomized controlled trial of a weight gain prevention program for breast cancer survivors that combines exercise and dietary changes during treatment. Feasibility will be evaluated by examining data on recruitment rate, attendance at intervention sessions, drop-out rates in both study conditions, assessment completion rates, and participant feedback.
2. To test the effect of a weight gain prevention program, compared to usual care, on weight, body composition, and biomarkers related to breast cancer prognosis.
3. To explore whether changes in physical activity, energy intake, and resting energy expenditure predict weight gain among breast cancer survivors.
4. To test the effect of a weight gain prevention program on quality of life variables.

Women who are breast cancer patients having chemotherapy before surgery will be invited to participate in the study. You will be allowed to participate in this study only if your physician feels it is safe for you to participate in moderate physical activity, so you will be asked to have him or her complete a form about your health conditions. Information about the cancer and your treatment history will be obtained from your medical records as part of the study.

If you agree to take part in this study, you will asked to come in for 2 visits at the beginning of the study. At your first visit, your resting energy expenditure (REE) will be measured. To test your REE, you will lie down on a bed while wearing a mask to measure the air you let out when you breathe. You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart). Blood (about 2 teaspoons) will be drawn to measure biomarkers, that may affect breast cancer. You will receive a packet of quality of life questionnaires which will take 45 minutes to complete. You will also receive an actigraph (a small, light-weight device that is worn on the waist during the day) that provides researchers with information on your physical activity. You will be asked to wear the actigraph for 7 days before your second visit. You will be given a diet questionnaire to complete at home. The diet questionnaire will take 60 minutes to complete. You will be asked to bring the actigraph and questionnaires to a baseline study visit.

At the second study visit you will also complete questionnaires about your physical activity.

Your blood pressure and heart rate will be measured. Your physical fitness will be checked by an exercise test done on a treadmill. The exercise test will be monitored by a qualified health care provider and performed by a certified exercise specialist with training in emergency procedures. The exercise intensity will begin at a low level and will be increased over time. The test may be stopped at any time if you experience signs of fatigue or changes in your heart rate, ECG, or blood pressure. You may also stop the test whenever you wish.

Your height, weight, skinfolds, and hip and waist circumference will be measured. Your arm, shoulder, and leg strength will be checked by asking you to stand on a platform and grasp a bar connected to a strain gauge that measures force. Your hip and lower back flexibility will checked using a 'sit and reach' method. Flexibility in your arm will be checked using a goniometer, a small plastic measuring device similar to a ruler.

You will be given a packet of 10 collection tubes for collecting saliva samples with instruction on collecting the samples over 2 days during the next week. You will also be given a special mailer with which to return the samples. The second study visit will take about 2 hours.

After your initial visit, you will be asked to come to M. D. Anderson to complete a Dual energy x-ray absorptiometry (DEXA) scan to evaluate body composition.

At your baseline study visit, you will be randomly assigned (as in the toss of a coin) to either a weight gain prevention group or a standard of care group. An equal number of people will be assigned to each group.

If you are assigned to the intervention group, you will attend individual in-person study visits at M. D. Anderson to receive instruction and counseling about exercise and diet.

While you are receiving chemotherapy, you will attend 1, 60-minute study visit per week for 16 weeks. During these visits, you will be given instructions on resistance and flexibility exercises, using a pedometer (a small device that is worn during the day to give you information about the number of steps you take), and making changes in your diet. You will practice the exercises during this session, and receive feedback. Some of these session might be video taped. You will be asked to give permission for the videotaping before the session begins.

After the 16 weeks of in-person sessions, you will receive 1 telephone counseling session per week for the remainder of the time you are on chemotherapy. Each telephone call will take about 15-20 minutes. Some of these sessions might be tape-recorded. You will be asked permission to tape-record the session before the telephone counseling session is begun. You will receive written materials about making changes to your diet and exercise behavior. The written materials will have information about overcoming barriers, rewarding yourself, and time management. You will also receive hand weights, a step, and a stability ball for exercising at home and a pedometer for monitoring your walking. The hand weights, step, stability ball, and pedometer will be yours to keep. Based on the strength assessment, tailored resistance exercises will be prescribed. You will do the exercises up to 3 times per week. The exercise will target the major muscle groups.

After you have recovered from surgery, you will have 1 study visit a week for 3 weeks. You will practice the exercises and again receive counseling to encourage you to exercise and to eat according to your dietary recommendations. The exercises may be modified at this visit, if necessary.

After these 3 weeks, you will receive 1 phone call a week for the next 6 weeks. Each telephone call will take about 15-20 minutes. You will also receive additional written materials that will include exercises and recommendations for maintaining the behavioral changes made.

Regardless of which group you are in, you will be asked to come to M. D. Anderson for follow-up assessments at the mid-point and end of chemotherapy, after recovering from surgery, then 9 weeks and 6 months after surgery. You will be asked to come to M. D. Anderson to complete a DEXA scan to evaluate body composition and bone mineral density at the end of chemotherapy. For safety purposes, researchers will look for lymphedema at follow-up evaluations after recovering from surgery, then 9 weeks and 6 months after surgery. About 8 days before each follow-up visit we will send you a packet of seven questionnaires that will take 45 minutes to complete, and an actigraph. You will be called on the day you are supposed to wear the actigraph, and you will be given instructions about completing the questionnaires. You will bring the questionnaires and actigraph to your study visits. You will have the same tests and procedures at these study visits as you had at the baseline visit.

You will be considered off-study 6 months after your surgery.

This is an investigational study. About 60 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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 Homes/Healthy Families (HH/HF) Intervention in 2-1-1 Callers	NCT04373434	Weight Change, ...	Health Homes/He... Control	18 Years - 70 Years	Emory University
Weight Gain Prevention for Breast Cancer Survivors	NCT00533338	Breast Cancer	Weight Gain Pre... Questionnaire	18 Years -	M.D. Anderson Cancer Center
Weight Gain Prevention for Breast Cancer Survivors	NCT00533338	Breast Cancer	Weight Gain Pre... Questionnaire	18 Years -	M.D. Anderson Cancer Center
Weight Gain Prevention for Breast Cancer Survivors	NCT00533338	Breast Cancer	Weight Gain Pre... Questionnaire	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for weight gain prevention