Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Overweight

Syndrome

Weight Loss

Obesity

Polycystic Ovary Syndrome

Body Weight

Overnutrition

Nutrition Disorders

Body Weight Changes

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

In the WLI, energy intake will be prescribed at 1200-1500 kcal/d using commercially available portion-controlled entrées, low calorie shakes, fruits/vegetables, and ad-libitum non-caloric beverages. Participants will be asked to consume a minimum daily total of 2 entrées (\~200 to 300 kcal each, saturated fat ≤ 3g), 3 shakes (\~100 kcal each), five 1-cup servings of fruits/vegetables, and ad libitum non-caloric beverages. Additionally, they will be asked to complete 225 min of moderate intensity PA, and self-monitor diet, PA (self-report) and body weight (home scale) across the 6 mo. intervention. Weekly behavioral counseling sessions (45 min) via Skype will be delivered by a professional health educator (HE) to participants in their homes.

In the WLI, energy intake will be prescribed at 1200-1500 kcal/d using commercially available portion-controlled entrées, low calorie shakes, fruits/vegetables, and ad-libitum non-caloric beverages. Participants will be asked to consume a minimum daily total of 2 entrées (\~200 to 300 kcal each, saturated fat ≤ 3g), 3 shakes (\~100 kcal each), five 1-cup servings of fruits/vegetables, and ad libitum non-caloric beverages. Additionally, they will be asked to complete 225 min of moderate intensity PA, and self-monitor diet, PA (self-report) and body weight (home scale) across the 6 mo. intervention. Weekly behavioral counseling sessions (45 min) via group phone callsSkype will be delivered by a professional health educator (HE) to participants in their homes.

Weight loss intervention

Courtney Marsh, MD

The proposed single arm 6 mo. trial will assess the impact of weight loss and fat loss due to a multicomponent remotely-delivered lifestyle intervention on ovulation rates and time-to-ovulation in overweight and obese women with anovulatory infertility caused by PCOS.

Obesity and visceral adiposity are associated with reproductive dysfunction, specifically infertility, problems with ovulation, and decreased rates of conception. Approximately 31% of reproductive aged women in the U.S. are obese. Obese women who become pregnant are at increased risk for miscarriage and pregnancy complications. Infertility treatment using assisted reproductive technologies such as fertility medications, in vitro fertilization or intracytoplasmic sperm injection, is time-intensive, costly, and less effective in obese compared with normal weight women. However, attempts at weight loss to date have been modest at best and the effectiveness of single component hypocaloric diets are questionable. A recently conducted large scale preconception weight loss study in the Netherlands randomized 577 obese infertile women to either a lifestyle intervention prior to fertility treatment or prompt fertility treatment. This study found significantly higher spontaneous pregnancies in the lifestyle intervention group compared to those who promptly received fertility treatment. Additionally, when post hoc analyses were completed on predetermined subgroups, researchers found women with anovulation had more spontaneous pregnancies compared to ovulatory women in the lifestyle intervention group. A few major limitations of this study include: 1) modest weight loss of 4.4 kg and only 38% obtained the minimum goal of 5% weight loss; 2) the study included women with a variety of infertility diagnoses; and 3) limited BMI range of 29-40 kg/m2. More prospective research is necessary to evaluate the effects of weight loss in anovulatory women caused by Polycystic ovarian syndrome (PCOS) as there may be larger benefits in this population such as restoration of ovulation and spontaneous conception. Additionally, there has been limited research investigating fat loss after a lifestyle intervention and the impact on ovulation. Fat loss may play a large role as the purported mechanism by which obesity influences ovulation is through insulin resistance and increased ovarian androgen secretion. Similar to other populations in need of lifestyle interventions, women seeking fertility treatment also have multiple barriers to weight management. Infertility treatment centers in major metropolitan cities often draw individuals from large geographical areas including rural dwelling individuals. Our research team has developed an efficacious weight management program that has shown superior weight loss compared to conventional treatment and has successfully been delivered remotely eliminating concerns of access and transportation and may be well suited for this unique population. However, the acceptability of a remote delivered weight loss intervention, attendance at behavioral sessions, compliance with diet and physical activity (PA) recommendations and self-monitoring (diet, PA, weight), as well as the impact of the magnitude of weight loss on ovulation rates in overweight and obese anovulatory women are unknown, and will be the focus of this study. Over a 2 mo. period, 20 overweight or obese women (BMI \> 25 -45 kg/m2, age 21-38 yrs.) seeking initial treatment after 12 mos. of unsuccessful conception (\~ 40 new women/mo.) will be recruited to complete a 6 mo. multicomponent weight loss intervention (WLI). Participants must be willing to withhold infertility treatment for the length of the 6 mo. intervention and have the diagnosis of ovulatory dysfunction (anovulation) caused by PCOS as the primary cause of infertility. In the WLI, energy intake will be prescribed at 1200-1500 kcal/d using commercially available portion-controlled entrées, low calorie shakes, fruits/vegetables, and ad-libitum non-caloric beverages. Participants will be asked to consume a minimum daily total of 2 entrées (\~200 to 300 kcal each, saturated fat ≤ 3g), 3 shakes (\~100 kcal each), five 1-cup servings of fruits/vegetables, and ad libitum non-caloric beverages. Additionally, they will be asked to complete 225 min of moderate intensity PA, and self-monitor diet, PA (self-report) and body weight (home scale) across the 6 mo. intervention. Weekly behavioral counseling sessions (45 min) via Skype will be delivered by a professional health educator (HE) to participants in their homes.

Weight Loss Intervention in Women With PCOS

Ovulation will be assessed weekly during the 6 mo. intervention by ovulation monitoring kit and the OvuSense device.

The fertility quality of life (FertiQoL) tool (questionnaire)

A dual energy x-ray absorptiometry scan will determine percent body fat.

University of Kansas Medical Center

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

This single-arm pre-post study, that involved one-hourly weekly diet sessions delivered by a dietician and 75-minute bi-weekly Physical Activity (AP) sessions of moderate-to-high intensity led by PA monitors, was offered to overweight and obese BC survivors shortly after treatment.

This single-arm pre-post study, that involved one-hourly weekly diet sessions delivered by a dietician and 75-minute bi-weekly Physical Activity (PA) sessions of moderate-to-high intensity led by PA monitors, was offered to overweight and obese BC survivors shortly after treatment. Before and after the intervention, anthropometry, dietary information, Quality of Life (QoL) and cardiorespiratory fitness (CRF) were collected.

Antonio Agudo, MsC PhD

This is a single-arm pre-post pilot study, to assess changes in weight, quality of life and cardiorespiratory fitness after a diet and physical activity intervention in breast cancer survivors and to asses possible relation between these changes.

Aim:

The present study assessed changes in weight, quality of life (QoL) and cardiorespiratory fitness (CRF) during a diet and physical activity (PA) intervention in breast cancer (BC) survivors and investigated the possible relation between these changes.

Methods:

The intervention of this 12-week single-arm pre-post pilot study involved group-based sessions: one-hour weekly diet sessions delivered by a dietician and 75-minute bi-weekly PA sessions of moderate-to-high intensity led by PA monitors. This intervention, designed to promote weight loss, targeted overweight/obese women who had completed treatment less than six months before recruitment. CRF and QoL were assessed before and after the intervention and compared using paired t-tests. Linear regression models, including CRF variables, weight change and participants' characteristics, were used to assess the independent association between change in CRF and change in QoL.

Effect of a Diet and Physical Activity Intervention in Breast Cancer Survivors

Effect of a Diet and Physical Activity Intervention on Body Weight and Nutritional Patterns in Overweight and Obese Breast Cancer Survivors

Blood analysis: Biomarkers related to glucose, lipid profile, IGF1, reproductive hormones, leptin, adiponectin, carotenoids, inflammation markers, oxidative stress markers and hematologic parameters, will be analysed

To determine peak oxygen uptake (VO2peak), an incremental cycle-ergometer test with monitoring ECG will be performed by exercise physiologists after a 24h period without physical activity in the Physiology Department of the University of Barcelona

A validated food frequency questionnaire will be used, designed to capture dietary habits, 24-hour dietary recalls (covering week days and weekends) will be taken to calculate the patients' energy intake and nutritional profile.

Institut Català d'Oncologia

Carcinoma

Patients will receive a standardized intervention focusing on healthy living. This will include mailings at study entry and one year later describing healthy lifestyle behaviors. All participants will also receive a 2-year subscription to a health magazine. In addition, all study participants will be invited to join twice-yearly Webinars/teleconferences that focus on breast cancer and other health topics, such as treatment updates in breast cancer, management of menopausal side effects, general cancer screening, etc. Finally, the study will also provide birthday and holiday greeting cards and a twice-yearly study newsletter with study updates and other general breast cancer news.

Patients will receive a standardized intervention focusing on healthy living as described in the Arm 1 (Health Education Program). In addition, patients will utilize a standardized, 2-year, telephone-based weight loss intervention. The intervention will include individual weight loss, caloric restriction, and physical activity goals for each participant. It will be administered through semi-structured phone calls delivered by trained coaches at the BWEL call center and supplemented through print and on-line materials. The intervention will utilize a toolbox approach that will allow for tailoring for the individual participant.

Health Education Program

Weight Loss Intervention

Jennifer Ligibel, MD

This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take part in the weight loss program. This study will help to show whether weight loss programs should be a part of breast cancer treatment.

This randomized controlled trial of weight loss interventions in overweight and obese women with early stage breast cancer consists of two arms, please see the arms section for more information. Patients will be randomized 1:1 within stratification factors: menopausal status (premenopausal vs. postmenopausal), hormone receptor status of the tumor (ER and/or PR positive vs. ER and PR negative), and race/ethnicity (African American vs. Hispanic vs. Other). The primary objective of this trial is to compare the effect of the telephone-based intervention versus a health educational control on invasive disease-free survival (IDFS). The total sample size is 3136 patients. Patient follow up for primary and secondary endpoints will continue to a maximum of 10 years, as per the standard protocol for cooperative group adjuvant trials.

The primary and secondary objectives of the study:

Primary objective To compare the effect of a supervised weight loss intervention plus health education materials versus health education materials alone upon invasive disease free survival (IDFS) in overweight (BMI 27-29.9 kg/m2) and obese (BMI ≥30kg/m2) women diagnosed with HER-2 negative, stage II and III breast cancer.

Secondary objectives

1. To determine the relationship between changes in weight and IDFS, and to explore interaction between the level of clinical benefit from weight loss and the intervention.
2. To evaluate the effect of a supervised weight loss intervention upon:

   1. Overall survival
   2. Distant disease free survival
   3. Weight
   4. Body composition (as measured by waist and hip circumference)
   5. Insulin Resistance Syndrome associated conditions - diabetes, hospitalization for CV disease
3. To determine the impact of a supervised weight loss intervention on IDFS within subgroups of women with 1) hormone receptor positive breast cancer and 2) hormone receptor negative breast cancer.
4. To determine the impact of a supervised weight loss intervention on IDFS within subgroups of 1) premenopausal women and 2) post-menopausal women.

Patients are to be followed every 6 months for the first 3 years after study enrollment and then annually until 10 years from registration. The intervention will last 2 years or until disease recurrence/progression, new invasive primary cancer as defined in the protocol or patient withdrawal.

Breast Cancer WEight Loss Study (BWEL Study)

Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women With Early Breast Cancer

National Cancer Institute (NCI)

Division of Cancer Control

NIH Biomarker, Imaging and Quality of Life Studies Funding Program (BIQSFP)

Canadian Cancer Trials Group

Alliance for Clinical Trials in Oncology

Blood and Lymph Conditions

Recurrence

Lymphedema

Lymphatic Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Benzocaine

Tannic Acid

All 4 groups receive lymphedema care as follows:

1. 2 custom fitted compression garments (baseline and 6 months)
2. evaluations for flare-ups at request (and at each measurement time point)
3. lymphedema treatment by a certified lymphatic therapist upon detection of a flare-up, paid for by the study. No limit was placed on number of sessions.

The Exercise Intervention combines 60-90 minute twice-weekly supervised weight-lifting sessions with 180 minutes of weekly aerobic exercise. Women will be trained by certified fitness professionals in both the weight-lifting intervention and in safely increasing their aerobic exercise activity over 6 weekly sessions, and then monitored through phone contact, and monthly in-person sessions. All exercise participants will be provided with 'Power Blocks' which are adjustable dumbbells with which they can increase resistance in 1-2 pound increments from 1-21 pounds. All weight training will be done in their homes except for the first 6 weekly session and monthly check-in sessions. Exercise only group members also received the Lymphedema care intervention described above.

The Weight Loss Intervention begins with a 24 week intensive phase that includes weekly meetings and provision of all meals and snacks from a commercial manufacturer (NutriSystem®, Inc., Fort Washington, PA). Daily caloric intake will be strictly controlled during this first 24 weeks at 1200-1500 calories per day. Participants will be guided to stay at the same number of calories per day until reaching goal weight, followed by a gradual increase in caloric intake (of approximately 500 calories/d) to maintain their weight throughout the remainder of the intervention. The treatment groups will be led by registered dietitians and will receive ongoing supervision via telephone and email contact. Weight loss only group members also received the Lymphedema care intervention described above.

Participants in this group will receive a combination of the supervised twice-weekly weight training sessions and the weight loss program. Combined group members also received the Lymphedema care intervention described above.

The Exercise Intervention combines the twice-weekly weight-lifting intervention from PAL with the 180 minutes of weekly aerobic exercise from the recently completed WISER trial and the ongoing WISER Sister Trial. Women will be trained by certified fitness professionals in both the PAL weight-lifting intervention and in safely increasing their aerobic exercise activity over 6 weekly sessions, and then monitored through phone contact, and monthly in-person sessions.

Exercise Intervention

The Weight Loss Intervention begins with a 24 week intensive phase that includes weekly meetings and provision of all meals and snacks from a commercial manufacturer (NutriSystem, Inc., Fort Washington, PA). Daily caloric intake will be strictly controlled during this first 24 weeks at 1200-1500 calories per day.

Kathryn H. Schmitz, MPH,PhD

WISER Survivor is a one year weight loss and exercise study for sedentary breast cancer survivors who are overweight or obese with breast cancer related lymphedema. There will be four groups in this trial: exercise only, weight loss only, exercise and weight-loss combined, and a control group. The primary purpose of this study is to test the effects of these interventions on clinical lymphedema outcomes. Secondary outcomes include weight loss, breast cancer related biomarkers, and quality of life. To the extent that funding will be available, participants will be followed long term to examine effects on recurrence and mortality.

All participants asked at the start of each measurement encounter not to inform measurement staff of their randomization group status. All measurement staff asked to guess group status at end of each measurement encounter. Patterns of responses beyond chance result in corrective action to improve masking (e.g.; requests from PI for participants to mask group status)

The Women In Steady Exercise Research (WISER) Survivor Trial

The Women In Steady Exercise Research (WISER) Survivor Trial & Cost of Illness and Cost Effectiveness of Alternative Management Strategies

participants will be followed for breast cancer recurrence

participants will be followed for mortality

Arm volumes for affected and unaffected limbs will be measured by perometry and the % difference will be determined at baseline and 12 months. the absolute percentage point difference of differences (% interlimb difference at 12 months minus % interlimb difference at baseline) will be the primary outcome

Flare-ups and cellulitic infections (number and type recorded)

Standardized clinical evaluation survey completed by certified lymphatic therapists

Thirteen symptoms, recorded within a standardized survey (Norman Lymphedema Survey)

circulating estradiol levels in the blood

circulating testosterone levels in the blood

circulating sex hormone binding globulin levels in the blood

Circulating interleukin six levels in the blood

Circulating c reactive protein levels in the blood

circulating Adiponectin levels in the blood

circulating F2-isoprostane levels in the blood

circulating levels of insulin like growth factor one in the blood

circulating levels of insulin like growth factor binding protein three in the blood

27 item survey on lymphedema quality of life

32 item survey on body image specifically developed for breast cancer survivors

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Weight Loss Intervention in Women With PCOS	NCT03677362	Polycystic Ovar... Overweight and ...	Weight loss int...	21 Years - 42 Years	University of Kansas Medical Center
Effect of a Diet and Physical Activity Intervention in Breast Cancer Survivors	NCT02067481	Breast Cancer	Weight loss int...	18 Years - 75 Years	Institut Català d'Oncologia
Breast Cancer WEight Loss Study (BWEL Study)	NCT02750826	Breast Carcinom...	Health Educatio... Weight Loss Int...	18 Years -	Alliance for Clinical Trials in Oncology
Effect of a Diet and Physical Activity Intervention in Breast Cancer Survivors	NCT02067481	Breast Cancer	Weight loss int...	18 Years - 75 Years	Institut Català d'Oncologia
The Women In Steady Exercise Research (WISER) Survivor Trial	NCT01515124	Lymphedema	Exercise Interv... Weight Loss Int...	- 80 Years	Milton S. Hershey Medical Center
Effect of a Diet and Physical Activity Intervention in Breast Cancer Survivors	NCT02067481	Breast Cancer	Weight loss int...	18 Years - 75 Years	Institut Català d'Oncologia

Spots Global Cancer Trial Database for weight loss intervention