Resnick 2014.
| Trial name or title | Protein‐sparing modified fast intervention for weight loss in obese endometrial cancer survivors |
| Methods | A pilot single‐group study |
| Participants | Patients previously diagnosed with endometrial cancer and successfully treated through surgery. Body mass index (BMI) > 30 kg/m² and > 8 weeks removed from surgery to treat the endometrial cancer |
| Interventions | This pilot clinical trial studies protein‐sparing modified fast (PSMF) intervention for weight loss in obese endometrial cancer survivors. The PSMF is a diet that is very low in carbohydrates and calories and is designed to induce fast, safe weight loss. The diet consists of only lean meats (beef, pork, poultry, and seafood) in amounts adequate to meet protein requirements based on the individual's body weight Experimental: supportive care (PSMF). Participants will take part in a Protein‐Sparing Modified Fast (PSMF) intervention for weight loss. Participants will undergo a dietary intervention high in protein for 6 weeks, or until they have lost 15% of their body weight. This intervention will be followed by weight maintenance, during which participants will reintroduce non‐starchy vegetables to their diet. At this time, participants will also receive informational material and dietary education, which teaches participants how to read nutrition labels and calculate carbohydrate loads in foods. Participants are given the Obesity and Weight‐Loss Quality of Life Questionnaire to survey the impact of the intervention |
| Outcomes | Weight loss, cholesterol and triglycerides, markers of inflammation (C‐reactive protein, interleukin 6), glucose, number of dropouts, percentage of positive urinary ketone tests as a marker of dietary adherence, adverse events, quality of life After completion of the study, participants are followed up at 2 weeks and at 4 weeks, and then at 2, 3, 4, 5, and 6 months |
| Starting date | May 2014 |
| Contact information | Kimberly Resnick, Case Comprehensive Cancer Center, USA 216 844 3954 kimberly.resnick@uhhospitals.org |
| Notes |
AJCC: American Joint Committee on Cancer.
BMI: body mass index.
BP: blood pressure.
CESD‐R: Center for Epidemiologic Studies Depression Scale Revised.
CWLP: commercial weight loss programme.
ECOG: Eastern Cooperative Oncology Group.
FACT‐G: Functional Assessment of Cancer Therapy ‐ General.
FFQ: Food Frequency Questionnaire.
HDL: high‐density lipoprotein.
HR: heart rate.
IPAQ‐SF: International Physical Activity Questionnaire Short Form.
MET: metabolic equivalent.
MOS SF‐36: Medical Outcomes Study Short Form Health Survey.
MVPA: moderate to vigorous physical activity.
PA: physical activity.
PSMF: protein‐sparing modified fast.
PSQI: Pittsburgh Sleep Quality Index.
QoL: quality of life.
SLM: standard lifestyle method.
SpO2: peripheral capillary oxygen saturation.
TLI: tailored lifestyle intervention.
TTMI: Targeting the Teachable Moment intervention.