Protein-Sparing Modified Fast Intervention for Weight Loss in Obese Endometrial Cancer Survivors
Condition: Endometrial Cancer; Obesity
MeSH terms: Endometrial Neoplasms; Weight Loss
Study type: Interventional

Summary: 
      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, 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. The PSMF may help endometrial cancer
      survivors achieve significant weight loss, reduce the risk of chronic disease, and improve
      quality of life.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Investigate whether the PSMF leads to significant weight loss in obese endometrial cancer
      survivors (ECS).

      II. To assess whether the approach is feasible, whether participants will remain in the study
      for the duration of the intervention while adhering to the various components of the
      protocol. To assess feasibility, examine the following variables: drop-out rates; rates of
      adherence to diet and supplemental protocol; and rates of common side-effects.

      III. Assess whether the PSMF improves biomarkers of disease risk in this population. To
      assess whether this objective has been met, assess the following variables: blood lipids
      (total cholesterol, low density lipid [LDL] cholesterol, high density lipid [HDL]
      cholesterol, and triglycerides); glucose; and markers of inflammation (C-reactive protein,
      interleukin-6, tumor necrosis factor [TNF]-alpha, and leptin).

      IV. Assess whether the PSMF leads to improvement in quality of life related to weight loss.

      OUTLINE:

      PSMF: Participants are instructed by a registered dietitian (RD) to consume enough lean beef,
      pork, poultry, and seafood to provide 1.2 grams of protein per kilogram of their obesity
      adjusted ideal body weight. The protein recommendation will be communicated to participants
      in terms of grams per day. Participants are encouraged to adhere as closely as possible to
      the protein recommendation. Based on the protein recommendation, participants are advised to
      consume a given amount (in ounces) of beef, pork, poultry and seafood daily, assuming that
      each ounce of these products contains seven grams of protein. Participants are provided with
      a digital kitchen scale to weigh protein-containing foods and are permitted up to 2 servings
      of non-starchy vegetables per day. Participants remain on the PSMF until they have
      successfully reduced their initial body weight by 15% or up to 6 months. Participants are
      also provided with supplements to consume daily.

      WEIGHT MAINTENANCE DIET: After successful weight loss of at least 15% of initial body weight,
      participants are instructed by a RD to consume a weight maintenance diet or they may remain
      on the PSMF. The weight maintenance diet consists of gradual addition of previously
      eliminated carbohydrate containing food groups to the PSMF and consumption of non-starchy
      vegetables is unlimited. Participants receive handouts that list common foods and the number
      of carbohydrates in each serving and educated on nutrition label reading for carbohydrates,
      with emphasis on serving size and total number of carbohydrates per serving.

      After completion of study, participants are followed up at 2 and 4 weeks and then at 2, 3, 4,
      5, and 6 months.
    

Intervention name(s): Dietary Intervention; Informational Material; Dietary Education; Weight Maintenance; Average score of Obesity and Weight-Loss Quality of Life Questionnaire
Intervention type(s): Dietary Supplement; Other; Other; Dietary Supplement; Other
Intervention description(s): Follow the Protein-Sparing Modified Fast (PSMF) intervention. This diet has participants consume enough lean beef, pork, poultry, and seafood to provide 1.2 grams of protein per kilogram of their obesity adjusted ideal body weight.; Receive carbohydrate reintroduction handout; Receive education on nutrition label reading for carbohydrates; weight maintenance diet consists of gradual addition of previously eliminated carbohydrate containing food groups to the high protein PSMF diet. During weight maintenance, consumption of non-starchy vegetables is unlimited; Participants will take a tailored quality of life questionnaire. These scores will be averaged and a group mean reported. Higher scores indicate greater quality of life.
Other intervention name(s): Dietary Modification; intervention, dietary; intervention, educational
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: endometrial cancer; survivor; obesity; diet; high protein; protein-sparing modified fast intervention; PSMF