Cancer Dietary Objectives Study (CanDo)

This study has been completed.
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by:
University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT00561977
First received: November 20, 2007
Last updated: August 2, 2011
Last verified: August 2011
Results First Received: January 18, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Cancer
Heart Disease
Interventions: Behavioral: High Fiber Diet
Behavioral: low saturated fat diet
Behavioral: Combination diet

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Of 78 patients responding to advertisements at UMass Medical School intranet, 36 (41%) eligible overweight and obese patients were consented to participate in the study. Dates of recruitment were May-August 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
23 ineligible, 5 refused screening, 12 patients put on waiting list, 2 patients dropped prior to randomization due to pregnancy. 2 patients added from waiting list to active participation.

Reporting Groups
  Description
High Fiber Diet high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
Low Saturated Fat low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
Combination Diet Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.

Participant Flow:   Overall Study
    High Fiber Diet     Low Saturated Fat     Combination Diet  
STARTED     12     12     12  
COMPLETED     12     9     10  
NOT COMPLETED     0     3     2  
Withdrawal by Subject                 0                 2                 1  
Pregnancy                 0                 1                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
High Fiber Diet high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
Low Saturated Fat low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
Combination Diet Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
Total Total of all reporting groups

Baseline Measures
    High Fiber Diet     Low Saturated Fat     Combination Diet     Total  
Number of Participants  
[units: participants]
  12     12     12     36  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     12     11     12     35  
>=65 years     0     1     0     1  
Age  
[units: years]
Mean ± Standard Deviation
  48.42  ± 9.77     53.00  ± 12.5     41.33  ± 15.89     47.58  ± 13.48  
Gender  
[units: participants]
       
Female     11     10     10     31  
Male     1     2     2     5  
Region of Enrollment  
[units: participants]
       
United States     12     12     12     36  



  Outcome Measures
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1.  Primary:   Dietary Quality   [ Time Frame: 6 mos ]

2.  Primary:   Dietary Quality, Possible Score From Zero to 80 (Best Quality Diet).   [ Time Frame: 3 months ]

3.  Secondary:   Change in Weight From Baseline to 3 Months   [ Time Frame: 3 months ]

4.  Secondary:   Change in Weight From Baseline to 6 Months   [ Time Frame: 6 months ]

5.  Secondary:   Change in Calories From Baseline to 3 Months   [ Time Frame: 3 months ]

6.  Secondary:   Change in Calories From Baseline to 6 Months   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Barbara Olendzki, RD MPH LDN
Organization: UMass Medical School
phone: 508-856-5195
e-mail: barbara.olendzki@umassmed.edu


Publications of Results:

Responsible Party: Barbara Olendzki, Nutrition Program Director, UMass Medical School
ClinicalTrials.gov Identifier: NCT00561977     History of Changes
Other Study ID Numbers: IRG 93-033
Study First Received: November 20, 2007
Results First Received: January 18, 2010
Last Updated: August 2, 2011
Health Authority: United States: Institutional Review Board