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

History of Changes

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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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 ]

Measure Type	Primary
Measure Title	Dietary Quality
Measure Description	Dietary quality was measured by the Alternative Healthy Eating Index (AHEI), a scale of healthy eating that goes from zero to 80 (best score).
Time Frame	6 mos
Safety Issue	No

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.

Measured Values

	High Fiber Diet	Low Saturated Fat	Combination Diet
Number of Participants Analyzed [units: participants]	12	9	10
Dietary Quality [units: score] Mean ± Standard Deviation	38.78 ± 3.20	41.18 ± 3.51	39.76 ± 3.70

Statistical Analysis 1 for Dietary Quality

Groups ^[1]	All groups
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.14

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Mean dietary quality score by visit and study group was estimated using SAS PROC MIXED. All analyses were performed using SAS 9.13 (SAS Institute, Cary, NC, USA).
[2]	Other relevant information, such as adjustments or degrees of freedom:
	time measurement, treatment group, interaction between time and group term as fixed effect, subject as random effect.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

2. Primary:

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

Measure Type	Primary
Measure Title	Dietary Quality, Possible Score From Zero to 80 (Best Quality Diet).
Measure Description	The AHEI consists of 8 components (eg, vegetables,trans fat). Each contributed 0–10 points to the total score; a score of 10 indicates that the recommendations were fully met, whereas a score of 0 represents the least healthy dietary behavior. Intermediate intakes were scored proportionately between 0 and 10. All component scores were summed to obtain a total AHEI score ranging from zero(worst) to 80(best).
Time Frame	3 months
Safety Issue	No

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.

Measured Values

	High Fiber Diet	Low Saturated Fat	Combination Diet
Number of Participants Analyzed [units: participants]	12	9	10
Dietary Quality, Possible Score From Zero to 80 (Best Quality Diet). [units: score] Mean ± Standard Deviation	44.90 ± 3.51	44.90 ± 3.20	43.75 ± 3.70

No statistical analysis provided for Dietary Quality, Possible Score From Zero to 80 (Best Quality Diet).

3. Secondary:

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

Measure Type	Secondary
Measure Title	Change in Weight From Baseline to 3 Months
Measure Description	No text entered.
Time Frame	3 months
Safety Issue	No

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.

Measured Values

	High Fiber Diet	Low Saturated Fat	Combination Diet
Number of Participants Analyzed [units: participants]	12	9	10
Change in Weight From Baseline to 3 Months [units: pounds] Mean ± Standard Deviation	-7.0 ± 2.0	-9.1 ± 2.2	-6.7 ± 2.3

No statistical analysis provided for Change in Weight From Baseline to 3 Months

4. Secondary:

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

Measure Type	Secondary
Measure Title	Change in Weight From Baseline to 6 Months
Measure Description	No text entered.
Time Frame	6 months
Safety Issue	No

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.

Measured Values

	High Fiber Diet	Low Saturated Fat	Combination Diet
Number of Participants Analyzed [units: participants]	12	9	10
Change in Weight From Baseline to 6 Months [units: pounds] Mean ± Standard Deviation	-9.1 ± 2.0	-10.2 ± 2.2	-7.0 ± 2.3

No statistical analysis provided for Change in Weight From Baseline to 6 Months

5. Secondary:

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

Measure Type	Secondary
Measure Title	Change in Calories From Baseline to 3 Months
Measure Description	kilocalories
Time Frame	3 months
Safety Issue	No

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.

Measured Values

	High Fiber Diet	Low Saturated Fat	Combination Diet
Number of Participants Analyzed [units: participants]	12	9	10
Change in Calories From Baseline to 3 Months [units: calories] Mean ± Standard Deviation	-464.05 ± 94.52	-190.90 ± 103.54	-638.91 ± 109.15

No statistical analysis provided for Change in Calories From Baseline to 3 Months

6. Secondary:

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

Measure Type	Secondary
Measure Title	Change in Calories From Baseline to 6 Months
Measure Description	kilocalories
Time Frame	6 months
Safety Issue	No

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.

Measured Values

	High Fiber Diet	Low Saturated Fat	Combination Diet
Number of Participants Analyzed [units: participants]	12	9	10
Change in Calories From Baseline to 6 Months [units: calories] Mean ± Standard Deviation	-364.82 ± 94.52	-187.19 ± 103.54	-626.32 ± 109.15

No statistical analysis provided for Change in Calories From Baseline to 6 Months

Serious Adverse Events

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Other Adverse Events

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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.

Limitations and Caveats

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
No text entered.

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:

Olendzki BC, Ma Y, Schneider KL, Merriam P, Culver AL, Ockene IS, Pagoto S. A simple dietary message to improve dietary quality: Results from a pilot investigation. Nutrition. 2009 Apr 7; [Epub ahead of print]

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

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