Cancer Dietary Objectives Study

NCT00561977 | Completed Results

• 1 other identifier: IRG 93-033
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

We hypothesize that adding beneficial high fiber foods to the diet will result in better overall dietary quality (measured by the Alternate Healthy Eating Index), which has been shown to be associated with cancer, than either reducing saturated fat, or a combination of high fiber and low saturated fat.

Conditions

Cancer; Heart Disease

Keywords

Nutrition; Dietary Quality; Weight loss

Outcome Measures

Primary Outcomes (2)

• Dietary Quality

  Dietary quality was measured by the Alternative Healthy Eating Index (AHEI), a scale of healthy eating that goes from zero to 80 (best score).

  6 mos

• Dietary Quality, Possible Score From Zero to 80 (Best Quality Diet).

  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).

  3 months

Secondary Outcomes (4)

• Change in Weight From Baseline to 3 Months

  3 months

• Change in Weight From Baseline to 6 Months

  6 months

• Change in Calories From Baseline to 3 Months

  3 months

• Change in Calories From Baseline to 6 Months

  6 months

Study Arms (3)

High Fiber Diet

ACTIVE COMPARATOR

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.

Behavioral: High Fiber Diet

Low Saturated Fat

ACTIVE COMPARATOR

low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.

Behavioral: low saturated fat diet

Combination Diet

ACTIVE COMPARATOR

Combination low saturated fat (≤7% of total calories);high fiber (\>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.

Behavioral: Combination diet

Interventions

High Fiber Diet BEHAVIORAL

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.

High Fiber Diet

low saturated fat diet BEHAVIORAL

low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal/day.

Low Saturated Fat

Combination diet BEHAVIORAL

combination low saturated fat high fiber diet, with calorie restriction as specified.

Combination Diet

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI ≥25, and ≤40.
• \>=21 years of age, less than 81 years of age.
• has primary care physician's approval to participate in all aspects of the study,
• speaks, reads, and understands English at 6th grade level minimum
• residing in local area for the duration of the study.
• available for bi-monthly sessions (6 individual nutrition counseling visits)

You may not qualify if:

• presence of a psychological disorder that will limit his/her ability to participate (such as an eating disorder, uncontrolled bipolar disorder)
• unwilling to provide informed consent
• presence of unstable medical disorder (e.g., uncontrolled hypertension, uncontrolled diabetes, etc), or a medical disorder associated with a life expectancy less than 2 years.
• currently taking any medication known to affect weight or appetite
• smokes more than 3 cigarettes a day on average
• Has a dietary restriction that precludes changing to the healthy diet, i.e.; Crohn's disease, ulcerative colitis, renal disease, active diverticulitis, etc.
• currently following a specific diet plan (low saturated fat/meat, or high fiber)
• does not have a telephone
• Pregnant, or planning to become pregnant (participant will be asked this question in telephone screening. If the participant becomes pregnant, they are asked to inform the principal investigator)
• Has an active drug or alcohol problem within the past year -

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

UMass Medical School

Worcester, Massachusetts, 01655, United States

Location

Related Publications (1)

• 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 Jul-Aug;25(7-8):736-44. doi: 10.1016/j.nut.2009.01.009. Epub 2009 Apr 9.

  PMID: 19359142 RESULT

MeSH Terms

Conditions

Neoplasms; Heart Diseases; Weight Loss

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Barbara Olendzki, RD MPH LDN
• Organization: UMass Medical School

barbara.olendzki@umassmed.edu

508-856-5195

Study Officials

• Barbara C Olendzki, RD MPH

  UMass Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 20, 2007
• First Posted: November 21, 2007
• Study Start: May 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: February 1, 2009
• Last Updated: September 2, 2011
• Results First Posted: September 2, 2011

Record last verified: 2011-08

Locations

US (1)