N/A
Completed N=36
Cancer Dietary Objectives Study
Source: ClinicalTrials.gov NCT00561977 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Sep 2011
Primary outcomePrimary: Dietary Quality — 38.78; 41.18; 39.76 score — p=0.14
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dietary Quality |
38.78; 41.18; 39.76 | 0.14 |
| PRIMARY Dietary Quality, Possible Score From Zero to 80 (Best Quality Diet). |
44.90; 44.90; 43.75 | — |
| SECONDARY Change in Weight From Baseline to 3 Months |
-7.0; -9.1; -6.7 | — |
| SECONDARY Change in Weight From Baseline to 6 Months |
-9.1; -10.2; -7.0 | — |
| SECONDARY Change in Calories From Baseline to 3 Months |
-464.05; -190.90; -638.91 | — |
| SECONDARY Change in Calories From Baseline to 6 Months |
-364.82; -187.19; -626.32 | — |
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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 -
Data sourced from ClinicalTrials.gov (NCT00561977). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.