Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Summary of Grant:
Several studies have demonstrated that poor dietary quality is associated with obesity and certain cancers, such as gastrointestinal, colorectal, and hormonal cancers. Dietary interventions aimed at improving diet are plagued by poor adherence, possibly due to the complexity of changing multiple diet components. Complex public health messages are associated with worse adherence and reduced capacity to impact health outcomes. If a simple public health recommendation for diet was effective at changing multiple aspects of diet, adherence and impact could be maximized. However, research has yet to test which single dietary message has the greatest impact on overall diet quality, and consequently, potential for cancer and heart disease prevention. Thus far, dietary interventions have tested varying combinations of multiple recommendations; however, a single dietary recommendation may have a synergistic beneficial effect on other areas of diet, precluding the need to make the message overly complex.
The present study compares 3 dietary change conditions that are hypothesized to have high potential for synergistic effects on other unaddressed areas of diet, and consequently overall dietary quality. Patients were randomized to one of three arms:
Each participant was instructed to reduce calories by -500 kcal/day from his/her resting metabolic rate (RMR), but total calories was not less than 1200 calories per day.
Additionally, Dr. Ira Ockene, professor of medicine, director of preventive cardiology program, generously offered to pay for blood draws and blood lipids and glucose analysis at each visit to make the study valuable from both cancer and heart disease research perspectives.
Specific aims:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Low Saturated Fat | Active Comparator | low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Barbara C Olendzki, RD MPH | UMass Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMass Medical School | Worcester | Massachusetts | 01655 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19359142 | Result | 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. |
Not provided
Not provided
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Low Saturated Fat | low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Low Saturated Fat |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | May 2009 | Mean | Standard Deviation | score | 6 mos |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| loss of consciousness from blood draw | Vascular disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara Olendzki, RD MPH LDN | UMass Medical School | 508-856-5195 | barbara.olendzki@umassmed.edu |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D006331 | Heart Diseases |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| low saturated fat diet | Behavioral | low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal/day. |
|
| Combination diet | Behavioral | combination low saturated fat high fiber diet, with calorie restriction as specified. |
|
kilocalories |
| 3 months |
| Change in Calories From Baseline to 6 Months | kilocalories | 6 months |
low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day. |
|
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | score | 3 months |
|
|
|
| Secondary | Change in Weight From Baseline to 3 Months | Posted | Mean | Standard Deviation | pounds | 3 months |
|
|
|
| Secondary | Change in Weight From Baseline to 6 Months | Posted | Mean | Standard Deviation | pounds | 6 months |
|
|
|
| Secondary | Change in Calories From Baseline to 3 Months | kilocalories | Posted | Mean | Standard Deviation | calories | 3 months |
|
|
|
| Secondary | Change in Calories From Baseline to 6 Months | kilocalories | Posted | Mean | Standard Deviation | calories | 6 months |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Low Saturated Fat | low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day. | 0 | 12 | 1 | 12 |
| EG002 | 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. | 0 | 12 | 0 | 12 |
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |