Carolyn Clifford

Validation of a self-administered diet history questionnaire using multiple diet records.

The validity of a self-administered diet history questionnaire has been estimated using as the reference data the mean of three 4-day diet records collected over the year prior to the administration of the questionnaire, in 1985-1986. Subjects were women ages 45-70 years, participants in the Womens Health Trial Feasibility Study, a multi-center clinical trial in which some women were randomized to be taught to adopt and maintain a low-fat diet, while others maintained their usual diet. The questionnaire produced group mean nutrient estimates closely approximating the values obtained by three 4-day records, e.g. in the usual-diet group, 37.7% of calories from fat by both food records and by questionnaire, and in the low-fat group, 21.3% of calories from fat by food records and 23.7% of calories from fat by questionnaire. Correlations between questionnaire and diet records for per cent of calories from fat were 0.67 and 0.65 respectively in the two groups; most correlations were in the 0.5-0.6 range, and were similar to those achievable by a single 4-day food record.

A brief dietary screen for high fat intake

Abstract A 13-item questionnaire has been developed to identify groups of individuals with a high (or low) fat intake. It is intended as a rapid screening tool to identify those who may benefit from counseling or who could then be subjected to a more definitive dietary assessment. It may be either self-or interviewer-administered. A correlation of r = 0.58 was observed between grams of total fat as estimated by the 13-item screener and grams of total fat as calculated from the mean of three four-day diet records, among 101 women aged 45 years and older. By dividing the screener fat distribution at its midpoint, two groups are identified which have a percent of calories from fat, by diet records, of 41 and 35 percent. The 13-item screener does nearly as well as a four-day diet record in correctly identifying those above and below the groups midpoint in percent of calories from fat.

Feasibility of a randomized trial of a low-fat diet for the prevention of breast cancer: dietary compliance in the Women's Health Trial Vanguard Study.

The Womens Health Trial Vanguard Study was conducted to examine the feasibility of a nationwide, randomized multicenter intervention trial to test the hypothesis that a low-fat diet followed for a period of 10 years will reduce breast cancer risk. Women ages 45-69 years at increased risk of breast cancer were randomized into intervention (low-fat diet, n = 184) and control (usual diet, n = 119) groups. On the basis of 4-day food records, baseline fat intakes were comparable in the two groups, averaging 1,718 kcal with 39% of energy as fat. Intervention women reported substantially lower fat intake at 6 (20.9% kcal), 12 (21.6%), and 24 months (22.6% kcal). In contrast, control women reported only slight reductions in fat intake (37.3% kcal at 12 months and 36.8% kcal at 24 months). Evidence that these women were indeed complying with the low-fat dietary intervention comes from (a) the reasonable nature of reported nutrient changes within food groups in the intervention women and (b) agreement between observed and expected differences in plasma total cholesterol between the control and the intervention groups. At 12 months, the observed control - intervention plasma cholesterol difference was 13.1 +/- 4.6 mg/dl while the expected difference based on the Keys equation was 15.1 +/- 1.1 mg/dl; at 24 months, the observed difference was 15.5 +/- 4.3 mg/dl and the expected difference was 12.0 +/- 1.2 mg/dl. These analyses indicate that the intervention women made substantial dietary changes and have successfully maintained these changes over a 2-year period. This study thus demonstrates the feasibility of a randomized trial with an intensive low-fat dietary intervention.

The Women's Health Trial Feasibility Study in Minority Populations: Design and baseline descriptions

The Womens Health Trial: Feasibility Study in Minority Populations (WHT:FSMP), a randomized trial of 2208 women, was conducted to investigate three questions. First, can women from minority and low-socioeconomic-status populations be recruited in numbers sufficient to evaluate a dietary intervention designed to lower fat intake. Second, the efficacy of a low fat, increased fruit/vegetable/ grain product intervention for reducing fat consumption. Third, will participation in the intervention lower plasma cholesterol and estradiol levels relative to the controls. The baseline results showed that an adequate number of minority and low SES women could be recruited to test the study hypotheses. A diverse study population of postmenopausal women consuming a high fat diet was recruited: 28% of participants were Black, 16% were Hispanic, 11% had less than a high school level of education, and 15.5% had household incomes of <

Statistical design of the women's health trial

15,000.

Original reportThe Women's Health Trial Feasibility Study in Minority Populations: Design and baseline descriptions☆

The National Cancer Institute has initiated a randomized trial to determine whether a low fat diet can reduce the incidence of breast cancer among women at increased risk for this disease. A feasibility trial involving 303 women has been conducted to examine recruitment strategies, study short-term compliance and, more generally, develop and refine trial procedures. The feasibility trial group also developed a detailed full-scale trial design plan, and randomization of participants to such a trial is currently underway. The purpose of this report is to describe the major design features of this Womens Health Trial, with particular emphasis on the statistical aspects of the design. The trial is planned to last 10 years and to include 32,000 participants. Of these 32,000 women, 12,800 will be assigned to a low fat diet intervention, and the other 19,200 will constitute a control group. The sample size of 32,000 arises from a range of estimates and assumptions pertaining to (a) the incidence of breast cancer at enrollment corresponding to selected eligibility criteria, (b) the relative risk of breast cancer as a function of a womans history of dietary fat intake, (c) compliance assumptions in terms of average percent fat in the intervention and control groups as a function of time from randomization, and (d) rates of competing causes of death. These estimates and assumptions will be discussed, as will the robustness of the intended sample sizes to departures from such design assumptions.

Analysis of the costs of a large prevention trial

The Womens Health Trial: Feasibility Study in Minority Populations (WHT:FSMP), a randomized trial of 2208 women, was conducted to investigate three questions. First, can women from minority and low-socioeconomic-status populations be recruited in numbers sufficient to evaluate a dietary intervention designed to lower fat intake. Second, the efficacy of a low fat, increased fruit/vegetable/ grain product intervention for reducing fat consumption. Third, will participation in the intervention lower plasma cholesterol and estradiol levels relative to the controls. The baseline results showed that an adequate number of minority and low SES women could be recruited to test the study hypotheses. A diverse study population of postmenopausal women consuming a high fat diet was recruited: 28% of participants were Black, 16% were Hispanic, 11% had less than a high school level of education, and 15.5% had household incomes of <

Diet as risk and therapy for cancer

15,000.

Meta-Analysis of Animal Experiments: Elucidating Relationships Between Dietary Fat and Mammary Tumor Development in Rodents

Total direct costs of the Womens Health Trial (WHT), a large multicenter prevention trial, were reduced by more than 50% by means of research cost analysis conducted during the trial design phase. The unit costs of specific trial activities were estimated so that total direct costs of the trial could be predicted from design parameters. The relative costs of screening, treatment, and follow-up, and the fixed costs associated with each clinical center in a multicenter prevention trial were taken into account. Direct costs of the WHT were reduced from +195 million to +95 million by refinement of the trial protocol, selection of an efficient design, and consideration of trial logistics. The analyses suggest several ways to reduce costs in a prevention trial. Use of the case-cohort approach can reduce costs substantially when the protocol includes collection of specimens or data that are costly to process. When establishing and maintaining a clinical center represents a significant proportion of a clinical centers costs, use of a smaller number of larger clinical centers offers important cost savings. Because restrictive eligibility requirements reduce the recruitment potential of each clinical center, use of high-risk participants may not improve the efficiency of a prevention trial; its favorable impact on sample size may fail to compensate for its cost in terms of additional clinical centers and higher recruitment costs.

New Directions in Dietary Studies in Cancer: The National Cancer Institute

This article provides a brief overview of the scientific rationale for dietary guidelines that may reduce the risk of some types of cancers--breast, colon, and prostate in particular. Dietary modification clinical trials currently sponsored by the National Cancer Institute are described. Other topics include the role of total parenteral nutrition in cancer therapy and low-fat dietary interventions as an adjunct to breast cancer treatment.