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Physical and Emotional Health Effects and Social Consequences After Participation in a Low-Fat, High-Carbohydrate Dietary Trial for More Than 5 Years

T. Gregory Hislop, Chris D. Bajdik, Lynda G. Balneaves, Andrea Holmes, Selina Chan, Evelyn Wu, Zenaida U. Abanto, Andrea L. Butler

From the Cancer Control Research, British Columbia Cancer Agency; and the Department of Health Care and Epidemiology, and School of Nursing, University of British Columbia, Vancouver, British Columbia

Address reprint requests to T. Gregory Hislop, MDCM, MSc, Cancer Control Research, BC Cancer Agency 2-109, 675 W 10th Ave, Vancouver, British Columbia, Canada V5Z 1L3; e-mail:ghislop{at}bccancer.bc.ca

	ABSTRACT

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PURPOSE: Little is known about the potential adverse effects of interventions to reduce dietary fat. We examined the physical and emotional health effects, and social consequences experienced by women at high risk for breast cancer who had participated in a low-fat diet intervention, randomized, controlled trial for at least 5 years.

METHODS: Participants in the Canadian Diet and Breast Cancer Prevention Trial from British Columbia were mailed a survey questionnaire that included the validated Medical Outcomes Study 36-item Short Form Health Survey (SF-36) and Women's Health Questionnaire (WHQ), and a series of questions on health-related and social constructs. Responses were compared between the diet intervention and control groups by menopausal status.

RESULTS: Completed questionnaires were returned by 359 women in the diet intervention group and 382 in the control group. No significant differences were found between these groups for SF-36 and WHQ health outcomes, hair/nail changes, physical activity levels, family/friend support levels, and doctor visits. Significantly more women in the intervention group reported taking products for arthritis (other than pain medication), greater difficulty in maintaining eating habits in social situations and at work, greater stress, and guilt related to personal eating habits. These findings persisted for both premenopausal and postmenopausal women.

CONCLUSION: Changes resulting from a low-fat diet intervention can be incorporated into women's daily lives with limited long-term negative effects.

	INTRODUCTION

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The Canadian Diet and Breast Cancer Prevention Trial (CDBCPT) began in 1988 in Ontario to determine whether dietary fat reduction would reduce breast cancer incidence in women at high risk for breast cancer. In 1994, the trial expanded to British Columbia (BC). Earlier work had demonstrated feasibility in lowering dietary fat intake by intensive dietary counseling¹ and nutrition education,² even among women with diverse backgrounds.³

A low-fat diet may have both beneficial^4,5 and adverse^6-8 health effects; however, little is known about low-fat dietary interventions. In Ontario CDBCPT participants, no detrimental effects were reported for physical health or emotional well-being; instead, less vasomotor symptoms (hot flushes and night sweats) and breast discomfort were reported in premenopausal women in the intervention group.⁹ Other trials report inconsistent physical and emotional health effects from low-fat dietary interventions.^10-17

Anecdotal concerns were sometimes expressed by BC CDBCPT participants, including arthritis-associated symptoms, hair and nail changes, and eating habits of family members. These concerns were examined, and the earlier Ontario study replicated, by surveying BC trial participants. We hypothesized more adverse effects on physical and emotional well-being, negative social consequences, and changes in household diets for women in the low-fat dietary intervention group than for women in the control group. This article presents the survey findings, comparing women in the dietary intervention and control groups, and considering menopausal status.

	METHODS

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Study Group
At trial recruitment, women were randomly assigned to dietary intervention and control groups to ensure that both groups were as similar as possible. Figure 1 shows the flowchart for BC trial participants, following Consolidated Standards of Reporting Trials principles.¹⁸ The current analysis maintains this randomization; however, the study group was restricted to women with known menopausal status, active trial participants for at least 5 years, and those surveyed in June 2004. A total of 987 eligible women were identified, 485 and 502 in the intervention and control groups, respectively.

View larger version (15K): [in this window] [in a new window]   Fig 1. Flowchart of the participants from British Columbia (BC) in the Canadian Diet and Breast Cancer Prevention Trial. HRT, hormone replacement therapy.

The mean percentage of energy from total fat intake in BC women, as measured from periodic completed food records, decreased from 29.1% to 17.7% at the end of the first year in the intervention group, and changed from 28.7% to 29.6% in the control group. Approximately 10% difference in fat intake was maintained between groups during the trial period.

Data Collection
Given that the survey was restricted to a subgroup of randomly assigned participants, data were collected on selected sociodemographic characteristics to confirm that the intervention and control groups were still comparable. Age, weight, body mass index, and family history of breast cancer were updated at the most recent visit to a trial dietitian; marital status, age at menarche, parity, and age at first live birth were obtained from baseline data. Menopausal status and usage of hormone replacement therapy (HRT) were obtained from the survey questionnaire.

Data on physical and emotional health effects, and social consequences of participating in the trial, were obtained from a self-administered survey questionnaire that was mailed to the participants in June 2004. The survey questionnaire contained the Medical Outcomes Study 36-item Short Form Health Survey (SF-36), the Women’s Health Questionnaire (WHQ), and a series of questions on health-related constructs.

SF-36. The SF-36 included 36 Likert-type items to measure general health and questions referred to experiences during the last 4 weeks. Responses were reduced to eight health subscales: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality (energy/fatigue), social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being).¹⁹ This instrument has been used widely in documenting quality of life and its reliability and validity have been demonstrated in previous research.^20,21

WHQ. The WHQ is composed of 36 questions that measure physical and emotional symptoms typically experienced by women at midlife. Again, questions referred to experiences during the last 4 weeks. Responses were reduced to nine health subscales: depressed mood, somatic symptoms, memory/concentration, vasomotor symptoms, anxiety/fears, sexual behaviors, sleep problems, menstrual symptoms, and attractiveness.²² The reliability and validity of this questionnaire have been demonstrated in the health literature.²²

Health-related constructs. The survey questionnaire also included questions on health-related constructs, developed and pretested by the research team with input from two focus groups of trial participants. Questions inquired about physical symptoms (associated with arthritis, hair/nail changes, and physical activity level), social consequences of trial participation (effects with family and friends, at work, and in other social situations), changes in household diet, concerns about family members’ eating habits, health care use in the last year, menstrual history, and HRT usage. These questions generally referred to experiences encountered since entering the trial.

Returned questionnaires were checked for completeness and coded, with monthly research team meetings to resolve unclear responses. Missing or ambiguous responses were verified with study participants. A systematic 10% sample of questionnaires was then selected, recoded, and compared with the original data set. The overall coding error rate was less than 0.5%; the majority of inconsistencies were for items with missing values.

This study was approved by the Research Ethics Board at the University of British Columbia.

Analysis
Survey data were available from only 69% of the originally randomly assigned women. Hence, sociodemographic characteristics of the intervention and control groups were compared to determine whether they remained equivalent, using t tests for continuous variables and ² tests for categoric variables. The distributions were similar (Table 1). Therefore, additional adjustment for these variables was not necessary.

Analysis was initially done for women overall and then separately for premenopausal and postmenopausal women who were and were not using HRT. Premenopausal women were defined as having had a menstrual period during the 12 months before completing the survey questionnaire and not taking HRT. Postmenopausal women were defined as currently taking HRT or not having had a menstrual period during the last 12 months. Results are shown in Tables 2 and 3 for women overall and are described in the text by menopausal status.

	RESULTS

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SF-36 Health Survey
Mean scores for the eight subscales are shown in Table 2 for women overall. Higher scores are associated with better health outcome. In general, the study participants had high scores; the lowest was the vitality score. This subscale included the following four questions: "Did you feel full of life?" "Did you have a lot of energy?" "Did you feel worn out?" and "Did you feel tired?" No significant differences were found between the intervention and control groups in women overall or by menopausal status.

WHQ
Mean scores for the nine subscales are also shown in Table 2 for women overall. The higher the score, the greater the symptom experience. In general, study participants had low symptom scores except for vasomotor symptoms (hot flushes and night sweats). No significant differences were found between the intervention and control groups in women overall. Somatic symptoms (headaches, fatigue, dizziness, back/leg pains, nausea, pins and needles in hands and feet, frequent urination) were less common in the intervention group than in the control group (nonsignificant at P = .04). When examined by menopausal status, only one comparison was noteworthy: postmenopausal women not using HRT reported more sleep problems in the intervention group than in the control group (mean score, 0.37 and 0.29, respectively; nonsignificant at P = .01). Sleep problems included waking early then sleeping badly for the rest of the night, feeling restless, and having difficulty in getting to sleep.

Health-Related Constructs
The findings regarding physical symptoms experienced since entering the trial are listed in Table 3 for women overall.

Arthritis. Approximately 25% and 40% of premenopausal and postmenopausal women, respectively, reported having been told by their physician that they had arthritis. For both menopausal subsets, current arthritis pain was generally mild; the most common symptoms were pain, and swelling and stiffness in the limbs, neck, and hips. Only postmenopausal women also mentioned involvement of hands. Significantly more women overall in the intervention group than in the control group reported taking products for arthritis other than pain medication (P < .001). The majority (80%) of these products were nonprescription drugs, most commonly glucosamine (42%). This finding persisted for both premenopausal (88.9% and 35.0%, respectively; P = .001) and postmenopausal women not using HRT (62.2% and 44.3%, respectively; nonsignificant at P = .03). A difference between groups was also found regarding arthritis pain medication taken for postmenopausal women not using HRT (52.6% and 36.4%, respectively; nonsignificant at P = .03).

Hair and nail changes. Nearly one third of participants reported hair or nail changes since entering the trial and they were generally "slightly concerned" about these changes, regardless of menopausal status. There were no significant differences between intervention and control groups for either hair or nail changes in women overall or by menopausal status. The most common changes reported by both premenopausal and postmenopausal women were increased hair loss and hair color change (graying), and increased nail brittleness (easily chipped and broken) and development of nail ridges.

Physical activity. There were no significant differences between intervention and control groups for physical activity level in women overall or by menopausal status. Physical activity level since entering the trial was generally "about the same" as before trial entry.

Social consequences of trial participation. Table 3 lists the findings regarding social consequences of participating in the trial. A significant difference for change in household diet was found between intervention and control groups for women overall (P < .001), which persisted in premenopausal (71.2% and 33.3%, respectively; P < .001) and postmenopausal women using HRT (70.7% and 41.3%, respectively; nonsignificant at P = .009) and not using HRT (72.0% and 42.3%, respectively; P < .001). Nearly all women (94%) reported positive dietary changes, with family members having healthier eating habits, making better food choices, controlling weight, and feeling happier.

Approximately 75% of both premenopausal and postmenopausal women reported living with at least one other family member for at least 1 year since trial entry. Of these women, 33% and 21%, respectively, reported concern about the eating habits of one or more family members. However, no significant differences in concern were found between intervention and control groups for women overall or by menopausal status. Interestingly, women in the intervention group reported less concern than in the control group. The greatest difference between groups for women overall was with the eating habits of sons (nonsignificant at P = .02). The main concern was too much consumption of fatty/junk/fast foods and not enough fruits and vegetables.

There were no significant differences between intervention and control groups in the level of support received during the trial from family and friends for women overall or by menopausal status. Family members were generally "completely supportive" and friends were "somewhat supportive."

Women reported greater difficulty in maintaining their eating habits while in social situations compared with while at work. Significant differences were found between intervention and control groups in the level of difficulty with maintaining eating habits in social situations for women overall and in all menopausal subsets (median values of 3 = "neither difficult nor easy" and 5 = "very easy," respectively; P < .001). The main difficulty was lack of food choices outside the home. Women overall in the intervention group also reported more difficulty with maintaining eating habits while at work (nonsignificant at P = .03).

Significant differences were found between intervention and control groups in the level of stress for women overall and in premenopausal and postmenopausal women separately (median value of 3 = "a little bit stressful" and 4 = "not stressful at all," respectively; P < .001). The main source of stress was trying to adhere to the diet while dining out or attending a social function. Many, however, mentioned that they understood the benefits of the diet and so felt less stressed in maintaining it. Significant differences were also found in the reported level of guilt associated with making food choices for women overall and in all menopausal subsets (median value of 4 = "slightly guilty" and 5 = "not guilty at all," respectively; P < .001). The most common source of guilt was giving into cravings for high fat or sweet foods. Some women reported that they could easily overcome this sense of guilt by reminding themselves that they had adhered to the diet on most occasions.

The majority (67%) of women reported visiting their doctor in the last year for a specific health problem, most commonly for breast-related symptoms and procedures in premenopausal women, and for depression or stress in postmenopausal women. There were no significant differences between intervention and control groups in the proportion of women making doctor visits for women overall or by menopausal status.

	DISCUSSION

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Participation in the dietary intervention trial for at least 5 years had few negative effects on physical health or emotional well-being in midlife women with increased risk for breast cancer. Overall, the results were comparable to those reported earlier in Ontario. However, several differences were observed, perhaps because BC participants were older and had longer participation in the trial. In Ontario, no negative effects were found but fewer vasomotor symptoms and less breast discomfort were observed for premenopausal women in the intervention group.⁹ We found more participants in the intervention group taking products for arthritis (other than pain medication) and having more difficulty with eating habits in social situations, stress in maintaining eating habits, and guilt in making food choices. These variables were not examined in the Ontario study.

Dietary fat reduction trials have reported increased vigor and decreased depression and anxiety¹⁵; reduced hostility and depression¹⁶; increased anger/hostility¹⁴; more deaths from accidents, suicide, or violence¹⁷; improved health-related quality of life¹²; and modest improvement in psychological well-being (depression, anxiety, hostility) with relative impairment in cognitive function.¹¹ Several have reported no negative impact on quality of life or social dysfunction.^10,13

The reason is not clear why we found more participants in the intervention group taking products for arthritis when the frequency of arthritis symptoms was similar in both intervention and control groups. One possibility is that these women may be more conscious of diet and willing to explore alternative supplements, such as glucosamine. It is also possible that they might be more subject to recall bias. Elsewhere, investigators found that a low-fat diet significantly reduced symptoms in patients with rheumatoid arthritis.²³

We found high levels of support from family and friends. Other studies have reported associations between social pressure and greater fat reduction,²⁴ and social support and dietary change.²⁵

We found no relationship between the intervention and concern for other family member’s eating habits, except possibly for sons. This latter finding surprised us. Others have reported that dietary intervention affects family members, especially husbands.^26-28 There is no consensus about the relationships between parent and child eating habits.²⁹ Dieting and encouragement to diet by a mother has had a negative effect on the eating habits of sons³⁰ and daughters,³¹ and perceived parental criticism has affected daughters, whereas perceived parental eating attitudes affected sons.³² Parents and children who lived together had similar dietary fat and nutrient intake.^33,34 Family eating patterns were influenced by the number of meals eaten together,^28,35 with high associations for foods eaten at home but not for foods eaten outside the home.³³

Several limitations to the findings need to be considered. First, a number of hypotheses were tested, which were addressed by using Bonferroni correction to set the level of significance. Second, information was collected retrospectively and hence subject to recall bias. However, the period for recall was generally short for most questions, which should favor more accurate recall. Third, the numbers are small and the statistical power is low for postmenopausal women using HRT. Fourth, the 75% response rate to the survey questionnaire is not a major concern because it is not large and responders and nonresponders shared similar demographic profiles.

In conclusion, our findings suggest that dietary changes can be incorporated into women’s daily lives with limited long-term negative physical and emotional health effects. Women may benefit from additional help in finding low-fat alternatives and making food choices when in social situations outside the home. One approach may be through individualized telephone counseling, which was shown to change substantially the dietary pattern of women previously treated for breast cancer.³⁶

	Authors' Disclosures of Potential Conflicts of Interest

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The authors indicated no potential conflicts of interest.

	Author Contributions

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Conception and design: T. Gregory Hislop, Lynda G. Balneaves, Andrea Holmes, Selina Chan, Evelyn Wu, Andrea L. Butler Administrative support: T. Gregory Hislop, Andrea Holmes Collection and assembly of data: T. Gregory Hislop, Lynda G. Balneaves, Andrea Holmes, Selina Chan, Evelyn Wu, Andrea L. Butler Data analysis and interpretation: T. Gregory Hislop, Chris D. Bajdik, Lynda G. Balneaves, Andrea Holmes, Selina Chan, Evelyn Wu, Zenaida U. Abanto, Andrea L. Butler Manuscript writing: T. Gregory Hislop, Chris D. Bajdik, Lynda G. Balneaves, Andrea Holmes, Selina Chan, Evelyn Wu, Zenaida U. Abanto, Andrea L. Butler Final approval of manuscript: T. Gregory Hislop, Chris D. Bajdik, Lynda G. Balneaves, Andrea Holmes, Selina Chan, Evelyn Wu, Zenaida U. Abanto, Andrea L. Butler

 

	ACKNOWLEDGMENTS

 
We thank the women in the Canadian Diet and Breast Cancer Prevention trial for their participation; Norman Boyd, MD, FRCPC, Lisa Martin, PhD, and Cary Greenberg for reviewing the manuscript; Valentina Kruikov for providing information on the participants; and Morag Cleathero for assistance in developing the survey.

	NOTES

 
Supported by the Canadian Breast Cancer Research Alliance and the Ontario Ministry of Health via joint funding to The Canadian Diet and Breast Cancer Prevention Trial. C.D.B. is the recipient of a scholar award from the Michael Smith Foundation for Health Research and L.G.B. is supported by a research scientist award from the Canadian Cancer Society, National Cancer Institute of Canada Prostate Cancer Research Initiative.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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Submitted September 19, 2005; accepted March 6, 2006.

This Article Abstract Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Hislop, T. G. Articles by Butler, A. L. Search for Related Content PubMed PubMed Citation Articles by Hislop, T. G. Articles by Butler, A. L.