Karen Konzelmann

Soy isoflavone supplementation and bone mineral density in menopausal women: a 2-y multicenter clinical trial

BACKGROUND Isoflavones are naturally occurring plant estrogens that are abundant in soy. Although purported to protect against bone loss, the efficacy of soy isoflavone supplementation in the prevention of osteoporosis in postmenopausal women remains controversial. OBJECTIVE Our aim was to test the effect of soy isoflavone supplementation on bone health. DESIGN A multicenter, randomized, double-blind, placebo-controlled 24-mo trial was conducted to assess the effects of daily supplementation with 80 or 120 mg of soy hypocotyl aglycone isoflavones plus calcium and vitamin D on bone changes in 403 postmenopausal women. Study subjects were tested annually and changes in whole-body and regional bone mineral density (BMD), bone mineral content (BMC), and T scores were assessed. Changes in serum biochemical markers of bone metabolism were also assessed. RESULTS After study site, soy intake, and pretreatment values were controlled for, subjects receiving a daily supplement with 120 mg soy isoflavones had a statistically significant smaller reduction in whole-body BMD than did the placebo group both at 1 y (P < 0.03) and at 2 y (P < 0.05) of treatment. Smaller decreases in whole-body BMD T score were observed among this group of women at 1 y (P < 0.03) but not at 2 y of treatment. When compared with the placebo, soy isoflavone supplementation had no effect on changes in regional BMD, BMC, T scores, or biochemical markers of bone metabolism. CONCLUSION Daily supplementation with 120 mg soy hypocotyl isoflavones reduces whole-body bone loss but does not slow bone loss at common fracture sites in healthy postmenopausal women. This trial was registered at clinicaltrials.gov as NCT00665860.

Clinical outcomes of a 2-y soy isoflavone supplementation in menopausal women

BACKGROUND Soy isoflavones are naturally occurring phytochemicals with weak estrogenic cellular effects. Despite numerous clinical trials of short-term isoflavone supplementation, there is a paucity of data regarding longer-term outcomes and safety. OBJECTIVE Our aim was to evaluate the clinical outcomes of soy hypocotyl isoflavone supplementation in healthy menopausal women as a secondary outcome of a trial on bone health. DESIGN A multicenter, randomized, double-blind, placebo-controlled 24-mo trial was conducted to assess the effects of daily supplementation with 80 or 120 mg aglycone equivalent soy hypocotyl isoflavones plus calcium and vitamin D on the health of 403 postmenopausal women. At baseline and after 1 and 2 y, clinical blood chemistry values were measured and a well-woman examination was conducted, which included a mammogram and a Papanicolaou test. A cohort also underwent transvaginal ultrasound measurements to assess endometrial thickness and fibroids. RESULTS The baseline characteristics of the groups were similar. After 2 y of daily isoflavone exposure, all clinical chemistry values remained within the normal range. The only variable that changed significantly was blood urea nitrogen, which increased significantly after 2 y (P = 0.048) but not after 1 y (P = 0.343) in the supplementation groups. Isoflavone supplementation did not affect blood lymphocyte or serum free thyroxine concentrations. No significant differences in endometrial thickness or fibroids were observed between the groups. Two serious adverse events were detected (one case of breast cancer and one case of estrogen receptor-negative endometrial cancer), which was less than the expected population rate for these cancers. CONCLUSION Daily supplementation for 2 y with 80-120 mg soy hypocotyl isoflavones has minimal risk in healthy menopausal women. This trial was registered at clinicaltrials.gov as NCT00665860.

Evaluation of a web-based program promoting healthy eating and physical activity for adolescents: Teen Choice: Food and Fitness

This randomized clinical trial tested the impact of a website promoting nutrition and physical activity for adolescents (Teen Choice: Food and Fitness). Participants, (408) 12- to 17-year-old adolescents in the Houston area, completed online surveys measuring diet, physical activity, sedentary behavior and diet/physical activity mediators at baseline. After randomization, they were asked to log onto either the intervention or the control condition website weekly for 8 weeks to review web content and set goals to improve dietary and physical activity behaviors. Post-test occurred after 8 weeks. Logistic regression analyses and one-way analyses of covariance were used in the analyses. At post, more intervention group adolescents reported eating three or more daily vegetable servings in the past week compared with the control group (P < 0.05); both groups reported significant increases in physical activity (P < 0.001) and significant decreases in TV watching (P < 0.01). Average log on rate was 75% over the 8 weeks; there was no difference by condition. The website enabled adolescents to improve vegetable intake and daily physical activity, reduce sedentary behavior and had a high log on rate. Future research should identify effective methods for disseminating this website to wider audiences.

Design of a website on nutrition and physical activity for adolescents: Results from formative research

Background Teens do not meet guidelines for healthy eating and physical activity. The Internet may be an effective method for delivering programs that help them adopt healthy behaviors. Objective To collect information to design content and structure for a teen-friendly website promoting healthy eating and physical activity behaviors. Methods Qualitative research, encompassing both focus group and interview techniques, were used to design the website. Participants were 12-17 year olds in Houston, Texas, and West Lafayette, Indiana. Results A total of 133 participants took part in 26 focus groups while 15 participated in one-on-one interviews to provide guidance for the development of teen-friendly content and structure for an online behavior change program promoting healthy eating and physical activity to 12-17 year olds. The youth made suggestions to overcome common barriers to healthy eating and physical activity. Their feedback was used to develop “Teen Choice: Food & Fitness,” a 12-week online behavior change program, populated by 4 cartoon character role models. Conclusions It is critical that members of the target audience be included in formative research to develop behavior change programs that are relevant, appealing, and address their needs and interests.

Effect of soy isoflavone supplementation on menopausal quality of life.

ObjectiveThe purpose of this study was to assess the effect of soy isoflavone supplementation on quality of life in postmenopausal women. MethodsA multicenter, randomized, double-blind, placebo-controlled 24-month trial was conducted to assess the effect of 80 or 120 mg of daily aglycone hypocotyl soy isoflavone supplementation on quality of life in 403 postmenopausal women using a validated Menopause-Specific Quality of Life questionnaire. ResultsMenopause-Specific Quality of Life domain scores at 1 year and 2 years were similar to baseline. There were no differences in domain scores among treatment groups. ConclusionsSoy isoflavone supplementation offers no benefit to quality of life in postmenopausal women.

The impact of goal attainment on behavioral and mediating variables among low income women participating in an Expanded Food and Nutrition Education Program intervention study.

This study examined the relationships between participant goal attainment and changes in mediating variables and food choice outcomes from a modified curriculum for the Texas Expanded Food and Nutrition Education Program (EFNEP) promoting healthy home food environments and parenting skills related to obesity prevention. EFNEP participants in 54 intervention classes received a goal sheet after each of 6 classes. Participants recorded goal attainment and returned at the next class, Diet and mediating variables were measured at baseline, immediate post, and 4 months later. Mixed model regression analysis over time assessed whether goal attainment was associated with the outcomes at post or follow-up, controlling for baseline assessment. Participants who reported attaining more goals reported greater self-efficacy for planning/encouraging fruit and vegetable consumption and making fruit and vegetables available, menu planning skills, improvement in the food preparation practices and higher home availability for regular vegetables. At post, those who reported attaining more fiber, vegetable, and water goals reported consuming more of these items. Goal attainment was related to some changes in food choice and mediating variables in an at risk population. Further research into the use and efficacy of goal setting and attainment in this population is warranted.

Body weight has no impact on self-esteem of minority children living in inner city, low-income neighborhoods: a cross-sectional study.

BackgroundThe relationship between body weight and self-esteem among underserved minority children is not well documented.MethodsWe measured the self-esteem profile using the Self-Perception Profile for Children among 910 minority children at 17 Houston community centers.ResultsWeight status had no effect on any of the self-esteem scores among the minority children (P ≥ 0.21). Black children had higher scholastic competence than Hispanic children (P = 0.05). Social acceptance was not affected by age, gender, and race/ethnicity (P ≥ 0.13). Significant age x gender (P = 0.006) and race x gender (P = 0.005) interactions were detected on athletic competence. The younger boys had higher athletic competence than the younger and older girls (P ≤ 0.01). The older boys had higher athletic competence than the older girls (P = 0.008) but their scores were not different from those of the younger girls (P = 0.07). Within each race/ethnicity group, boys had higher athletic competence than girls (P ≤ 0.03). Black boys had higher athletic competence than Hispanic girls (P = 0.007) but their scores were not different from those of the Hispanic boys (P = 0.08). Age and gender had no effect on physical appearance but black children had higher scores than Hispanic children (P = 0.05). Behavioral conduct was not affected by age, gender, or race/ethnicity (P ≥ 0.11). There was an age x gender interaction on global self-worth (P = 0.02) with boys having similar scores regardless of ages (P = 0.40) or ethnicity (P = 0.98). However, boys from both age groups had higher global self-worth than the older girls (P ≤ 0.04) but their scores were not different from those of the younger girls (P ≥ 0.07).ConclusionsFor the first time, we documented that being normal weight did not necessarily guarantee positive self-esteem among minority children. Their self-esteem scores were similar to those found among children who were diagnosed with obesity and obesity-related co-morbidities and lower than those reported among normal-weight white children. Therefore, activities to promote self-esteem are important when working with underserved minority children in order to promote a healthy lifestyle.

Formative assessment in the development of an obesity prevention component for the expanded food and nutrition education program in Texas.

This study conducted formative research (surveys, focus groups) to assess the nutrition education needs of clients in the Texas Expanded Food and Nutrition Education Program prior to curriculum revision. Participants were current Expanded Food and Nutrition Education Program participants in 3 Texas cities (Austin, Houston, San Antonio). Data were used to tailor the curriculum to the target population. This research provides evidence that members of the target audience can provide valuable insights into a particular topic. Formative work prior to intervention development should be conducted to identify key issues regarding a particular topic and to evaluate potential educational approaches.