Judy Bahnson

Long-term effects of a lifestyle intervention on weight and cardiovascular risk factors in individuals with type 2 diabetes mellitus: Four-year results of the look AHEAD trial

BACKGROUND Lifestyle interventions produce short-term improvements in glycemia and cardiovascular disease (CVD) risk factors in individuals with type 2 diabetes mellitus, but no long-term data are available. We examined the effects of lifestyle intervention on changes in weight, fitness, and CVD risk factors during a 4-year study. METHODS The Look AHEAD (Action for Health in Diabetes) trial is a multicenter randomized clinical trial comparing the effects of an intensive lifestyle intervention (ILI) and diabetes support and education (DSE; the control group) on the incidence of major CVD events in 5145 overweight or obese individuals (59.5% female; mean age, 58.7 years) with type 2 diabetes mellitus. More than 93% of participants provided outcomes data at each annual assessment. RESULTS Averaged across 4 years, ILI participants had a greater percentage of weight loss than DSE participants (-6.15% vs -0.88%; P < .001) and greater improvements in treadmill fitness (12.74% vs 1.96%; P < .001), hemoglobin A(1c) level (-0.36% vs -0.09%; P < .001), systolic (-5.33 vs -2.97 mm Hg; P < .001) and diastolic (-2.92 vs -2.48 mm Hg; P = .01) blood pressure, and levels of high-density lipoprotein cholesterol (3.67 vs 1.97 mg/dL; P < .001) and triglycerides (-25.56 vs -19.75 mg/dL; P < .001). Reductions in low-density lipoprotein cholesterol levels were greater in DSE than ILI participants (-11.27 vs -12.84 mg/dL; P = .009) owing to greater use of medications to lower lipid levels in the DSE group. At 4 years, ILI participants maintained greater improvements than DSE participants in weight, fitness, hemoglobin A(1c) levels, systolic blood pressure, and high-density lipoprotein cholesterol levels. CONCLUSIONS Intensive lifestyle intervention can produce sustained weight loss and improvements in fitness, glycemic control, and CVD risk factors in individuals with type 2 diabetes. Whether these differences in risk factors translate to reduction in CVD events will ultimately be addressed by the Look AHEAD trial. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00017953.

The use of illustrations and narrative text style to improve readability of a health education brochure.

Research suggests that much of the available health education literature requires a level of reading ability that makes it inaccessible to a large proportion of the population in greatest need of health information. The present study tested the value of illustrations and a narrative text style as means of improving the readability of a brochure designed to provide information on cervical cancer and condyloma. Two versions of the brochure were designed, one that had only text presented as simple sentences in bullet-type format (SMOG reading level score of 7.7), and a second version that had somewhat more difficult text formatted in a narrative style (SMOG grade level score of 8.4) together with drawings designed to complement the text. A randomized study design was used to test for comprehension, perceived ease of understanding, and overall rating of the two brochures. Women selected from one private and three public health primary-care clinics were randomly assigned to read one of the two brochures. The brochure with illustrations and narrative text was given a significantly higher overall rating than the one with bullet-type text and no illustrations, while no difference was found in perceived ease of reading. Among poor readers, comprehension was significantly greater for women who read the brochure with illustrations and narrative text, with no difference in comprehension of the two brochures for better readers. The results suggest that the use of aids such as illustrations and text style can make health education literature more accessible to high-risk populations, while remaining interesting enough to appeal to individuals at all levels of reading ability.

Effects of Weight Loss Intervention on Erectile Function in Older Men with Type 2 Diabetes in the Look AHEAD Trial

INTRODUCTION Overweight men with diabetes often report erectile dysfunction (ED), but few studies have examined effects of weight loss on this problem. AIM This study examined 1-year changes in erectile function (EF) in overweight/obese men with type 2 diabetes participating in the Look AHEAD (Action for Health in Diabetes) trial. METHODS Participants in Look AHEAD were randomly assigned to a control condition involving diabetes support and education (DSE) or to intensive lifestyle intervention (ILI) involving group and individual sessions to reduce weight and increase physical activity. Men from five of the clinical sites in Look AHEAD completed the International Index of Erectile Function (IIEF) at baseline (N = 372) and at 1 year (N = 306) (82%). MAIN OUTCOME MEASURES Changes in EF as reported on the EF subscale of the IIEF. RESULTS At 1 year, the ILI group lost a greater percent of initial body weight (9.9% vs. 0.6 %) and had greater improvements in fitness (22.7% vs. 4.6%) than DSE. EF improved more in ILI (17.3 +/- 7.6 at baseline; 18.6 +/- 8.1 at 1 year) than in DSE (18.3 +/- 7.6 at baseline; 18.4 +/- 8.0 at 1 year); P = 0.04 and P = 0.06 after adjusting for baseline differences. Using established norms for none (i.e., normal EF), and three grades (i.e., mild, moderate, and severe) ED, 8% of men in ILI reported a worsening of EF from baseline to 1 year, 70% stayed in the same category, and 22% reported improvements. In contrast, 20% of DSE reported worsening, 57% stayed in the same category, and 23% improved (P = 0.006). CONCLUSION In this sample of older overweight/obese diabetic men, weight loss intervention was mildly helpful in maintaining EF.

Impact of intensive lifestyle intervention on depression and health-related quality of life in type 2 diabetes: the Look AHEAD Trial.

OBJECTIVE We examined the effects of an intensive lifestyle intervention (ILI), compared with a diabetes support and education (DSE) control intervention, on long-term changes in depression symptoms, antidepressant medication (ADM) use, and health-related quality of life (HRQoL) in overweight/obese individuals with type 2 diabetes. RESEARCH DESIGN AND METHODS Look AHEAD was a multisite randomized controlled trial of 5,145 overweight/obese participants assigned to ILI (designed to produce weight loss) or DSE and followed for a median of 9.6 years. The Beck Depression Inventory (BDI) was administered at baseline, annually at years 1–4, and again at year 8. Mean BDI scores and incidence of BDI scores ≥10, indicative of likely mild or greater depression, were examined. Annually through year 10, participants reported their ADM use and completed the Medical Outcomes Study Short Form 36 (SF-36) questionnaire, which yields physical component summary (PCS) and mental component summary (MCS) scores. RESULTS ILI significantly reduced the incidence of mild or greater depression symptoms (BDI scores ≥10) compared with DSE (hazard ratio [HR] = 0.85; 95% CI 0.75–0.97; P = 0.0145). Although SF-36 PCS scores worsened over time in both groups, ILI participants reported better physical function than DSE throughout the first 8 years (all P values <0.01). There were no significant differences between treatment arms in the proportion of participants who used ADMs or in SF-36 MCS scores. CONCLUSIONS ILI for overweight/obese patients with type 2 diabetes may reduce the risk of developing clinically significant symptoms of depression and preserve physical HRQoL. These findings should be considered when evaluating the potential benefits of ILIs.

Erectile Dysfunction in Type 2 Diabetic Men: Relationship to Exercise Fitness and Cardiovascular Risk Factors in the Look AHEAD Trial

INTRODUCTION Determinants of erectile dysfunction in diabetic men have not been adequately investigated as potential mediators of change. AIM To determine the prevalence and correlates of erectile dysfunction (ED) in overweight men with type 2 diabetes in the multicenter, Look AHEAD trial (Action for Health in Diabetes). MAIN OUTCOME MEASURES International Index of Erectile Function (IIEF), self-reported use of phosphodiesterase type 5 inhibitors, laboratory measures of adiposity, cardiometabolic parameters, and exercise fitness. METHODS Male participants aged 45-75 in the Look AHEAD trial in a committed relationship were recruited for an ongoing study of sexual function and diabetes. Eligible participants completed the IIEF questionnaire and provided updated information on use of medical treatments for sexual dysfunction. Baseline sexual function results for participants in the male ancillary study are reported here; intervention data and results for female participants are presented elsewhere. RESULTS A total of 373 eligible male participants completed all sexual function questionnaires, of whom 263 (68.7%) were sexually active at the time of the study. Almost half (49.8%) of the men reported mild or moderate degrees of ED, and 24.8% had complete ED. Among sexually active participants, 42.6% had sought medical help for their problem, and 39.7% reported use of ED medications. ED was significantly associated with age (odds ratio [OR] = 1.05; confidence interval [CI]: 1.01-1.10) baseline HbA(1c) (OR = 1.31; CI: 1.05-1.63), hypertension history (OR = 2.41; CI: 1.34-4.36), and metabolic syndrome (OR = 3.05, CI: 1.31-7.11). Of note, cardiorespiratory fitness was found to be protective of ED in a multivariable analysis (OR = 0.61; P < 0.001). CONCLUSIONS ED is prevalent in this sample of obese, type 2 diabetic men in the Look AHEAD study. Cardiovascular risk factors were highly associated with ED in this population, and cardiorespiratory fitness was protective in this analysis.

Exercise Capacity and Cardiovascular/Metabolic Characteristics of Overweight and Obese Individuals With Type 2 Diabetes: The Look AHEAD clinical trial

OBJECTIVE— We examined associations of cardiovascular, metabolic, and body composition measures with exercise capacity using baseline data from 5,145 overweight and/or obese (BMI ≥25.0 kg/m2) men and women with type 2 diabetes who were randomized participants for the Look AHEAD (Action for Health in Diabetes) clinical trial. RESEARCH DESIGN AND METHODS— Peak exercise capacity expressed as METs and estimated from treadmill speed and grade was measured during a graded exercise test designed to elicit a maximal effort. Other measures included waist circumference, BMI, type 2 diabetes duration, types of medication used, A1C, history of cardiovascular disease, metabolic syndrome, β-blocker use, and race/ethnicity. RESULTS— Peak exercise capacity was higher for men (8.0 ± 2.1 METs) than for women (6.7 ± 1.7 METs) (P < 0.001). Exercise capacity also decreased across each decade of age (P < 0.001) and with increasing BMI and waist circumference levels in both sexes. Older age, increased waist circumference and BMI, a longer duration of diabetes, increased A1C, a history of cardiovascular disease, having metabolic syndrome, β-blocker use, and being African American compared with being Caucasian were associated with a lower peak exercise capacity for both sexes. Hypertension and use of diabetes medications were associated with lower peak exercise capacity in women. CONCLUSIONS— Individuals with diabetes who are overweight or obese have impaired exercise capacity, which is primarily related to age, female sex, and race, as well as poor metabolic control, BMI, and central obesity.

Recruitment in the Trial of Nonpharmacologic Intervention in the Elderly (TONE)

OBJECTIVE: To compare the effectiveness of different approaches to participant enrollment in a behavior modification trial.

The role of focus groups in health education for cervical cancer among minority women

Focus groups were used in the development of community-based public health education designed to reduce mortality from cervical cancer among black women in Forsyth County, North Carolina. The educational goals of this National Cancer Institute (NCI) funded project were to increase the proportion of black women, age 18 and older, who obtain Pap smears on a regular basis and return for followup care when necessary.A series of four focus groups were conducted to help develop the conceptual basis for designing educational messages and materials. The groups were led by a black, female professional focus group moderator, and explored a variety of health-related topics ranging from general, ordinary concerns of daily living to knowledge and attitudes about cancer screening.The group discussions suggested that health is regarded as very important to the target population, particularly when related to family functioning. Regarding the Pap smear, most women knew about the test, but had little awareness of its role in the early detection of cervical cancer. Fear and fatalism were clearly the dominant, top-of-mind reactions to cancer, and there was little differentiation among sites or types of cancer. Despite the overall pessimism, the groups agreed that early diagnosis and treatment provide the best hope for good outcomes with cancer.

Effect of Intensive Lifestyle Intervention on Sexual Dysfunction in Women With Type 2 Diabetes Results from an ancillary Look AHEAD study

OBJECTIVE Sexual dysfunction is a prevalent problem in obese women with type 2 diabetes. This study examined the effects of intensive lifestyle intervention (ILI) in these women. RESEARCH DESIGN AND METHODS Look AHEAD is a 16-center, randomized, controlled trial evaluating the health effects of ILI compared with a control group (diabetes support and education [DSE]). The Look AHEAD Sexual Function Ancillary study included 375 female participants at five Look AHEAD sites. Participants completed the Female Sexual Function Inventory (FSFI) and Beck Depression Inventory (BDI), and assessments of weight and cardiovascular risk factors at baseline and 1 year were made. RESULTS At baseline, 50% of the 229 participants who reported being sexually active met criteria for female sexual dysfunction (FSD); only BDI score was related to FSD. One-year weight losses were greater in the ILI group than in the DSE group (7.6 vs. 0.45 kg; P < 0.001). Among women with FSD at baseline, those in the ILI group (N = 60) compared with those in the DSE group (N = 53) were significantly more likely to remain sexually active (83 vs. 64%; P < 0.008), reported greater improvement in total FSFI scores and in most FSFI domains (P < 0.05), and were more likely to experience remission of FSD (28 vs. 11%; P < 0.04) at 1 year. No significant differences between ILI and DSE were seen in women who did not have FSD at baseline. CONCLUSIONS Participation in ILI appeared to have beneficial effects on sexual functioning among obese women with diabetes, particularly in those who had FSD at baseline.

Readability of the public education literature on cancer prevention and detection

This paper presents an analysis of the readability level of the educational literature on cancer prevention and early detection. Cancer education brochures and pamphlets were obtained from the American Cancer Society, the National Cancer Institute, private companies, public nonprofit agencies, and state health departments. A total of 183 brochures and pamphlets were examined and reading level (SMOG) scores were computed for 159 of them. The average reading level of the printed cancer education materials was found to be between 10th and 11th grade, with little overall variation by publishing agency, topic, cancer site, focus, or target population. In general, the results suggest that much of the cancer education literature may be of limited value in providing information to the low-income, low-education population.