A Randomized, Controlled Multisite Study of Behavioral Interventions for Veterans with Mental Illness and Antipsychotic Medication-Associated Obesity.

BACKGROUND: Weight gain and other metabolic sequelae of antipsychotic medications can lead to medication non-adherence, reduced quality of life, increased costs, and premature mortality. Of the approaches to address this, behavioral interventions are less invasive, cost less, and can result in sustained long-term benefits. OBJECTIVE: We investigated behavioral weight management interventions for veterans with mental illness across four medical centers within the Veterans Affairs (VA) Healthcare System. DESIGN: We conducted a 12-month, multi-site extension of our previous randomized, controlled study, comparing treatment and control groups. PARTICIPANTS: Veterans (and some non-veteran women) diagnosed with mental illness, overweight (defined as having a BMI over 25), and required ongoing antipsychotic therapy. INTERVENTIONS: One group received "Lifestyle Balance" (LB; modified from the Diabetes Prevention Program) consisting of classes and individual nutritional counseling with a dietitian. A second group received less intensive "Usual Care" (UC) consisting of weight monitoring and provision of self-help. MAIN MEASURES: Participants completed anthropometric and nutrition assessments weekly for 8 weeks, then monthly. Psychiatric, behavioral, and physical assessments were conducted at baseline and months 2, 6, and 12. Metabolic and lipid laboratory tests were performed quarterly. KEY RESULTS: Participants in both groups lost weight. LB participants had a greater decrease in average waist circumference [F(1,1244) = 11.9, p < 0.001] and percent body fat [F(1,1121) = 4.3, p = 0.038]. Controlling for gender yielded statistically significant changes between groups in BMI [F(1,1246) = 13.9, p < 0.001]. Waist circumference and percent body fat decreased for LB women [F(1,1243) = 22.5, p < 0.001 and F(1,1221) = 4.8, p = 0.029, respectively]. The majority of LB participants kept food and activity journals (92%), and average daily calorie intake decreased from 2055 to 1650 during the study (p < 0.001). CONCLUSIONS: Behavioral interventions specifically designed for individuals with mental illness can be effective for weight loss and improve dietary behaviors. "Lifestyle Balance" integrates well with VA healthcare's patient-centered "Whole Health" approach. ClinicalTrials.gov identifier NCT01052714.

Behavioral interventions for antipsychotic medication-associated obesity: a randomized, controlled clinical trial.

OBJECTIVE: To demonstrate the effectiveness of a Diabetes Prevention Program-inspired 12-month behavioral intervention for patients with severe mental illness (SMI) and medication-associated obesity. METHOD: This randomized, controlled, parallel, superiority study screened 225 volunteers from November 2005 to August 2008 at the VA Greater Los Angeles Healthcare System. 122 outpatients with DSM-IV-diagnosed SMI taking antipsychotic medications who had ≥ 7% weight gain or body mass index (BMI) > 25 were randomized by computer-generated number to Lifestyle Balance treatment intervention (n = 60) or usual care control (n = 62) groups. Clinical raters were masked to randomization. Treatment intervention included weekly classes and individual counseling for 8 weeks, food and exercise diaries, rewards, caregiver consultations, and monthly booster classes and counseling for 1 year. Controls received self-help materials and visited at equivalent intervals without formal classes or counseling. Outcomes were changes in anthropometric measurements, psychiatric symptoms, health knowledge, and glucose, hemoglobin A1c, and lipid levels. RESULTS: Our intention-to-treat analysis found significant differences in predicted trajectory of mean weight change between the groups over 12 months (P < .01), with treatment participants expected to lose an average 4.6 kg, while control participants would gain an average 0.6 kg. BMI and body fat percentage followed the same pattern. Both groups demonstrated statistically significant improvements in health knowledge quiz scores over time (P = .006), without significant difference between groups. CONCLUSIONS: Treatment was more effective than usual care control in treating medication-associated obesity, independent of SMI diagnosis, antipsychotic medication, and knowledge gained, suggesting that behavioral interventions are effective in SMI patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00344500.

Ergometric performance during exercise training in men with intermittent claudication.

OBJECTIVE: To determine and describe changes in weekly work, power, exercise times, and recovery times during an exercise training intervention in men with peripheral arterial disease (PAD) and intermittent calf claudication. DESIGN: Tracking of weekly exercise training parameters involved repeated measures over time in one group of participants. Other outcomes of this pilot study used a one-group, pretest-posttest design. SETTING: Tertiary-care medical center. PARTICIPANTS: Fifteen male veterans (mean age, 69 years) with Fontaine stage IIa PAD and classic intermittent calf claudication. MAIN OUTCOME MEASUREMENTS: Participants completed graded treadmill exercise tests before and after intervention from which maximal walking power was calculated. Work, power, and exercise and recovery times for each exercise training session were computed and averaged for each week. INTERVENTION: The intervention consisted of an intensive 3-month exercise training program involving walking and calf muscle exercises: 3 sessions per week at the clinic (treadmill walking and calf ergometry) and 2 sessions per week at home (free walking and standing heel raises). RESULTS: After training, participants increased treadmill maximal walking power from 220 to 414 W (by 87%). Treadmill and calf exercise work, power, and exercise time per session increased linearly during 13 weeks of training, whereas recovery time per session of treadmill exercise decreased. During the same period, treadmill and calf exercise training power outputs increased by averages of 227% and 92%, respectively. CONCLUSION: Calculation of work and power during exercise training can be used to track progress quantitatively at short intervals. Weekly linear increases in training work and power per exercise session suggest that optimal intervention duration may be longer than 3 months for men with PAD and intermittent calf claudication.

Preamputation evaluation of lower-limb skeletal muscle perfusion with H(2) (15)O positron emission tomography.

OBJECTIVE: To establish whether muscle blood flow (MBF) measurements with O-water positron emission tomography could reliably identify patients with critical limb ischemia and detect and quantify a distal deficit in skeletal MBF in these cases. DESIGN: O-water positron emission tomography scans were performed at rest or during unloaded ankle plantar and dorsiflexion exercise of the diseased leg in 17 subjects with leg ischemia or on a randomly selected leg of 18 age-matched healthy control subjects. TcPO2 was evaluated with Novametrix monitors and perfusion of skin topically heated to 44 degrees C and adjacent nonheated areas with a Moor Instruments laser Doppler imaging scanner. RESULTS: The enhancement of MBF induced by exercise was significantly lower in ischemic than in normal legs, and the sensitivity and specificity of this phenomenon were similar to those of laser Doppler imaging or TcPO2 in identifying ischemia subjects. In addition, the exercise MBF deficit was predominant at the distal-leg levels, indicating the ability of the technique to help determine the correct level of amputation. CONCLUSIONS: Skeletal MBF of legs with severe ischemia can be detected accurately with O-water positron emission tomography and could add valuable information about viability of skeletal muscle in the residual limb when deciding the level of an amputation.

Effects of exercise training on calf tissue oxygenation in men with intermittent claudication.

OBJECTIVE: To determine the effects of exercise training on calf tissue oxygenation in men with peripheral arterial disease and intermittent calf claudication. DESIGN: This pilot study was prospective and longitudinal and used a one-group, pretest-posttest design. SETTING: Tertiary care medical center for veterans. PARTICIPANTS: Fifteen male veterans (mean age 69 years) with Fontaine stage IIa peripheral arterial disease and classic intermittent claudication. MAIN OUTCOME MEASUREMENTS: Before and after intervention, participants performed graded treadmill exercise tests while medial calf tissue oxygenation (StO(2), % oxyhemoglobin saturation) was monitored continuously with near-infrared spectroscopy. INTERVENTION: The intervention consisted of a 3-month exercise training program involving 3 sessions per week at the clinic (treadmill walking, calf ergometry) and 2 sessions per week at home (free walking, standing heel raises). RESULTS: After completion of the intervention, participants significantly increased their maximal treadmill exercise time from 7.19 to 11.27 minutes. Mean exercise StO(2) decreased from 29% to 19% saturation, StO(2) x time area increased from 421% * min to 730% * min StO(2) nadir, and StO(2) recovery time did not change significantly. CONCLUSIONS: After the exercise intervention, the improved treadmill walking performance was accompanied by greater calf tissue deoxygenation during exercise. Given the continued presence of ischemia, this finding may represent increased capillarization and diffusion-based enhancement of arteriovenous O(2) extraction.

Scanning laser-Doppler imaging of leg- and foot-skin perfusion in normal subjects: analysis of age, gender, site, and laser-type effects.

OBJECTIVES: To report normal values of skin perfusion in healthy subjects in three age groups using a laser Doppler imager; to determine differences attributable to gender, age, site, and use of red or near-infrared lasers; and to correlate transcutaneous oxygen with laser flux values. DESIGN: Flux and transcutaneous oxygen were measured at ten sites in the lower extremity in 60 subjects from three age groups. Heated and unheated sites were scanned with red and near-infrared lasers. RESULTS: Heat hyperemia was prominent at all sites. Small, statistically significant mean +/- SD differences were found between heated and nonheated sites for the red and near-infrared lasers (P = 0.02). All flux ratios were independent of gender but were higher in the oldest group. Plantar sites demonstrated higher flux in unheated areas and lower flux ratios compared with leg sites. Transcutaneous oxygen did not correlate significantly with flux for either laser type. CONCLUSIONS: Scanning laser-Doppler imaging flux values provide a reference for identifying patients at risk for tissue ischemia and poor healing potential caused by impaired circulatory reserve in the legs and distal feet. The lack of correlation between flux and transcutaneous oxygen in healthy individuals suggests that they measure different physiologic processes.

Preamputation evaluation of limb perfusion with laser Doppler imaging and transcutaneous gases.

We studied 31 subjects with severe leg ischemia and 29 age-matched nonischemic control subjects to compare preamputation assessments of leg ischemia using laser Doppler imaging (LDI), transcutaneous partial pressure of oxygen (TcPO(2)), and transcutaneous partial pressure of carbon dioxide (TcPCO(2)). TcPO(2) and TcPCO(2) were evaluated with Novametrix Medical Systems, Inc, monitors (Wallingford, Connecticut) and perfusion (flux) of skin topically heated to 44 degrees C, and adjacent nonheated areas were evaluated with a Moor Laser Doppler Imager (Moor Instruments, Ltd; Devon, England). LDI flux of heated areas, its ratio to nonheated areas, and TcPO(2) (not TcPCO(2)) were lower in ischemic subjects than in control subjects. LDI flux ratio performed better than TcPO(2) in identifying ischemia, with fewer false positive and false negative results. Moreover, LDI flux of heated skin detected a proximal to a distal gradient of perfusion in ischemic subjects, while TcPO(2) did not. LDI was superior to TcPO(2) in discriminating correctly between ischemic and nonischemic skin. The results suggest that an LDI ratio below 5 indicates nonviable skin.

Cognitive behavioral therapy and aerobic exercise for Gulf War veterans' illnesses: a randomized controlled trial.

CONTEXT: Gulf War veterans' illnesses (GWVI), multisymptom illnesses characterized by persistent pain, fatigue, and cognitive symptoms, have been reported by many Gulf War veterans. There are currently no effective therapies available to treat GWVI. OBJECTIVE: To compare the effectiveness of cognitive behavioral therapy (CBT), exercise, and the combination of both for improving physical functioning and reducing the symptoms of GWVI. DESIGN, SETTING, AND PATIENTS: Randomized controlled 2 x 2 factorial trial conducted from April 1999 to September 2001 among 1092 Gulf War veterans who reported at least 2 of 3 symptom types (fatigue, pain, and cognitive) for more than 6 months and at the time of screening. Treatment assignment was unmasked except for a masked assessor of study outcomes at each clinical site (18 Department of Veterans Affairs [VA] and 2 Department of Defense [DOD] medical centers). INTERVENTIONS: Veterans were randomly assigned to receive usual care (n = 271), consisting of any and all care received from inside or outside the VA or DOD health care systems; CBT plus usual care (n = 286); exercise plus usual care (n = 269); or CBT plus exercise plus usual care (n = 266). Exercise sessions were 60 minutes and CBT sessions were 60 to 90 minutes; both met weekly for 12 weeks. MAIN OUTCOME MEASURES: The primary end point was a 7-point or greater increase (improvement) on the Physical Component Summary scale of the Veterans Short Form 36-Item Health Survey at 12 months. Secondary outcomes were standardized measures of pain, fatigue, cognitive symptoms, distress, and mental health functioning. Participants were evaluated at baseline and at 3, 6, and 12 months. RESULTS: The percentage of veterans with improvement in physical function at 1 year was 11.5% for usual care, 11.7% for exercise alone, 18.4% for CBT plus exercise, and 18.5% for CBT alone. The adjusted odds ratios (OR) for improvement in exercise, CBT, and exercise plus CBT vs usual care were 1.07 (95% confidence interval [CI], 0.63-1.82), 1.72 (95% CI, 0.91-3.23), and 1.84 (95% CI, 0.95-3.55), respectively. The OR for the overall (marginal) effect of receiving CBT (n = 552) vs no CBT (n = 535) was 1.71 (95% CI, 1.15-2.53) and for exercise (n = 531) vs no exercise (n = 556) was 1.07 (95% CI, 0.76-1.50). For secondary outcomes, exercise alone or in combination with CBT significantly improved fatigue, distress, cognitive symptoms, and mental health functioning, while CBT alone significantly improved cognitive symptoms and mental health functioning. Neither treatment had a significant impact on pain. CONCLUSION: Our results suggest that CBT and/or exercise can provide modest relief for some of the symptoms of chronic multisymptom illnesses such as GWVI.