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Family caregivers of individuals with dementia are at heightened risk for emotional and mental health problems. Many caregivers do not seek assistance or become isolated in their caregiving role. Multi-component interventions have demonstrated efficacy for reducing emotional distress and burden, although these approaches are potentially costly and are not widely accessible. In response to these issues, we developed the Family Intervention: Telephone Tracking – Caregiver (FITT-C), which is an entirely telephone-based psychosocial intervention. The purpose of this paper is to describe the study design, methodology, and baseline data for the trial. This study uses a randomized controlled trial design to examine the efficacy of the FITT-C to reduce depressive symptoms and burden in distressed dementia caregivers. All participants (n = 250) received a packet of educational materials and were randomly assigned to receive 6 months of the FITT-C intervention or non-directive telephone support. The FITT-C intervention was designed to reduce distress in caregivers and is based on the McMaster Model of Family Functioning and the Lazarus, transition theory, and Folkman Stress and Coping Models. The primary dependent variables were depressive symptoms (Centers for Epidemiological Studies – Depression) and burden (Zarit Burden Interview, Revised Memory and Behavior Problems Checklist – Reaction). Secondary outcome measures included family functioning, self-efficacy, and health-related quality of life. Results of the study will provide important data about the efficacy of a telephone-based approach to reduce distress in dementia caregivers.

Background Research demonstrates a link between migraine and obesity. Obesity increases the risk of frequent migraines and is associated with migraine prevalence among reproductive-aged women. These findings are substantiated by several plausible mechanisms and emerging evidence of migraine improvements after surgical and non-surgical weight loss. However, no previous study has examined the effect of weight loss on migraine within a treatment-controlled framework. The WHAM trial is an RCT to test the efficacy of behavioral weight loss as a treatment for migraine. Study design Overweight/obese women ( n = 140; BMI = 25.0–49.9 kg/m 2 ) who meet international diagnostic criteria for migraine and record ≥ 3 migraines and 4–20 migraine days using a smartphone-based headache diary during a 4-week baseline period, will be randomly assigned to 4 months of either group-based behavioral weight loss (intervention) or migraine education (control). Intervention participants will be taught strategies to increase physical activity and consume fewer calories in order to lose weight. Control participants will receive general education on migraine symptoms/triggers and various treatment approaches. Both groups will use smartphones to record their headaches for 4 weeks at baseline, after the 16-week treatment period, and at the end of a 16-week follow-up period. Changes in weight and other potential physiological (inflammation), psychological (depression), and behavioral (diet and physical activity) mediators of the intervention effect will also be assessed. Conclusion The WHAM trial will evaluate the efficacy of a standardized behavioral weight loss intervention for reducing migraine frequency, and the extent to which weight loss and other potential mediators account for intervention effects.

This paper describes the application of best practice recommendations for using accelerometers in a physical activity (PA) intervention trial, and the concordance of different methods for measuring PA. A subsample (n = 63; 26%) of the 239 healthy, sedentary adults participating in a PA trial (mean age = 47.5; 82% women) wore the ActiGraph monitor at all 3 assessment time points. ActiGraph data were compared with self-report (i.e., PA weekly recall and monthly log) and fitness variables. Correlations between the PA recall and ActiGraph for moderate intensity activity ranged from 0.16-0.48 and from 0.28-0.42 for vigorous intensity activity. ActiGraph and fitness [estimated VO(2)(ml/kg/min)] had correlations of 0.15-0.45. The ActiGraph and weekly self-report were significantly correlated at all time points (correlations ranged from 0.23 to 0.44). In terms of detecting intervention effects, intervention groups recorded more minutes of at least moderate-intensity PA on the ActiGraph than the control group at 6 months (min = 46.47, 95% CI = 14.36-78.58), but not at 12 months. Limitations of the study include a small sample size and only 3 days of ActiGraph monitoring. To obtain optimal results with accelerometers in clinical trials, the authors recommend following best practice recommendations: detailed protocols for monitor use, calibration of monitors and validation of data quality, and use of validated equations for analysis. The ActiGraph has modest concordance with other assessment tools and is sensitive to change over time. However, until more information validating the use of accelerometry in clinical trials becomes available, properly administered self-report measures of PA should remain part of the assessment battery.

Background Project STRIDE is a 4-year randomized controlled trial comparing two computer-based expert system guided intervention delivery channels (phone vs. print) for physical activity adoption and short-term maintenance among previously sedentary adults. Methods Sedentary adults ( n = 239) were randomized to one of the following (1) telephone-based, individualized motivationally-tailored feedback; (2) print-based, individualized motivationally-tailored feedback; (3) contact-control delayed treatment group (received intervention after 12 months as control). This paper: (1) outlines the study design, rationale, and participant sample; and (2) describes relationships between baseline variables to better understand their influence on the efficacy of the intervention. Results Participants averaged 19.8 ± 25.0 min of physical activity/week that was at least of moderate intensity, with no group differences. The average estimated VO 2 at 85% of maximum heart rate was 25.6 ml/kg/min. Body fat was 34.1% for women and 23.2% for men and the BMI of the sample averaged 28.5 kg/m 2 . Conclusions Project STRIDE examines non face-to-face approaches for promoting physical activity behavior. It has unique features including a direct comparison of an expert system guided intervention delivered via phone or print. Future analyses will examine the cost-effectiveness of the interventions and this will likely yield important information for policy-makers.