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Technological advances in remote monitoring offer new opportunities to quantify body weight patterns in free-living populations. This paper describes body weight fluctuation patterns in response to weekly, holiday (Christmas) and seasonal time periods in a large group of individuals engaged in a weight loss maintenance intervention. Data was collected as part The NoHoW Project which was a pan-European weight loss maintenance trial. Three eligible groups were defined for weekly, holiday and seasonal analyses, resulting in inclusion of 1,421, 1,062 and 1,242 participants, respectively. Relative weight patterns were modelled on a time series following removal of trends and grouped by gender, country, BMI and age. Within-week fluctuations of 0.35% were observed, characterised by weekend weight gain and weekday reduction which differed between all groups. Over the Christmas period, weight increased by a mean 1.35% and was not fully compensated for in following months, with some differences between countries observed. Seasonal patterns were primarily characterised by the effect of Christmas weight gain and generally not different between groups. This evidence may improve current understanding of regular body weight fluctuation patterns and help target future weight management interventions towards periods, and in groups, where weight gain is anticipated.

The Ten Top Tips (10TT) is an intervention based on the habit formation theory that promotes a set of weight management behaviors alongside advice about repetition in a consistent context. Overall, 3 studies have demonstrated that the 10TT can support individuals to lose weight when delivered in a leaflet format. Delivery of 10TT via new technology such as a mobile app could potentially improve its effectiveness and make it more convenient, appealing, and wide reaching. This study aimed to provide preliminary indications of the usage, effectiveness, and acceptability of an Android app of the 10TT intervention (Top Tips only app) and a second version including self-regulatory strategies for dealing with tempting foods (Top Tips plus app). The 3-month pilot randomized adults with overweight or obesity to (1) Top Tips only app, (2) Top Tips plus app, or (3) waiting list condition. Automated data from app users were collected. Validated questionnaires assessed self-regulatory skills, weight loss (kg), and behaviors at baseline and 3 months. Users' feedback on their experience using the app was assessed using open questions. A total of 81 participants took part in the pilot; 28 participants were randomized to the Top Tips only app, 27 to the Top Tips plus app, and 26 to the waiting list condition. On average, participants viewed a mean of 43.4 (SD 66.9) screens during a mean of 24.5 (SD 44.07) log-ins and used the app for 124.2 (SD 240.2) min over the 3-month period. Participants randomized to the Top Tips only app reported the greatest improvement in self-regulatory skills (mean 0.59, SD 1.0), weight loss (mean 4.5 kg, SD 5.2), and adherence to the target behaviors (mean 0.59, SD 0.49) compared with the Top Tips plus (mean 0.15, SD 0.42; mean -1.9, SD 3.9; and mean 0.29, SD 0.29) and waiting list condition (mean -0.02, SD 0.29; mean -0.01, SD 0.51; and mean 0.08, SD 0.38). Participants who reported the largest improvements, on average, viewed pages 2 to 3 times more, had 2 to 3 times more log-ins, logged their weight 2 to 3 times more, and achieved the tips more than those who reported smaller changes in these outcomes. According to users' feedback, engagement with the app could be increased by making the app more interactive and allowing more tailoring. This study suggests that the Top Tips app could potentially be a useful intervention for promoting eating self-regulatory skills, weight loss, and weight management behaviors among adults with overweight or obesity. Future research should develop the app further based on user feedback and test it in larger sample sizes. ISRCTN Registry ISRCTN10470937; http://www.isrctn.com/ISRCTN10470937 (Archived by Webcite at http://www.webcitation.org/76j6rQibI).

Background/objectiveMaintenance interventions inherently require BMI improvement to maintain. This overlooks individuals initially unresponsive to obesity interventions. Staged pediatric clinical treatment guidelines were adapted to the school setting to develop an escalated treatment option for individuals initially unresponsive. This staged randomized controlled trial examined differences between escalated treatment (Take CHARGE!) and a maintenance program (PE Planners). Take CHARGE was hypothesized to have greater improvements in BMI as a percentage of the 95th BMI Percentile (%BMIp95) than PE Planners.Subjects/methodsFrom 2018 to 2020, 171 middle and high schoolers (BMI Percentile ≥ 85) were recruited from a Houston school district to participate in a staged obesity intervention in their physical education (PE) class. After receiving a semester-long intensive lifestyle intervention (ILI) with established efficacy, all participants were randomized to Take CHARGE (n = 85) or PE Planners (n = 86). Take CHARGE escalated the behavioral treatment of obesity received in ILI with more frequent individual sessions, additional opportunities for parental and school staff involvement, and increased mentorship from trained college students. PE Planners allowed participants to decide how they wanted to be active in PE class. Mixed linear modeling examined %BMIp95 overtime between groups. This trial was registered at ClinicalTrials.gov (#NCT04362280).ResultsParticipants were 13.63 ± 1.32 years old; 59% were female, and 85% were Hispanic. Among those initially unresponsive to ILI, Take CHARGE had significantly greater decreases in %BMIp95 than PE Planners (β = −0.01, p < 0.01). Conversely, among those initially responsive, Take CHARGE had significantly smaller decreases in %BMIp95 than PE Planners (β = 0.02, p < 0.05). Intention-to-treat analysis had similar results.ConclusionsParticipant outcomes in semester two differed based on initial response. Individuals responsive to initial intervention were most likely to benefit from a maintenance intervention and those initially unresponsive benefited more from escalated treatment. This indicates the need for staged intervention protocols to better address obesity in the school setting.

Background Children’s health and welfare have a special place in research and policy in many countries. One of the most important concerns is the increasing rate of backache in children due to many of behavioral risk factors. The aim of this study was to evaluate the effectiveness of an educational program on promoting back-related behavior as well as knowledge, skills, beliefs, and self-efficacy among fifth grade girls. Methods The theory-based back care (T-Bak) study was a school-based randomised controlled trial (RCT) that assessed the effectiveness of developing a back care training program based on the social cognitive theory (SCT). A total of 104 schoolchildren aged 11 ± 1.0 years were assigned to intervention ( n  = 52) and control ( n  = 52) groups. The intervention group received six sessions training on proper lifting and carrying techniques, having proper posture during daily activities, and correct backpack wearing techniques with a 1-week interval while the control group received nothing. Then, the two groups were assessed for knowledge, skills, self-efficacy, beliefs, and behavior at four points in time: baseline, immediate, three and six-months post-intervention. The changes of the outcomes investigated using univariate repeated measures analysis of variance. Partial eta squared measure (η p 2 ) was used to calculate effect sizes. Results A positive change was found for the intervention group back-related behavior from baseline to immediate post-intervention and follow-ups ( F  = 78.865, p  < 0.001, η p 2  = 0.22). Overall there were 36.4% improvement for knowledge (η p 2  = 0.21), 53.2% for the skills (η p 2  = 0.25), 19.5% for the self-efficacy (η p 2  = 0.11), and 25.6% for the beliefs (η p 2  = 0.14) scores from baseline to 6 months’ follow-up assessments among the intervention group ( p  < 0.001). The results also showed a significant interaction effect between group and time. Conclusion The T-Bak intervention was effective in improving back-related behavior in pupils. It is now available and could be evaluated further in back-care related studies. Trial registration Current Controlled Trials IRCT20180528039885N1 , 30th Oct 2018, ‘Prospectively registered’. https://www.irct.ir/trial/31534

Background In the United States, problematic stimulant use is a prevalent and difficult to treat problem among men who have sex with men (MSM), as well as a major driver of HIV transmission through the large number of sexual partners and concomitant condomless anal sex (CAS). Evidence-based behavioral studies that address problematic stimulant use in MSM at risk for HIV infection are also lacking. In this paper, we describe the design of a behavioral intervention trial to reduce sexual risk behavior and stimulant use in HIV-uninfected MSM. Methods This study, funded by the National Institute on Drug Abuse (NIDA), is a randomized controlled trial (RCT) testing an integrated HIV risk reduction and behavioral activation counseling intervention (IMPACT) for HIV-uninfected, stimulant using MSM in Boston, MA, and Miami, FL. Participants are randomized (2:2:1) to either (1) the IMPACT intervention; (2) a relaxation condition, an active therapy time- and intensity-matched control; or (3) a standard of care risk reduction counseling comparison. At enrollment, all participants receive an HIV test and pre- and post-test counseling. The primary outcome is the difference in the rate of change in the number of self-reported condomless anal sex acts without the protection of consistent Pre-Exposure Prophylaxis (PrEP) use, as well as reductions in stimulant use during the prior 4-months. Major assessments are conducted at baseline, 4-, 8-, and 12-month follow-up visits. Discussion Effective and sustainable behavioral interventions are sorely needed to reduce HIV acquisition in stimulant using MSM at risk for HIV infection. In this study, we will evaluate the evidence of efficacy of the IMPACT intervention to reduce HIV acquisition in HIV-uninfected, stimulant-using MSM. If found effective, the intervention tested here holds promise for being readily integrated into real-world clinical settings. Trial registration ClinicalTrials.gov number NCT03175159 , registered June 5, 2017.

The need for a multisectoral approach to tackle stunting has gained attention in recent years. Baduta project aims to address undernutrition among children during their first 1000 days of life using integrated nutrition-specific and nutrition-sensitive interventions. We undertook this cohort study to evaluate the Baduta project’s effectiveness on growth among children under 2 years of age in two districts (Sidoarjo and Malang Districts) in East Java. Six subdistricts were randomly selected, in which three were from the intervention areas, and three were from the control areas. We recruited 340 pregnant women per treatment group during the third trimester of pregnancy and followed up until 18 months postpartum. The assessment of breastfeeding and complementary feeding practices used standard infant and young child feeding (IYCF) indicators in a tablet-based application. We measured weight and length at birth and every three-months after that. The enumerators met precision and accuracy criteria following an anthropometry standardization procedure. Among the breastfed children, the percentage of children who achieved the minimum dietary diversity score (DDS) and minimum acceptable diet (MAD) was higher for the intervention group than the comparison group across all age groups. The odd ratios were 3.49 (95% CI: 2.2–5.5) and 2.79 (95% CI: 1.7–4.4) for DDS and 3.49 (95% CI: 2.2–5.5) and 2.74 (95% CI: 1.8–5.2) for MAD in the 9–11 month and 16–18-month age groups, respectively. However, there was no significant improvement in growth or reduction in the prevalence of anemia. The intervention was effective in improving the feeding practices of children although it failed to show significant improvement in linear growth of children at 18 months of age.

Background The majority of participants in weight loss trials are non-Hispanic White women, while men and women of color are underrepresented. This study presents data obtained from non-targeted and targeted recruitment approaches in a trial of behavioral weight loss programs to (1) describe the yields from each approach and (2) compare the demographics, weight control histories, and study involvement of samples recruited by each approach. Methods Data for this observational study include source of recruitment, demographic information, weight loss experiences (e.g., lifetime weight loss, current weight loss behaviors), and completion of the 6-month assessment visit. Results Men comprised 14.2% of participants who responded to non-targeted recruitment efforts, while targeted efforts yielded 50.4% men. Similarly, people of color comprised 12.8% of those who responded to non-targeted approaches, whereas targeted recruitment methods yielded 47.2% people of color. Men recruited through targeted methods were younger ( p  = 0.01) than men recruited through non-targeted means but were otherwise similar. Women of color recruited through targeted methods reported use of fewer weight loss strategies relative to women of color recruited through non-targeted means ( p  = 0.006) but were otherwise similar. There were no differences by recruitment method on retention to the study. Conclusions Using targeted recruitment methods increased the ethnic and gender diversity of the recruited sample without reducing study retention. This targeting also increased the enrollment of women with less weight loss experience who may not have otherwise sought out a weight loss program. Developing and implementing a targeted recruitment plan should be considered early in the clinical trial development process. Trial registration Clinicaltrials.gov, NCT02368002 . Registered on 20 February 2015.

Intimate partner violence (IPV) strongly predicts depression, but it is unknown if women experiencing IPV can benefit from depression treatments in contexts where depression and IPV are prevalent. This study explored whether women experiencing IPV in Goa, India, can benefit from the Healthy Activity Program (HAP), a culturally adapted behavioral activation treatment, compared with enhanced usual care (EUC). Cross-sectional and longitudinal analyses were performed on data from a clinical trial. Measures assessed at baseline and 3 and 12 months included depressive symptoms. Measures assessed at 3 and 12 months included activation and IPV. Independent t tests were conducted to assess if participants experiencing IPV had higher depressive symptoms and lower activation at 3 and 12 months; hierarchical linear regression was conducted to determine if 3-month IPV predicted 12-month depressive symptoms across trial arms (Hypothesis 1). Hierarchical linear regression was then conducted to examine if the relationship between 3-month activation and 12-month depressive symptoms was moderated by 3-month IPV within each trial arm (Hypothesis 2). As expected, participants experiencing IPV had significantly lower activation levels and higher depressive symptoms compared with participants who did not experience IPV at 3 and 12 months in cross-sectional analyses. Similarly, IPV endorsed at 3 months significantly predicted depressive symptoms at 12 months. However, activation was significantly associated with less severe depressive symptoms at 12 months, irrespective of IPV endorsement among HAP participants. For EUC participants, IPV remained the only significant predictor of depressive symptoms at 12 months. Results suggest that women experiencing IPV can still benefit from behavioral activation.

Objective: People with borderline personality disorder (BPD) are at high risk for attempting suicide. There are some data to suggest that risk factors for suicide attempts change over time. We conducted a prospective cohort study to examine risk factors for suicide attempts in a treated sample of patients with BPD. Method: One hundred eighty participants with BPD were followed over a year-long course of dialectical behaviour therapy or general psychiatric management and then for 2 more years in naturalistic follow-up. Participants were assessed for suicidal and self-injurious behaviours at baseline, every 4 months over the 1-year treatment phase, and every 6 months over a 2-year follow-up period. Participants were classified as suicide or nonsuicide attempters based on their behaviour at the end of the 1-year treatment phase and after the 2-year follow-up period. Groups were then compared on baseline clinical and demographic variables. Results: Nearly 26% of participants made a suicide attempt during the 1-year treatment phase, while 16.7% reported a suicide attempt over the 2-year follow-up period. Baseline number of suicide attempts during the 4 months prior to study and severity of childhood sexual abuse predicted suicide attempts during the treatment year. Similarly, baseline suicide attempts, severity of childhood sexual abuse, and number of hospitalizations in the 4 months prior to study entry predicted suicide attempts during the 2-year follow-up. Conclusions: Risk factors for suicide attempts in this treated sample of patients with BPD were fairly stable, largely nonmodifiable, and unrelated to psychopathology or psychosocial functioning at baseline.

Published research on the use of Web-based behavior change programs is growing rapidly. One of the observations characterized as problematic in these studies is that participants often make relatively few website visits and spend only a brief time accessing the program. Properly structured websites permit the unobtrusive measurement of the ways in which participants access (are exposed to) program content. Research on participant exposure to Web-based programs is not merely of interest to technologists, but represents an important opportunity to better understand the broader theme of program engagement and to guide the development of more effective interventions. The current paper seeks to provide working definitions and describe initial patterns of various measures of participant exposure to ChewFree.com, a large randomized controlled trial of a Web-based program for smokeless tobacco cessation. We examined measures of participant exposure to either an Enhanced condition Web-based program (interactive, tailored, and rich-media program) or a Basic condition control website (static, text-based material). Specific measures focused on email prompting, participant visits (number, duration, and pattern of use over time), and Web page viewing (number of views, types of pages viewed, and Web forum postings). Participants in the ChewFree.com Enhanced condition made more visits and spent more time accessing their assigned website than did participants assigned to the Basic condition website. In addition, exposure data demonstrated that Basic condition users thoroughly accessed program content, indicating that the condition provided a meaningful, face-valid control to the Enhanced condition. We recommend that researchers conducting evaluations of Web-based interventions consider the collection and analysis of exposure measures in the broader context of program engagement in order to assess whether participants obtain sufficient exposure to relevant program content.