scholarly journals Formative Evaluation of a Home-Based Physical Activity Intervention for Adolescent Girls—The HERizon Project: A Randomised Controlled Trial

Children ◽  
2021 ◽  
Vol 8 (2) ◽  
pp. 76
Author(s):  
Emma S. Cowley ◽  
Paula M. Watson ◽  
Lawrence Foweather ◽  
Sarahjane Belton ◽  
Chiara Mansfield ◽  
...  

Background. This is a formative evaluation study of the HERizon Project, a home-based multi-component physical activity (PA) intervention for adolescent girls in the UK and Ireland. Although not intended, this study coincided with the initial COVID-19 lockdown restrictions. Methods. A total of 42 female participants, aged 13 to 16 years old (mean = 14.2, SD = 1.1), were randomly allocated to: (i) the HERizon group (n = 22) or (ii) the wait-list control group (n = 20). Participants in the six-week HERizon group were asked to complete three PA sessions each week and engage in weekly behaviour change support video calls. The primary outcome measure was self-reported habitual PA. Secondary outcomes measures included cardiorespiratory fitness (20 m shuttle run), muscular strength (standing long jump), muscular endurance (push up test), and psychosocial outcomes (Perceived Competence Scale, Body Appreciation Scale, Self-Esteem Questionnaire, Behavioural Regulation in Exercise Questionnaire). Quantitative and qualitative process evaluation data were also collected. Outcome measures were assessed at baseline and after the six-week intervention. Results. There was no significant change in habitual PA between groups (LMM group*time interaction: p = 0.767). The HERizon group had significantly increased cardiorespiratory fitness (p = 0.001), muscular endurance (p = 0.022), intrinsic motivation (p = 0.037), and body appreciation (p < 0.003) in comparison to the wait-list control group. All participants in the intervention group completed the intervention and compliance to the intervention was high (participants completed 18 ± 2 sessions). Conclusions. Although no change in PA was observed, HERizon resulted in improved physical fitness and psychosocial outcomes. These preliminary findings, alongside positive findings for feasibility and acceptability, highlight potential benefits from the home-based intervention, thus further investigation is warranted.

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e046216
Author(s):  
Laura García-Garcés ◽  
Sergio Lacamara Cano ◽  
Yago Cebolla Meliá ◽  
María I Sánchez-López ◽  
David Marqués Azcona ◽  
...  

IntroductionNumerous studies support the practice of different physical exercise modalities as an effective treatment to address the problems associated with schizophrenia, reporting that they result in improvements in patient symptoms and quality of life. Given the lack of studies comparing different types of training in controlled environments, the aim of this proposed study will be to compare the effects of three physical exercise programmes (strength, aerobic and mixed) on the symptoms, body composition, level of physical activity and health-related quality of life of patients with schizophrenia.Methods and analysisA multicentre, single-blinded (evaluator), randomised, wait-list controlled (ratio 2:2:2:1) trial will be conducted with 105 patients recruited from different psychosocial care centres. The participants will be randomised into three 16-week training groups comprising 48 sessions lasting 1 hour each, or to the wait-list control group. The training groups will complete aerobic, strength or mixed (aerobic+strength) training. The participants will be assessed before, immediately after and 6 months after the end of the intervention. The patients in the wait-list control group (n=15) will receive one of the three trainings immediately after the intervention. The study variables will include positive, negative and general symptomology (Positive and Negative Syndrome Scale) as the primary outcome; as secondary outcome: body composition (by assessing body mass index, body fat mass and waist circumference), physical activity levels (International Physical Activity Questionnaire-Short Form) and quality of life (abbreviated WHO Quality of Life questionnaire).Ethics and disseminationThis study was approved by the ethics committees for Biomedical Research at the CEU Cardenal Herrera University of Valencia, Spain (CEI18/215). Participants will be fully informed of the purpose and procedures of the study, and written informed consent will be obtained. The results from this study will be published in peer-reviewed journals and presented in scientific conferences.Trial registration numberNCT04987151.


Author(s):  
Nicola D. Ridgers ◽  
Anna Timperio ◽  
Kylie Ball ◽  
Samuel K. Lai ◽  
Helen Brown ◽  
...  

Abstract Background There has been increasing interest in using wearable activity trackers to promote physical activity in youth. This study examined the short- and longer-term effects of a wearable activity tracker combined with digital behaviour change resources on the physical activity of adolescents attending schools in socio-economically disadvantaged areas. Methods The Raising Awareness of Physical Activity (RAW-PA) Study was a 12-week, multicomponent intervention that combined a Fitbit Flex (and accompanying app), and online digital behaviour change resources and weekly challenges delivered via Facebook. RAW-PA was evaluated using a cluster-randomised controlled trial with 275 adolescents (50.2% female; 13.7 ± 0.4 years) from 18 Melbourne secondary schools (intervention n = 9; wait-list control group n = 9). The primary outcome was moderate- to vigorous-intensity physical activity (MVPA), measured using hip-worn ActiGraph accelerometers. The secondary outcome was self-reported physical activity. Data were collected at baseline, 12-weeks (immediately post-intervention), and 6-months post-intervention (follow-up). Multilevel models were used to determine the effects of the intervention on daily MVPA over time, adjusting for covariates. Results No significant differences were observed between intervention and wait-list control adolescents’ device-assessed MVPA immediately post-intervention. At 6-months post-intervention, adolescents in the intervention group engaged in 5 min (95% CI: − 9.1 to − 1.0) less MVPA per day than those in the wait-list control group. Males in the intervention group engaged in 11 min (95% CI: − 17.6 to − 4.5) less MVPA than males in the wait-list control group at 6-months post-intervention. No significant differences were observed for females at either time point. For self-reported physical activity, no significant effects were found at 12-weeks and 6-months post-intervention. Conclusions Combining a wearable activity tracker with digital behaviour change resources and weekly challenges did not increase inactive adolescents’ accelerometer-derived and self-reported physical activity levels immediately post-intervention. This contrasts previous research that has suggested wearable activity tracker may increase youth physical activity levels in the short-term. Lower engagement in MVPA 6-months post-intervention was observed for males but not for females, though it is unclear why this finding was observed. The results suggest wearable activity trackers, in combination with supporting materials, may not be effective for increasing physical activity levels in adolescents. Trial registration ACTRN12616000899448. Australian and New Zealand Clinical Trials Registry. Registered 7 July 2016.


2021 ◽  
pp. 136749352110037
Author(s):  
Alison E. Parker ◽  
Tracy M. Scull ◽  
Abigail M. Morrison

Pediatric clinical trials allow for the testing of appropriate and effective treatments for children. However, some challenges exist with recruitment. This study examined the effectiveness of DigiKnowIt News, an interactive, multimedia website (which includes activities, videos, and comic books) designed to educate children about clinical trials. A randomized controlled trial was conducted in 2018 with 91 participants ( M age = 10.92 years; SD = 2.06). Participants were randomly assigned to intervention or wait-list control groups and completed questionnaires at pretest and posttest (1 week later) about their knowledge, attitudes, beliefs about clinical trials, and self-efficacy for participating in clinical trials. Participants in the intervention group received access to DigiKnowIt News between pretest and posttest and completed a satisfaction questionnaire at posttest. At the end of the study, participants in the wait-list control group were offered the option to use the website and complete a satisfaction questionnaire. At posttest, participants in the intervention group, compared to participants in the wait-list control group, had more knowledge about clinical trials and more reported confidence for participating in clinical trials. Participants reported high levels of satisfaction with DigiKnowIt News. The findings suggest that an educational website can improve factors related to increasing rates of participation in clinical trials.


2021 ◽  
Vol 30 (2S) ◽  
pp. 920-932
Author(s):  
Elisabeth Cochran D'Angelo ◽  
Beth A. Ober ◽  
Gregory K. Shenaut

Purpose The study aimed to test a combination of semantic memory and traditional episodic memory therapies on episodic memory deficits in adults with traumatic brain injury. Method Twenty-five participants who had been diagnosed with traumatic brain injury and had episodic memory deficits were randomly assigned either to a combined memory treatment group ( n = 16) or to a wait-list control group ( n = 9). Before and after treatment, they completed standardized neuropsychological testing for episodic memory and related cognitive domains, including the California Verbal Learning Test–Second Edition, the Controlled Oral Word Association Test, the University of Southern California Repeatable Episodic Memory Test, the Wechsler Abbreviated Scale of Intelligence–Second Edition Matrices, the Test of Everyday Attention, the Memory Assessment Clinics Self-Rating Scale, the Expressive Vocabulary Test–Second Edition, and the Story Recall subtest from the Rivermead Behavioural Memory Test. In addition to a traditional episodic memory therapy, the treatment group received a novel semantic memory–focused therapy, which involved participants finding meaningful connections between diverse concepts represented by sets of two or three words. Results The treatment group demonstrated statistically significant improvement in memory for list learning tasks, and there was a significant difference from pretest to posttest between the treatment group and the wait-list control group. Clinical significance was demonstrated for the treatment group using minimally important difference calculations. Conclusion Combined memory therapy resulted in significant improvements in episodic memory, semantic memory, and attention, in comparison to no treatment. Supplemental Material https://doi.org/10.23641/asha.14049968


Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Artjom Frick ◽  
Isabel Thinnes ◽  
Ulrich Stangier

Abstract Background Depression is a widespread disorder with severe impacts for individuals and society, especially in its chronic form. Current treatment approaches for persistent depression have focused primarily on reducing negative affect and have paid little attention to promoting positive affect. Previous studies have shown that metta meditation increases positive affect in chronically depressed patients. Results from previous trials provide evidence for the efficacy of a stand-alone metta meditation group treatment in combination with mindfulness-based approaches. Further research is needed to better understand the implementation of meditation practice into everyday life. Therefore, mindfulness and metta meditation in a group setting are combined with individual cognitive behavioral therapy (CBT) into a new, low-intensity, cost-effective treatment (“MeCBT”) for chronic depression. Methods/design In this single-center, randomized, observer-blinded, parallel-group clinical trial we will test the efficacy of MeCBT in reducing depression compared to a wait-list control condition. Forty-eight participants in a balanced design will be allocated randomly to a treatment group or a wait-list control group. Metta-based group meditation will be offered in eight weekly sessions and one additional half-day retreat. Subsequent individual CBT will be conducted in eight fortnightly sessions. Outcome measures will be assessed at four time points: before intervention (T0); after group meditation (T1); after individual CBT (T2); and, in the treated group only, at 6-month follow-up (T3). Changes in depressive symptoms (clinician rating), assessed with the Quick Inventory of Depressive Symptoms (QIDS-C) are the primary outcome. We expect a significant decline of depressive symptoms at T2 compared to the wait-list control group. Secondary outcome measures include self-rated depression, mindfulness, benevolence, rumination, emotion regulation, social connectedness, social functioning, as well as behavioral and cognitive avoidance. We will explore changes at T1 and T2 in all these secondary outcome variables. Discussion To our knowledge this is the first study to combine a group program focusing on Metta meditation with state-of-the art individual CBT specifically tailored to chronic depression. Implications for further refinement and examination of the treatment program are discussed. Trial registration ISRCTN, ISRCTN97264476. Registered 29 March 2018 (applied on 14 December 2017)—retrospectively registered.


2010 ◽  
Vol 32 (1) ◽  
pp. 35-57 ◽  
Author(s):  
Steven Sandage ◽  
Everett Worthington

Undergraduate student volunteers (N=97) were randomly assigned to one of two six-hour forgiveness psychoeducational seminars or to a wait-list control group. Based on attachment theory, forgiveness was conceptualized in relation to the care-giving behavioral system (Mikulincer & Shaver, 2007). Both the Empathy Forgiveness Seminar and the Self-enhancement Forgiveness Seminar facilitated forgiveness to a greater degree than the wait-list control group at post-test and six-week follow-up. Empathy mediated changes in participants' forgiveness scores regardless of seminar condition. Shame-proneness was negatively related to post-test forgiveness scores and guilt-proneness was positively related to forgiveness at post-test and follow-up. Implications for interventions are discussed.


2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S852-S852
Author(s):  
Chien-Ning Tseng

Abstract This study evaluated the effectiveness of a combined cognitive training (CT) and physical activity (PA) intervention in improving cognitive function for institutionalized older residents with cognitive impairment. An experimental design with pre/post-test evaluations in a double-blind assessments at three points (baseline, T0; post-treatment, T1; 8-weeks-follow-up, T2), conducted an 8-week-CTPA intervention. Participants (N=134) were recruited from 12 institutions. Centers were randomly assigned into wait-list control, treatment I or treatment II groups. Treatment I group (low frequency) underwent combined 30-minutes sessions of individual-non-computer-based multi-domain CT (twice a week) with 30-minutes-group-chair-based PA (3 times a week). Treatment II group underwent the same protocol as Treatment I group, but with high frequency, 5 days per week for both CT and PA. The primary outcome, Cognitive Assessment Screening Instrument(CASI) total scores showed significant improvement in the treatment I and treatment II groups at T1-T0 and T2-T0, compared to the wait-list control group(10.55±9.60, 12.75±11.64, -8.01±6.61, p=0.000; 8.32±7.81, 11.75±10.19, -7.11±5.78, p=0.000), however there were no significant differences between two treatment groups. In CASI’s nine sub-domains, all the mean difference between groups were also significant at T1-T0 and T2-T0 (all p&lt;0.05). The two treatment groups only significantly differ on CASI-ORIENT domain at T2-T0 (p=0.02). The findings revealed that a combined CT-and-PA intervention have positive immediate (T1-T0) and delayed (T2-T0) effects in cognitive function for older institutional residents with cognition-impairment. The two treatment groups did not show dose-response relationship. Even more, the low frequency intervention was more effective on several domains than high frequency intervention did.


2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Bettina Wollesen ◽  
Madeleine Fricke ◽  
Carl-Philipp Jansen ◽  
Katharina Gordt ◽  
Michael Schwenk ◽  
...  

Abstract Background In nursing home residents, the combination of decreasing mobility and declining cognitive abilities, including spatial orientation, often leads to reduced physical activity (PA) and life-space (LS) mobility. As a consequence of sedentary behavior, there is a lack of social interaction and cognitive stimulation, resulting in low quality of life. It has not yet been examined whether cognitive-motor training including spatial cognitive tasks is suitable to improve spatial orientation and, as a consequence, to enlarge LS mobility, and increase well-being and general cognitive-motor functioning. Therefore, the overall goal of this multicentric randomized controlled trial (RCT) is to compare the effect of three different intervention approaches including functional exercise and orientation tasks on PA, LS and spatial orientation in nursing home residents. Methods A three-arm single-blinded multicenter RCT with a wait-list control group will be conducted in a sample of 513 individuals (needed according to power analysis) in three different regions in Germany. In each nursing home, one of three different intervention approaches will be delivered to participating residents for 12 weeks, twice a week for 45 min each: The PROfit basic group will perform functional strength, balance, flexibility, and walking exercises always at the same location, whereas the PROfit plus group changes the location three times while performing similar/the same exercises as the PROfit basic group. The PROfit orientation group receives navigation tasks in addition to the relocation during the intervention. Physical and cognitive functioning as well as psychological measures will be assessed in all study groups at baseline. Participants will then be randomized into either the intervention group or the wait-list control group. After 12 weeks, and after 24 weeks the measures will be repeated. Discussion This study evaluates whether the three different interventions are feasible to reduce the decline of or even improve PA, LS, and spatial orientation in nursing home residents. By adding different training locations in PROfit plus, the program is expected to be superior to PROfit basic in increasing physical and cognitive parameters. Moreover, we expect the PROfit orientation intervention to be most effective in terms of PA, LS, and spatial orientation due to two mechanisms: (1) increased physical and cognitive activity will enhance cognitive-motor capacity and (2) the spatial training will help to build up cognitive strategies to compensate for age-related loss of spatial orientation abilities and related limitations. Trial registration The trial was prospectively registered at DRKS.de with registration number DRKS00021423 on April 16, 2020 and was granted permission by the Technical University Berlin local ethics committee (No. GR_14_20191217).


2011 ◽  
Vol 21 (6) ◽  
pp. 737-746 ◽  
Author(s):  
Lani V. Jones ◽  
Lynn A. Warner

Purpose: This study examined the efficacy of a culturally congruent group treatment model, entitled “Claiming Your Connections” (CYC) aimed at reducing depressive symptoms and perceived stress, and enhancing psychosocial competence (i.e., locus of control and active coping) among Black women. Method: A total of 58 Black women recruited from health and human service community-based organizations were randomly assigned to either the CYC intervention or a wait-list control group. Women in the CYC program attended weekly group intervention sessions over a 10-week period, and the wait-list control group did not receive any treatment for the same duration. Results: At pretreatment both groups indicated moderate levels of depressive symptoms, perceived stress, and psychosocial competence. After the intervention, the CYC group reported a significant reduction in depressive symptoms and perceived stress. There was no statistically significant change on these variables for the control group. Implications: Results suggest that the CYC group intervention program is effective with Black women who report having difficulty managing stressors of daily life.


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