scholarly journals Feasibility outcomes of a presurgical randomized controlled trial exploring the impact of caloric restriction and increased physical activity versus a wait-list control on tumor characteristics and circulating biomarkers in men electing prostatectomy for prostate cancer

BMC Cancer ◽  
2016 ◽  
Vol 16 (1) ◽  
Author(s):  
Wendy Demark-Wahnefried ◽  
Jeffery W. Nix ◽  
Gary R. Hunter ◽  
Soroush Rais-Bahrami ◽  
Renee A. Desmond ◽  
...  
Keyword(s):  
Physical Activity ◽  
Prostate Cancer ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Tumor Characteristics ◽  
Wait List ◽  
Circulating Biomarkers ◽  
Wait List Control ◽  
Randomized Controlled ◽  
The Impact

Paternal Lifestyle-Related Parenting Practices Mediate Changes in Children’s Dietary and Physical Activity Behaviors: Findings From the Healthy Dads, Healthy Kids Community Randomized Controlled Trial

2015 ◽  
Vol 12 (9) ◽  
pp. 1327-1335 ◽  
Author(s):  
Adam B. Lloyd ◽  
David R. Lubans ◽  
Ronald C. Plotnikoff ◽  
Philip J. Morgan
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Parenting Practices ◽  
Controlled Trial ◽  
Control Group ◽  
Intervention Effect ◽  
Wait List Control ◽  
Randomized Controlled ◽  
Logistic Support ◽  
Children’S Physical Activity

Background:This study examined potential parenting-related mediators of children’s physical activity and dietary behavior change in the Healthy Dads, Healthy Kids (HDHK) community program.Methods:A randomized controlled trial was conducted with 45 overweight/obese (mean [SD] age = 39.8 [5.4] years; BMI = 32.4 [3.8]) fathers and their children (n = 77; 58% boys; mean [SD] age = 7.7 [2.5] years). Families were randomized to either the HDHK program or wait-list control group. The program involved 7 sessions. Fathers and their children were assessed at baseline and at 14 weeks for physical activity (pedometery) and core food intake (Questionnaire). Fathers’ lifestyle-related parenting practices included; self-efficacy, beliefs, modeling, logistic support, rules, cophysical activity, shared mealtime frequency and intentions.Results:Significant intervention effects were found for cophysical activity and modeling physical activity. Cophysical activity mediated children’s physical activity in the intervention (‘mediated effect,’ AB = 653, 95% CI = 4–2050) and was responsible for 59.5% of the intervention effect. Fathers’ beliefs mediated children’s percent energy from core foods (AB = 1.51, 95% CI = 0.05–5.55) and accounted for 72.9% of the intervention effect.Conclusions:Participation in the HDHK program positively impacted on fathers’ cophysical activity with their child and beliefs about healthy eating which mediated changes in children’s diet and physical activity behaviors.

Meaning and Purpose (MaP) therapy II: Feasibility and acceptability from a pilot study in advanced cancer

2019 ◽  
Vol 17 (1) ◽  
pp. 21-28 ◽  
Author(s):  
David W. Kissane ◽  
Carrie Lethborg ◽  
Joanne Brooker ◽  
Courtney Hempton ◽  
Sue Burney ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pilot Study ◽  
Posttraumatic Growth ◽  
Advanced Cancer ◽  
Controlled Trial ◽  
Effect Sizes ◽  
Wait List ◽  
Wait List Control ◽  
Randomized Controlled ◽  
Meaning And Purpose

AbstractObjectiveMeaning and Purpose (MaP) therapy aims to enhance meaning-based coping through a life review that focuses on the value and worth of the person, key relationships, sources of fulfillment, roles, and future priorities in living life out fully. We sought to test the feasibility and acceptability of a six-session model of MaP therapy against a wait-list control cohort in a pilot study seeking effect sizes on measures of adaptation.MethodWe randomized patients with advanced cancer to MaP therapy or wait-list control, with measures administered at baseline and after 6–8 weeks. Wait-list patients could then crossover to receive therapy, with further measures collected postintervention. Adherence to the manualized model was sustained through weekly supervision and fidelity coding of recorded sessions. We used generalized estimating equations to control for baseline and any correlation of data.ResultFrom 134 eligible participants, 57 (43%) consented, and 40 of 45 (89%) offered therapy completed 6 sessions. Key barriers to consenting patients were poor health (15 refusers and 4 withdrawals) and death intervened in 6 participants. MaP therapy generated adequate effect sizes in posttraumatic growth (new possibilities, appreciation of life, and personal strength) and life attitudes (choices and goal seeking) to permit calculation of power for a formal randomized, controlled trial.Significance of resultsDelivery of this model of existentially oriented therapy is feasible and acceptable to patients. A properly powered randomized controlled trial is justified to examine the efficacy of this intervention.

The physical activity counselling (PAC) randomized controlled trial: rationale, methods, and interventions

2007 ◽  
Vol 32 (6) ◽  
pp. 1170-1185 ◽  
Author(s):  
Michelle S. Fortier ◽  
William Hogg ◽  
Tracey L. O’Sullivan ◽  
Christopher Blanchard ◽  
Robert D. Reid ◽  
...  
Keyword(s):  
Physical Activity ◽  
Primary Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Care Practice ◽  
Randomized Controlled ◽  
Physical Activity Counselling ◽  
Metabolic Outcomes ◽  
Motivation And Confidence ◽  
The Impact

Primary care is a promising venue to build patient motivation and confidence to increase physical activity (PA). Physician PA counselling has demonstrated some success; however, maintenance of behaviour change appears to require more intensive interventions. In reality, most physicians do not have the necessary training nor the time for this type of counselling. The purpose of this paper is to outline the rationale, methods, and interventions for the ongoing physical activity counselling (PAC) randomized controlled trial (RCT), which aims to assess the impact of integrating a PA counsellor into a primary care practice. This RCT has 2 arms: (i) brief PA counselling (2–4 min) from a health care provider and (ii) brief PA counselling + intensive PA counselling from a PA counsellor (3 months). The impact of this intervention is being evaluated using the comprehensive RE-AIM framework. One hundred twenty insufficiently active adult patients, aged 18 to 69 y and recruited during regular primary care visits have been randomized. Dependent measures include psychological mediators, PA participation, quality of life, and physical and metabolic outcomes. The PAC project represents an innovative, theoretically-based approach to promoting PA in primary care, focusing on psychological mediators of change. We anticipate that key lessons from this study will be useful for shaping future public health interventions, theories, and research.

scholarly journals Testing a mindfulness meditation mobile app for the treatment of sleep-related symptoms in adults with sleep disturbance: A randomized controlled trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (1) ◽  
pp. e0244717
Author(s):  
Jennifer L. Huberty ◽  
Jeni Green ◽  
Megan E. Puzia ◽  
Linda Larkey ◽  
Breanne Laird ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Sleep Disturbance ◽  
Daytime Sleepiness ◽  
Controlled Trial ◽  
Intervention Group ◽  
Mobile App ◽  
Wait List ◽  
Wait List Control ◽  
Randomized Controlled ◽  
Sleep Arousal

The objective of this randomized controlled trial was to test whether a commercially available, mindfulness meditation mobile app, (i.e., Calm app), was effective in reducing fatigue (primary outcome), pre-sleep arousal, and daytime sleepiness (secondary outcomes) in adults with sleep disturbance (Insomnia Severity Index Score >10) as compared to a wait-list control group. Associations between the use of the Calm app (i.e., adherence to the intervention) and changes in sleep quality was also explored in the intervention group only. Adults with sleep disturbance were recruited (N = 640). Eligible and consenting participants (N = 263) were randomly assigned to the intervention (n = 124) or a wait-list control (n = 139) group. Intervention participants were asked to meditate using the Calm app ≥10 minutes/day for eight weeks. Fatigue, daytime sleepiness, and pre-sleep arousal were assessed at baseline, mid- (4-weeks) and post-intervention (8-weeks) in both groups, whereas sleep quality was evaluated only in the intervention group. Findings from intent-to-treat analyses suggest the use of the Calm app for eight weeks significantly decreased daytime fatigue (p = .018) as well as daytime sleepiness (p = .003) and cognitive (p = .005) and somatic (p < .001) pre-sleep arousal as compared to the wait-list control group. Within the intervention group, use of the Calm app was associated with improvements in sleep quality (p < .001). This randomized controlled trial demonstrates that the Calm app can be used to treat fatigue, daytime sleepiness, and pre-sleep arousal in adults with sleep disturbance. Given that the Calm app is affordable and widely accessible, these data have implications for community level dissemination of a mobile app to improve sleep-related symptoms associated with sleep disturbance. Trial registration: ClinicalTrials.gov NCT04045275.

scholarly journals A Mobile and Web-Based Self-Directed Complementary and Integrative Health Program for Veterans and Their Partners (Mission Reconnect): Protocol for a Mixed-Methods Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Jolie N Haun ◽  
Lisa M Ballistrea ◽  
Christine Melillo ◽  
Maisha Standifer ◽  
Kevin Kip ◽  
...  
Keyword(s):  
Posttraumatic Stress Disorder ◽  
Chronic Pain ◽  
Randomized Controlled Trial ◽  
Stress Disorder ◽  
Controlled Trial ◽  
Wait List ◽  
Web Based ◽  
Wait List Control ◽  
Integrative Health ◽  
Randomized Controlled

BACKGROUND Complementary and integrative health (CIH) is a viable solution to PTSD and chronic pain. Many veterans believe CIH can be performed only by licensed professionals in a health care setting. Health information technology can bring effective CIH to veterans and their partners. OBJECTIVE This paper describes the rationale, design, and methods of the Mission Reconnect protocol to deliver mobile and Web-based complementary and integrative health programs to veterans and their partners (eg, spouse, significant other, caregiver, or family member). METHODS This three-site, 4-year mixed-methods randomized controlled trial uses a wait-list control to determine the effects of mobile and Web-based CIH programs for veterans and their partners, or dyads. The study will use two arms (ie, treatment intervention arm and wait-list control arm) in a clinical sample of veterans with comorbid pain and posttraumatic stress disorder, and their partners. The study will evaluate the effectiveness and perceived value of the Mission Reconnect program in relation to physical and psychological symptoms, global health, and social outcomes. RESULTS Funding for the study began in November 2018, and we are currently in the process of recruitment screening and data randomization for the study. Primary data collection will begin in May 2019 and continue through May 2021. Projected participants per site will be 76 partners/dyads, for a total of 456 study participants. Anticipated study results will be published in November 2022. CONCLUSIONS This work highlights innovative delivery of CIH to veterans and their partners for treatment of posttraumatic stress disorder and chronic pain. CLINICALTRIAL ClinicalTrials.gov NCT03593772; https://clinicaltrials.gov/ct2/show/NCT03593772 (Archived by WebCite at http://www.webcitation.org/77Q2giwtw) INTERNATIONAL REGISTERED REPOR PRR1-10.2196/13666

scholarly journals Implementation of a School Physical Activity Policy Improves Student Physical Activity Levels: Outcomes of a Cluster-Randomized Controlled Trial

2020 ◽  
Vol 17 (10) ◽  
pp. 1009-1018
Author(s):  
Nicole K. Nathan ◽  
Rachel L. Sutherland ◽  
Kirsty Hope ◽  
Nicole J. McCarthy ◽  
Matthew Pettett ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Vigorous Physical Activity ◽  
Cluster Randomized Controlled Trial ◽  
Randomized Controlled ◽  
School Day ◽  
Cluster Randomized ◽  
The Impact

Aim: To assess the impact of a multistrategy intervention designed to improve teachers’ implementation of a school physical activity (PA) policy on student PA levels. Methods: A cluster-randomized controlled trial was conducted in 12 elementary schools. Policy implementation required schools to deliver 150 minutes of organized PA for students each week via physical education, sport, or class-based activities such as energizers. Schools received implementation support designed using the theoretical domains framework to help them implement the current policy. Results: A total of 1,502 children in kindergarten to grade 6 participated. At follow-up compared with control, students attending intervention schools had, measured via accelerometer, significantly greater increases in school day counts per minute (97.5; 95% confidence interval [CI], 64.5 to 130.4; P < .001) and moderate to vigorous physical activity (MVPA) (3.0; 95% CI, 2.2–3.8, P < .001) and a greater decrease in sedentary time (−2.1; 95% CI, −3.9 to −0.4, P = .02) per school day. Teachers in intervention schools delivered significantly more minutes (36.6 min) of PA to their students at follow-up (95% CI, 2.7–70.5, P = .04). Conclusions: Supporting teachers to implement a PA policy improves student PA. Additional strategies may be needed to support teachers to implement activities that result in larger gains in student MVPA.

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