scholarly journals The Healthy Children, Strong Families 2 (HCSF2) Randomized Controlled Trial Improved Healthy Behaviors in American Indian Families with Young Children

2018 ◽  
Vol 3 (Supplement_2) ◽  
pp. 53-62 ◽  
Author(s):  
Emily J Tomayko ◽  
Ronald J Prince ◽  
Kate A Cronin ◽  
KyungMann Kim ◽  
Tassy Parker ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Health Behaviors ◽  
Obesity Prevention ◽  
Screen Time ◽  
Healthy Lifestyle ◽  
Controlled Trial ◽  
Healthy Children ◽  
Randomized Controlled ◽  
Home Based

ABSTRACT Background American Indian (AI) families experience a disproportionate risk of obesity due to a number of complex reasons, including poverty, historic trauma, rural isolation or urban loss of community connections, lack of access to healthy foods and physical activity opportunities, and high stress. Home-based obesity prevention interventions are lacking for these families. Objective Healthy Children, Strong Families 2 (HCSF2) was a randomized controlled trial of a healthy lifestyle promotion/obesity prevention intervention for AI families. Methods Four hundred and fifty dyads consisting of an adult primary caregiver and a child ages 2 to 5 y from 5 AI communities were randomly assigned to a monthly mailed healthy lifestyle intervention toolkit (Wellness Journey) with social support or to a child safety control toolkit (Safety Journey) for 1 y. The Wellness Journey toolkit targeted increased fruit/vegetable (F/V) intake and physical activity, improved sleep, decreased added sugar intake and screen time, and improved stress management (adults only). Anthropometrics were collected, and health behaviors were assessed via survey at baseline and at the end of Year 1. Adults completed surveys for themselves and the participating child. Repeated measures analysis of variance was used to assess change over the intervention period. Results Significant improvements to adult and child healthy diet patterns, adult F/V intake, adult moderate-to-vigorous physical activity, home nutrition environment, and adult self-efficacy for health behavior change were observed in Wellness Journey compared with Safety Journey families. No changes were observed in adult body mass index (BMI), child BMI z-score, adult stress measures, adult/child sleep and screen time, or child physical activity. Qualitative feedback suggests the intervention was extremely well-received by both the families and our community partners across the 5 participating sites. Conclusions This multi-site community-engaged intervention addressed key gaps regarding family home-based approaches for early obesity prevention in AI communities and showed several significant improvements in health behaviors. Multiple communities are working to sustain intervention efforts. This trial was registered at clinicaltrials.gov as NCT01776255.

scholarly journals Effects of the Preschool-Based Family-Involving DAGIS Intervention Program on Children’s Energy Balance-Related Behaviors and Self-Regulation Skills: A Clustered Randomized Controlled Trial

Nutrients ◽  
2020 ◽  
Vol 12 (9) ◽  
pp. 2599 ◽  
Author(s):  
Carola Ray ◽  
Rejane Figuereido ◽  
Henna Vepsäläinen ◽  
Reetta Lehto ◽  
Riikka Pajulahti ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Energy Balance ◽  
Repeated Measures ◽  
Screen Time ◽  
Controlled Trial ◽  
Self Regulation ◽  
Control Group ◽  
Randomized Controlled ◽  
Multicomponent Intervention

The study examines the effects of a preschool-based family-involving multicomponent intervention on children’s energy balance-related behaviors (EBRBs) such as food consumption, screen time and physical activity (PA), and self-regulation (SR) skills, and whether the intervention effects differed among children with low or high parental educational level (PEL) backgrounds. The Increased Health and Wellbeing in Preschools (DAGIS) intervention was conducted as a clustered randomized controlled trial, clustered at preschool level, over five months in 2017–2018. Altogether, 802 children aged 3–6 years in age participated. Parents reported children’s consumption of sugary everyday foods and beverages, sugary treats, fruits, and vegetables by a food frequency questionnaire, and screen time by a 7-day diary. Physical activity was assessed by a hip-worn accelerometer. Cognitive and emotional SR was reported in a questionnaire by parents. General linear mixed models with and without repeated measures were used as statistical methods. At follow-up, no differences were detected in EBRBs or SR skills between the intervention and control group, nor did differences emerge in children’s EBRBs between the intervention and the control groups when stratified by PEL. The improvement in cognitive SR skills among low PEL intervention children differed from low PEL control children, the significance being borderline. The DAGIS multicomponent intervention did not significantly affect children’s EBRBs or SR. Further sub-analyses and a comprehensive process evaluation may shed light on the non-significant findings.

scholarly journals Home-based physical activity in breast cancer patients and cardiorespiratory fitness: during and/or after chemotherapy? A three-arm randomized controlled trial (APAC)

2020 ◽  
Author(s):  
Francois Vincent ◽  
Elise Deluche ◽  
Joelle Bonis ◽  
Sophie Leobon ◽  
Marie-Thérèse Antonini ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Cardiorespiratory Fitness ◽  
Controlled Trial ◽  
Categorical Variables ◽  
Randomized Controlled ◽  
Home Based ◽  
Group A ◽  
Group B

Abstract ObjectivesAdapted physical activity (APA) program is recommended for breast cancer care. However, their modalities have not been defined. The aim of this study was to determine the best time to begin APA. This randomized controlled trial evaluated at 12 months the effect of home-based APA performed during and/or after treatment on cardiorespiratory fitness. The primary endpoint was peak oxygen consumption (VO2peak) compared at 12 months (group A vs C and B vs C). Secondary endpoints included the 6-min walking test (6MWT), assessment of muscular strength, fatigue, quality of life, anxiety, and depression, and a questionnaire of PA levels. All tests were evaluated at baseline, 6 months, and 12 months.MethodA total of 94 patients with breast cancer were randomized to three different groups: group A, performing 6 months of APA during adjuvant care; group B, 6 months of APA after adjuvant care; and group C, 12 months of APA during and after specific care. The program combined one resistance session and two aerobic sessions per week. Analysis of variance was used for repeated measures, Student’s t-test or the Mann–Whitney U-test for continuous variables, and χ2 test for binary or categorical variables.Results A total of 81 participants were assessed at 6 months and 73 participants at 12 months. The majority of patients completed more than 85% of the exercise sessions. The baseline for VO2peak and secondary outcomes did not differ among the groups. VO2peak increased during the exercise period and decreased during the chemotherapy period without APA, but at 12 months no significant difference was observed. The same variations were observed in the 6MWT, with a significance at 6 months between A+C vs. B (p=0.04), but no difference among the groups at 12 months. In the three groups, no decrease in other studied parameters were noted, except at 6 months in group B without APA. ConclusionsHome-based APA in breast cancer survivors can decrease some of the negative side effects of cancer treatment and has a positive effect on physical function with no differences based on the timing of this program.TRIAL REGISTRATIONClinicalTrials.gouv.fr (NCT01795612). Registered 20 February 2013,https://clinicaltrials.gov/ct2/show/NCT01795612?term=APAC&draw=2&rank=3

scholarly journals Promoting Physical Activity With Self-Tracking and Mobile-Based Coaching for Cardiac Surgery Patients During the Discharge–Rehabilitation Gap: Protocol for a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Chao Zhang ◽  
Mohamed Soliman-Hamad ◽  
Roxanne Robijns ◽  
Niels Verberkmoes ◽  
Frank Verstappen ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Exercise Program ◽  
Digital Technologies ◽  
Bicycle Ergometer ◽  
Randomized Controlled ◽  
Home Based ◽  
Ergometer Test ◽  
Bicycle Ergometer Test

BACKGROUND Home-based cardiac rehabilitations (CRs) with digital technologies have been researched and implemented to replace, augment, and complement traditional center-based CR in recent years with considerable success. One problem that technology-enhanced home-based CR can potentially address is the gap between cardiac interventions and formal CR programs. In the Netherlands and some other countries (eg, Australia), patients after cardiac interventions stay at home for 3-4 weeks without much support from their physicians, and often engage in very little physical activity (PA). A home-based exercise program enabled by digital technologies may help patients to better prepare for the later center-based CR programs, potentially increasing the uptake rate of those programs. OBJECTIVE In a randomized controlled trial (RCT), we will evaluate the effectiveness of a home-based walking exercise program enhanced by self-tracking and mobile-based coaching (treatment condition), comparing it with a version of the same program without these technologies (control condition). The added value of the digital technologies is justified if patients in the treatment group walk more steps on average (primary outcome) and show better physical fitness in a bicycle ergometer test and higher self-efficacy toward PA (secondary outcomes). METHODS Based on a power analysis, we will recruit 100 cardiac patients and assign them evenly to the 2 parallel groups. Eligible patients are those who are scheduled in the postanesthesia care unit, know the Dutch language, have basic literacy of using smartphones, and are without medical conditions that may increase risks associated with PA. In a face-to-face meeting with a nurse practitioner, all patients are prescribed a 3-week exercise program at home (2 walking exercises per day with increasing duration), based on national and international guidelines and tailored to their physical conditions after cardiac intervention. Their physical activities (daily steps) will be measured by the Axivity AX3 accelerometer worn at hip position. Patients in the treatment group will also be supported by a Neo Health One self-tracking device and a mobile platform called Heart Angel, through which they are monitored and coached by their nurses. After the study, all patients will perform a bicycle ergometer test and return the devices within 1 week. In addition, 5 questionnaires will be sent to the patients by emails to assess their self-efficacy toward PA and other psychological states for exploratory analyses (at discharge, at the end of each monitoring week, and 1 week after the study). To minimize bias, the randomization procedure will be performed after introducing the exercise program, so the nurse practitioners are blind to the experimental conditions until that point. RESULTS The study protocol has been approved by the Medical Research Ethics Committees United on February 26, 2018 (NL 62142.100.17/R17.51). By the end of 2018, we completed a small pilot study with 8 patients and the results based on interviews and app usage data suggest that a larger clinical trial with the targeted population is feasible. We expect to complete the RCT by the end of 2021, and statistical analyses will follow. CONCLUSIONS Results of the RCT will help us to test the hypothesized benefits of self-tracking and mobile-based coaching for cardiac patients in home-based exercise programs during the discharge–rehabilitation gap. If the results are positive, cost-effectiveness analysis will be performed based on the insights of the study to inform the translation of the technology-enhanced program to clinical practice. We also note limitations of the trial in the discussion. CLINICALTRIAL Registered at Netherlands Trial Register NL8040; https://www.trialregister.nl/trial/8040 INTERNATIONAL REGISTERED REPORT PRR1-10.2196/16737

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