The ‘healthy Dads, Healthy Kids’ randomised controlled trial: Efficacy of a healthy lifestyle program for overweight fathers and their children

2010 ◽  
Vol 4 ◽  
pp. S71
Author(s):  
P.J. Morgan ◽  
D.R. Lubans ◽  
R. Callister ◽  
A.D. Okely ◽  
T.L. Burrows ◽  
...  
Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Emma Robson ◽  
Steven J. Kamper ◽  
Alix Hall ◽  
Hopin Lee ◽  
Simon Davidson ◽  
...  

Abstract Background This paper describes the statistical analysis plan for a randomised controlled trial of a Healthy Lifestyle Program (HeLP) for low back pain targeting multiple health risks and behaviours, weight, physical activity, diet and smoking, to improve disability. We describe the methods for the main analyses and economic analysis of the trial. Methods and design The trial is a two-arm pragmatic randomised controlled trial comparing the effect of the HeLP intervention to usual care on low back pain disability at 26 weeks. A total of 346 adults with low back pain were recruited from the Newcastle and Hunter region between September 2017 and November 2019 and randomised to either HeLP or usual care. HeLP is a 6-month intervention with participant outcomes measured at weeks 6, 12, 26 and 52 post randomisation. This statistical analysis plan describes data integrity, handling and preparation of data for analyses and methods for analyses. The primary endpoint for the trial is disability at 26 weeks using the 24-item self-report Roland Morris Disability Questionnaire. The primary analysis will follow the intention-to-treat principle using linear mixed regression models. Discussion The statistical analysis plan for this trial was produced to reduce outcome reporting bias arising from knowledge of the study findings. Any deviations will be described and justified in the final report. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12617001288314. Registered on 6 September 2017.


Trials ◽  
2015 ◽  
Vol 16 (1) ◽  
Author(s):  
Leopoldo J. Cabassa ◽  
Ana Stefancic ◽  
Kathleen O’Hara ◽  
Nabila El-Bassel ◽  
Roberto Lewis-Fernández ◽  
...  

Circulation ◽  
2014 ◽  
Vol 129 (suppl_1) ◽  
Author(s):  
Steven Barnett ◽  
Erika Sutter ◽  
Thomas Pearson ◽  

Introduction: Deaf people who use American Sign Language (ASL) comprise linguistic and cultural minority populations without access to language-concordant health information and healthcare. Deaf ASL users are rarely included in health research or public health surveillance. Recent research with Deaf ASL users found a higher prevalence of obesity than in the general population. No randomized trials of lifestyle modification or weight reduction have ever been attempted with Deaf ASL users. Methods: We worked with the Rochester (NY) Deaf community to adapt a 16-week healthy lifestyle program previously shown to be effective with hearing people. We adapted the curriculum and research measures to be culturally and linguistically appropriate. We used a group intervention format recommended by our Deaf partners, and trained group leaders who were Deaf, ASL fluent and had backgrounds in counseling, public health, or healthcare. For this Deaf Weight Wise (DWW) trial, we recruited Deaf adults aged 40-70 with a BMI of 25-45 from community settings, and randomized participants to immediate intervention or intervention delayed 1 year. We will collect data from DWW trial participants over two years. We present analyses of data after 6 months here. Primary outcomes were changes in weight, BMI and scores on two standard measures: Dietary Risk Assessment (DRA) and Physical Activity Assessment (PAA). We used group by time repeated measures ANOVA to examine changes from baseline to 6 months for the immediate group and delayed group (no intervention yet). Hypothesis: The immediate intervention group would have greater reduction in weight and BMI as well as improvement in DRA and PAA scores six months after baseline compared with the delayed intervention group. Results: At baseline, the 104 participants’ mean age was 53.5 years; 68.3% (71 of 104) were female and 91.3% (95/104) were White. Randomization was successful based on baseline data. At 6 months, the immediate group weight changed -3.35kg (1.0 s.e.; p=.002) and BMI changed -1.35 (0.4 s.e.; p≤.0001) compared with the delayed group. Most of the immediate group (58.3%, 28/48) lost ≥ 5% of baseline weight versus 14.3% (8/56) of the delayed group (p≤.0001). Changes in mean DRA (p=.055) and moderate PAA (p=.054) scores numerically favored the immediate group. Conclusions: Deaf Weight Wise is the first randomized controlled trial of a healthy lifestyle program with Deaf ASL users. This culturally appropriate and language accessible behavioral intervention was feasible and highly effective with this underserved and rarely studied population.


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