The OptimalMe healthy lifestyle in preconception, pregnancy and postpartum (HiPPP) intervention: Trial protocol for a randomised controlled implementation effectiveness trial (Preprint)

2021 ◽  
Author(s):  
Cheryce L Harrison ◽  
Bonnie R Chivers ◽  
Rhonda Garad ◽  
Helena Teede
Keyword(s):  
Health Outcomes ◽  
Lifestyle Intervention ◽  
Study Design ◽  
Implementation Research ◽  
Healthy Lifestyle ◽  
Lifestyle Interventions ◽  
Implementation Effectiveness ◽  
Pregnancy And Postpartum ◽  
Healthy Lifestyle Interventions ◽  
Randomised Controlled

BACKGROUND Reproductive aged women are a high-risk population group for accelerated weight gain and obesity development, with pregnancy recognised as a critical contributory life-phase. Healthy lifestyle interventions during the antenatal period improve maternal and infant health outcomes, yet translation and implementation into real-world healthcare settings remains limited. OBJECTIVE OptimalMe is a randomised, hybrid implementation effectiveness study of an evidence based healthy lifestyle intervention. Which will evaluate intervention penetration and reach and the feasibility, acceptability, adoption and fidelity of the intervention implemented into, and in partnership with, private healthcare. Secondary outcomes include evaluation of individual health outcomes associated with implementation delivery mode, including knowledge, risk perception, health literacy, self-management and health behaviours. METHODS The study design is a parallel, two arm, randomised trial at the level of the individual. Three hundred participants aged 18-44, who are not pregnant, but wish to conceive within the next 12 months at point of recruitment and with access to the internet will be recruited. All participants will receive the same digital lifestyle intervention, OptimalMe, which is supported by health coaching and ongoing text messages across preconception, pregnancy and postpartum. Implementation delivery will be tested comparing two remote delivery methods for health coaching including telephone or video conferencing. All methods are theoretically underpinned by the Consolidated Framework for Implementation Research (CFIR) and outcomes based on the Reach, Engagement, Adaptation, Implementation and Maintenance (RE-AIM) and the Penetration, Implementation, Participation, Effectiveness (PIPE) frameworks. RESULTS The Monash Health Human Research and Ethics Committee has approved the study (reference: RES-19-0000291A, approved: 16 August 2019) which has been registered on the Australian and New Zealand Clinical Trial Registry (ACTRN12620001053910). The project is supported with funding from Medibank Private Ltd. Recruitment commenced in July 2020 with results expected to be published in 2022. CONCLUSIONS Our study design aligns with best practice implementation research, informed by evidence from across efficacy trials, integrated into systematic reviews, meta-analyses and guidelines. Results generated will inform translation of evidence from randomised controlled trials on healthy lifestyle interventions into practice targeting women across preconception, pregnancy and postpartum. Learnings will target consumers, program facilitators, health professionals, services and policy makers to inform future scale-up to ultimately benefit the health of women across these life-phases.ults expected to be published in 2022. CLINICALTRIAL ACTRN12620001053910

scholarly journals Cultural Adaptation of Evidence-Based Lifestyle Interventions for African American Men With Prostate Cancer: A Dyadic Approach

2020 ◽  
Vol 14 (6) ◽  
pp. 155798832094544
Author(s):  
Dalnim Cho ◽  
Karen Basen-Engquist ◽  
Chiara Acquati ◽  
Curtis Pettaway ◽  
Hilary Ma ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
African American ◽  
Cancer Survivors ◽  
Lifestyle Intervention ◽  
Cancer Progression ◽  
Healthy Lifestyle ◽  
African American Men ◽  
Evidence Based ◽  
Lifestyle Interventions ◽  
Intervention Adaptation

Although a number of lifestyle interventions have been developed for cancer survivors, the extent to which they are effective for African American men with cancer is unclear. Given that African American men have the highest prostate cancer burden and the lack of proven interventions, this study developed a culturally-tailored lifestyle intervention for African American men with prostate cancer and their partners that aimed to improve healthy lifestyle behaviors (physical activity and healthy eating) and quality of life. The aim of the present study is to provide a detailed overview of the model-based process of intervention adaptation. Based on the IM Adapt approach (Highfield et al., 2015) and Typology of Adaptation (Davidson et al., 2013), the present study adapted existing, evidence-based interventions to address African American prostate cancer survivors’ and their partners’ potential unmet needs including anxiety/uncertainty about cancer progression, communication between partners, cultural sensitivity, and concordance/discordance of motivation and behaviors between partners. The intervention adaptation was a comprehensive and fluid process. To the best knowledge of the author, this is the first couple-based lifestyle intervention specifically developed for African American men with prostate cancer. The present study will be highly informative to future investigators by providing flexible and detailed information regarding lifestyle intervention adaptation for racial/ethnic minority men with prostate cancer and their partners.

scholarly journals Healthy lifestyle interventions in general practice

2008 ◽  
Vol 50 (6) ◽  
pp. 6-14 ◽  
Author(s):  
MP Schwellnus ◽  
DN Patel ◽  
C Nossel ◽  
M Dreyer ◽  
S Whitesman ◽  
...  
Keyword(s):  
General Practice ◽  
Healthy Lifestyle ◽  
Lifestyle Interventions ◽  
Healthy Lifestyle Interventions

scholarly journals Towards Prepared mums (TOP-mums) for a healthy start, a lifestyle intervention for women with overweight and a child wish: study protocol for a randomised controlled trial in the Netherlands

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e030236
Author(s):  
Yvon E G Timmermans ◽  
Kim D G van de Kant ◽  
Dorien Reijnders ◽  
Lina M P Kleijkers ◽  
Edward Dompeling ◽  
...  
Keyword(s):  
Physical Activity ◽  
Smoking Cessation ◽  
Randomised Controlled Trial ◽  
Breast Milk ◽  
Lifestyle Intervention ◽  
Controlled Trial ◽  
Lifestyle Interventions ◽  
Perinatal Complications ◽  
National Implementation ◽  
Randomised Controlled

IntroductionPericonception obesity is associated with a higher risk for adverse perinatal outcomes such as gestational diabetes mellitus, preeclampsia, large for gestational age, operative delivery and preterm birth. Lifestyle interventions during pregnancy have resulted in insufficient effects on reducing these perinatal complications. A few reasons for this disappointing effect can be suggested: (1) the time period during pregnancy for improvement of developmental circumstances is too short; (2) the periconception period in which complications originate is not included; and (3) lifestyle interventions may not have been sufficiently multidisciplinary and customised. A preconception lifestyle intervention might be more effective to reduce perinatal complications. Therefore, the aim of the Towards Prepared mums study is to evaluate the effect of a lifestyle intervention starting prior to conception on lifestyle behaviour change.Methods and analysisThis protocol outlines a non-blinded, randomised controlled trial. One hundred and twelve women (18–40 years of age) with overweight or obesity (body mass index≥25.0 kg/m2) who plan to conceive within 1 year will be randomised to either the intervention or care as usual group. The intervention group will receive a multidisciplinary, customised lifestyle intervention stimulating physical activity, a healthy diet and smoking cessation, if applicable. The lifestyle intervention and monitoring will take place until 12 months postpartum. The primary outcome is difference in weight in kg from baseline to 6 weeks postpartum. Secondary outcomes are gestational weight gain, postpartum weight retention, smoking cessation, dietary and physical activity habits. Furthermore, exploratory outcomes include body composition, cardiometabolic alterations, time to pregnancy, need for assisted reproductive technologies, perinatal complications of mother and child, and lung function of the child. Vaginal and oral swabs, samples of faeces, breast milk, placenta and cord blood will be stored for evaluation of microbial flora, epigenetic markers and breast milk composition. Furthermore, a cost-effectiveness analysis will take place.Ethics and disseminationEthical approval was obtained from the Medical Ethical Committee of Maastricht University Medical Centre+ (NL52452.068.15/METC152026). Knowledge derived from this study will be made available by publications in international peer-reviewed scientific journals and will be presented at (inter)national scientific conferences. A dissemination plan for regional and national implementation of the intervention is developed.Trial registration numberClinicalTrials.gov NCT02703753.

scholarly journals Healthy lifestyle interventions in general practice

2008 ◽  
Vol 50 (4) ◽  
pp. 6-12 ◽  
Author(s):  
EW Derman ◽  
D N Patel ◽  
CJ Nossel ◽  
MP Schwellnus
Keyword(s):  
General Practice ◽  
Healthy Lifestyle ◽  
Lifestyle Interventions ◽  
Healthy Lifestyle Interventions

scholarly journals Individual differences in processes of lifestyle changes among people with obesity: an acceptance and commitment therapy (ACT) intervention in a primary health care setting

2020 ◽  
Vol 21 ◽  
Author(s):  
Kirsti Kasila ◽  
Suvi Vainio ◽  
Mari Punna ◽  
Päivi Lappalainen ◽  
Raimo Lappalainen ◽  
...  
Keyword(s):  
Health Care ◽  
Primary Health Care ◽  
Lifestyle Intervention ◽  
Acceptance And Commitment Therapy ◽  
Healthy Lifestyle ◽  
Lifestyle Changes ◽  
Learning Processes ◽  
Lifestyle Interventions ◽  
Primary Health ◽  
Acceptance And Commitment

Abstract Aim: To explore what thoughts, feelings, and learning processes were involved in obese participants’ lifestyle change during an acceptance and commitment therapy (ACT) lifestyle intervention delivered in primary health care. Background: Previous studies have revealed that lifestyle interventions are effective at promoting initial weight loss, but reduced weight is often difficult to sustain because of the failure to maintain healthy lifestyle changes. Achieving and maintaining lifestyle changes requires to learn self-regulation skills. ACT-based lifestyle interventions combine many self-regulatory skill factors, and the results from previous studies are promising. Research on the individual learning processes of lifestyle change is still needed. Methods: This study investigated a subset of data from a larger web-based lifestyle intervention. This subset consisted of online logbooks written by 17 obese participants (n = 17, body mass index mean 41.26 kg/m2) during the six-week online module. The logbooks were analyzed via data-driven content analysis. Findings: Four groups were identified based on the participants being at different phases in their lifestyle changes: stuck with barriers, slowly forward, reflective and hardworking, and convincingly forward with the help of concrete goals. Differences between the groups were manifested in personal barriers, goal setting, training of mindfulness and acceptance, and achieving healthy actions. The ACT-based lifestyle intervention offered participants an opportunity to reflect on how their thoughts and feelings may hinder healthy lifestyle changes and provided tools for learning psychological flexibility.

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