Designing Ruby: a brief digital randomized controlled trial for internalized weight bias (Preprint)

2021 ◽  
Author(s):  
Christina Maria Hopkins ◽  
Hailey N. Miller ◽  
Taylor L. Brooks ◽  
Lihua Mo-Hunter ◽  
Dori M. Steinberg ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Data Collection ◽  
Controlled Trial ◽  
Weight Bias ◽  
Health Concern ◽  
Randomized Controlled ◽  
Self Compassion ◽  
Weight Bias Internalization ◽  
Body Concerns ◽  
Internalized Weight Bias

UNSTRUCTURED Weight bias internalization – also known as weight self-stigma - is a serious health concern for individuals at higher body weights. Weight bias internalization is associated with more avoidance of healthcare and health-promoting activities, more disordered eating, more social isolation, and weight gain. Elevated weight bias internalization has been associated with low self-compassion, yet few investigations have explored self-compassion as a potential mechanism in reduction of internalized weight bias. Ruby is a two-arm randomized controlled trial designed to test the efficacy of a 4-week digital self-compassion intervention to reduce internalized weight bias, compared to wait list control. Adults with elevated internalized weight bias and a body mass index over 30 kg/m2 (n=80) will be recruited. Ruby is a standalone digital trial and will be delivered entirely via smartphone using web-based data collection and text messages. Intervention content will include psychoeducation and daily mindfulness practices with a focus on self-compassion and body concerns. We will use intent-to-treat analyses to examine changes in weight bias internalization over time by treatment arm using one-way analysis of covariance (ANCOVA) models and linear mixed models. The present protocol was designed in May 2020 and approved in December 2020. Data collection is currently underway. Ruby will be the first digital standalone self-compassion based intervention designed to reduce internalized weight bias. Due to its standalone digital delivery, Ruby may be a highly-scalable treatment for internalized weight bias that can be delivered on its own or combined with other treatments. We expect Ruby to be accessible to many, as participants can access the digital intervention at times of the day most convenient in their schedule and are not burdened by in-person time commitments, which can be a barrier for participants with competing demands on their time and resources. If efficacious, Ruby will be poised to expand a burgeoning body of literature related to psychological intervention in this area of need.

scholarly journals Designing Ruby: a brief digital randomized controlled trial for internalized weight bias (Preprint)

10.2196/31307 ◽  
2021 ◽  
Author(s):  
Christina Maria Hopkins ◽  
Hailey N. Miller ◽  
Taylor L. Brooks ◽  
Lihua Mo-Hunter ◽  
Dori M. Steinberg ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Weight Bias ◽  
Randomized Controlled ◽  
Internalized Weight Bias

scholarly journals Group versus individual antenatal and first year postpartum care: Study protocol for a multi-country cluster randomized controlled trial in Kenya and Nigeria

2019 ◽  
Vol 2 ◽  
pp. 56 ◽  
Author(s):  
Mark M. Kabue ◽  
Lindsay Grenier ◽  
Stephanie Suhowatsky ◽  
Jaiyeola Oyetunji ◽  
Emmanuel Ugwa ◽  
...  
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Data Collection ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Phase 1 ◽  
First Year ◽  
Phase 2 ◽  
Randomized Controlled ◽  
Cluster Randomized

Background: Antenatal care (ANC) in many low- and middle-income countries is under-utilized and of sub-optimal quality. Group ANC (G-ANC) is an intervention designed to improve the experience and provision of ANC for groups of women (cohorts) at similar stages of pregnancy. Methods: A two-arm, two-phase, cluster randomized controlled trial (cRCT) (non-blinded) is being conducted in Kenya and Nigeria. Public health facilities were matched and randomized to either standard individual ANC (control) or G-ANC (intervention) prior to enrollment. Participants include pregnant women attending first ANC at gestational age <24 weeks, health care providers, and sub-national health managers. Enrollment ended in June 2017 for both countries. In the intervention arm, pregnant women are assigned to cohorts at first ANC visit and receive subsequent care together during five meetings facilitated by a health care provider (Phase 1). After birth, the same cohorts meet four times over 12 months with their babies (Phase 2). Data collection was performed through surveys, clinical data extraction, focus group discussions, and in-depth interviews. Phase 1 data collection ended in January 2018 and Phase 2 concludes in November 2018. Intention-to-treat analysis will be used to evaluate primary outcomes for Phases 1 and 2: health facility delivery and use of a modern method of family planning at 12 months postpartum, respectively. Data analysis and reporting of results will be consistent with norms for cRCTs. General estimating equation models that account for clustering will be employed for primary outcome analyzes. Results: Overall 1,075 and 1,013 pregnant women were enrolled in Nigeria and Kenya, respectively. Final study results will be available in February 2019. Conclusions: This is the first cRCT on G-ANC in Africa. It is among the first to examine the effects of continuing group care through the first year postpartum. Registration: Pan African Clinical Trials Registry PACTR201706002254227 May 02, 2017

scholarly journals Comparing a Mobile Phone Automated System With a Paper and Email Data Collection System: Substudy Within a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Diana M Bond ◽  
Jeremy Hammond ◽  
Antonia W Shand ◽  
Natasha Nassar
Keyword(s):  
Randomized Controlled Trial ◽  
Data Collection ◽  
Cost Analysis ◽  
Mobile Phone ◽  
Response Rate ◽  
Controlled Trial ◽  
Treatment Compliance ◽  
Automated System ◽  
Collection System ◽  
Randomized Controlled

BACKGROUND Traditional data collection methods using paper and email are increasingly being replaced by data collection using mobile phones, although there is limited evidence evaluating the impact of mobile phone technology as part of an automated research management system on data collection and health outcomes. OBJECTIVE The aim of this study is to compare a web-based mobile phone automated system (MPAS) with a more traditional delivery and data collection system combining paper and email data collection (PEDC) in a cohort of breastfeeding women. METHODS We conducted a substudy of a randomized controlled trial in Sydney, Australia, which included women with uncomplicated term births who intended to breastfeed. Women were recruited within 72 hours of giving birth. A quasi-randomized number of women were recruited using the PEDC system, and the remainder were recruited using the MPAS. The outcomes assessed included the effectiveness of data collection, impact on study outcomes, response rate, acceptability, and cost analysis between the MPAS and PEDC methods. RESULTS Women were recruited between April 2015 and December 2016. The analysis included 555 women: 471 using the MPAS and 84 using the PEDC. There were no differences in clinical outcomes between the 2 groups. At the end of the 8-week treatment phase, the MPAS group showed an increased response rate compared with the PEDC group (56% vs 37%; <i>P</i>&lt;.001), which was also seen at the 2-, 6-, and 12-month follow-ups. At the 2-month follow-up, the MPAS participants also showed an increased rate of self-reported treatment compliance (70% vs 56%; <i>P</i>&lt;.001) and a higher recommendation rate for future use (95% vs 64%; <i>P</i>&lt;.001) as compared with the PEDC group. The cost analysis between the 2 groups was comparable. CONCLUSIONS MPAS is an effective and acceptable method for improving the overall management, treatment compliance, and methodological quality of clinical research to ensure the validity and reliability of findings.

scholarly journals The ESCAPS study: a feasibility randomized controlled trial of early electrical stimulation to the wrist extensors and flexors to prevent post-stroke complications of pain and contractures in the paretic arm

2019 ◽  
Vol 33 (12) ◽  
pp. 1919-1930
Author(s):  
Joanna C Fletcher-Smith ◽  
Dawn-Marie Walker ◽  
Kate Allatt ◽  
Nikola Sprigg ◽  
Marilyn James ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Electrical Stimulation ◽  
Data Collection ◽  
Usual Care ◽  
Controlled Trial ◽  
Cost Effective ◽  
Outcome Data ◽  
Attrition Rates ◽  
Post Stroke ◽  
Randomized Controlled

Objective: To establish feasibility of initiating electrical stimulation treatment of wrist extensors and flexors in patients early after stroke to prevent muscle contractures and pain. Design: Feasibility randomized controlled trial with economic evaluation. Setting: A specialist stroke unit in Nottinghamshire. Subjects: A total of 40 patients recruited within 72 hours post-stroke with arm hemiparesis. Interventions: Participants were randomized to receive usual care or usual care and electrical stimulation to wrist flexors and extensors for 30 minutes, twice a day, five days a week for three months. Initial treatment was delivered by an occupational therapist or physiotherapist who trained participants to self-manage subsequent treatments. Measures: Measures of feasibility included recruitment and attrition rates, completion of treatment, and successful data collection. Outcome data on wrist range of motion, pain, arm function, independence, quality of life, and resource use were measured at 3-, 6-, and 12-months post-randomization. Results: A total of 40 participants (of 215 potentially eligible) were recruited in 15 months (20 men; mean age: 72 (SD: 13.0)). Half the participants lacked mental capacity and were recruited by consultee consent. Attrition at three-month follow-up was 12.5% (death ( n = 2), end-of-life care ( n = 2), and unable to contact ( n = 1)). Compliance varied (mean: 65 (SD: 53)) and ranged from 10 to 166 treatments per patient (target dosage was 120). Data for a valid economic analysis can be adequately collected. Conclusion: Early initiation of electrical stimulation was acceptable and feasible. Data collection methods used were feasible and acceptable to participants. A large definitive study is needed to determine if electrical stimulation is efficacious and cost effective.

Improving Women's Self‐Compassion Through an Online Program: A Randomized Controlled Trial

2020 ◽  
Vol 99 (1) ◽  
pp. 47-59
Author(s):  
Miranda M. Nadeau ◽  
Norian A. Caporale‐Berkowitz ◽  
Aaron B. Rochlen
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Online Program ◽  
Randomized Controlled ◽  
Self Compassion

Reducing Body Image–Related Distress in Women With Breast Cancer Using a Structured Online Writing Exercise: Results From the My Changed Body Randomized Controlled Trial

2018 ◽  
Vol 36 (19) ◽  
pp. 1930-1940 ◽  
Author(s):  
Kerry A. Sherman ◽  
Astrid Przezdziecki ◽  
Jessica Alcorso ◽  
Christopher Jon Kilby ◽  
Elisabeth Elder ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Body Image ◽  
Randomized Controlled Trial ◽  
Psychological Distress ◽  
Expressive Writing ◽  
Controlled Trial ◽  
Mediating Effect ◽  
Body Appreciation ◽  
Randomized Controlled ◽  
Self Compassion

Purpose Breast cancer treatment adverse effects result in one in three survivors experiencing body image–related distress (BID) that negatively impacts on a woman’s ability to recover after cancer and into survivorship. My Changed Body (MyCB) is a Web-based psychological intervention to alleviate BID and improve body appreciation in survivors of breast cancer (BCSs) through a single-session, self-compassion focused writing activity. This randomized controlled trial evaluated the impact of MyCB on BID and body appreciation in BCSs. The moderating effect of lymphedema status (affected or unaffected) and appearance investment (self-importance placed on personal appearance) and the mediating effect of self-compassion were evaluated. Patients and Methods Women (disease-free stage I to III BCSs who had experienced at least one negative event related to bodily changes after breast cancer) were randomly assigned to MyCB (n = 149) or an expressive writing control arm (n = 155). Primary outcomes were reduction in BID and improvement in body appreciation 1 week after intervention. Secondary outcomes included psychological distress (depression and anxiety) and self-compassion. Follow-up assessments occurred 1 week, 1 month, and 3 months after writing. Results Compliance with the MyCB intervention was 88%, and attrition was 9.2%. Intent-to-treat linear mixed models indicated that participants who received MyCB reported significantly less BID ( P = .035) and greater body appreciation ( P = .004) and self-compassion ( P < .001) than expressive writing participants. Intervention effects on BID were moderated by lymphedema status ( P = .007) and appearance investment ( P = .042). Self-compassion mediated effects on both primary outcomes. Therapeutic effects were maintained at 1 month (BID and body appreciation) and 3 months (body appreciation) after intervention. Significant reductions in psychological distress (1-month depression, P = .001; 1-week and 1-month anxiety, P = .007) were evident for MyCB participants with lymphedema. Conclusion This study supports the efficacy of MyCB for reducing BID and enhancing body appreciation among BCSs.

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