Exploring Empathy and Compassion Using Digital Narratives (the Learning to Care project): A Study Protocol (Preprint)

BACKGROUND Digital stories – first-person, self-made, 2-3-minute videos – generate awareness, impart knowledge, and promote understanding around topics like mental illness. Digital stories are a narrative-based art form often created by individuals without formal training in filmmaking to relate personal experiences. Somewhat like digital narratives, video testimonies created within the social marketing or fundraising campaigns of government agencies and private or public corporations aim to reduce the stigma of mental illness while supporting research and services. In video testimonies personal stories are captured on camera by professional filmmakers. Sharing critical life events greatly benefits tellers and listeners alike, supporting catharsis, healing, connectiveness, and citizenship. OBJECTIVE The proposed study explores digital stories and video testimonies featuring mental illness and recovery in their ability to elicit empathy and compassion while reducing stigma among viewers. METHODS Using mixed methods, Phase 1 will involve a search of Canadian social marketing activities and fundraising campaigns concerning mental illness and recovery while organizing digital storytelling workshops in which participants create digital stories about their own experiences of mental illness and recovery. During Phase 2, a pilot randomized controlled trial will be undertaken to compare marketing and fundraising campaigns versus digital stories for their impact on viewers. RESULTS Ethics approval was received in March 2021.Data on feasibility of the study design and results of the controlled trial will be generated. This study will produce new knowledge on effective ways of promoting mental health awareness and decreasing stigma with practical importance for future social marketing and fundraising campaigns. Anticipated time to completion within the two-year study period includes nine months for Phase 1 (preparation), eleven months for Phase 2 (feasibility assessment and data collection: RCT) and two months for Phase 3 (knowledge dissemination). CONCLUSIONS The knowledge generated will have practical implications for the public and for future social marketing and fundraising campaigns promoted by government agencies as well as non-profit and for-profit organizations by enhancing our understanding of how individuals and societies respond to stories of suffering and what prompts citizens to help others. CLINICALTRIAL ClinicalTrials.gov Identifier: NCT04881084

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Impact of oral-health-related quality of life and self-esteem on patients with missing maxillary lateral incisor after orthodontic space closure: a single-blinded, randomized, controlled trial

European Journal of Orthodontics ◽

10.1093/ejo/cjaa075 ◽

2020 ◽

Author(s):

Matheus Melo Pithon ◽

Eduardo Otero Amaral Vargas ◽

Raildo da Silva Coqueiro ◽

Rogério Lacerda-Santos ◽

Orlando Motohiro Tanaka ◽

...

Keyword(s):

Oral Health ◽

Controlled Trial ◽

Phase 1 ◽

Self Esteem ◽

Lateral Incisor ◽

Phase 2 ◽

Space Closure ◽

Related Quality ◽

Health Related ◽

Maxillary Lateral Incisor

Summary Background The maxillary lateral incisor is one of the teeth most likely to suffer agenesis, resulting in spacing between the central incisor and the canine. Objective To compare maxillary lateral incisor agenesis with space closure treatment versus non-treatment based on measurements of the self-perceived oral-health-related quality of life (OHRQoL) and self-esteem of the participants. Subjects and methods A total of 44 people, aged 17–49 years, with missing lateral incisors were randomly assigned to two groups (n = 22 in each)—a treated group in which the space was orthodontically closed (TG) and a control group that remained untreated (CG). Randomization was performed by a researcher who was not involved in the clinical part of the study. The outcomes were assessed using the Oral Health Impact Profile and Rosenberg’s Self-Esteem Scale, which were applied before (phase 1) and after (phase 2) the orthodontic treatment in the TG, and at baseline (phase 1) and 12 months after (phase 2) in the CG. All the data were blindly evaluated, supporting the single-blinded design of the study. Results All participants finished the randomized controlled trial, and the demographic characteristics were similar between the groups. In phase 1, the levels of self-esteem and OHRQoL at baseline were similar (P = 0.079, P = 0.693, respectively). In phase 2, the self-esteem scores of the CG decreased and the OHRQoL increased (P = 0.005, P < 0.001, respectively), while self-esteem increased in the TG and the OHRQoL decreased (P < 0.001). The CG had lower scores than the TG for self-esteem, but the opposite was observed for OHRQoL (P < 0.001). Limitations Information bias may have occurred. Since the questionnaires could not have been applied at the same time in both groups, the time difference between the two assessments may have led to random and systematic error. Conclusions The spacing resulting from missing maxillary lateral incisors had a negative impact on the OHRQoL and self-esteem of the participants, while orthodontically closing those spaces had a positive impact on those aspects. Clinical trial registration This study was not registered. Protocol The protocol was not published before trial commencement.

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

Gates Open Research ◽

10.12688/gatesopenres.12867.2 ◽

2019 ◽

Vol 2 ◽

pp. 56 ◽

Cited By ~ 1

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

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Socio-Ecological Natural Experiment with Randomized Controlled Trial to Promote Active Commuting to Work: Process Evaluation, Behavioral Impacts, and Changes in the Use and Quality of Walking and Cycling Paths

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph16091661 ◽

2019 ◽

Vol 16 (9) ◽

pp. 1661 ◽

Cited By ~ 1

Author(s):

Minna Aittasalo ◽

Johanna Tiilikainen ◽

Kari Tokola ◽

Jaana Suni ◽

Harri Sievänen ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Natural Experiment ◽

Controlled Trial ◽

Phase 1 ◽

Active Commuting ◽

Phase 2 ◽

Behavioral Strategies ◽

Beneficial Effects ◽

Randomized Controlled ◽

Journey To Work

Active commuting to work (ACW) has beneficial effects on health, traffic, and climate. However, more robust evidence is needed on how to promote ACW. This paper reports the findings of a multilevel natural experiment with a randomized controlled trial in 16 Finnish workplaces. In Phase 1, 11 workplaces (1823 employees) from Area 1 were exposed to environmental improvements in walking and cycling paths. In Phase 2, five more workplaces (826 employees) were recruited from Area 2 and all workplaces were randomized into experimental group (EXP) promoting ACW with social and behavioral strategies and comparison group (COM) participating only in data collection. Process and impact evaluation with questionnaires, travel diaries, accelerometers, traffic calculations, and auditing were conducted. Statistics included Wilcoxon Signed Ranks Test, Mann-Whitney U-test, and after-before differences with 95% confidence intervals (95% CI). After Phase 1, positive change was seen in the self-reported number of days, which the employees intended to cycle part of their journey to work in the following week (p = 0.001). After Phase 2, intervention effect was observed in the proportion of employees, who reported willingness to increase walking (8.7%; 95% CI 1.8 to 15.6) and cycling (5.5%; 2.2 to 8.8) and opportunity to cycle part of their journey to work (5.9%; 2.1 to 9.7). To conclude, the intervention facilitated employees’ motivation for ACW, which is the first step towards behavior change.

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Connecting Youth and Young Adults to Optimize Antiretroviral Therapy Adherence (YouTHrive): Protocol for a Randomized Controlled Trial

JMIR Research Protocols ◽

10.2196/11502 ◽

2019 ◽

Vol 8 (7) ◽

pp. e11502 ◽

Cited By ~ 1

Author(s):

K J Horvath ◽

R F MacLehose ◽

A Martinka ◽

J DeWitt ◽

L Hightow-Weidman ◽

...

Keyword(s):

Controlled Trial ◽

Phase 1 ◽

Art Adherence ◽

Phase 2 ◽

Phase 3 ◽

Randomized Controlled ◽

Adherence Intervention ◽

Living With Hiv ◽

Beta Testing ◽

Us Cities

Background Despite intensive efforts to engage people living with HIV in the United States, less than half of the youth aged 13 to 24 years achieve viral suppression. There is a clear and continued need for innovative behavioral programs that support optimizing adherence among young persons with HIV. Objective There are 3 phases of this project. Phase 1 involves conducting focus groups to obtain feedback from youth about an existing technology-based antiretroviral therapy (ART) adherence intervention. Phase 2 will be used to conduct beta testing with youth to refine and finalize the YouTHrive (YT) intervention. Phase 3 is a randomized controlled trial (RCT) to test the efficacy of the YT intervention among youth living with HIV (YLWH). Methods In phase 1, we will conduct 6 focus groups with approximately 8 youths (aged 15-19 years) and young adults (aged 20-24 years), each in 3 US cities to obtain (1) feedback from YLWH about the look and feel and content of an existing adult-focused Web-based ART adherence intervention and (2) suggestions for adapting the intervention for YLWH similar to themselves. Phase 2 will involve updating the existing intervention to include features and functionality recommended by YLWH in phase 1; it will conclude with beta testing with 12 participants to gain feedback on the overall design and ensure proper functionality and ease of navigation. For phase 3, we will enroll 300 YLWH in 6 US cities (Atlanta, Chicago, Houston, New York City, Philadelphia, and Tampa) into a 2-arm prospective RCT. Participants will be randomized 1:1 to YT intervention or control group. The randomization sequence will be stratified by city and use random permuted blocks of sizes 2 and 4. Participants randomized to the control condition will view a weekly email newsletter on topics related to HIV, with the exception of ART adherence, for 5 months. Participants randomized to the YT intervention condition will be given access to the YT site for 5 months. Study assessments will occur at enrollment and 5, 8, and 11 months post enrollment. The primary outcome that will be assessed is sustained viral load (VL), defined as the proportion of participants in each study arm who have suppressed VL at both the 5- and 11-month assessment; the secondary outcome that will be assessed is suppressed VL at both the 5- and 11-month assessment between drug-using and nondrug-using participants assigned to the YT intervention arm. Results Participant recruitment began in May 2017 for phase 1 of the study. The data collection for aim 3 is anticipated to end in April 2020. Conclusions The efficacy trial of the YT intervention will help to fill gaps in understanding the efficacy of mobile interventions to improve ART adherence among at-risk populations. Trial Registration ClinicalTrials.gov NCT03149757; https://clinicaltrials.gov/ct2/show/NCT03149757 (Archived by WebCite at http://www.webcitation.org/73pw57Cf1) International Registered Report Identifier (IRRID) DERR1-10.2196/11502

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A Feasible and Efficacious Mobile-Phone Based Lifestyle Intervention for Filipino Americans with Type 2 Diabetes: Randomized Controlled Trial (Preprint)

10.2196/preprints.8156 ◽

2017 ◽

Author(s):

Melinda S Bender ◽

Bruce A Cooper ◽

Linda G Park ◽

Sara Padash ◽

Shoshana Arai

Keyword(s):

Weight Loss ◽

Controlled Trial ◽

Phase 1 ◽

Intervention Group ◽

Filipino Americans ◽

Phase 2 ◽

Filipino American ◽

Potential Efficacy

BACKGROUND Filipino Americans have a high prevalence of obesity, type 2 diabetes (T2D), and cardiovascular disease compared with other Asian American subgroups and non-Hispanic whites. Mobile health (mHealth) weight loss interventions can reduce chronic disease risks, but these are untested in Filipino Americans with T2D. OBJECTIVE The objective of this study was to assess feasibility and potential efficacy of a pilot, randomized controlled trial (RCT) of a culturally adapted mHealth weight loss lifestyle intervention (Pilipino Americans Go4Health [PilAm Go4Health]) for overweight Filipino Americans with T2D. METHODS This was a 2-arm pilot RCT of the 3-month PilAm Go4Health intervention (phase 1) with an active waitlist control and 3-month follow-up (phase 2). The waitlist control received the PilAm Go4Health in phase 2, whereas the intervention group transitioned to the 3-month follow-up. PilAm Go4Health incorporated a Fitbit accelerometer, mobile app with diary for health behavior tracking (steps, food/calories, and weight), and social media (Facebook) for virtual social support, including 7 in-person monthly meetings. Filipino American adults ≥18 years with T2D were recruited from Northern California. Feasibility was measured by rates of recruitment, engagement, and retention. Multilevel regression analyses assessed within and between group differences for the secondary outcome of percent weight change and other outcomes of weight (kg), body mass index (BMI), waist circumference, fasting plasma glucose, HbA1c, and steps. RESULTS A total of 45 Filipino American adults were enrolled and randomized. Mean age was 58 (SD 10) years, 62% (28/45) were women, and mean BMI was 30.1 (SD 4.6). Participant retention and study completion were 100%, with both the intervention and waitlist group achieving near-perfect attendance at all 7 intervention office visits. Groups receiving the PilAm Go4Health in phase 1 (intervention group) and phase 2 (waitlist group) had significantly greater weight loss, −2.6% (−3.9 to −1.4) and −3.3% (−1.8 to −4.8), respectively, compared with the nonintervention group, resulting in a moderate to small effect sizes (d=0.53 and 0.37, respectively). In phase 1, 18% (4/22) of the intervention group achieved a 5% weight loss, whereas 82% (18/22) maintained or lost 2% to 5% of their weight and continued to maintain this weight loss in the 3-month follow-up. Other health outcomes, including waist circumference, BMI, and step counts, improved when each arm received the PilAm Go4Health, but the fasting glucose and HbA1c outcomes were mixed. CONCLUSIONS The PilAm Go4Health was feasible and demonstrated potential efficacy in reducing diabetes risks in overweight Filipino Americans with T2D. This study supports the use of mHealth and other promising intervention strategies to reduce obesity and diabetes risks in Filipino Americans. Further testing in a full-scale RCT is warranted. These findings may support intervention translation to reduce diabetes risks in other at-risk diverse populations. CLINICALTRIAL Clinicaltrials.gov NCT02290184; https://clinicaltrials.gov/ct2/show/NCT02290184 (Archived by WebCite at http://www.webcitation.org/6vDfrvIPp)

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ALLogeneic Heart STem Cells to Achieve Myocardial Regeneration (ALLSTAR) Trial: Rationale and Design

Cell Transplantation ◽

10.3727/096368916x692933 ◽

2017 ◽

Vol 26 (2) ◽

pp. 205-214 ◽

Cited By ~ 46

Author(s):

Tarun Chakravarty ◽

Raj R. Makkar ◽

Deborah D. Ascheim ◽

Jay H. Traverse ◽

Richard Schatz ◽

...

Keyword(s):

Stem Cells ◽

Infarct Size ◽

Controlled Trial ◽

Phase 1 ◽

Left Ventricular ◽

Myocardial Regeneration ◽

Therapeutic Modality ◽

Patient Specific ◽

Phase 2 ◽

Double Blind

Autologous cardiosphere-derived cells (CDCs) were the first therapeutic modality to demonstrate myocardial regeneration with a decrease in scar size and an increase in viable, functional tissue. Widespread applicability of autologous CDC therapy is limited by the need for patient-specific myocardial biopsy, cell processing, and quality control, resulting in delays to therapy and inherent logistical and economic constraints. Preclinical data had demonstrated equivalent efficiency of allogeneic to autologous CDCs. The ALLogeneic Heart STem Cells to Achieve Myocardial Regeneration (ALLSTAR) trial is a multicenter randomized, double-blind, placebo-controlled phase 1/2 safety and efficacy trial of intracoronary delivery of allogeneic CDCs (CAP-1002) in patients with myocardial infarction (MI) and ischemic left ventricular dysfunction. The phase 1 safety cohort enrolled 14 patients in an open-label, nonrandomized, dose-escalation safety trial. The phase 2 trial is a doubleblind, randomized, placebo-controlled trial that will compare intracoronary CDCs to placebo in a 2:1 allocation and will enroll up to 120 patients. The primary endpoint for both phases is safety at 1 month. For phase 2, the primary efficacy endpoint is relative change from baseline in infarct size at 12 months, as assessed by magnetic resonance imaging. The ALLSTAR trial employs a “seamless” WOVE 1 design that enables continuous enrollment from phase 1 to phase 2 and will evaluate the safety of intracoronary administration of allogeneic CDCs and its efficacy in decreasing infarct size in post-MI patients.

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Evaluating Social Marketing Messages in New Zealand’s Like Minds Campaign and Its Effect on Stigma

Social Marketing Quarterly ◽

10.1177/15245004211005828 ◽

2021 ◽

pp. 152450042110058

Author(s):

Joya Kemper ◽

Ann-Marie Kennedy

Keyword(s):

Mental Health ◽

Mental Illness ◽

Identity Formation ◽

Social Marketing ◽

Phase 1 ◽

Mental Health Stigma ◽

Attitudes And Beliefs ◽

Moral Norms ◽

Institutional Norms ◽

Social Marketing Campaigns

Background: A key objective of government and social marketers is to remove the institutionalized stigma of mental illness, increasing mental health service uptake. While research has evaluated past campaigns based on changes in attitudes and beliefs, very little research has examined the communication messages used in social marketing campaigns. Focus of the Article: This impact evaluation research identifies the institutionalized cultural-moral norms incorporated into New Zealand’s Like Minds mental health advertisements and examines how attitudes and beliefs changed over time in response to these norms. Importance to the Social Marketing Field: This research offers a new approach to social marketing evaluation and demonstrates the importance of consistent incorporation of cultural-moral institutional norms in social marketing campaigns. Method: Using macro-social marketing theory, thematic analysis is used to identify the cultural-moral institutional norms in the Like Minds campaign advertisements over a 10-year period (2002–2012). Results: The Like Minds campaign was found to have multiple cultural-moral institutional norms, such as Mental illness as a villain, Personal responsibility, and Inherent human dignity, as well as utilizing two different institutionalization processes of Socialization and Identity Formation. However, these norms were inconsistently and sometimes contradictorily presented and as a result, not all changes in mental health stigma beliefs and attitudes show long term change. Rates for service uptake also had mixed results during the campaign duration, though overall an increase in uptake was found. Recommendations for Research and Practice: The research highlights the importance of understanding the underlying institutionalized cultural-moral norms presented in communications and aligning those with the overall objectives of a social marketing campaign. Limitations: Like Minds campaign phases 2 to 5 are analyzed, phase 1 was inaccessible for analysis and advertisements after 2012 are not analyzed.

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Effectiveness of a stand-alone, smartphone-based virtual reality exposure app to reduce fear of heights in real-life: a randomized trial

npj Digital Medicine ◽

10.1038/s41746-021-00387-7 ◽

2021 ◽

Vol 4 (1) ◽

Author(s):

Dorothée Bentz ◽

Nan Wang ◽

Merle K. Ibach ◽

Nathalie S. Schicktanz ◽

Anja Zimmer ◽

...

Keyword(s):

Virtual Reality ◽

Controlled Trial ◽

Phase 1 ◽

Real Life ◽

Phase 2 ◽

Parallel Group ◽

Real Life Situation ◽

Repeated Use ◽

Virtual Reality Exposure ◽

Fear Of Heights

AbstractSmartphone-based virtual reality (VR) applications (apps) might help to counter low utilization rates of available treatments for fear of heights. Demonstration of effectiveness in real-life situations of such apps is crucial, but lacking so far. Objective of this study was to develop a stand-alone, smartphone-based VR exposure app—Easy Heights—and to test its effectiveness in a real-life situation. We performed a single-blind, parallel group, randomized controlled trial. We recruited 70 participants with fear of heights, aged 18–60 years. Primary outcome was performance in a real-life Behavioral Avoidance Test (BAT) on a lookout tower after a single 1-h app use (phase 1) and after additional repeated (6 × 30 min) app use at home (phase 2). After phase 2, but not phase 1, participants in the Easy Heights condition showed significantly higher BAT scores compared to participants in the control condition (Cohen’s d = 1.3, p = 0.0001). Repeated use of our stand-alone, smartphone-based VR exposure app reduces avoidance behavior and fear, providing a low-threshold treatment for fear of heights.

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Anesthesiology Control Tower—Feasibility Assessment to Support Translation (ACTFAST): Mixed-Methods Study of a Novel Telemedicine-Based Support System for the Operating Room (Preprint)

10.2196/preprints.12155 ◽

2018 ◽

Author(s):

Teresa Murray-Torres ◽

Aparna Casarella ◽

Mara Bollini ◽

Frances Wallace ◽

Michael S Avidan ◽

...

Keyword(s):

Support System ◽

Information Technologies ◽

Phase 1 ◽

Usability Testing ◽

Barriers And Facilitators ◽

Routine Practice ◽

Software Components ◽

Phase 2 ◽

Feasibility Assessment ◽

Usability Problems

BACKGROUND Despite efforts to improve patient outcomes, major morbidity and mortality remain common after surgery. Health information technologies that provide decision support for clinicians might improve perioperative and postoperative patient care. Evaluating the usability of these technologies and barriers to their implementation can facilitate their acceptance within health systems. OBJECTIVE This manuscript describes usability testing and refinement of an innovative telemedicine-based clinical support system, the Anesthesiology Control Tower (ACT). It also reports stakeholders’ perceptions of the barriers and facilitators to implementation of the intervention. METHODS Three phases of testing were conducted in an iterative manner. Phase 1 testing employed a think-aloud protocol analysis to identify surface-level usability problems with individual software components of the ACT and its structure. Phase 2 testing involved an extended qualitative and quantitative real-world usability analysis. Phase 3 sought to identify major barriers and facilitators to implementation of the ACT through semistructured interviews with key stakeholders. RESULTS Phase 1 and phase 2 usability testing sessions identified numerous usability problems with the software components of the ACT. The ACT platform was revised in seven iterations in response to these usability concerns. Initial satisfaction with the ACT, as measured by standardized instruments, was below commonly accepted cutoffs for these measures. Satisfaction improved to acceptable levels over the course of revision and testing. A number of barriers to implementation were also identified and addressed during the refinement of the ACT intervention. CONCLUSIONS The ACT model can improve the standard of perioperative anesthesia care. Through our thorough and iterative usability testing process and stakeholder assessment of barriers and facilitators, we enhanced the acceptability of this novel technology and improved our ability to implement this innovation into routine practice. INTERNATIONAL REGISTERED REPOR RR2-10.1186/s40814-018-0233-4

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Effects of caloric restriction on human physiological, psychological, and behavioral outcomes: highlights from CALERIE phase 2

Nutrition Reviews ◽

10.1093/nutrit/nuaa085 ◽

2020 ◽

Vol 79 (1) ◽

pp. 98-113

Author(s):

James L Dorling ◽

Stephan van Vliet ◽

Kim M Huffman ◽

William E Kraus ◽

Manjushri Bhapkar ◽

...

Keyword(s):

Caloric Restriction ◽

Controlled Trial ◽

Phase 1 ◽

Behavioral Outcomes ◽

Phase 2 ◽

Long Term Effects ◽

Eating Disorder Symptoms ◽

Healthy Humans

Abstract Caloric restriction (CR) is a strategy that attenuates aging in multiple nonhuman species. The Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy (CALERIE) trials are part of a research program aiming to test the effects of CR on aging and longevity biomarkers in humans. Building on CALERIE phase 1, CALERIE phase 2 (CALERIE 2) was the largest study to date to assess sustained CR in healthy humans without obesity. In a 24-month randomized controlled trial comprising 218 participants at baseline, CALERIE 2 showed that moderate CR, 11.9% on average, induced improvements in aging-related biomarkers without adversely affecting psychological or behavioral outcomes. The objectives of this report are to summarize and review the highlights of CALERIE 2 and report previously unpublished results on eating disorder symptoms and cognitive function. This article specifically summarizes the physiological, psychological, aging, behavioral, and safety results of the trial. Also provided are research directions beyond CALERIE 2 that highlight important opportunities to investigate the role of CR in aging, longevity, and health span in humans.

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