Obesity-Related Behavioral Intervention Trials Research Articles

Intervention Mapping for Refining a Sport-Based Public Health Intervention in Rural Schools

Sport-based youth development programs, delivered through campus–community partnerships, can create impactful experiences for college students, meet university objectives, and improve the health of children in under-resourced rural communities. This study aimed to pilot test intervention mapping (IM), a systematic approach to intervention development and implementation, to refine the Hoosier Sport intervention, which is a local public health initiative that utilizes the Obesity-Related Behavioral Intervention Trials (ORBITs) model to improve physical activity in middle school children. The IM process, which included a diverse IM planning and advisory group of university representatives and local schools, was guided by self-determination theory (SDT) and social cognitive theory (SCT) and followed four steps: Logic Model of the Problem, Logic Model of Change, Program Design, and Program Production. Using SDT and SCT, we identified our personal determinants as autonomy, competence, and relatedness, while our environmental determinants were role-modeling and sports equipment access. We then created change methods and practical applications for refining and implementing our intervention and gathered pilot test data to assess the feasibility of the intervention. The IM process provided a more robust and evidence-based approach to intervention design and production, while involving stakeholders to foster meaningful collaboration and increase program success. By using IM in program development, public health interventions that promote youth development through sport will likely be more easily scaled up.

Training physicians in motivational communication: An integrated knowledge transfer study protocol.

While behavior change counseling (BCC) targeting health risk behaviors has shown efficacy for improving patient health outcomes, barriers to knowledge translation have resulted in poor uptake among health care providers (HCPs). This article outlines the development of a new BCC training framework for HCPs, from inception to readiness for efficacy testing. It provides an example of integrated knowledge translation (iKT) used in alignment with the obesity-related behavioral intervention trials model. (a) A modified Delphi process identified essential BCC skills for HCPs; (b) a survey assessed HCP attitudes and training needs; (c) an online competency assessment tool was developed using iKT mixed methods; (d) a training program was developed and refined using a logic model; and (e) the program was optimized using iterative rounds of participant feedback. A future proof-of-concept trial (f) will determine the program's readiness for full efficacy testing. A Delphi panel (n = 46) identified 11 core BCC competencies for HCPs, defining "motivational communication." The HCP survey (n = 80) showed willingness to devote 4 hr to introductory training in BCC. The Motivational Communication Competency Assessment Test (MC-CAT: an online, interactive evaluation tool) and a motivational communication training program (MOTIVATOR: accredited for continuing education by the Royal College of Physicians and Surgeons of Canada) were collaboratively developed with knowledge users. The optimization process (n = 11) provided key feedback, with minor changes being made to the program. In developing a new BCC framework, obstacles to BCC implementation were addressed through an iterative iKT process. This should improve eventual intervention uptake. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

A Chatbot-Based Version of the World Health Organization-Validated Self-Help Plus Intervention for Stress Management: Co-Design and Usability Testing.

Advancements in technology offer new opportunities to support vulnerable populations, such as pregnant women and women diagnosed with breast cancer, during physiologically and psychologically stressful periods. This study aims to adapt and co-design the World Health Organization's Self-Help Plus intervention into a mobile health intervention for these target groups. On the basis of the Obesity-Related Behavioral Intervention Trials and Center for eHealth Research and Disease Management models, low-fidelity and high-fidelity prototypes were developed. Prototypes were evaluated by 13 domain experts from diverse sectors and 15 participants from the target groups to assess usability, attractiveness, and functionality through semantic differential scales, the User Version of the Mobile Application Rating Scale questionnaire, and semistructured interviews. Feedback from participants indicated positive perceptions of the mobile health intervention, highlighting its ease of use, appropriate language, and attractive multimedia content. Areas identified for improvement included enhancing user engagement through reminders, monitoring features, and increased personalization. The quality of the content and adherence to initial protocols were positively evaluated. This research provides valuable insights for future studies aiming to enhance the usability, efficacy, and effectiveness of the app, suggesting the potential role of a chatbot-delivered Self-Help Plus intervention as a supportive tool for pregnant women and women with a breast cancer diagnosis.

Impact of an intergenerational program to improve loneliness and social isolation in older adults initiated at the time of emergency department discharge: study protocol for a three-arm randomized clinical trial

BackgroundSocial isolation and loneliness (SIL) worsens mortality and other outcomes among older adults as much as smoking. We previously tested the impact of the HOW R U? intervention using peer support from similar-aged volunteers and demonstrated reduced SIL among older adults discharged from the emergency department (ED). Generativity, defined as “the interest in establishing and guiding the next generation,” can provide an alternative theoretical basis for reducing SIL via intergenerational programs between members of younger and older generations. The current protocol will examine the impact of younger intergenerational volunteers providing the HOW RU? intervention.MethodsIn this randomized clinical trial, we will compare the following three arms: (1) the standard same-generation peer support HOW R U? intervention, (2) HOW R U? intervention delivered by intergenerational volunteers, and (3) a common wait-list control group. Outcome assessors will be blinded to the intervention. Trained volunteers will deliver 12 weekly telephone support calls. We will recruit participants ≥ 70 years of age with baseline loneliness (six-item De Jong loneliness score of 2 or greater) from two EDs. Research staff will assess SIL, depression, quality of life, functional status, generativity, and perceived benefit at baseline, at 12 weeks, and 24 weeks post-intervention.DiscussionWe hypothesize participants receiving the intergenerational intervention will show improved outcomes compared to the control group and peer support HOW R U? intervention. We also hypothesize that participants with higher perceptions of generativity will have greater reductions in SIL than their lower generativity counterparts. Aging is experienced diversely, and social interventions combatting associated SIL should reflect that diversity. As part of a program of research following the Obesity-Related Behavioral Intervention Trials (ORBIT) model, the findings of this RCT will be used to define which intervention characteristics are most effective in reducing SIL.Trial registrationClinicalTrials.gov NCT05998343 Protocol ID:21-0074E. Registered on 24 July 2023.

Developing a narrative communication intervention in the context of HPV vaccination

ObjectiveWe outline the development of a narrative intervention guided by the Common-Sense Model of Self-Regulation (CSM) to promote Human Papillomavirus (HPV) vaccination in a diverse college population. MethodsWe adapted the Obesity-Related Behavioral Intervention Trials (ORBIT) model to guide the development, evaluation, and refinement of a CSM-guided narrative video. First, content experts developed a video script containing information on HPV, HPV vaccines, and HPV-related cancers. The script and video contents were evaluated and refined, in succession, utilizing the think-aloud method, open-ended questions, and a brief survey during one-on-one interviews with university students. ResultsScript and video content analyses led to significant revisions that enhanced quality, informativeness, and relevance to the participants. We highlight the critical issues that were revealed and revised in the iterative process ConclusionsWe developed and refined a CSM guided narrative video for diverse university students. This framework serves as a guide for developing health communication interventions for other populations and health behaviors. InnovationThis project is the first to apply the ORBIT framework to HPV vaccination and describe a process to develop, evaluate, and refine comparable CSM guided narrative interventions that are tailored to specific audiences.

Designing a Perioperative Mind-Body Intervention for Peripheral Vascular Interventions.

Peripheral vascular interventions (PVIs) performed under procedural sedation and analgesia (PSA) can be associated with anxiety and poor compliance with patient instructions during surgery. Mind-body interventions (MBIs) such as meditation have demonstrated the potential to decrease perioperative anxiety, though this area is understudied, and no tailored interventions have been developed for the vascular surgical patient population. We aimed to design a perioperative MBI that specifically targeted vascular surgical patients undergoing PVIs under PSA. We sought to perform this in a scientifically rigorous, multi-disciplinary collaborative manner. Following the Obesity-Related Behavioral Intervention Trials (ORBIT) model, we designed (Phase 1a) and then refined (Phase 1b) a MBI for patients undergoing PVIs under PSA to decrease perioperative anxiety and sedation and facilitate patient intraoperative compliance. Phase 1a involved a literature review, informal information gathering and synthesis, and drafting a preliminary protocol for a perioperative MBI. Phase 1b involved assembling a multi-disciplinary expert panel of perioperative and mind-body clinicians and researchers to improve the MBI using an iterative, modified Delphi approach. The modified Delphi process was completed, and a consensus was reached after three iterations. The resulting MBI consisted of two seven-minute preoperative guided meditations on the day of surgery, including diaphragmatic breathing, body scans, and guided imagery emphasizing awareness of the ipsilateral leg where the vascular surgery was performed. A document delineating the integration of the MBI into the operating room workflow was produced, including details regarding the intervention's timing, duration, and modality. Using a multi-specialty expert panel, we designed a novel MBI in the form of a guided meditation with elements of mindfulness and guided imagery to decrease anxiety and increase intraoperative compliance for patients undergoing PVIs under PSA. A prospective pilot study is being planned to test the program's feasibility.

Updating the Foodbot Factory serious game with new interactive engaging features and enhanced educational content.

Serious games (i.e., digital games designed for educational purposes) can foster positive learning attitudes and are increasingly used as educational tools. Foodbot Factory is a serious game application (app) that helps children learn about healthy eating based on Canada's Food Guide principles and has demonstrated to increase nutrition knowledge among this group. This paper describes the process followed to expand Foodbot Factory's educational content and integrate immersive technologies and innovative features into the app. The revision process, which was guided by the Obesity-Related Behavioral Intervention Trials model, included the following phases: first, an interdisciplinary team of nutrition scientists, education experts, and computer scientists analyzed data from the original pilot study, recently published literature, and feedback from stakeholders to define areas to improve Foodbot Factory. The five original Foodbot Factory modules were evaluated by the team during weekly meetings, where the educational content, interactive features, and other elements that required updates (e.g., aesthetics and accessibility) were identified. Second, prototypes were created and refined until a final version of Foodbot Factory was approved. Nineteen children tested the updated Foodbot Factory and found it "easy to use" (89%) and "fun" (95%). The new version of Foodbot Factory contains 19 learning objectives, including 13 original and six new objectives. Interactive engagement features in the updated Foodbot Factory included augmented reality incorporated into two learning modules; new mini-games were created, including a memory game; an overhaul of the aesthetics; (e.g., new food images); and accessibility features were included to support users with cognitive and vision disabilities.

Integration of Person-Centered Narratives Into the Electronic Health Record.

Care delivery that is not person-centered has been called discordant care . There has been a shift to incorporate more of a person's narrative into their individual healthcare treatment plan to reduce discordant care. Aligning with this shift in healthcare delivery, we developed a person-centered narrative intervention (PCNI) to address existing gaps in delivery of person-centered care. This study aimed to evaluate the feasibility of conducting a randomized study and describe the outcomes of PCNI to usual care on the following person (patient)-reported outcomes: perceptions of the quality of communication with their nurses and their psychosocial and existential well-being. This study's design was an Obesity-Related Behavioral Intervention Trials model Phase II proof-of-concept randomized study. The participants were people admitted to an acute care hospital diagnosed with heart failure and/or end-stage renal disease. Despite COVID-19 challenges, the PCNI was feasible in an acute care setting; it showed a moderate positive difference between conditions in the person's perception of their quality of communication and a small positive difference in their perception of feeling heard and understood. For our secondary outcomes of anxiety, depression, and psychosocial illness effect, there were small or no effects in the acute care setting. Using a person-centered narrative, such as the PCNI, can help inform delivery of care that incorporates a person's (patient's) beliefs, values, and preferences into their healthcare. This study used a pragmatic approach to evaluate the PCNI in real time in an acute care setting to assess patient-reported outcomes. These positive results in a small sample indicate the need for continued testing of the PCNI. These promising effects require further testing in a Phase III efficacy study within a larger randomized controlled clinical trial.

Cancer Resource and Information Support (CRIS) for Bladder Cancer Survivors and Their Caregivers: Development and Usability Testing Study.

Bladder cancer survivors and their caregivers face profound practical (eg, use of stoma appliances and care for urinary diversion methods) and psychosocial (eg, depression and anxiety) challenges after surgical treatment with cystectomy. To improve the health-related quality of life and postsurgical outcomes of both bladder cancer survivors and their caregivers, the team, in collaboration with Sourcetop, Inc (software design) and Dappersmith (graphic design), developed the Cancer Resource and Information Support (CRIS) software. The purpose of this manuscript is to report on the development and usability testing of the CRIS software. The development of the CRIS software was guided by the Obesity-Related Behavioral Intervention Trials (ORBIT) model for developing behavioral treatments for chronic diseases. The ORBIT model is unique in that it proposes a flexible and progressive process with prespecific clinically significant milestones for forward movement and returns to earlier stages for refinement, and it facilitates communication among diverse groups by using terminology from the drug development model. This paper focuses on 2 phases of the ORBIT model: phase IA: define and IB: refine. During phase IA, the study team developed solutions for the stated clinical problem-adjustment to life post cystectomy-by reviewing the literature and collecting feedback from clinicians, professional organizations, bladder cancer survivors, and their caregivers. During Phase IB, the study team focused on tailoring content in the CRIS software to the user as well as usability testing with 7 participants. The finished product is CRIS, a web-based software for survivors of bladder cancer and their caregivers to serve as a health management and lifestyle resource after surgery. Overarching themes from phase IA (participant feedback) included how to use new medical equipment, tips and tricks for easier living with new medical equipment, questions about health maintenance, and questions about lifestyle modifications. To accommodate our target population, we also incorporated recommendations from the Americans with Disabilities Act for website design, such as large text size, large paragraph spacing, highly contrasting text and background colors, use of headings and labels to describe the purpose of the content, portrait orientation without the need for horizontal scrolling, multiple ways to access a web page within a set of pages, ability to navigate web pages in sequential order, and in-text links that are descriptive. Usability participants evaluated CRIS very positively, indicating that it was easy to use, the functions were well-integrated, and if available, they would use CRIS frequently. CRIS, developed over the course of 18 months by integrating feedback from experts, literature reviews, and usability testing, is the first web-based software developed for bladder cancer survivors and their caregivers to help them adjust to life following cystectomy. The efficacy of CRIS in improving patients' and caregivers' quality of life is currently being evaluated in a randomized controlled trial.

Modification of an Intervention to Improve Adherence in Adolescents and Young Adults With Bipolar Disorder

Managing bipolar disorder (BD) is particularly challenging for adolescents and young adults (AYAs) ages 16 to 21. Few interventions exist that address self-management in AYAs with BD. Thus, this study aimed to modify the customized adherence enhancement behavioral intervention for AYAs through an iterative, patient-centered process. The Obesity-Related Behavioral Intervention Trials (ORBIT) model was used for intervention development. In phase 1a, adherence barriers and facilitators were identified to refine intervention content. Phase 1b occurred following curriculum modification to ensure that the modified intervention was relevant and usable by the target population. Data were collected via focus groups and interviews with AYAs with BD, parents, and providers. Transcripts were analyzed using directed content analysis. Phase 1a included focus groups/interviews with AYAs (n = 10), parents (n = 4), and providers (n = 9) who described the difficulties and successes in managing BD symptoms, improving adherence, and transitioning care from caregivers. Phase 1b included an advisory board composed of 8 phase 1a participants who provided feedback on modified session activities, module delivery, and curriculum. Phase 1b involved usability testing with new participants (n = 8), revealing the need for modifiable language based on developmental level, more engaging visual images, and confirmation that topics were salient to AYAs with BD. Though sample sizes were small and not representative of the population of AYAs with BD, the ORBIT methodology informed the adaptation of the customized adherence enhancement intervention to improve adherence in AYAs with BD. Important next steps are to conduct a pilot randomized clinical trial of customized adherence enhancement for AYAs.

174 Development of an Individualized Responsive Feeding Coaching Intervention

OBJECTIVES/GOALS: Responsive infant feeding (RIF) promotes healthy dietary patterns and infant weight gain. Research is needed to assist caregivers recognize infant hunger/satiety cues and overcome barriers to using RIF. The Learning Early Infant Feeding Cues (LEIFc) intervention was designed to fill this gap by using a validated coaching approach to promote RIF. METHODS/STUDY POPULATION: Guided by the Obesity-Related Behavioral Intervention Trials (ORBIT) model, this proof-of-concept study tests the feasibility and fidelity of the LEIFc intervention in mother-infant dyads (N=25). Study visits from the 3rd trimester of pregnancy to 4 months postpartum (PP) are conducted in family homes. Use of RIF via subjective (survey) and objective (video) measures is collected at 1 and 4 months PP. Prenatally written and video material on infant feeding and infant hunger/satiety cues is provided. At 2 and 3 months PP, coaching during a feeding session is provided by a trained interventionist using the SS-OO-PP-RR (super, Setting the Stage, Observation & Opportunities, Problem Solving & Planning, Reflection & Review) approach. Qualitative data on LEIFc are provided by the interventionist and participants. RESULTS/ANTICIPATED RESULTS: To date 25 dyads have been enrolled and 4 have completed all study visits. Preliminary analyses showed that subjective measure of awareness of infant cues increased post intervention (pre, M=4.38 vs post, M=4.63). LEIFc has been well accepted by participants including use of the SS-OO-PP-RR approach. Data suggests refinement to LEIFc is needed to include breastfeeding and mental health support as well as a longer duration of intervention through at least 6 months PP. An experienced interventionist is key to success of the research. All lost to follow-up (n=7) have occurred before the first PP visit suggesting that at study visit closer to birth is needed. Enrollment will continue through December 2022 and data collection through April 2023. DISCUSSION/SIGNIFICANCE: After refinement, the LEIFc intervention will be tested in a pilot RCT. The long-term goal is to implement LEIFc in the curricula of federally funded maternal-child home visiting programs who serve vulnerable populations; those that often have infant feeding practices that do not align with recommendations and are less likely to use RIF.

Development of an Individualized Responsive Feeding Intervention-Learning Early Infant Feeding Cues: Protocol for a Nonrandomized Study.

Responsive infant feeding occurs when a parent recognizes the infant's cues of hunger or satiety and responds promptly to these cues. It is known to promote healthy dietary patterns and infant weight gain and is recommended as part of the Dietary Guidelines for Americans. However, the use of responsive infant feeding can be challenging for many parents. Research is needed to assist caregivers recognize infant hunger or satiety cues and overcoming barriers to using responsive infant feeding. The Learning Early Infant Feeding Cues (LEIFc) intervention was designed to fill this gap by using a validated coaching approach, SS-OO-PP-RR ("super," Setting the Stage, Observation and Opportunities, Problem Solving and Planning, Reflection and Review), to promote responsive infant feeding. Guided by the Obesity-Related Behavioral Intervention Trials model, this study aims to test the feasibility and fidelity of the LEIFc intervention in a group of mother-infant dyads. This pre-post quasi-experimental study with no control group will recruit mothers (N=30) in their third trimester (28 weeks and beyond) of pregnancy from community settings. Study visit 1 will occur prenatally in which written and video material on infant feeding and infant hunger and satiety cues is provided. Demographic information and plans for infant feeding are also collected prenatally via self-report surveys. The use of responsive infant feeding via subjective (survey) and objective (video) measures is recorded before (study visit 2, 1 month post partum) and after (study visit 5, 4 months post partum) intervention. Coaching on responsive infant feeding during a feeding session is provided by a trained interventionist using the SS-OO-PP-RR approach at study visits 3 (2 months post partum) and 4 (3 months post partum). Infant feeding practices are recorded via survey, and infant weight and length are measured at each postpartum study visit. Qualitative data on the LEIFc intervention are provided by the interventionist and mother. Infant feeding videos will be coded and tabulated for instances of infant cues and maternal responses. Subjective measures of responsive infant feeding will also be tabulated. The use of responsive infant feeding pre-post intervention will be analyzed using matched t tests. Qualitative data will be examined to guide intervention refinement. This study initially began in spring 2020 but was halted because of the COVID-10 pandemic. With new funding, recruitment, enrollment, and data collection began in April 2022 and will continue until April 2023. After refinement, the LEIFc intervention will be tested in a pilot randomized controlled trial. The long-term goal is to implement LEIFc in the curricula of federally funded maternal-child home visiting programs that serve vulnerable populations-those that often have infant feeding practices that do not align with recommendations and are less likely to use responsive infant feeding. DERR1-10.2196/44329.

Definition and refinement of HYlaDO, a self-hypnosis training program for chronic pain management: A qualitative exploratory study

One in four Canadians is affected by chronic pain, frequently treated with opioids, which present a risk of addiction and overdose. The development of non-pharmacological interventions is therefore crucial. In a pilot project, a self-hypnosis training program showed encouraging results in improving breast cancer patients’ quality of life. Based on this program, we developed a new self-hypnosis program for chronic pain patients: HYlaDO (Hypnosis of pain in French, HYpnose de la DOuleur). To structure the process of adapting an existing program to a new context, we used the ORBIT model (Obesity-Related Behavioral Intervention Trials), which consists of four development phases. This study aimed to collect patients' opinions and recommendations, and to refine HYlaDO (ORBIT Phase Ib). Fifteen participants took part in individual semi-structured interviews about this program. Two analysts coded the verbatims, and a thematic categorization was performed. Six themes emerged: practice training, expected vs. perceived effects, chronic pain management, individual practice, satisfaction, and participants’ recommendations. Improvements to be considered in this type of program were finally discussed.

Use of the ORBIT model to refine and test a novel approach to exercise promotion for breast cancer survivors based on affect regulation.

TPS12153 Background: Physical inactivity is a modifiable risk factor for breast cancer recurrence, but estimates suggest at least 50% of breast cancer survivors are insufficiently active. Guidelines specify all cancer survivors should avoid inactivity, and 90-minutes of moderate-vigorous physical activity (MVPA) per week is associated with clinically meaningful benefits (e.g., reduced cancer-related fatigue). Among the general population, how people feel during exercise (i.e., “affective response to exercise”) predicts future exercise engagement. Past work shows prescribing affect-regulated exercise can increase MVPA among inactive adults; however, this strategy has yet to be tested with cancer survivors. The overarching goal of this trial-in-progress is to test the hypothesis that an affect-regulated exercise prescription (Affect-Rx) can promote clinically meaningful increases in MVPA among inactive breast cancer survivors. Methods: Design: The Obesity-Related Behavioral Intervention Trials (ORBIT) model was used to inform all choices about design and key research milestones for two sequential studies. Study 1 (Phase Ib) is a stakeholder-centered, single-arm pilot trial (NCT04903249). Study 2 (Phase IIa) is a randomized (2:1) proof-of-concept trial. In both studies, MVPA will be measured using waist-worn ActiGraph wGT3X-BT accelerometers for 10 days at baseline, 2-, 6- and 12-weeks follow-up. Participants also complete brief ecological momentary assessments (EMAs) of their feeling states (e.g., pain, fatigue) three times per day for the same 10-day data collection periods. Participants: >18 years or older, physically inactive, stage 0-III breast cancer survivors, with primary cancer-treatment completed within the last 5-years. Intervention: Both studies deliver the Affect-Rx prescription: Exercise at the highest pace that still feels good. The Control condition in Study 2 is a heart-rate regulated exercise prescription. Endpoints and Planned Analyses: The goal of Study 1 is to refine the study protocol for acceptability via participant interviews and objective indicators of acceptability (e.g., accelerometer wear-time). The primary milestone for Study 1 is a fixed protocol ready for testing in Study 2. The goal of Study 2 is to quantify the effect of Affect-Rx on MVPA at 12-weeks relative to Control. The primary milestone for Study 2 is clinically meaningful impact on MVPA operationalized as >50% participants completing 90-minutes of MVPA at the end of 12 weeks. The associations between daily variability in feeling states and MVPA will be analyzed using a mixed-effects, hierarchical regression modeling approach. Current Enrollment: Data collection for Study 1 are ongoing. To date, N = 37 women have enrolled in Study 1 and data collection is complete for N = 13 at week-12. We aim to collect complete data from at least N = 20 women in Study 1 and N = 60 women in Study 2. Clinical trial information: NCT04903249.

515 Development of an online intervention prototype for gestational weight management in rural women

OBJECTIVES/GOALS: Despite the importance of addressing maternal weight to promote healthy pregnancies, previous gestational weight management programs have overlooked rural women. Accordingly, this study used an optimization framework to develop and refine a prototype for an online gestational weight management intervention targeting rural women. METHODS/STUDY POPULATION: Methods were guided by the Obesity-Related Behavioral Intervention Trials (ORBIT) model, an optimization framework focused on intervention development and refinement. In line with this framework, three major steps were followed. First, qualitative interviews were conducted with 16 rural women who were currently or had recently been pregnant to identify barriers, facilitators, and desired resources for gestational weight management. A template analysis approach was applied to the resulting interview transcripts to identify pertinent themes. Second, themes derived from the initial interviews were used to inform the development of an online intervention prototype. Third, feedback on this prototype was sought from an additional sample of 15 rural women who were currently or had recently been pregnant. RESULTS/ANTICIPATED RESULTS: Themes from the initial interviews highlighted numerous barriers, facilitators, and desired resources for rural gestational weight management that aligned with common social determinants of health (e.g., neighborhood and built environment, social and community context) and pregnancy-specific factors. Women also described wanting an online gestational weight management program that included a user-friendly interface, psychoeducation, tailored health recommendations, accountability, and simple behavior-logging tools. Using this feedback, an online intervention prototype was developed. Results from the feedback interviews are currently being qualitatively analyzed for themes and will be used to further refine the prototype prior to feasibility testing. DISCUSSION/SIGNIFICANCE: This study used an optimization framework to develop an online intervention aimed at supporting healthy maternal weight outcomes in rural communities. Because rural women experience notable weight disparities compared to their urban peers, this intervention has the potential to promote more equitable maternal health outcomes in rural areas.

Feasibility of an MI-CBT ketogenic adherence program for older adults with mild cognitive impairment

BackgroundThe National Institutes of Health Obesity-Related Behavioral Intervention Trials model for intervention development was used to establish the feasibility and proof of concept of a motivational ketogenic nutrition adherence program for older adults with mild cognitive impairment.MethodsThis was a single-arm, single-center feasibility trial. A comprehensive assessment protocol, including a clinical interview, neuropsychological testing, and genetic sequencing was used as an initial screening. Nine participants (aged 64–75) with possible amnestic mild cognitive impairment were consented for the intervention. Participants completed pre- and post-intervention neuropsychological assessments using the updated Repeatable Battery for Assessment of Neuropsychological Status. Participants tracked their macronutrient consumption using food diaries and ketone levels using urinalysis test strips daily. Mood and other psychosocial variables were collected through surveys, and qualitative exit interviews were completed.Results100% of participants who began the trial completed the 6-week ketogenic nutrition adherence program, including completion of the pre- and post-assessments. Eight participants achieved measurable levels of ketones during the program. The average self-rated adherence across the program was 8.7 out of 10. A Wilcoxon Signed-Rank test demonstrated significant improvement in cognitive performance from baseline (median = 88) to follow up (median = 96, Z = − 2.26, p = .024). The average difference in cognitive performance from baseline to follow-up was − 7.33 (95% CI − 12.85, − 1.82).ConclusionsResults supported the feasibility for moving to the next phase and demonstrated proof of concept for the intervention. The next step is a randomized pilot trial to test clinical signals of effect compared to a control condition.Trial registrationThis trial was retrospectively registered with clinicaltrials.gov on July 13, 2021. The trial number is NCT04968041.

Multidomain interventions for dementia risk reduction: Can we detect a change in the signal?

AbstractBackgroundThere is increasing evidence that modifiable lifestyle factors account for around 40% of worldwide dementia cases. Given the multifactorial etiology of dementia, multidomain lifestyle interventions have generated major interest. Results from randomized controlled trials (RCTs) suggest that implementing multidomain interventions in at‐risk individuals is an effective strategy to delay disease onset. As per the Obesity‐Related Behavioral Intervention Trials (ORBIT) model, to ensure successful interventions, pre‐efficacy trials are needed to ascertain that each intervention component can yield a predefined clinically significant change (CSC). Therefore, the main objective of this Proof‐of‐Concept was to determine if each individual part of an online multidomain dementia risk reduction program can achieve a CSC in the targeted behavioural risk outcome.MethodThis was a 12‐week, within‐subject, treatment‐only study with three single‐domain groups (Diet, Physical Activity [PA] or Cognitive Engagement [CE]) and one multidomain group. The study enrolled cognitively healthy individuals aged 50‐70 with at least one risk factor among the targeted domains. The personalized intervention was delivered via a digital, coach‐supported application. Primary outcomes were the percentage of participants showing a CSC at study end in each domain. CSCs were defined as a change ≥ 1 point on the Canadian Mediterranean Diet Score, ≥ 300 METs‐min/week on the short version of the International Physical Activity Questionnaire, and ≥ 6 points on the Cognitive Activity Questionnaire, respectively. Additional outcomes comprised feasibility indicators.ResultThirty‐nine participants (mean age=63.1 [51‐68]; 82.1% female) were recruited, with 31 participants enrolled in the single‐domain groups (Diet, N=11; PA, N=7; CE, N=13). Within the single‐domain groups, participants received 7.9 (6‐9) coaching sessions. The number of participants achieving a CSC was 5 (45.5%) in the Diet group, 3 (42.9%) in the PA group and 6 (50.0%) in the CE group. Overall compliance and retention were 93.5% (89.6‐98.0) and 97.4% (92.3‐100), respectively.ConclusionThe results of this study support moving forward to the next ORBIT framework step, which includes refinement of the Luci intervention components and the design of a pilot feasibility trial to test the program in a larger sample of participants.

A Novel Behavioral Intervention for Rural Appalachian Cancer Survivors (weSurvive): Participatory Development and Proof-of-Concept Testing

BackgroundAddressing the modifiable health behaviors of cancer survivors is important in rural communities that are disproportionately impacted by cancer (eg, those in Central Appalachia). However, such efforts are limited, and existing interventions may not meet the needs of rural communities.ObjectiveThis study describes the development and proof-of-concept testing of weSurvive, a behavioral intervention for rural Appalachian cancer survivors.MethodsThe Obesity-Related Behavioral Intervention Trials (ORBIT) model, a systematic model for designing behavioral interventions, informed the study design. An advisory team (n=10) of community stakeholders and researchers engaged in a participatory process to identify desirable features for interventions targeting rural cancer survivors. The resulting multimodal, 13-week weSurvive intervention was delivered to 12 participants across the two cohorts. Intervention components included in-person group classes and group and individualized telehealth calls. Indicators reflecting five feasibility domains (acceptability, demand, practicality, implementation, and limited efficacy) were measured using concurrent mixed methods. Pre-post changes and effect sizes were assessed for limited efficacy data. Descriptive statistics and content analysis were used to summarize data for other domains.ResultsParticipants reported high program satisfaction (acceptability). Indicators of demand included enrollment of cancer survivors with various cancer types and attrition (1/12, 8%), recruitment (12/41, 30%), and attendance (median 62%) rates. Dietary (7/12, 59%) and physical activity (PA; 10/12, 83%) behaviors were the most frequently chosen behavioral targets. However, the findings indicate that participants did not fully engage in action planning activities, including setting specific goals. Implementation indicators showed 100% researcher fidelity to delivery and retention protocols, whereas practicality indicators highlighted participation barriers. Pre-post changes in limited efficacy outcomes regarding cancer-specific beliefs and knowledge and behavior-specific self-efficacy, intentions, and behaviors were in desired directions and demonstrated small and moderate effect sizes. Regarding dietary and PA behaviors, effect sizes for fruit and vegetable intake, snacks, dietary fat, and minutes of moderate-to-vigorous activity were small (Cohen d=0.00 to 0.32), whereas the effect sizes for change in PA were small to medium (Cohen d=0.22 to 0.45).ConclusionsweSurvive has the potential to be a feasible intervention for rural Appalachian cancer survivors. It will be refined and further tested based on the study findings, which also provide recommendations for other behavioral interventions targeting rural cancer survivors. Recommendations included adding additional recruitment and engagement strategies to increase demand and practicality as well as increasing accountability and motivation for participant involvement in self-monitoring activities through the use of technology (eg, text messaging). Furthermore, this study highlights the importance of using a systematic model (eg, the ORBIT framework) and small-scale proof-of-concept studies when adapting or developing behavioral interventions, as doing so identifies the intervention’s potential for feasibility and areas that need improvement before time- and resource-intensive efficacy trials. This could support a more efficient translation into practice.

Development of a Health Information Technology Tool for Behavior Change to Address Obesity and Prevent Chronic Disease Among Adolescents: Designing for Dissemination and Sustainment Using the ORBIT Model.

Health information technology (HIT) has not been broadly adopted for use in outpatient healthcare settings to effectively address obesity in youth, especially among disadvantaged populations that face greater barriers to good health. A well-designed HIT tool can deliver behavior change recommendations and provide community resources to address this gap, and the Obesity-Related Behavioral Intervention Trials (ORBIT) model can guide its development and refinement. This article reports the application of the ORBIT model to (1) describe the characteristics and design of a novel HIT tool (the PREVENT tool) using behavioral theory, (2) illustrate the use of stakeholder-centered “designing for dissemination and sustainability” principles, and (3) discuss the practical implications and directions for future research. Two types of stakeholder engagement (customer discovery and user testing) were conducted with end users (outpatient healthcare teams). Customer discovery interviews (n = 20) informed PREVENT tool components and intervention targets by identifying (1) what healthcare teams (e.g., physicians, dietitians) identified as their most important “jobs to be done” in helping adolescents who are overweight/obese adopt healthy behaviors, (2) their most critical “pains” and “gains” related to overweight/obesity treatment, and (3) how they define success compared to competing alternatives. Interviews revealed the need for a tool to help healthcare teams efficiently deliver tailored, evidence-based behavior change recommendations, motivate patients, and follow-up with patients within the constraints of clinic schedules and workflows. The PREVENT tool was developed to meet these needs. It facilitates prevention discussions, delivers tailored, evidence-based recommendations for physical activity and food intake, includes an interactive map of community resources to support behavior change, and automates patient follow-up. Based on Self-Determination Theory, the PREVENT tool engages the patient to encourage competence and autonomy to motivate behavior change. The use of this intentional, user-centered design process should increase the likelihood of the intended outcomes (e.g., behavior change, weight stabilization/loss) and ultimately increase uptake, implementation success, and long-term results. After initial tool development, user-testing interviews (n = 13) were conducted using a think-aloud protocol that provided insight into users' (i.e., healthcare teams) cognitive processes, attitudes, and challenges when using the tool. Overall, the PREVENT tool was perceived to be useful, well-organized, and visually appealing.

Early-phase study of a telephone-based intervention to reduce weight regain among bariatric surgery patients.

This study describes early-phase development of a behavioral intervention to reduce weight regain following bariatric surgery. We utilized the Obesity-Related Behavioral Intervention Trials model to guide intervention development and evaluation. We sought to establish recruitment, retention, and fidelity monitoring procedures; evaluate feasibility of utilizing weight from the electronic medical record (EMR) as an outcome; observe improvement in behavioral risk factors; and evaluate treatment acceptability. The intervention comprised 4 weekly telephone calls addressing behavior change strategies for diet, physical activity, and nutrition supplement adherence and 5 biweekly calls addressing weight loss maintenance constructs. Veterans (N = 33) who received bariatric surgery 9-15 months prior consented to a 16-week, pre-post study. Self-reported outcomes were obtained by telephone at baseline and 16 weeks. Clinic weights were obtained from the EMR 6 months pre- and postconsent. Qualitative interviews were conducted at 16 weeks to evaluate treatment acceptability. We aimed to achieve a recruitment rate of ≥ 25% and retention rate of ≥ 80%, and have ≥ 50% of participants regain < 3% of their baseline weight. Results supported the feasibility of recruiting (48%) and retaining participants (93% provided survey data; 100% had EMR weight). Pre-post changes in weight (73% with < 3% weight regain) and physical activity (Cohen's ds 0.38 to 0.52) supported the potential for the intervention to yield clinically significant results. Intervention adherence (mean 7.8 calls of 9 received) and positive feedback from interviews supported treatment acceptability. The intervention should be evaluated in an adequately powered randomized controlled trial. (PsycInfo Database Record (c) 2020 APA, all rights reserved).