Phone-based Counseling Research Articles

Effect of Phone-based Counseling on Physical Activity and Fatigue in Postpartum Women

Objectives: Research shows that physical activity during postpartum affects maternal physical and mental health. In this study, we examined the associations of a phone-based physical activity intervention on objectively measured physical activity and self-reported fatigue. Methods: Participants (N=450) were randomly assigned to either a phone-based physical activity group (N=150), a wellness group (N=150), or a control group (N=150). Participants were on average 4.35 weeks postpartum at the time of the study. Physical activity was measured via accelerometer, and fatigue was measured via self-reported survey. We used a series of one-way analyses of variance (ANOVAs) to examine differences between study groups at the 6-month timepoint. Results: The physical activity group was significantly more active than the control group at 6 months, F(2, 243) = 4.27, p < .05. The control group had significantly higher levels of reduced motivation at 6 months F(2,372) = 3.534, p < .05. Other subscales of the fatigue measure were not significantly different by group. Conclusions: Phone-based counseling may be a useful tool to increase physical activity among postpartum women, but more research is needed to see if those benefits are sustained.

Mental Health Service Use, Barriers, and Service Preferences During COVID-19 among Low-Income Housing and Market-Rate Housing Residents of Harlem in New York City.

This study examined the differences in mental health service use, barriers, and service preferences among 393 low-income housing (LIH) and market-rate housing (MRH) Harlem residents in New York City. One-third (34.6%) endorsed the need for professional support for psychological issues, 27.2% and 15.8% reported using counseling services and psychotropic medication, with no differences between housing types. LIH residents (21.6-38.8%) reported significantly higher use of all types of mental health resources (e.g., websites, anonymous hotlines, self-help tools) compared with MRH residents (16.1-26.4%). Eighty-six percent reported barriers to mental health access, with LIH residents reporting more than double the barriers. Particularly, LIH residents reported greater difficulty getting time off work (34.1% vs. 14%), lack of health insurance (18.7% vs. 9.8%), lack of trust in mental health providers (14.6% vs. 4.7%), and stigma (12.2% vs. 5.1%) compared with MRH residents. Residents most preferred places of services were health clinics and houses of worship; provided by healthcare and mental health providers; and services delivered in-person and phone-based counseling. In contrast, residents least preferred getting support at mental health clinics; from family/friends; and by the Internet. No differences were found between service preferences by housing type. LIH residents reported higher use of mental health services and resources, but they face significantly more barriers to mental health care, suggesting a need to address specific barriers. Preferences for mental health services suggest a need for expanding mental health services to different settings given the low preference for services to be delivered at mental health clinics.

An effectiveness-implementation hybrid trial of phone-based tobacco cessation interventions in the Lebanese primary healthcare system: protocol for project PHOENICS

BackgroundTobacco use remains the leading cause of preventable disease, disability, and death in the world. Lebanon has an exceptionally high tobacco use burden. The World Health Organization endorses smoking cessation advice integrated into primary care settings as well as easily accessible and free phone-based counseling and low-cost pharmacotherapy as standard of practice for population-level tobacco dependence treatment. Although these interventions can increase access to tobacco treatment and are highly cost-effective compared with other interventions, their evidence base comes primarily from high-income countries, and they have rarely been evaluated in low- and middle-income countries. Recommended interventions are not integrated as a routine part of primary care in Lebanon, as in other low-resource settings. Addressing this evidence-to-practice gap requires research on multi-level interventions and contextual factors for implementing integrated, scalable, and sustainable cessation treatment within low-resource settings.MethodsThe objective of this study is to evaluate the comparative effectiveness of promising multi-component interventions for implementing evidence-based tobacco treatment in primary healthcare centers within the Lebanese National Primary Healthcare Network. We will adapt and tailor an existing in-person smoking cessation program to deliver phone-based counseling to smokers in Lebanon. We will then conduct a three-arm group-randomized trial of 1500 patients across 24 clinics comparing (1) ask about tobacco use; advise to quit; assist with brief counseling (AAA) as standard care; (2) ask; advise; connect to phone-based counseling (AAC); and (3) AAC + nicotine replacement therapy (NRT). We will also evaluate the implementation process to measure factors that influence implementation. Our central hypothesis is that connecting patients to phone-based counseling with NRT is the most effective alternative. This study will be guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework, supported by Proctor’s framework for implementation outcomes.DiscussionThe project addresses the evidence-to-practice gap in the provision of tobacco dependence treatment within low-resource settings by developing and testing contextually tailored multi-level interventions while optimizing implementation success and sustainability. This research is significant for its potential to guide the large-scale adoption of cost-effective strategies for implementing tobacco dependence treatment in low-resource settings, thereby reducing tobacco-related morbidity and mortality.Trial registrationClinicalTrials.gov, NCT05628389, Registered 16 November 2022.

Pregnant women and male partner perspectives of secondary distribution of HIV self-testing kits in Uganda: A qualitative study.

HIV self-testing (HIVST) is a promising strategy to increase awareness of HIV status among sub-Saharan African (SSA) men. Understanding user perspectives on HIVST secondary distribution from pregnant women attending antenatal care (ANC) to their male partners is crucial to optimizing delivery strategies. We sampled pregnant women attending ANC without their partners and purposively oversampled pregnant women living with HIV (PWHIV) to understand their unique views. We recruited male partners after obtaining contact information from women. We conducted 14 focus group discussions and 10 in-depth interviews with men and pregnant women. We assessed acceptability of HIVST secondary distribution, barriers, facilitators, and interventions to increase HIVST uptake. Participants felt that HIVST secondary distribution was acceptable, particularly for women in stable relationships. However, many expressed concerns about accusations of mistrust, relationship dissolution, fear of discovering serodifference, and lack of counseling associated with HIVST. PWHIV reported hesitation about secondary distribution, citing fears of unintended HIV status disclosure and abandonment resulting in financial hardship for themselves and their infant. Some participants preferred that providers contact men directly to offer HIVST kits instead of distribution via women. Participants reported that community sensitization, availability of phone-based counseling, male clinic staff, extended clinic hours, and financial incentives could increase men's HIVST use and linkage to care. Participants expressed high interest in using HIVST, but secondary distribution was not universally preferred. We identified potential strategies to increase HIVST acceptability, particularly among PWHIV and those in unstable partnerships which can inform strategies to optimize HIVST distribution.

Efficacy of a centralized, blended electronic, and human intervention to improve direct oral anticoagulant adherence: Smartphones to improve rivaroxaban ADHEREnce in atrial fibrillation (SmartADHERE) a randomized clinical trial

Improving adherence to direct oral anticoagulants (DOAC) is challenging, and simple text messaging reminders have not been effective. SmartADHERE was a randomized trial that tested a personalized digital and human direct oral anticoagulant adherence intervention compared to usual care. Eligibility required age ≥18, newly-prescribed (≤90 days) rivaroxaban for atrial fibrillation (AF), 1 of 4 at-risk criteria for nonadherence, and a smartphone. The intervention consisted of combination of a medication management smartphone app, daily app-based reminders, adaptive text messaging, and phone-based counseling for severe nonadherence. The primary outcome was the proportion of days covered by rivaroxaban (PDC) at 6 months. There were 25 U.S. sites, all cardiology and electrophysiology outpatient practices, activated for a target sample size of 378, but the study was terminated by the sponsor prior to reaching target enrollment. There were 139 participants (age 65±9.6 years, 30% female, median CHA2DS2-VASc score 3 with IQR 2 to 4, mean total medication burden 7.7±4.4). DOAC adherence was high in both arms with no difference in the primary outcome (PDC 0.86±0.25 intervention vs 0.88±0.25 control, p=0.62) or in secondary outcomes including PDC ≥ 0.80 and medication persistence. Per protocol analyses had similar results. Because of the high overall PDC, the likelihood to answer the primary hypothesis was only 51% even if target enrollment were achieved. There were no study-related adverse events. The use of a centralized digital and human adherence intervention was feasible across multiple sites. Overall adherence was much higher than expected despite prescreening for at-risk individuals. SmartADHERE illustrates the challenges of trials of behavioral and technology interventions, where enrollment itself may lead to selection bias or treatment effects. Pragmatic study designs, such as cluster randomization or stepped-wedge implementation, should be considered to improve enrollment and generalizability.

Linkage of Maternal Caregiver Smoking Behaviors on Environmental and Clinical Outcomes of Children with Asthma: A Post-Hoc Analysis of a Financial Incentive Trial Targeting Reduction in Pediatric Tobacco Smoke Exposures.

(1) Background: Monthly variability in smoking behaviors in caregivers of pediatric asthmatics yields questions of how much and when does smoking reduction result in improved environmental and clinical outcomes. (2) Methods: Post hoc analysis of data from a 6 month pilot randomized-control trial occurring from May 2017 to May 2018 in Baltimore City (MD, USA). The initial trial’s primary intervention explored the utility of financial incentives in modifying caregiver smoking behaviors. Post hoc analyses examined all dyads independent of the initial trial’s randomization status. All caregivers received pediatric tobacco smoke harm reduction education, in addition to monthly encouragement to access the state tobacco quitline for individual phone-based counseling and nicotine replacement therapy. Maternal caregivers who were active cigarette smokers and their linked asthmatic child (aged 2–12 years) were grouped into two classifications (“high” versus “low”) based on the child and caregiver’s cotinine levels. A “low” cotinine level was designated by at least a 25% reduction in cotinine levels during 3 months of the trial period; achieving ≤2 months of low cotinine levels defaulted to the “high” category. Twenty-seven dyads (caregivers and children) (total n = 54) were assigned to the “high” category, and eighteen dyads (caregivers and children) (total n = 36) were allocated to the “low” category. The primary outcome measure was the correlation of caregiver cotinine levels with pediatric cotinine values. Secondary outcomes included asthma control, in addition to caregiver anxiety and depression. (3) Results: Caregivers with 3 months of ≥25% decrease in cotinine levels had a significantly greater mean change in child cotinine levels (p = 0.018). “Low” caregiver cotinine levels did not significantly improve pediatric asthma control (OR 2.12 (95% CI: 0.62–7.25)). Caregiver anxiety and depression outcomes, measured by Patient Health Questionnaire (PHQ)-4 scores, was not significantly different based on cotinine categorization (p = 0.079); (4) Conclusion: Reduced pediatric cotinine levels were seen in caregivers who reduced their smoking for at least 3 months, but clinical outcome measures remained unchanged.

Positive Deviance for Promoting Dual-Method Contraceptive Use Among Women in Uganda: A Cluster Randomized Controlled Trial

Background: Dual-method use, or using condoms with highly effective contraceptives, is effective at preventing both pregnancies and HIV infections. Although it remains uncommon among women in long-term relationships in sub-Saharan Africa, some do practice it. The positive deviance approach aims to promulgate practices of such individuals to other members in the community. We examined the effects of a positive deviance intervention on dual-method use among married or in-union women. Methods: We conducted a cluster randomized controlled trial in 20 health facilities in Mbarara District, Uganda, with 960 women aged 18–49 years. The intervention was a combination of clinic- and phone-based counseling and a participatory workshop, which was developed based on the qualitative study of women using dual-method in the study area and delivered by them. The control group received regular clinic-based counseling and health-related messages via phone. We assessed dual-method use at the last sexual intercourse and consistent dual-method use at two, four, six and eight months after enrollment. Findings: More women in the intervention group reported dual-method use at the last sexual intercourse at two months (AOR = 4·29; 95% CI: 2·12–8·69; p < 0·001) and at eight months (AOR = 2·19; 95% CI: 1·07–4·48; p = 0·032). Consistent dual-method use was also more prevalent in the intervention group at two months (AOR = 13·71; 95% CI: 3·59–52·43; p < 0·001), and the intervention effect remained at four, six, and eight months. Interpretation: The intervention can be a potential option for promoting dual-method use among women in long-term relationships in Uganda. Trial Registration: The protocol was registered at UMIN-CTR Clinical Trial under identifier number UMI37065. Funding: Scholarship grant from Foundation for Advanced Studies on International Development (FASID), Tokyo, Japan. Declaration of Interests: The authors declare no conflict of interest. S.M. works at UNICEF Uganda, but the information in this article represents S.M.’s personal views and opinions and does not necessarily represent UNICEF Uganda’s position. Ethics Approval Statement: The study was approved by the Research Ethics Committee of the Graduate School of Medicine, University of Tokyo (2019085NI), Institutional Research and Ethics Committee of Mbarara University of Science and Technology (IRB15/06-19), and Uganda National Council of Science and Technology (HS439ES). Participation was voluntary, and the participants provided written informed consent.

A health coach-led smoking cessation program for Chinese Americans at a community health center in New York City

AbstractIntroductionA health coach-led smoking cessation program was implemented in a community of immigrant Chinese Americans. Follow-up was provided face-to-face or over-the-phone to provide support and address barriers. Free nicotine replacement treatment was provided for eligible participants.AimThe aim is to assess smoking cessation outcome by program components.MethodsQuitting was defined as self-reported smoking abstention for at least 3 months. Factors contributing to successful cessation were evaluated using chi-squared tests and regression analysis. Participants were randomly surveyed to measure the helpfulness of and satisfaction with the program.Results/FindingsThe program enrolled 184 participants from November 2015 to January 2017. Participants were mostly men (89%) with a mean age of 44. An intent-to-treat analysis found that 19% quit. Phone counseling had the same success as face-to-face counseling. Each additional session attended was associated with 2.1 times the odds of quitting, P &lt; 0.001. Among the participants who quit, 70% reported the health coach was helpful in their cessation.ConclusionsA health coach-led smoking cessation program that offered phone-based counseling was successful in reducing smoking. Future programs should consider using a health coach to reduce physician burden and phone-based counseling for difficult-to-access patients to increase program reach.

Acceptability of Mobile Phone-Based Nurse-Delivered Counseling Intervention to Improve HIV Treatment Adherence and Self-Care Behaviors Among HIV-Positive Women in India

We assessed the acceptability of nurse-delivered mobile phone-based counseling to support adherence to antiretroviral treatment (ART) and self-care behaviors among HIV-positive women in India. We conducted open-ended, in-depth interviews with 27 HIV-positive women and 19 key informants at a government ART center in Karnataka, India. Data were analyzed with interpretive techniques. About half of the HIV-positive women owned a mobile phone and many had access to mobile phones of their family members. Most women perceived phone-based counseling as a personalized care approach to get information on demand. Also, women felt that they could discuss mental health issues and ask sensitive information that they would hesitate to discuss face-to-face. Findings indicate that, when compared with text messaging, mobile phone-based counseling could be a more acceptable way to engage with women on ART, especially those with limited literacy. Future studies should focus on testing mobile phone-based information/counseling and adherence interventions that take the local context into account.

Comparative Effectiveness of Proactive Tobacco Treatment among Smokers with and without Chronic Lower Respiratory Disease.

Adults with chronic lower respiratory disease differ in their barriers to smoking cessation but also suffer from tobacco-related health concerns, which may motivate quit attempts. Few studies have examined differences in tobacco treatment response between smokers with and without chronic lower respiratory disease. We examined the effectiveness of a proactive outreach program for cessation among smokers with and without chronic lower respiratory disease. Subgroup analysis of the Veterans Victory over Tobacco Study, a pragmatic randomized controlled trial that demonstrated the effectiveness of proactive outreach and the choice of tobacco treatments compared with usual care. Smokers identified via the electronic medical record were proactively offered phone-based counseling and care coordination to receive medication from their Veterans Affairs providers or in-person care. We compared the response among those with and without an International Classification of Diseases, 9th Revision diagnosis of a chronic lower respiratory disease (chronic obstructive pulmonary disease, chronic bronchitis, emphysema, asthma). We used stratification by propensity scores to adjust for imbalanced covariates between groups with and without chronic lower respiratory disease within each treatment arm, using complete case analysis accounting for the stratified sampling by site. The study participants were predominantly older, white, male smokers. Overall, 19.6% had chronic lower respiratory disease. A total of 3,307 had outcome data with the following assignments to the intervention: proactive care: n = 1,272 without chronic lower respiratory disease, n = 301 with chronic lower respiratory disease; usual care: n = 1,387 without chronic lower respiratory disease, n = 347 with chronic lower respiratory disease. A total of 1,888 had both complete baseline and outcome data and were included in the primary analysis. In unadjusted analyses (n = 3,307), among individuals with chronic lower respiratory disease, 13.1% in the proactive group reported 6-month prolonged abstinence compared with 8.7% of those in the usual care group (odds ratio, 1.57; 95% confidence interval, 0.93-2.65). Among individuals without chronic lower respiratory disease, 13.1% quit in the proactive group compared with 11.0% in the usual care group (odds ratio, 1.22; 95% confidence interval, 0.95-1.55). In adjusted analyses (n = 1,888), the association between treatment arm and quit rate varied by the presence of chronic lower respiratory disease, with a stronger association between allocation to the proactive group and quit rate among those with chronic lower respiratory disease (odds ratio, 3.45; 95% confidence interval, 1.59-7.47) than those without chronic lower respiratory disease (odds ratio, 1.34; 95% confidence interval, 0.95-1.88; P for interaction with chronic lower respiratory disease = 0.03). Smokers with chronic lower respiratory disease may be more likely to respond to a proactive outreach intervention for tobacco cessation treatment than those without chronic lower respiratory disease. Clinical trial registered with www.clinicaltrials.gov (NCT 00608426).

Offering self-administered oral HIV testing to truck drivers in Kenya to increase testing: a randomized controlled trial

ABSTRACTWe conducted a randomized controlled trial among 305 truck drivers from two North Star Alliance roadside wellness clinics in Kenya to see if offering HIV testing choices would increase HIV testing uptake. Participants were randomized to be offered (1) a provider-administered rapid blood (finger-prick) HIV test (i.e., standard of care [SOC]) or (2) a Choice between SOC or a self-administered oral rapid HIV test with provider supervision in the clinic. Participants in the Choice arm who refused HIV testing in the clinic were offered a test kit for home use with phone-based posttest counseling. We compared HIV test uptake using the Mantel Haenszel odds ratio (OR) adjusting for clinic.Those in the Choice arm had higher odds of HIV test uptake than those in the SOC arm (OR = 1.5), but the difference was not statistically significant (p = 0.189). When adding the option to take an HIV test kit for home use, the Choice arm had significantly greater odds of testing uptake (OR = 2.8, p = 0.002). Of those in the Choice arm who tested, 26.9% selected the SOC test, 64.6% chose supervised self-testing in the clinic, and 8.5% took a test kit for home use.Participants varied in the HIV test they selected when given choices. Importantly, when participants who refused HIV testing in the clinic were offered a test kit for home use, an additional 8.5% tested. Offering truck drivers a variety of HIV testing choices may increase HIV testing uptake in this key population.

Design and Implementation of a Community Health Worker HIV Treatment and Prevention Intervention in an HIV Hot Spot Fishing Community in Rakai, Uganda.

Innovative approaches are needed to increase engagement in HIV treatment and prevention services, particularly in HIV hot spots. Here, we detail our design, training approach, and early implementation experiences of a community-based HIV intervention called "health scouts." The intervention, utilizing a novel, theory-based approach, trained 10 community residents in an HIV hot spot fishing community to use motivational interviewing strategies and a mobile phone-based counseling application. During the first 3 months, 771 residents (median 82/health scout, range 27-160) were counseled. A directly observed Motivational Interviewing Treatment Integrity scale-based evaluation found adequate performance (median score 20/25, range 11-23). The health scout intervention was feasible to implement in a high HIV-prevalence fishing community, and its impact on HIV care outcomes will be evaluated in an ongoing cluster randomized trial. If found to be effective, it may be an important strategy for responding to HIV in high-burden settings.

Antiretroviral Therapy Adherence Enhancing Interventions for Adolescents and Young Adults 13-24 Years of Age: A Review of the Evidence Base.

Introduction:Youth living with HIV are highly under-represented in the evidence base for adherence interventions, despite their diverse and unique needs and barriers.Objective:This systematic review aimed to identify antiretroviral therapy (ART) adherence interventions specifically targeting adolescents and young adults (defined as ages 13–24) with the goal of characterizing the evidence base.Methods:Articles were identified using the PubMed database and cover work published through September 14, 2015. Inclusion criteria: (1) average age 13 to 24, (2) HIV positive, (3) on or beginning ART, (4) intervention targeted ART adherence in full or in part, (5) reported adherence, viral load, and/or CD4 count outcomes. Strength of evidence was defined as level 1 [randomized controlled trial (RCT) with significance testing on outcomes], 2 (within group studies with statistical testing on outcomes), 3 (RCTs with descriptive results), or 4 (within group studies with descriptive results).Results:Of 151 articles, 10 met inclusion criteria. Published between 2003 and 2014, these studies evaluated diverse intervention approaches. Most were conducted in the US and were small pilots that have yet to be replicated despite promising results. Only 3 studies met criteria for highest level strength of evidence; 2 supported a phone-based counseling approach with adherence monitors and 1 for weekly individual and family counseling.Conclusions:Despite nearly 20 years passing since the wide-scale availability of ART, and clear recognition that adolescents and youth adults fair worse on the cascade of HIV care, the evidence base remains sparse and underdeveloped. Promising approaches need replication and more rigorous studies are desperately needed.

Design and initial enrollment in the Vascular Physicians Offer and Report (VAPOR) trial

Although patient smoking cessation is a key priority for vascular surgeons, significant variation exists in the manner in which vascular surgeons address this key process of care. We describe a multicenter, cluster-randomized trial that compares a standardized, brief smoking cessation intervention to usual care for patients facing vascular surgery or endovascular interventions. Eight centers were randomized to provide usual care for smoking cessation or a standardized protocol consisting of (1) physician "very brief advice" to stop smoking, (2) offering nicotine replacement therapy, and (3) referral to a phone-based counseling service. Trial enrollment began on September 1, 2014. At present, 142 patients had been enrolled in the trial across eight sites. Compared with patients in the usual care arm, patients enrolled in the smoking cessation intervention arm were more likely to receive physician advice (98% vs 77%), a prescription for nicotine replacement therapy (77% vs 13%), and quitline referral (93% vs 33%; all P< .001). Although final results of the intervention on smoking cessation rates are still forthcoming, surgeon delivery of a brief, evidence-based smoking cessation intervention appears feasible for patients facing invasive vascular care.

Protocol for the Rural Engagement in Primary Care for Optimizing Weight Reduction (RE-POWER) Trial: Comparing three obesity treatment models in rural primary care

Obesity disproportionately affects rural residents in the United States, and primary care has the potential to fill a major gap in the provision of weight management services for rural communities. The objective of this cluster-randomized pragmatic trial is to evaluate the comparative effectiveness of three obesity treatment models in rural primary care: the Intensive Behavior Therapy fee-for-service (FFS) model reimbursed by Medicare, a team-based model that recognizes the patient-centered medical home (PCMH) as a preferred delivery approach, and the centralized disease management (DM) model, in which phone-based counseling is provided outside of the primary care practice. We hypothesize that the PCMH and DM treatments will be more effective than FFS in reducing weight at 24months. Thirty-six practices from the rural Midwestern U.S. are randomized to deliver one of the three interventions to 40 patients (N=1440) age 20 to 75 with a BMI 30–45kg/m2. In the FFS arm, primary care providers and their personnel counsel patients to follow evidence-based weight loss guidelines using the Medicare-designated treatment schedule. In the PCMH arm, patients receive a comprehensive weight management intervention delivered locally by practice personnel using a combination of in-person and phone-based group sessions. In the DM arm, the same intervention is delivered remotely by obesity treatment specialists via group conference calls. The primary outcome is weight loss at 24months. Additional measures include fasting glucose, lipids, quality of life indicators, and implementation process measures. Findings will illuminate effective obesity treatment intervention(s) in rural primary care.

Abstract P3-08-02: Comparison of strategies for weight loss maintenance among rural breast cancer survivors: The rural women connecting for better health randomized controlled trial

Abstract Background: Breast cancer survivors who reside in rural areas represent one of the largest medically underserved populations of breast cancer survivors in the nation and have higher obesity prevalence compared to their urban counterparts. Given the evidence linking obesity with poor breast cancer prognosis, trials are needed to demonstrate ability to produce long-term weight loss maintenance in this hard-to-reach group. Group phone-based counseling via conference calls is a low-technology approach with excellent reach to rural areas. This treatment delivery approach capitalizes on the support benefits of in-person groups by allowing participants to interact in real time while also diminishing costs. Methods: In this 2 phase trial, overweight and obese (BMI 27 to 45 kg/m2) rural breast cancer survivors (with initial stage 0-III disease) were randomized to one of two extended care interventions for weight loss maintenance (Phase 2) subsequent to an initial 6-month weekly group phone-based behavioral weight loss intervention (Phase 1). To be eligible for randomization for maintenance, participants must have lost ≥ 5% of their baseline weight during Phase 1. In Phase 2, participants were randomized to continued group phone-based counseling reduced in frequency to every other week during maintenance vs every other week mailed newsletters that followed the same content. Results: 210 breast cancer survivors with a mean time since treatment of 3.5 years ± 2.4 years, mean age of 58.1 ± 9.9 years, and mean BMI of 33.9 ± 4.4 kg/m2 residing in a three state region of the rural Midwest were entered in the 6-month weight loss phase. Retention from baseline to 6 months (Phase 1) was 91%. Mean percent weight loss at 6 months for the total sample was 12.9% with 82% of enrolled participants ≥ 5% below baseline weight. 172 participants with a mean initial loss of 14.0% of baseline weight (12.8 ± 4.9 kg) were randomized to a maintenance intervention. Retention from 6 to 18 months (Phase 2) was 92%. Intent-to-treat analyses with imputation of missing data revealed participants in the group phone condition regained less weight (3.3 ± 4.8 kg) compared to participants in the newsletter condition (4.9 ± 4.8 kg; p = 0.03). Mean percent weight loss from baseline to 18 months did not significantly differ between the group phone condition (10.2 ± 7.5%) and the newsletter condition (9.2 ± 7.9%). However, at 18 months 75.3% of participants in the group phone condition remained ≥ 5% below baseline weight compared to 57.8% in the newsletter condition (p = .02). Discussion: The initial group phone-based weight loss intervention exceeded typical weight losses reported in the literature with over 80% of enrolled participants achieving clinically meaningful weight loss. Continued group phone counseling was modestly better in sustaining weight loss at 18 months than a mailed newsletter. However, for both maintenance approaches, the majority of participants maintained a weight at 18 months that was 5% or more below baseline. Citation Format: Befort CA, Klemp JR, Sullivan DK, Diaz FJ, Schmitz KH, Perri MG, Fabian CJ. Comparison of strategies for weight loss maintenance among rural breast cancer survivors: The rural women connecting for better health randomized controlled trial. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P3-08-02.

Protocol and recruitment results from a randomized controlled trial comparing group phone-based versus newsletter interventions for weight loss maintenance among rural breast cancer survivors

Obesity is a risk factor for breast cancer recurrence and death. Women who reside in rural areas have higher obesity prevalence and suffer from breast cancer treatment-related disparities compared to urban women. The objective of this 5-year randomized controlled trial is to compare methods for delivering extended care for weight loss maintenance among rural breast cancer survivors. Group phone-based counseling via conference calls addresses access barriers, is more cost-effective than individual phone counseling, and provides group support which may be ideal for rural breast cancer survivors who are more likely to have unmet support needs. Women (n=210) diagnosed with Stage 0 to III breast cancer in the past 10years who are ≥3months out from initial cancer treatments, have a BMI 27–45kg/m2, and have physician clearance were enrolled from multiple cancer centers. During Phase I (months 0 to 6), all women receive a behavioral weight loss intervention delivered through group phone sessions. Women who successfully lose 5% of weight enter Phase II (months 6 to 18) and are randomized to one of two extended care arms: continued group phone-based treatment or a mail-based newsletter. During Phase III, no contact is made (months 18 to 24). The primary outcome is weight loss maintenance from 6 to 18months. Secondary outcomes include quality of life, serum biomarkers, and cost-effectiveness. This study will provide essential information on how to reach rural survivors in future efforts to establish weight loss support for breast cancer survivors as a standard of care.

Efficacy of a Randomized Cell Phone-Based Counseling Intervention in Postponing Subsequent Pregnancy Among Teen Mothers

Adolescent mothers in Washington, DC have a high rate of subsequent teen pregnancies, often within 24 months. Children of teen mothers are at risk for adverse psychosocial outcomes. When adolescents are strongly attached to parents, schools, and positive peers, they may be less likely to repeat a pregnancy. This study tested the efficacy of a counseling intervention delivered by cell phone and focused on postponing subsequent teen pregnancies by strengthening healthy relationships, reproductive practices, and positive youth assets. The objective of this study was to compare time to a repeat pregnancy between the intervention and usual care groups, and, secondarily, to determine whether treatment intensity influenced time to subsequent conception. Primiparous pregnant teens ages 15-19, were recruited in Washington, DC. Of 849 teens screened, 29.3% (n = 249) met inclusion criteria, consented to participate, and completed baseline measures. They were then randomized to the intervention (N = 124) or to usual care (N = 125). Intervention group teens received cell phones for 18 months of counseling sessions, and quarterly group sessions. Follow-up measures assessed subsequent pregnancy through 24 months post-delivery. A survival analysis compared time to subsequent conception in the two treatment groups. Additional models examined the effect of treatment intensity. By 24 months, 31% of the intervention and 36% of usual care group teens had a subsequent pregnancy. Group differences were not statistically significant in intent-to-treat analysis. Because there was variability in the degree of exposure of teens to the curriculum, a survival analysis accounting for treatment intensity was performed and a significant interaction with age was detected. Participants who were aged 15-17 years at delivery showed a significant reduction in subsequent pregnancy with increased levels of intervention exposure (P < 0.01), but not those ≥ 18 years. Adolescents ≥ 18 years faced considerable challenges to treatment success. Individual, social, and contextual factors are all important to consider in the prevention of repeat teen pregnancy. Cell phone-based approaches to counseling may not be the most ideal for addressing complex, socially-mediated behaviors such as this, except for selective subgroups. A lack of resources within the community for older teens may interfere with program success.

Behavioral Counseling and Varenicline Treatment for Smoking Cessation

Smoking remains the primary preventable cause of death and illness in the U.S. Effective, convenient treatment programs are needed to reduce smoking prevalence. This study compared the effectiveness of three modalities of a behavioral smoking-cessation program in smokers using varenicline. Current treatment-seeking smokers (n=1202) were recruited from a large healthcare organization between October 2006 and October 2007. Eligible participants were randomized to one of three smoking-cessation interventions: web-based counseling (n=401); proactive telephone-based counseling (PTC; n=402); or combined PTC and web counseling (n=399). All participants received a standard 12-week FDA-approved course of varenicline. Self-report determined the primary outcomes (7-day point prevalent abstinence at 3- and 6-month follow-ups); the number of days varenicline was taken; and treatment-related symptoms. Behavioral measures determined utilization of both the web- and Phone-based counseling. Intent-to-treat analyses revealed relatively high percentages of abstinence at 3 months (38.9%, 48.5%, 43.4%) and at 6 months (30.7%, 34.3%, 33.8%) for the web, PTC, and PTC-web groups, respectively. The PTC group had a significantly higher percentage of abstinence than the web group at 3 months (OR=1.48, 95% CI=1.12, 1.96), but no between-group differences in abstinence outcomes were seen at 6 months. Phone counseling had greater treatment advantage for early cessation and appeared to increase medication adherence, but the absence of differences at 6 months suggests that any of the interventions hold promise when used in conjunction with varenicline.

Health Outcomes of a 58-Year-Old Man With Type 2 Diabetes Who Had Roux-en-Y Gastric Bypass

J.M. is a 58-year-old man with a history of type 2 diabetes since 1996. He has struggled with his weight throughout most of his life, with his highest adult weight at 407 lb. In March 1998, J.M. enrolled in a phone-based counseling service with a registered dietitian (RD) offered through his managed care organization. The phone program is voluntary and consists of regular phone calls, usually every 2-4 weeks, to discuss diabetes and weight management. J.M.'s height and weight on initial assessment were 69” and 335 lb. (BMI = 49.5 kg/m2). His hemoglobin A1c (A1C) was 5.4% on extended-release glipizide, 5 mg twice daily. His blood pressure was 144/78 mmHg, and his lipid panel revealed a total cholesterol of 220 mg/dl and an HDL cholesterol of 52 mg/dl. LDL cholesterol and triglycerides were not separately measured at that time. In addition to the diabetes medication, J.M. was also taking hydrochlorothiazide, 25 mg/day, and lisinopril, 10 mg/day, to manage hypertension. Throughout the 3 years that J.M. participated in the phone program, he underwent several medical setbacks, including diagnoses of hypercholesterolemia and myasthenia gravis, a neuromuscular disorder characterized by muscle weakness and fatigue. The myasthenia gravis limited his ability to exercise regularly and caused symptoms such as diplopia, difficulty chewing and swallowing, and extensive fatigue. Months later, J.M. discovered a tumor growth, which was removed successfully in 2001. However, detection of the tumor caused him to lose motivation. He struggled with setting lifestyle goals, especially regarding nutrition, because he felt he could not make a significant impact on his health. Consequently, J.M.'s weight continued to escalate and reached 350 lb. Several medications were added during these years to manage his increasingly poor health. In September 2001, J.M.'s internal medicine physician encouraged him to seek surgical treatment for obesity. The provider …