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2.
Contemp Clin Trials ; 109: 106539, 2021 Aug 13.
Artigo em Inglês | MEDLINE | ID: mdl-34400362

RESUMO

INTRODUCTION: Over 100 million adults in the United States have hypertension. The DASH (Dietary Approaches to Stop Hypertension) eating pattern is an evidence-based first-line treatment option for hypertension; however, adherence to the DASH eating pattern at a population level remains low. To address this gap, we will implement Nourish, a randomized controlled efficacy trial that will leverage a commercially-available smartphone application and evidence-based behavior change principles to improve adherence to the DASH eating pattern among adults with hypertension. METHODS: The Nourish trial is a two-arm, 12-month randomized control trial that will enroll adults (N = 300) with hypertension, defined as a systolic blood pressure of 120-159 mmHg; a diastolic blood pressure of 80-99 mmHg; and/or adults on blood pressure-lowering medication. Nourish will test the efficacy of a digital health intervention, as compared to the attention control arm, on DASH eating pattern adherence and blood pressure. Intervention components will include skills training, self-monitoring, personalized feedback, and responsive coaching. The primary outcome of the trial is 6-month changes in adherence to the DASH eating pattern, as measured by 24-h dietary recalls. DISCUSSION: Millions of Americans remain in need of effective behavioral interventions to manage and improve their hypertension and its adverse consequences. The ubiquity of smartphones offers a promising approach to disseminate the DASH eating pattern. By leveraging these widely used smartphone applications, combined with evidence-based behavior change principles and the DASH eating plan, Nourish will demonstrate the effectiveness of a digital health intervention to improve DASH adherence, and ultimately, to reduce blood pressure. Trial Number: NCT03875.

4.
Obesity (Silver Spring) ; 29(3): 478-499, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-33624440

RESUMO

OBJECTIVE: Self-monitoring is a core component of behavioral obesity treatment, but it is unknown how digital health has been used for self-monitoring, what engagement rates are achieved in these interventions, and how self-monitoring and weight loss are related. METHODS: This systematic review examined digital self-monitoring in behavioral weight loss interventions among adults with overweight or obesity. Six databases (PubMed, Embase, Scopus, PsycInfo, CINAHL, and ProQuest Dissertations & Theses) were searched for randomized controlled trials with interventions ≥ 12 weeks, weight outcomes ≥ 6 months, and outcomes on self-monitoring engagement and their relationship to weight loss. RESULTS: Thirty-nine studies from 2009 to 2019 met inclusion criteria. Among the 67 interventions with digital self-monitoring, weight was tracked in 72% of them, diet in 81%, and physical activity in 82%. Websites were the most common self-monitoring modality, followed by mobile applications, wearables, electronic scales, and, finally, text messaging. Few interventions had digital self-monitoring engagement rates ≥ 75% of days. Rates were higher in digital- than in paper-based arms in 21 out of 34 comparisons and lower in just 2. Interventions with counseling had similar rates to standalone interventions. Greater digital self-monitoring was linked to weight loss in 74% of occurrences. CONCLUSIONS: Self-monitoring via digital health is consistently associated with weight loss in behavioral obesity treatment.


Assuntos
Aplicativos Móveis , Obesidade/terapia , Sobrepeso/terapia , Autogestão/métodos , Programas de Redução de Peso/métodos , Adulto , Terapia Comportamental/instrumentação , Terapia Comportamental/métodos , Peso Corporal , Dieta , Exercício Físico/fisiologia , Feminino , Humanos , Masculino , Monitorização Fisiológica/métodos , Monitorização Fisiológica/estatística & dados numéricos , Obesidade/epidemiologia , Obesidade/psicologia , Sobrepeso/epidemiologia , Sobrepeso/psicologia , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Autogestão/psicologia , Autogestão/estatística & dados numéricos , Telemedicina/métodos , Telemedicina/tendências , Perda de Peso , Programas de Redução de Peso/estatística & dados numéricos , Programas de Redução de Peso/tendências
5.
JMIR Res Protoc ; 10(1): e19506, 2021 Jan 18.
Artigo em Inglês | MEDLINE | ID: mdl-33459600

RESUMO

BACKGROUND: Effective weight loss interventions exist, yet few can be scaled up for wide dissemination. Further, none has been fully delivered via text message. We used the multiphase optimization strategy (MOST) to develop multicomponent interventions that consist only of active components, those that have been experimentally determined to impact the chosen outcome. OBJECTIVE: The goal of this study is to optimize a standalone text messaging obesity intervention, Charge, using the MOST framework to experimentally determine which text messaging components produce a meaningful contribution to weight change at 6 months. METHODS: We designed a 6-month, weight loss texting intervention based on our interactive obesity treatment approach (iOTA). Participants are randomized to one of 32 experimental conditions to test which standalone text messaging intervention components produce a meaningful contribution to weight change at 6 months. RESULTS: The project was funded in February 2017; enrollment began in January 2018 and data collection was completed in June 2019. Data analysis is in progress and first results are expected to be submitted for publication in 2021. CONCLUSIONS: Full factorial trials are particularly efficient in terms of cost and logistics when leveraged for standalone digital treatments. Accordingly, MOST has the potential to promote the rapid advancement of digital health treatments. Subject to positive findings, the intervention will be low cost, immediately scalable, and ready for dissemination. This will be of great potential use to the millions of Americans with obesity and the providers who treat them. TRIAL REGISTRATION: ClinicalTrials.gov NCT03254940; https://clinicaltrials.gov/ct2/show/NCT03254940. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/19506.

6.
Transl Behav Med ; 11(1): 226-235, 2021 Feb 11.
Artigo em Inglês | MEDLINE | ID: mdl-31586443

RESUMO

Evidence-based behavioral weight loss treatment is under-utilized. To increase initiation of treatment, we developed a single-session, online, primary care-based intervention ("mobilization tool"). We evaluated the mobilization tool's acceptability for primary care patients with obesity, trial design feasibility, and signal of an effect of the tool on treatment initiation. In this cluster randomized feasibility trial, primary care providers (PCPs) were randomized to a mobilization tool or comparator tool arm. Patients with obesity and a scheduled appointment with a randomized PCP were assigned to complete the mobilization or comparator tool prior to their appointment. The online mobilization tool asks patients to answer questions about a variety of weight-related topics and then provides automated, tailored feedback that addresses psychosocial determinants of weight loss treatment initiation. The comparator tool provided a nontailored description of treatments. All participants were offered free enrollment in behavioral weight loss treatments. Six PCPs were randomized. Sixty patients (57% female; 66% white; aged 55 ± 13 years) participated in this study of 296 contacted for eligibility evaluation (20.2%). Six-month follow-up assessments were completed by 65% (22/34) of the mobilization and 73% (19/26) of comparator tool participants. Participants completing the acceptability survey reported that the mobilization tool was usable, enjoyable, informative, and useful. Weight loss treatment was initiated by 59% (n = 19) of mobilization and 33% (n = 8) of comparator tool participants. The mobilization tool shows promise for increasing treatment initiation among primary care patients, which may increase population weight loss. Trial Registration: Clinicaltrials.gov identifier: NCT02708121.

7.
JMIR Mhealth Uhealth ; 8(12): e17536, 2020 12 07.
Artigo em Inglês | MEDLINE | ID: mdl-33284116

RESUMO

BACKGROUND: Over 100 million individuals have high blood pressure, and more than half of them are women. The Dietary Approaches to Stop Hypertension (DASH) dietary pattern is a proven lifestyle approach to lower blood pressure, yet population-level adherence is poor. Innovative strategies that promote DASH are needed. OBJECTIVE: This paper aims to improve adherence to the DASH diet among women with hypertension or prehypertension. METHODS: We conducted a 3-month randomized controlled feasibility trial comparing app-based diet tracking (active comparator) to app-based diet tracking plus feedback on DASH adherence via text message (intervention). The intervention platform extracted nutrient data from the app, compared it to DASH recommendations, and sent tailored feedback text messages. Outcomes included the number of days participants tracked their diet, changes in their DASH adherence score, and blood pressure. RESULTS: The women (N=59) had a mean age of 49.9 (SD 11.9) years and were primarily non-Hispanic White (41/59, 69%) and college educated (49/59, 83%). The mean baseline DASH score was 2.3 (SD 1.3). At 3 months, the intervention and active comparator participants had similar mean days tracked per week (4.2, SD 2.1 days vs 4.6, SD 2.7 days; P=.54) and mean changes in their DASH score (0.8, 95% CI 0.2-1.5 vs 0.8, 95% CI 0.4-1.2; P=.75). Intervention participants had lower systolic (mean difference: -2.8 mmHg, 95% CI -1.8 to 7.4; P=.23) and diastolic (mean difference: -3.6 mmHg, 95% CI -0.2 to 7.3; P=.07) blood pressure compared with active comparator participants. Most intervention participants (23/29, 79%) said they would recommend the DASH Cloud intervention to a friend or family member. However, only 34% (10/59) indicated that the feedback text messages helped them reach their diet goals. CONCLUSIONS: A digital health intervention to improve DASH adherence is feasible and produces moderately high engagement among women with elevated blood pressure. The intervention did not enhance DASH adherence over diet tracking alone but resulted in greater reductions in blood pressure. Larger studies are needed to determine how digital health interventions can improve population-level adherence to DASH. TRIAL REGISTRATION: ClinicalTrials.gov NCT03215472; https://clinicaltrials.gov/ct2/show/study/NCT03215472.


Assuntos
Hipertensão , Envio de Mensagens de Texto , Pressão Sanguínea , Dieta , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
8.
Ethn Dis ; 30(2): 331-338, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32346279

RESUMO

Objectives: The metabolic syndrome (MetS) refers to a cluster of interrelated physiological characteristics that are associated with an increased risk of cardiovascular disease and diabetes. While the clinical usefulness of the MetS has been the subject of controversy for years, increasingly sophisticated methods are being used to measure the concept. Participants: Study of community health center patients who were not diabetic; study group was evenly divided between Black and White adults. Main Outcome Measures: Latent MetS score and MetS status based on the five-point scale developed by the National Cholesterol Education Panel (NCEP). Methods: Structural equation modeling of MetS incorporating the effects of race/ethnicity, racial discrimination, socioeconomic position (SEP), and selected mediating variables. Results: The largest influences on latent MetS scores were SEP (negative relationship) and male gender (higher scores for men). Two mediating variables, physical activity and stress-related eating, had smaller impacts. Self-reported racial discrimination was associated with cynical hostility but did not influence the MetS level among nondiabetics. Despite higher NCEP scores and MetS prevalence rates for Blacks compared with Whites, race did not have direct effect on MetS levels when adjusted for the other characteristics in our model. Conclusions: Neither race nor self-reported racial discrimination had direct effects on MetS level in our structural model. The large effects of socioeconomic position and male gender were not mediated by the other variables in the model.


Assuntos
Doenças Cardiovasculares , Diabetes Mellitus , Síndrome Metabólica/etnologia , Determinantes Sociais da Saúde/etnologia , Grupo com Ancestrais do Continente Africano/estatística & dados numéricos , Fatores de Risco Cardiometabólico , Doenças Cardiovasculares/etnologia , Doenças Cardiovasculares/metabolismo , Doenças Cardiovasculares/prevenção & controle , Diabetes Mellitus/etnologia , Diabetes Mellitus/metabolismo , Diabetes Mellitus/prevenção & controle , Grupo com Ancestrais do Continente Europeu/estatística & dados numéricos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Modelos Estruturais , Prevalência , Estados Unidos/epidemiologia
9.
J Behav Med ; 43(3): 391-401, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-31396820

RESUMO

Self-monitoring is the strongest predictor of success in lifestyle interventions for obesity. In this secondary analysis of the GoalTracker trial, we describe outcomes of consistently self-monitoring in a standalone weight loss intervention. The 12-week intervention focused on daily self-monitoring of diet and/or body weight in a commercial app (MyFitnessPal). Participants (N = 100; 21-65 years; BMI 25-45 kg/m2) were categorized as Consistent Trackers if they tracked ≥ 6 out of 7 days for at least 75% of the targeted weeks. One-fourth of participants were Consistent Trackers. This subset was more likely to be married or living with a partner, be non-Hispanic White, and have higher health literacy than Inconsistent Trackers (ps < .05). Consistent tracking was associated with greater weight change than inconsistent tracking at 1 month (mean difference [95% CI] - 1.11 kg [- 2.12, - 0.10]), 3 months (- 2.42 kg [- 3.80, - 1.04]), and 6 months (- 2.13 kg [- 3.99, - 0.27]). Over 3 times as many Consistent Trackers as Inconsistent Trackers achieved ≥ 5% weight loss at 3 months (48 vs. 13%) and at 6 months (54 vs. 15%; ps < .001). Though causality cannot be determined by the present study, tracking weight and/or diet nearly every day per week for 12 weeks in a commercial app may serve as an effective strategy for weight loss. Strategies are needed to promote greater consistency in tracking.


Assuntos
Software , Perda de Peso , Programas de Redução de Peso/métodos , Peso Corporal , Dieta , Feminino , Humanos , Estilo de Vida , Masculino , Pessoa de Meia-Idade , Obesidade
10.
Child Obes ; 16(2): 122-128, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31618046

RESUMO

Background: Previous studies show inconsistent relations between child care and obesity, but few assessed longitudinal associations during infancy and even fewer included racially diverse children. We examined associations of time infants spent in child care, both overall and in different types of care, with weight status at 6 and 12 months. Methods: We examined 664 infants living in central North Carolina. We conducted adjusted multivariable linear regressions examining (1) child care from birth to 6 months and 6-month weight-for-length (WFL) z-score, and (2) child care from birth to 12 months and 12-month WFL z-score. We assessed any child care and child care by type, including relative care, informal care by a nonrelative, formal child care, and a combination of care (e.g., relative and informal care). Results: Nearly 70% of infants were black and 49% were female. After adjustment for potential confounders, any child care was not associated with WFL z-score at 6 months (0.07; 95% confidence intervals [CI] -0.02 to 0.16; p = 0.13) or 12 months (0.05; 95% CI -0.02 to 0.12; p = 0.19). However, greater combination care was associated with higher WFL z-score at 6 months (0.68; 95% CI 0.23-1.13; p = 0.003) and greater care by a relative was associated with higher WFL z-score at 12 months (0.16; 95% CI 0.05-0.26; p = 0.005). Conclusions: Although we did not observe associations with any child care, combination care and relative care during infancy were associated with higher weight. Interventions aimed at preventing excessive weight gain in early life may target relatives who provide regular care for infants.

11.
Health Psychol ; 38(12): 1168-1174, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31580127

RESUMO

To optimize digital health interventions, intervention creators must determine what intervention dose will produce the most substantial health behavior change-the dose-response relationship-while minimizing harms or burden. In this article we present important concepts, considerations, and challenges in studying dose-response relationships in digital health interventions. We propose that interventions make three types of prescriptions: (1) intervention action prescriptions, prescriptions to receive content from the intervention, such as to read text or listen to audio; (2) participant action prescriptions, prescriptions to produce and provide content to the intervention, such as to send text messages or post intervention-requested photos on social media; and (3) behavioral target action prescriptions, prescriptions to engage in behaviors outside the intervention, such as changing food intake or meditating. Each type of prescription has both an intended dose (i.e., what the intervention actually prescribes) and an enacted dose (i.e., what portion of the intended dose is actually completed by the participant). Dose parameters of duration, frequency, and amount can be applied to each prescription type. We consider adaptive interventions and interventions with ad libitum prescriptions as examples of tailored doses. Researchers can experimentally manipulate the intended dose to determine the dose-response relationship. The enacted dose cannot be directly manipulated; however, we consider the applicability of "controlled concentration" research design to the study of enacted dose. We consider challenges in dose-response research in digital health interventions, including characterizing amount with self-paced activities and combining doses across modality. The presented concepts and considerations may help contribute to the optimization of digital health interventions. (PsycINFO Database Record (c) 2019 APA, all rights reserved).


Assuntos
Telemedicina/métodos , Relação Dose-Resposta a Droga , Comportamentos Relacionados com a Saúde , Humanos , Masculino , Projetos de Pesquisa , Envio de Mensagens de Texto
12.
Digit Health ; 5: 2055207619878627, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31632684

RESUMO

Background: Development and uptake of digital health technologies benefit from cross-sectoral efforts from academia and industry. Our study aims to identify the barriers and facilitators associated with academia-industry collaborations in digital health in middle- and high-income countries. Methods: Trained personnel conducted semi-structured interviews with 23 stakeholders who were active in industry, academia or both. Stakeholders were based in middle-income countries (including China) and high-income countries (including the United States) as defined by the World Bank. Interviews were conducted in the stakeholder's language of choice (Chinese, n = 12; English, n = 11). Qualitative interview questions elicited perspectives on stakeholders' experience with academia-industry collaboration, challenges faced, and factors that facilitated the process. Interviews were audiotaped, transcribed verbatim, thematically coded by bilingual coders and analyzed using inductive content analysis. Results: Stakeholders in both academia and industry identified complementary roles, authentic communication between partners, and clearly outlined goals or expectations prior to the collaboration as primary facilitators for success. Misaligned goals or expectations, differences in timelines for productivity and difficulties balancing expectations for business outcomes versus generation of scientific evidence were identified as primary barriers. Stakeholders in high-income countries reported inauthentic communication as a significant barrier to collaboration, whereas those in middle-income countries did not. Conclusion: Outlining and communicating openly about goals and expectations for timeline and priorities as well as establishing complementary roles will facilitate fruitful academia-industry collaborations in the future. Best practices for communication styles may be dependent on the cultural setting, and thus should be adopted accordingly.

13.
Contemp Clin Trials ; 87: 105822, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31400513

RESUMO

BACKGROUND: Obesity affects African American women more than any other group in the US. Pregnancy represents a critical life stage of heightened vulnerability for new or persistent obesity, yet few interventions have been effective in reducing excessive gestational weight gain among African American women. We describe the design and baseline findings of Healthy Babies, a two-arm randomized controlled trial testing a mobile health intervention to minimize excessive gestational weight gain versus usual care in this high risk group. METHODS: African American women in early pregnancy were recruited from two large obstetric practices as well as Philadelphia Women, Infants, and Children's clinics. Participants randomized to the intervention received behavior change goals, daily text messages with feedback, web-based weight gain graphs, health coaching, and a Facebook support group. Data collection included baseline (<22 weeks' gestation), 36-38 weeks' gestation, and 6-month postpartum anthropometric measures and assessments of demographics, contextual factors and behavioral targets. The primary outcome was prevalence of excessive gestational weight gain. RESULTS: Among participants at baseline (n = 262), the majority met criteria for obesity (63%), were multiparous (62%), single (77%), and were on average 25.6 ±â€¯5.4 years old with a gestational age of 13.9 ±â€¯4.1 weeks. While 82% completed high school, 61% met criteria for inadequate health literacy. Nearly 20% were food insecure. Eighty-eight percent reported a gestational weight gain goal discordant with Institute of Medicine guidelines. There were no significant differences in baseline characteristics between study arms. CONCLUSIONS: Participants represent a high-risk group for excessive gestational weight gain with demonstrated need for intervention.


Assuntos
Ganho de Peso na Gestação , Promoção da Saúde/métodos , Obesidade/etnologia , Obesidade/terapia , Complicações na Gravidez/terapia , Envio de Mensagens de Texto , Adulto , Afro-Americanos , Feminino , Idade Gestacional , Comportamentos Relacionados com a Saúde , Humanos , Gravidez , Complicações na Gravidez/etnologia , Fatores Socioeconômicos , Telemedicina , Adulto Jovem
14.
BMC Public Health ; 19(1): 596, 2019 May 17.
Artigo em Inglês | MEDLINE | ID: mdl-31101037

RESUMO

BACKGROUND: For patients with obesity who are not ready for or experience barriers to weight loss, clinical practice guidelines recommend provider counseling on preventing further weight gain as a first-line treatment approach. Unfortunately, evidence-based weight gain prevention interventions are not routinely available within primary care. To address this gap, we will implement a pragmatic 12-month randomized controlled trial of a digital weight gain prevention intervention delivered to patients receiving primary care within a network of Federally Qualified Community Health Centers in central North Carolina. METHODS: Balance (Equilibrio in Spanish) is a pragmatic effectiveness trial that will randomize adult patients who have overweight or obesity (BMI of 25-40 kg/m2) to either: 1) a weight gain prevention intervention with tailored behavior change goals and tracking, daily weighing on a network-connected electronic scale, and responsive weight and goal coaching delivered remotely by health center registered dietitians; or 2) a usual care program with automated healthy living text messages and print materials and routine primary care. The primary outcome will be weight gain prevention at 24-months, defined as ≤3% change in baseline weight. To align with its pragmatic design, trial outcome data will be pulled from the electronic health record of the community health center network. DISCUSSION: For underserved, often rurally-located patients with obesity, digital approaches to promote a healthy lifestyle can curb further weight gain. Yet enrolling medically vulnerable patients into a weight gain prevention trial, many of whom are from racial/ethnic minorities, can be difficult. Despite these potential challenges, we plan to recruit a large, diverse sample from rural areas, and will implement a remotely-delivered weight gain prevention intervention to medically vulnerable patients. Upcoming trial results will demonstrate the effectiveness of this pragmatic approach to implement and evaluate a digital weight gain prevention intervention within primary care. TRIALS REGISTRATION: NCT03003403 . Registered December 28, 2016.


Assuntos
Aconselhamento/métodos , Obesidade/terapia , Sobrepeso/terapia , Atenção Primária à Saúde/métodos , Programas de Redução de Peso/métodos , Adulto , Centros Comunitários de Saúde , Feminino , Hispano-Americanos , Humanos , Masculino , Tutoria , North Carolina , Obesidade/psicologia , Sobrepeso/psicologia , Ensaios Clínicos Controlados Aleatórios como Assunto , População Rural , Envio de Mensagens de Texto , Resultado do Tratamento , Populações Vulneráveis , Ganho de Peso , Perda de Peso
15.
J Med Internet Res ; 21(5): e12201, 2019 05 17.
Artigo em Inglês | MEDLINE | ID: mdl-31102373

RESUMO

BACKGROUND: Obesity is one of the largest drivers of health care spending but nearly half of the population with obesity demonstrate suboptimal readiness for weight loss treatment. Black women are disproportionately likely to have both obesity and limited weight loss readiness. However, they have been shown to be receptive to strategies that prevent weight gain. OBJECTIVE: The aim of this study was to evaluate the costs and cost-effectiveness of a digital weight gain prevention intervention (Shape) for black women. Shape consisted of adaptive telephone-based coaching by health system personnel, a tailored skills training curriculum, and patient self-monitoring delivered via a fully automated interactive voice response system. METHODS: A cost and cost-effectiveness analysis based on a randomized clinical trial of the Shape intervention was conducted from the payer perspective. Costs included those of delivering the program to 91 intervention participants in the trial and were summarized by program elements: self-monitoring, skills training, coaching, and administration. Effectiveness was measured in quality-adjusted life years (QALYs). The primary outcome was the incremental cost per QALY of Shape relative to usual care. RESULTS: Shape cost an average of US $758 per participant. The base-case model in which quality of life benefits decay linearly to zero 5 years post intervention cessation, generated an incremental cost-effectiveness ratio (ICER) of US $55,264 per QALY. Probabilistic sensitivity analyses suggest an ICER below US $50,000 per QALY and US $100,000 per QALY in 39% and 98% of simulations, respectively. Results are highly sensitive to durability of benefits, rising to US $165,730 if benefits end 6 months post intervention. CONCLUSIONS: Results suggest that the Shape intervention is cost-effective based on established benchmarks, indicating that it can be a part of a successful strategy to address the nation's growing obesity epidemic in low-income at-risk communities.


Assuntos
Terapia Comportamental/economia , Terapia Comportamental/métodos , Análise Custo-Benefício/métodos , Qualidade de Vida/psicologia , Ganho de Peso/fisiologia , Feminino , Humanos , Masculino , Atenção Primária à Saúde
16.
JMIR Public Health Surveill ; 5(2): e11666, 2019 Apr 02.
Artigo em Inglês | MEDLINE | ID: mdl-30938689

RESUMO

BACKGROUND: Traditional methods for recruiting and maintaining contact with participants in cohort studies include print-based correspondence, which can be unidirectional, labor intensive, and slow. Leveraging technology can substantially enhance communication, maintain engagement of study participants in cohort studies, and facilitate data collection on a range of outcomes. OBJECTIVE: This paper provides an overview of the development process and design of a cohort management platform (CMP) used in the Newborn Epigenetic STudy (NEST), a large longitudinal birth cohort study. METHODS: The platform uses short message service (SMS) text messaging to facilitate interactive communication with participants; it also semiautomatically performs many recruitment and retention procedures typically completed by research assistants over the course of multiple study follow-up visits. RESULTS: Since February 2016, 302 participants have consented to enrollment in the platform and 162 have enrolled with active engagement in the system. Daily reminders are being used to help improve adherence to the study's accelerometer wear protocol. At the time of this report, 213 participants in our follow-up study who were also registered to use the CMP were eligible for the accelerometer protocol. Preliminary data show that texters (138/213, 64.8%), when compared to nontexters (75/213, 35.2%), had significantly longer average accelerometer-wearing hours (165.6 hours, SD 56.5, vs 145.3 hours, SD 58.5, P=.01) when instructed to wear the devices for 1 full week. CONCLUSIONS: This platform can serve as a model for enhancing communication and engagement with longitudinal study cohorts, especially those involved in studies assessing environmental exposures.

17.
J Gen Intern Med ; 34(6): 992-998, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-30891688

RESUMO

BACKGROUND: Primary care-based digital health weight loss interventions offer promise for addressing obesity in underserved populations. OBJECTIVES: To determine if primary care providers' weight counseling is associated with weight change during a weight loss intervention. DESIGN: This is a secondary analysis of a randomized clinical trial testing a 12-month primary care-based digital health weight loss intervention. PARTICIPANTS: Participants were community health center patients with body mass indexes of 30-44.9 kg/m2. INTERVENTIONS: The weight loss intervention included tailored behavioral goal setting; weekly goal monitoring via text messaging or interactive voice response calls; counseling calls; skills training material; and participant-tailored recommendations for provider counseling. MAIN MEASURES: At 6 and 12 months, participants' weight was measured and they reported if their provider delivered weight counseling (general or intervention-specific) at their most recent visit and their perception of providers' empathy. Providers' documentation of weight counseling was extracted from health records. KEY RESULTS: Participants (n = 134-141) were predominantly female (70%) and African American (55%) with a mean age of 51 years and BMI of 36 kg/m2. Participant-reported provider weight counseling was not associated with weight change. However, participants whose providers documented intervention-specific counseling at any point during the intervention (n = 35) lost 3.1 kg (95% CI 0.4 to 5.7 kg) more than those whose providers documented only general weight counseling (n = 82) and 4.0 kg (95% CI 0.1 to 7.9 kg) more than those whose providers did not document weight counseling (n = 17). Perceptions of provider empathy were associated with greater weight loss from 6 to 12 months (0.8 kg per measure unit, 95% CI 0.07 to 1.5 kg, p = .03). CONCLUSIONS: Provider counseling that focuses specifically on engagement in a weight loss intervention may enhance weight loss outcomes relative to more general weight loss advice. Counseling that enhances patients' perceptions of empathy may be most beneficial for patients' weight loss. TRIAL REGISTRATION: NCT01827800.


Assuntos
Aconselhamento/métodos , Pessoal de Saúde , Obesidade/terapia , Atenção Primária à Saúde/métodos , Perda de Peso/fisiologia , Programas de Redução de Peso/métodos , Adulto , Centros Comunitários de Saúde , Feminino , Pessoal de Saúde/psicologia , Humanos , Masculino , Pessoa de Meia-Idade , Obesidade/psicologia , Resultado do Tratamento
18.
JMIR Mhealth Uhealth ; 7(2): e12209, 2019 02 28.
Artigo em Inglês | MEDLINE | ID: mdl-30816851

RESUMO

BACKGROUND: Self-monitoring of dietary intake is a valuable component of behavioral weight loss treatment; however, it declines quickly, thereby resulting in suboptimal treatment outcomes. OBJECTIVE: This study aimed to examine a novel behavioral weight loss intervention that aims to attenuate the decline in dietary self-monitoring engagement. METHODS: GoalTracker was an automated randomized controlled trial. Participants were adults with overweight or obesity (n=105; aged 21-65 years; body mass index, BMI, 25-45 kg/m2) and were randomized to a 12-week stand-alone weight loss intervention using the MyFitnessPal smartphone app for daily self-monitoring of either (1) both weight and diet, with weekly lessons, action plans, and feedback (Simultaneous); (2) weight through week 4, then added diet, with the same behavioral components (Sequential); or (3) only diet (App-Only). All groups received a goal to lose 5% of initial weight by 12 weeks, a tailored calorie goal, and automated in-app reminders. Participants were recruited via online and offline methods. Weight was collected in-person at baseline, 1 month, and 3 months using calibrated scales and via self-report at 6 months. We retrieved objective self-monitoring engagement data from MyFitnessPal using an application programming interface. Engagement was defined as the number of days per week in which tracking occurred, with diet entries counted if ≥800 kcal per day. Other assessment data were collected in-person via online self-report questionnaires. RESULTS: At baseline, participants (84/100 female) had a mean age (SD) of 42.7 (11.7) years and a BMI of 31.9 (SD 4.5) kg/m2. One-third (33/100) were from racial or ethnic minority groups. During the trial, 5 participants became ineligible. Of the remaining 100 participants, 84% (84/100) and 76% (76/100) completed the 1-month and 3-month visits, respectively. In intent-to-treat analyses, there was no difference in weight change at 3 months between the Sequential arm (mean -2.7 kg, 95% CI -3.9 to -1.5) and either the App-Only arm (-2.4 kg, -3.7 to -1.2; P=.78) or the Simultaneous arm (-2.8 kg, -4.0 to -1.5; P=.72). The median number of days of self-monitoring diet per week was 1.9 (interquartile range [IQR] 0.3-5.5) in Sequential (once began), 5.3 (IQR 1.8-6.7) in Simultaneous, and 2.9 (IQR 1.2-5.2) in App-Only. Weight was tracked 4.8 (IQR 1.9-6.3) days per week in Sequential and 5.1 (IQR 1.8-6.3) days per week in Simultaneous. Engagement in neither diet nor weight tracking differed between arms. CONCLUSIONS: Regardless of the order in which diet is tracked, using tailored goals and a commercial mobile app can produce clinically significant weight loss. Stand-alone digital health treatments may be a viable option for those looking for a lower intensity approach. TRIAL REGISTRATION: ClinicalTrials.gov NCT03254953; https://clinicaltrials.gov/ct2/show/NCT03254953 (Archived by WebCite at http://www.webcitation.org/72PyQrFjn).


Assuntos
Aplicativos Móveis/normas , Autogestão/psicologia , Perda de Peso , Adulto , Idoso , Comportamento Alimentar/psicologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Aplicativos Móveis/estatística & dados numéricos , North Carolina , Autogestão/métodos , Autogestão/estatística & dados numéricos
19.
J Acad Nutr Diet ; 119(4): 574-584, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30905430

RESUMO

BACKGROUND: Obesity treatment focuses primarily on reducing overall caloric intake with limited focus on improving diet quality. The Dietary Approaches to Stop Hypertension (DASH) dietary pattern is effective in managing hypertension and other chronic conditions, yet it is not clear whether behavioral weight control interventions improve DASH adherence. We conducted a post hoc analysis of a behavioral weight loss intervention that did not emphasize diet quality and examined whether the intervention impacted DASH adherence in medically vulnerable community health center patients. METHODS: Participants (n=306) were enrolled in Track, a randomized controlled weight loss intervention for patients with elevated cardiovascular risk. The trial compared usual care to an intervention with weekly self-monitoring, tailored feedback on diet and exercise goals, and dietitian and provider counseling in community health centers. Dietary intake was measured using the Block Food Frequency Questionnaires collected at baseline and 12 months. DASH adherence was determined using previously validated scoring indices that assessed adherence based on recommended nutrient or food group targets. Total scores for both indices ranged from 0 to 9, with higher scores indicating greater DASH adherence. RESULTS: The mean (and standard deviation [SD]) age of participants was 51.1 (SD=8.8) years and the mean body mass index was 35.9 (SD=3.9). Most were female (69%) and black (51%); 13% were Hispanic. Half (51%) had an annual income <$25,000 and 33% had both diabetes and hypertension. At baseline, the mean DASH nutrient score was 1.81 (SD=1.42) with 6% achieving at least a score of 4.5. Similar scores were seen for the DASH foods index. The intervention group saw significantly greater, albeit small, improvements in mean DASH nutrient score (intervention: 1.28 [SD=1.5] vs control: 0.20 [SD=1.3]; P<0.001), and there was no difference in DASH food score between study arms. There were no significant predictors of change in DASH score and no association between DASH adherence and changes in blood pressure. Within the intervention arm, improvements in DASH nutrient score were associated with greater weight loss (r=-0.28; P=0.003). CONCLUSION: Although the intervention was not designed to increase adoption of DASH, the Track intervention produced significant weight loss and small improvements in DASH adherence. Despite these small improvements, overall adoption of DASH was poor among the medically vulnerable patients enrolled in Track. To further reduce chronic disease burden, weight loss interventions should include a focus on both caloric restriction and increasing diet quality.


Assuntos
Terapia Comportamental/métodos , Abordagens Dietéticas para Conter a Hipertensão/psicologia , Obesidade/terapia , Cooperação do Paciente/psicologia , Populações Vulneráveis/psicologia , Índice de Massa Corporal , Aconselhamento , Inquéritos sobre Dietas , Dieta Saudável , Abordagens Dietéticas para Conter a Hipertensão/métodos , Feminino , Comportamentos Relacionados com a Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Obesidade/psicologia , Atenção Primária à Saúde , Resultado do Tratamento , Perda de Peso , Programas de Redução de Peso/métodos
20.
Transl Behav Med ; 9(6): 1047-1056, 2019 11 25.
Artigo em Inglês | MEDLINE | ID: mdl-30590759

RESUMO

The multiphase optimization strategy (MOST) is an increasingly popular framework to prepare, optimize, and evaluate multicomponent behavioral health interventions. Within this framework, it is common to use a factorial trial to assemble an optimized multicomponent intervention by simultaneously testing several intervention components. With the possibility of a large number of conditions (unique combinations of components) and a goal to balance conditions on both sample size (for statistical efficiency) and baseline covariates (for internal validity), such trials face additional randomization challenges compared to the standard two-arm trial. The purpose of the current paper is to compare and contrast potential randomization methods for factorial trials in the context of MOST and to provide guidance for the reporting of those methods. We describe the principles, advantages, and disadvantages of several randomization methods in the context of factorial trials. We then provide examples to examine current practice in the MOST-related literature and provide recommendations for reporting of randomization. We identify two key randomization decisions for MOST-related factorial trials: (i) whether to randomize to components or conditions and (ii) whether to use restricted randomization techniques, such as stratification, permuted blocks, and minimization. We also provide a checklist to assist researchers in ensuring complete reporting of randomization methods used. As more investigators use factorial trials within the MOST framework for assembling optimized multicomponent behavioral interventions, appropriate implementation and rigorous reporting of randomization procedures will be essential for ensuring the efficiency and validity of the results.


Assuntos
Medicina do Comportamento/métodos , Ensaios Clínicos como Assunto/normas , Distribuição Aleatória , Projetos de Pesquisa/normas , Humanos
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