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A randomized controlled trial of a theoretically-based behavioral nutrition intervention for community elders: lessons learned from the Behavioral Nutrition Intervention for Community Elders Study.

ABSTRACT: Older adults with multiple comorbidities are often undernourished or at high risk for becoming so, especially after a recent hospitalization. Randomized controlled trials of effective, innovative interventions are needed to support evidence-based approaches for solving nutritional problems in this population. Self-management approaches where participants select their own behavioral goals can enhance success of interventions. The purpose of this study was to evaluate the feasibility and efficacy of a multilevel self-management intervention to improve nutritional status in a group of high-risk older adults. The Behavioral Nutrition Intervention for Community Elders (B-NICE) trial used a prospective randomized controlled design to determine whether the intervention, compared to standard care, maintained or increased caloric intake (depending on baseline body mass index) and, consequently, stabilized or increased body weight. Participants were 34 Medicare-eligible, age 65 years old or older, homebound adults who were consuming insufficient calories and/or had a history of weight loss ?2.5% over 6 months. The intervention took place within participants' homes. Outcome measures, including energy intake (based on collection of three 24-hour dietary recalls) and body weights were assessed at baseline and at 60 days post randomization. The primary analyses included analyses of covariance and Pearson's ?(2). We hypothesized that the intervention would result in increased caloric intake and weight gain in underweight older adults and increased or stabilized caloric intake and weight for everyone else. The intervention was feasible; however, it did not result in differences between groups for desired outcomes of either caloric intake or body weight. Future interventions might either deliberately involve caregivers or reduce burden for both patients and caregivers.

SUBMITTER: Locher JL

PROVIDER: S-EPMC3834184 | biostudies-literature | 2013 Dec

REPOSITORIES: biostudies-literature

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A randomized controlled trial of a theoretically-based behavioral nutrition intervention for community elders: lessons learned from the Behavioral Nutrition Intervention for Community Elders Study.

Locher Julie L JL Vickers Kristin S KS Buys David R DR Ellis Amy A Lawrence Jeannine C JC Newton Laura Elizabeth LE Roth David L DL Ritchie Christine S CS Bales Connie W CW

Journal of the Academy of Nutrition and Dietetics 20130908 12

Older adults with multiple comorbidities are often undernourished or at high risk for becoming so, especially after a recent hospitalization. Randomized controlled trials of effective, innovative interventions are needed to support evidence-based approaches for solving nutritional problems in this population. Self-management approaches where participants select their own behavioral goals can enhance success of interventions. The purpose of this study was to evaluate the feasibility and efficacy ...[more]

PMID: 24021733

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Project description:BackgroundSmoking rates are significantly higher among young people experiencing homelessness than in the general population. Despite a willingness to quit, homeless youth have little success in doing so on their own, and existing cessation resources tailored to this population are lacking. Homeless youth generally enjoy the camaraderie and peer support that group-based programs offer, but continuous in-person support during a quit attempt can be prohibitively expensive.ObjectiveThis study aimed to assess the feasibility and acceptability of an automated text messaging intervention (TMI) as an adjunct to group-based cessation counseling and provision of nicotine patches to help homeless youth quit smoking. This paper outlines the lessons learned from the implementation of the TMI intervention.MethodsHomeless youth smokers aged 18 to 25 years who were interested in quitting (n=77) were recruited from drop-in centers serving homeless youth in the Los Angeles area. In this pilot randomized controlled trial, all participants received a group-based cessation counseling session and nicotine patches, with 52% (40/77) randomly assigned to receive 6 weeks of text messages to provide additional support for their quit attempt. Participants received text messages on their own phone rather than receiving a study-issued phone for the TMI. We analyzed baseline and follow-up survey data as well as back-end data from the messaging platform to gauge the acceptability and feasibility of the TMI among the 40 participants who received it.ResultsParticipants had widespread (smart)phone ownership-16.4% (36/219) were ineligible for study participation because they did not have a phone that could receive text messages. Participants experienced interruptions in their phone use (eg, 44% [16/36] changed phone numbers during the follow-up period) but reported being able to receive the majority of messages. These survey results were corroborated by back-end data (from the program used to administer the TMI) showing a message delivery rate of about 95%. Participant feedback points to the importance of carefully crafting text messages, which led to high (typically above 70%) approval of most text messaging components of the intervention. Qualitative feedback indicated that participants enjoyed the group counseling session that preceded the TMI and suggested including more such group elements into the intervention.ConclusionsThe TMI was well accepted and feasible to support smoking cessation among homeless youth. Given high rates of smartphone ownership, the next generation of phone-based smoking cessation interventions for this population should consider using approaches beyond text messages and focus on finding ways to develop effective approaches to include group interaction using remote implementation. Given overall resource constraints and in particular the exigencies of the currently ongoing COVID-19 epidemic, phone-based interventions are a promising approach to support homeless youth, a population urgently in need of effective smoking cessation interventions.Trial registrationClinicalTrials.gov NCT03874585; https://clinicaltrials.gov/ct2/show/NCT03874585.International registered report identifier (irrid)RR2-10.1186/s13722-020-00187-6.

Project description:Obesity and hypertension and their associated health complications disproportionately affect communities of color and people of lower socioeconomic status. Recruitment and retention of these populations in research trials, and retention in weight loss trials has been an ongoing challenge.Be Fit, Be Well was a pragmatic randomized weight loss and hypertension management trial of patients attending one of three community health centers in Boston, Massachusetts. Participants were asked to complete follow-up assessments every 6-months for two years. We describe challenges encountered and strategies implemented to recruit and retain trial participants over the 24-month intervention. We also identify baseline participant characteristics associated with retention status. Retention strategies included financial incentives, contact between assessment visits, building relationships with health center primary care providers (PCPs) and staff, and putting participant convenience first.Active refusal rates were low with 130 of 2,631 patients refusing participation (4.9%). Of 474 eligible persons completing telephone screening, 365 (77.0%) completed their baseline visit and were randomized into the study. The study population was predominantly non-Hispanic Black (71.2%), female (68.5%) and reported annual household income of less than $35,000 (70.1%). Recruitment strategies included use of passive approval of potential participants by PCPs, use of part-time staff, and outsourcing calls to a call center. A total of 314 (86.0%) people completed the 24-month visit. Retention levels varied across study visits and intervention condition. Most participants completed three or more visits (69.6%), with 205 (56.2%) completing all four. At 24-months, lower retention was observed for males and the intervention condition. Retention strategies included building strong relationships with clinic staff, flexibility in overcoming participant barriers through use of taxi vouchers, night and weekend appointments, and keeping participants engaged via newsletters and social gatherings.We were able to retain 86.0% of participants at 24-months. Recruitment and retention of high percentages of racial/ethnic minorities and lower income samples is possible with planning, coordination with a trusted community setting and staff (e.g. community health centers and RAs), adaptability and building strong relationships.Clinicaltrials.gov Identifier: NCT00661817.

Project description:BACKGROUND:Clinical trials management can be studied using project management theory. The CYCLE pilot randomized controlled trial (RCT) was conducted to determine the feasibility of a future rehabilitation trial of early in-bed cycling in the intensive care unit (ICU). In-bed cycling is a novel intervention, not typically available in ICUs. Implementation of this intervention requires personnel with specialized clinical expertise caring for critically ill patients and use of the in-bed cycle. Our objective was to describe the implementation and conduct of our pilot RCT using a project management approach. METHODS:We retrospectively reviewed activities, timelines, and personnel involved in the trial. We organized activities into four project management phases: initiation, planning, execution, and monitoring and controlling. Data sources included Methods Centre documents used for trial coordination and conduct, and the trial data set. We report descriptive statistics as counts and proportions and also medians and quartiles, and we summarize the lessons learned. RESULTS:Seven ICUs in Canada participated in the trial. Time from research ethics board and contracts submission to first enrolment was a median (first quartile, third quartile) of 185 (146, 209) and 162 (114, 181) days, respectively. We trained 128 personnel on the CYCLE pilot RCT protocol, and 80 (63%) completed trial-related activities. Four sites required additional training after start-up due to staff turnover and leaves of absence. Over 15?months, we screened 864 patients: 256 were eligible and 66 were enrolled. Despite an 85% consent rate, 74% (190/256) of eligible patients were not randomized, largely (80% [152/190]) due to physiotherapist availability. Thirteen percent of recruitment weeks were lost due to physiotherapist staffing shortages. We highlight five key lessons learned: (1) prepare and anticipate site needs; (2) communicate regularly; (3) proactively analyse and act on process measure data; (4) develop contingency plans; (5) express appreciation to participating sites. CONCLUSIONS:Our analysis highlights the scope of relevant activities, rigorous training and monitoring, number and types of required personnel, and time required to conduct a multicentre ICU rehabilitation intervention trial. Our lessons learned can help others interested in implementing complex intervention trials, such as rehabilitation. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02377830 . Registered prospectively on 4 March 2015.

Project description:BACKGROUND:Nutrition interventions typically rely on self-reported intake that may be susceptible to differential reporting bias due to exposure to the intervention. Such differences may result from increased social desirability, increased attention to eating or improved recall accuracy, and may bias estimates of the intervention effect. This study investigated differential reporting bias of fruit and vegetable intake in youth with type 1 diabetes participating in a randomized controlled trial targeting increased whole plant food intake. METHODS:Participants (treatment n = 66, control n = 70) completed 3-day food records at baseline, 6-,12-, and 18-months, from which fruit and vegetable intake (servings/day) was calculated. Serum carotenoids were assessed at these visits using a high-performance liquid chromatography-based assay. Linear regression estimated associations of fruit and vegetable intake with serum carotenoids by treatment assignment. Multiplicative interaction terms tested the interaction of treatment assignment with fruit and vegetable intake on serum carotenoids for each visit and within each group over time. RESULTS:The association of fruit and vegetable intake with serum carotenoids was significantly lower in the control versus intervention group at baseline (β = 0.22 Vs 0.46) and 6-month visits (β = 0.37 Vs 0.54), as evidenced by significant interaction effects. However, the association of fruit and vegetable intake with serum carotenoids did not significantly differ over time for either group. CONCLUSIONS:While the stronger association of fruit and vegetable with carotenoids in the treatment arm suggests greater reporting accuracy, this difference was evident at baseline, and did not change significantly over time in either group. Thus, results indicate greater subject-specific bias in the control arm compared to the treatment, and lack of evidence for reactivity to the intervention by treatment assignment. CLINICAL TRIAL REGISTRY NUMBER AND WEBSITE:NCT00999375.

Dataset Information

A randomized controlled trial of a theoretically-based behavioral nutrition intervention for community elders: lessons learned from the Behavioral Nutrition Intervention for Community Elders Study.

Publications

A randomized controlled trial of a theoretically-based behavioral nutrition intervention for community elders: lessons learned from the Behavioral Nutrition Intervention for Community Elders Study.

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