scholarly journals Telehealth versus Self-Directed Lifestyle Intervention to Promote Healthy Blood Pressure: A Protocol for a Randomized Controlled Trial

2020 ◽  
Author(s):  
Mohamed Taher ◽  
Christina Yule ◽  
Heather Bonaparte ◽  
Sara Kwiecien ◽  
Charlotte Collins ◽  
...  
Keyword(s):  
Physical Activity ◽  
Blood Pressure ◽  
Randomized Controlled Trial ◽  
Systolic Blood Pressure ◽  
Lifestyle Intervention ◽  
Controlled Trial ◽  
Healthy Eating Index ◽  
Dietary Quality ◽  
Web Based ◽  
Randomized Controlled

Introduction: Weight loss, consumption of a Dietary Approaches to Stop Hypertension (DASH) dietary pattern, reduced sodium intake, and increased physical activity have been shown to lower blood pressure. Use of web-based tools and telehealth to deliver lifestyle counseling could be potentially scalable solutions to improve blood pressure through behavioral modification though limited data exists to support these approaches in clinical practice. Methods and analysis: This randomized controlled trial will compare the efficacy of a telehealth versus self-directed lifestyle intervention in lowering 24-hour systolic blood pressure in patients with body mass index ≥ 25 kg/m2 and 24-hour SBP 120-160 mmHg. All participants receive personalized recommendations to improve dietary quality based on a web-based food frequency questionnaire, access to an online comprehensive weight management program, and a smartphone dietary app. The telehealth arm additionally includes weekly calls with registered dietitian nutritionists who use motivational interviewing. The primary outcome is change from baseline to 3-months in 24-hour systolic blood pressure. Secondary outcomes include changes from baseline in Healthy Eating Index-2015 score, weight, waist circumference, and physical activity. Ethics and dissemination: The study has been approved by the Geisinger Institutional Review Board. Results will be disseminated through peer-reviewed publications and conference presentations. Trial registration number: ClinicalTrials.gov Identifier NCT03700710

Abstract P169: Randomized Controlled Trial Comparing a Self-guided vs. Dietitian-led Approach Using Web-based Tools to Lower Blood Pressure: Study Design and Rationale

Circulation ◽  
2020 ◽  
Vol 141 (Suppl_1) ◽  
Author(s):  
Alex R CHANG ◽  
Heather Bonaparte ◽  
Christina Yule ◽  
Allison Naylor ◽  
Sara Kwiecien ◽  
...  
Keyword(s):  
Physical Activity ◽  
Blood Pressure ◽  
Randomized Controlled Trial ◽  
Waist Circumference ◽  
Short Form ◽  
Controlled Trial ◽  
Healthy Eating Index ◽  
Electronic Health Record Data ◽  
Web Based ◽  
Randomized Controlled

Background: Weight loss, consumption of a Dietary Approaches to Stop Hypertension (DASH) dietary pattern, reduced sodium intake, and increased physical activity have been shown to lower systolic blood pressure (SBP). Use of website or smartphone-based tools could be potentially scalable solutions to improve lifestyle behaviors and lower SBP, but little data exists to support their use in clinical practice. Methods: In an ongoing single-center, 2-arm, randomized controlled trial, we compare the efficacy of a dietitian-guided approach vs. a self-guided approach in lowering 24-hour SBP in overweight/obese patients with 24-hour SBP 120-160 mmHg on 0-1 BP medication. As part of standard of care, participants with outpatient SBP ≥ 130 mmHg are identified using Geisinger electronic health record data and through Geisinger Health Plan’s health and wellness program and invited to complete 24-hour ambulatory BP monitoring (ABPM). Qualifying participants are then invited to a research visit to sign informed consent and for data collection, including a web-based food frequency questionnaire (Viocare®), which provides personalized recommendations to improve dietary quality. After a 2-week run-in period in which participants must regularly log data into www.bmiq.com, a comprehensive weight management program, and a smartphone app (Lose It!), participants are randomized 1:1 to a self-guided arm or a dietitian-led arm. All participants are instructed to use the website and app, and the dietitian-led arm additionally receives weekly telephone calls from registered dietitian nutritionists, trained in motivational interviewing. The primary outcome is 3-month change in 24-hour SBP. Other outcomes include changes in other ABPM measures, total healthy eating index-2015 (HEI) score, weight, waist circumference, metabolic equivalent of task-minutes per week (International Physical Activity Questionnaire short form), and study satisfaction. Results: Out of 210 patients who have thus far completed ABPM, 128 were eligible for the trial, 85 consented for the trial, and 78 were randomized after completing the run-in period. In a preplanned interim analysis of the first 34 randomized patients, 28 (82%) completed the 3-month study visit. Mean (SD) changes from baseline to 3 months were: -8.0 mmHg (9.9) for 24-hour SBP, -5.4 kg (4.5) for weight, -6.1 cm (7.4) for waist circumference, and 11.2 units (12.0) for HEI score. Conclusions: Confirmation of elevated BP using ABPM may provide an opportunity to engage patients in making lifestyle modifications, as more than 60% of eligible patients after 24-hour ABPM screening were successfully randomized into the trial. Completion of the study is expected by the end of 2020 and will determine the efficacy of a self-directed vs. dietitian-led approach to lower 24-hour SBP using web-based tools.

scholarly journals Telehealth versus self-directed lifestyle intervention to promote healthy blood pressure: a protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e044292
Author(s):  
Mohamed Taher ◽  
Christina Yule ◽  
Heather Bonaparte ◽  
Sara Kwiecien ◽  
Charlotte Collins ◽  
...  
Keyword(s):  
Physical Activity ◽  
Blood Pressure ◽  
Randomised Controlled Trial ◽  
Lifestyle Intervention ◽  
Healthy Eating ◽  
Controlled Trial ◽  
Healthy Eating Index ◽  
Dietary Quality ◽  
Web Based ◽  
Randomised Controlled

IntroductionWeight loss, consumption of a Dietary Approaches to Stop Hypertension dietary pattern, reduced sodium intake and increased physical activity have been shown to lower blood pressure (BP). Use of web-based tools and telehealth to deliver lifestyle counselling could be potentially scalable solutions to improve BP through behavioural modification though limited data exists to support these approaches in clinical practice.Methods and analysisThis randomised controlled trial will compare the efficacy of a telehealth versus self-directed lifestyle intervention in lowering 24-hour SBP in patients with overweight/obesity (body mass index ≥25 kg/m2) and 24-hour SBP 120–160 mm Hg. All participants receive personalised recommendations to improve dietary quality based on a web-based Food Frequency Questionnaire, access to an online comprehensive weight management programme and a smartphone dietary app. The telehealth arm additionally includes weekly calls with registered dietitian nutritionists who use motivational interviewing. The primary outcome is change from baseline to 12 weeks in 24-hour SBP. Secondary outcomes include changes from baseline in 24-hour diastolic BP, daytime SBP, nighttime SP, daytime diastolic BP, nighttime diastolic BP, total Healthy Eating Index-2015 score, weight, waist circumference and physical activity. Other prespecified outcomes will include change in individual components of the Healthy Eating Index-2015 score, and satisfaction with the Healthy BP research study measured on a 5-point Likert scale.Ethics and disseminationThe study has been approved by the Geisinger Institutional Review Board. Results will be disseminated through peer-reviewed publications and conference presentations.Trial registration numberNCT03700710.

scholarly journals Healthy Immigrant Families: Randomized Controlled Trial of a Family-Based Nutrition and Physical Activity Intervention

2017 ◽  
Vol 32 (2) ◽  
pp. 473-484 ◽  
Author(s):  
Mark L. Wieland ◽  
Marcelo M. M. Hanza ◽  
Jennifer A. Weis ◽  
Sonja J. Meiers ◽  
Christi A. Patten ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Healthy Eating ◽  
Physical Activity Intervention ◽  
Controlled Trial ◽  
Immigrant Families ◽  
Healthy Eating Index ◽  
Dietary Quality ◽  
Randomized Controlled ◽  
Phone Calls

Purpose: To evaluate a healthy eating and physical activity intervention for immigrant families, derived through community-based participatory research. Design: The Healthy Immigrant Families study was a randomized controlled trial with delayed intervention control group, with families as the randomization unit. Setting: US Midwest city. Participants: Participants were recruited by community partners from Hispanic, Somali, and Sudanese immigrant communities. Intervention: Family health promoters from participating communities delivered 6 healthy eating modules, 4 physical activity modules, and 2 modules synthesizing information in 12 home visits (60-90 minutes) within the first 6 months. Up to 12 follow-up phone calls to each participant occurred within the second 6 months. Measures: Primary measures were dietary quality measured with weekday 24-hour recall and reported as Healthy Eating Index score (0-100) and physical activity measured with accelerometers (14 wear days) at baseline, 6, 12, and 24 months. Results: In total, 151 persons (81 adolescents and 70 adults; 44 families) were randomly assigned. At 12 months, significant improvement occurred in Healthy Eating Index scores for adults in the intervention group compared with controls (change, +8.6 vs −4.4; P < .01) and persisted at 24 months (+7.4 from baseline; P < .01). No differences were observed for adolescents and no significant differences occurred between groups for physical activity. Conclusion: This intervention produced sustained dietary quality improvement among adults but not among adolescents. Program outcomes are relevant to communities working to decrease cardiovascular risk among immigrant populations.

scholarly journals Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lena Violetta Krämer ◽  
Nadine Eschrig ◽  
Lena Keinhorst ◽  
Luisa Schöchlin ◽  
Lisa Stephan ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Mixed Model ◽  
Controlled Trial ◽  
Control Group ◽  
Web Based ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

scholarly journals Predictors of Self-Determined Module Choice in a Web-Based Computer-Tailored Diet and Physical Activity Intervention: Secondary Analysis of Data From a Randomized Controlled Trial

10.2196/15024 ◽  
2020 ◽  
Vol 22 (7) ◽  
pp. e15024
Author(s):  
Juul M J Coumans ◽  
Catherine A W Bolman ◽  
Anke Oenema ◽  
Lilian Lechner
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Physical Activity Intervention ◽  
Multinomial Logistic Regression ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Motivation To Change ◽  
Web Based ◽  
Multinomial Logistic Regression Analysis ◽  
Randomized Controlled

Background Tailoring an online intervention to participant preferences (eg, by giving participants a choice which modules to follow) may increase engagement in the intervention, motivation for behavioral change, and possibly intervention effects. So far, little is known about what characteristics predict these module choices. Filling this knowledge gap is useful for optimizing program engagement. Objective We investigated participant choice for a dietary and/or physical activity (PA) promotion module in our web-based computer-tailored intervention based on self-determination theory (SDT) and motivational interviewing (MI). Furthermore, we investigated which demographic characteristics, current behavior, psychosocial constructs and constructs from SDT and MI, and program-related variables such as advice on which module to follow were associated with these choices. Methods Observational data were used from the randomized controlled trial MyLifestyleCoach of participants who were randomized into the intervention condition, completed the baseline questionnaire, and made a module choice in the opening session of the intervention. Here, they received advice on their own dietary and PA behavior. At the session’s end, they chose which lifestyle modules they would like to follow (both, diet, PA, or no module). Measurements included demographic information; self-reported diet and PA; and several psychosocial, SDT, and MI constructs. In total, data from 619 Dutch adults (59.6% women; mean age was 51.9 [SD 13.5] years) were analyzed. A stepwise multinomial logistic regression analysis was conducted to investigate which characteristics are related to module choice; the diet module served as reference category as almost everyone was advised to follow this module. Results Of this sample, 54.8% (339/619) chose to do both the diet and PA module, 25.4% (157/619) chose to follow the diet module, 17.8% (110/619) preferred to follow no module, and 2.1% (13/619) chose to do the PA module only. Furthermore, it was found that older people, those who consumed more fruit, and those who scored lower on importance to change their current diet were more likely to choose no module compared to the diet module. People who had more motivation to change their current PA and those who received strong advice compared with slight advice to follow the diet module were more likely to choose both modules compared with the diet module only. Conclusions The results show that more than half of the sample was interested in following both the diet and PA module in this online lifestyle intervention. Several characteristics were found to be related to module choice. A future challenge is to examine how this knowledge can be used to improve future interventions, such as tailoring (messages or content) on specific groups or examining where and how MI could be used to motivate people to make a certain module choice. Trial Registration Netherlands Trial Register NL7333; https://www.trialregister.nl/trial/7333

scholarly journals Effect of Steamed Potato Bread Intake on Glucose, Lipids, and Urinary Na+ and K+: A Randomized Controlled Trial with Adolescents

2020 ◽  
Vol 17 (6) ◽  
pp. 2096
Author(s):  
Haiquan Xu ◽  
Yanzhi Guo ◽  
Shijun Lu ◽  
Yunqian Ma ◽  
Xiuli Wang ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Randomized Controlled Trial ◽  
Systolic Blood Pressure ◽  
Total Cholesterol ◽  
Controlled Trial ◽  
Intervention Group ◽  
High Density Lipoproteins ◽  
Control Group ◽  
Randomized Controlled ◽  
Potato Bread

Although potatoes are highly nutritious, many epidemiological studies have connected their consumption with abnormal lipids, diabetes, and hypertension. Steamed potato bread has recently become one of China’s staple foods. A randomized controlled trial was designed to evaluate the effect of steamed potato bread consumption on Chinese adolescents. Four classes from a high school were randomly selected and assigned to the intervention group (two classes) or control group (two classes). The steamed wheat bread (100% raw wheat flour) and potato bread (raw wheat flour to cooked potato flour ratio of 3:7) were provided to the control group and intervention group as staple food once a school day for 8 weeks, respectively. Compared with the control group, the intervention group had significant net changes in systolic blood pressure (4.6 mmHg, p = 0.010), insulin (−4.35 mIU/L, p < 0.001), total cholesterol (−0.13 mmol/L, p = 0.032), and high-density lipoproteins cholesterol (−0.07 mmol/L, p = 0.010). The urinary level of Na+/K+ did not differ between the groups. In conclusion, the intake of steamed potato bread for 8 weeks resulted in positive effects on the total cholesterol and insulin profiles but a negative effect on the systolic blood pressure and high-density lipoproteins cholesterol of adolescents.

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