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Health Behavior clinical trials

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NCT ID: NCT04923997 Recruiting - Cancer Clinical Trials

The HealthScore Health Coaching Program

HealthScore
Start date: May 11, 2020
Phase: N/A
Study type: Interventional

Purpose: The HealthScore Health Coaching Program aims to deliver 6-months of 1:1 home-based health coaching to cancer patients receiving treatment and survivors of any diagnosis at UNC Cancer Hospital. This study hopes to preserve physical function, address unmet physical, nutritional, psychological, social and other needs. Procedures: This will be done through individualized health coaching, weekly symptom survey administration, monthly supportive care questionnaires, and physical assessments at baseline, 3 months and 6 months. Participants: All cancer patients with appointments at UNC Cancer Hospitals.

NCT ID: NCT04895995 Recruiting - Clinical trials for Cardiovascular Diseases

Initial Assessment of the Feasibility and Efficacy of a Scalable Digital CBT for Generalized Anxiety and Associated Health Behaviors in a Cardiovascular Disease Population

Start date: February 2, 2022
Phase: N/A
Study type: Interventional

The treatment of generalized anxiety disorder (GAD) in an accessible manner represents an unmet need for those with cardiovascular disease (CVD), given that patients with CVD experience numerous barriers for in-person treatment engagement. The research plan for the proposed pilot project will entail: (1) open study of the acceptability of the digital intervention (N=5), followed by (2) recruitment and randomization of 90 individuals with a history of acute CVD events and clinical levels of GAD symptoms to dCBT or a waitlist (Control) condition, using a 1.5:1 allocation (dCBT:Control).

NCT ID: NCT04836117 Recruiting - Health Behavior Clinical Trials

Evaluating the Impact of SomaSignal Tests on Medical Management and Change in Risk in Patients at Higher Risk of Cardiovascular Disease: A Feasibility and an Adaptive Implementation Study

SomaSignal
Start date: August 12, 2021
Phase: N/A
Study type: Interventional

Feasibility Study Informed consent will be obtained using an IRB-approved form. The first 12 consenting patients will be placed in the planned assessment group for feasibility and will not be randomized. These participants will undergo visits and blood draw collection at 3 months. They will be informed of their SomaSignal Test results at baseline and 3 months. Recommendations for any medical management changes will be made based on an understanding of those results. Randomized Study The succeeding 200 participants will be randomized using permuted mixed block randomization, in a 2:1 ratio, i.e., 2 participants to Group 1 (informed of their test results) and 1 participant to Group 2 (uninformed of their test results). At enrollment, and for 6 months thereafter, clinical information will be obtained from each participant's medical records, and/or directly from the participant during procedures, treatments, study-specific visits, and/or follow-up visits. Data collected for the study will have data linkage at SomaLogic, Inc., where data analysis will be done. At baseline and 6-months (+30 days) post-enrollment, patients will undergo a patient visit and blood collection. Blood will be collected as a stand-alone sample collection, or when other ordered lab work is done, or from access lines inserted during a usual or specialized care. Samples will be sent to the Intermountain Central laboratory for clinical testing. A sample will also be processed and shipped to SomaLogic, Inc. for analysis at baseline and 6 months. For the informed arm, the SomaSignal Test reports will be provided at the time they are available (2 to 4 weeks after the blood draw). Any recommended changes in medical management will be recorded in the case report forms and will be verified by the Principal Investigator. For the uninformed arm, the SomaSignal Test results will not be provided to the study team until after the 6-month post-test visit. Adjustments, if any, would be made to the participant's management at that time.

NCT ID: NCT04665219 Recruiting - Health Behavior Clinical Trials

HBM for Empowering Parental Toothbrushing and Sugar Intake Control

Start date: September 1, 2020
Phase: N/A
Study type: Interventional

It has been recognized that oral health education for parents is critical for the prevention of early childhood caries (ECC). Few parents practiced caries prevention procedures for their children in daily life, though. Inspired by Health Belief Model (HBM) and using text messaging as a vehicle, a novel intervention scheme will be developed in this study. The objective of the present randomized clinical trial (RCT) is to investigate the effectiveness of the HBM-based behavioral intervention using text message to reduce early childhood caries of children at age 4 through promoting the parental oral health care behaviors (toothbrushing and sugar intake control) for their young children compared to conventional oral health education. This RCT will recruit child-parent dyads in 26-36 child help centers or kindergartens with nursery classes located in Hong Kong. A total of 518-628 dyads will be recruited and randomly allocated into the test or control group with a 1:1 ratio. For parents in the test group, the intervention will consist of a set of HBM-based text messages sent regularly in the following 48 weeks. A standard text message will be sent to the parents in the control group. The primary outcome will be dental caries measured by dmft/dmfs of the children at 4 years old. By HBM-based intervention via a low-cost text messaging vehicle, it should be able to help the parents establish proper oral health behaviors for their children and safeguard the oral health of children in Hong Kong.

NCT ID: NCT04474509 Recruiting - Health Behavior Clinical Trials

ACTyourCHANGE Study Protocol. Promoting Healthy Lifestyle With ACT for Obesity

ACTyourCHANGE
Start date: February 1, 2021
Phase: N/A
Study type: Interventional

Background: as treatment of choice in promoting psychological flexibility, Acceptance and Commitment Therapy (ACT) was found to be effective in several conditions, and among different populations, including weight management in individuals with obesity. However, the mechanism of action of psychological flexibility is less known. The aim of the present study is, within the context of a brief ACT intervention for behavioral change and behavioral maintenance of a healthy lifestyle in a sample of inpatients with obesity, to explore the effect of each subcomponent of the psychological flexibility model on treatment processes and outcomes. Methods: a randomized controlled trial will be conducted. 90 Italian adult inpatients with obesity attending a rehabilitation program for weight loss will be randomly allocated into three experimental conditions targeting respectively each subcomponent of the psychological flexibility model: group Engage focused on values-oriented behaviors, group Openness focused on acceptance and cognitive defusion, and group Awareness focused on being present and aware of thought, feelings, and behaviors at every moment. Weight, BMI (Kg/m2), the Psychological General Well Being Inventory (PGWBI), the Outcome Questionnaire-45.2 (OQ-45.2), the Depression Anxiety and Stress Scale (DASS-21), the Difficulties in Emotion regulation scale (DERS) the Dutch eating Behaviors Questionnaire (DEBQ), the Brief Values Inventory (BVI), the Committed Action Questionnaire (CAQ), the Italian-Cognitive Fusion Questionnaire (I-CFQ), and the Five Facet Mindfulness Questionnaire (FFMQ) and the Acceptance and Action Questionnaire (AAQ II) will be assessed at the beginning (Time 0), at the end of psychological intervention (Time 1), after 3 (Time 2) and 6 months (Time 3) and 9 months (Time 4) from discharge. During the following month after discharge, outpatients will be monitored in their adherence to a healthy lifestyle, using a wearable device. To assess the effectiveness of intervention, mixed between-withing 3 (conditions) x 4 (times) repeated measure ANOVAs will be conducted to examine changes from time 0 to time 1, 2, 3 and 4 in means of weight, BMI, and means scores PGWBI, OQ-45.2, DASS; DERS; DEBQ, AAQ-II, BVI, CAQ, I-CFQ, and FFMQ, between three groups Discussion: This study will contribute to clarify the mechanism of action of each subcomponent of the psychological flexibility model and understand its impact on the promotion of a healthy lifestyle.

NCT ID: NCT04438291 Recruiting - Health Behavior Clinical Trials

HPV Vaccination Health-promotion Programme on Vaccine Acceptance and Uptake Among Female Adolescents

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

The MDL-SHPVP will be developed and a clustered randomised controlled trial will be conducted to evaluate the effects of the MDL-SHPVP and to examine whether the effect of the MDL-SHPVP on the rate of HPV vaccine uptake 1 year after intervention is mediated by parents'/guardians' and female adolescents' HPV knowledge, attitudes and beliefs, adolescents' intention to receive HPV vaccination and vaccine acceptance among their parents/guardians.

NCT ID: NCT04356924 Recruiting - Clinical trials for Cognitive Impairment

Psychological Treatment to Support the Consequences of Cognitive Impairment

Start date: September 7, 2023
Phase: N/A
Study type: Interventional

The burden of cognitive impairment is severe, and often hinders affected people to act independently in daily life. Individuals in different stages of cognitive decline are frequently affected by existential distress and associated health issues (such as stress symptoms, anxiety, and depression), as well as social avoidance due to the unclear prognosis. Although the need for psychological support is large, there is a lack of efficient individualized psychological treatments- and methods to maintain psychological health that sufficiently impact daily life and promote behavioral- and biological change. In keeping with that notion, the investigators have developed a novel psychological treatment manual focused on supporting individuals with early phase cognitive impairment. The treatment manual is centered on facilitating behavioral change in accordance with personal values and long-term goals even in the presence of negative experiences, as well as to promote meaningful life-style changes. Conceptually, the treatment manual has its basis in the cognitive behavioral therapy (CBT) tradition, but the investigators have strived to adapt the manual to suit a cognitively affected population. The investigators will evaluate the psychological treatment in a RCT were the investigators will include approximately 138 individuals in their early phases of cognitive decline and randomize them into either an experimental group (psychological treatment), an active control group (cognitive training), or a treatment as usual control group. Evaluations will be conducted with, psychological health measures, cognitive assessments, and with biological markers. The investigators hypothesize that in comparison with the control conditions, the response to psychological treatment will be associated with improved psychological health and improved cellular protection.

NCT ID: NCT04309461 Recruiting - Health Behavior Clinical Trials

Make Better Choices 2 for Rural Appalachians

MBC2
Start date: August 1, 2020
Phase: N/A
Study type: Interventional

The program consists of four interconnected components: (1) app, (2) accelerometer, (3) health coaching, and (4) behavioral incentives to increase food and vegetable intake, reduce saturated fat intake, increase physical activity, and decrease sedentary screen time among adults Appalachia Kentuckians.

NCT ID: NCT04252924 Recruiting - Physical Activity Clinical Trials

Habits, Orthorexia Nervosa and LIfestyle in STudents

HOLISTic
Start date: April 20, 2018
Phase:
Study type: Observational

Non-communicable diseases (NCDs) compose a substantial proportion of the global burden of diseases, posing a significant challenge in both high-income and low- and middle-income countries. In particular, certain lifestyle-related risk factors, such as unhealthy diet, physical inactivity, smoking, excessive alcohol consumption, and sleep deprivation are the leading risk factors, which place people at an increased risk of developing NCDs. On the other hand, a growing phenomenon of excessive concern about diet and health is emerging, and it is contributing to the development of a novel eating behavior disorder named orthorexia nervosa. According to recent studies, orthorexic behavior is very common among young adults and especially so in health-care professionals. The main objective of this multi-center study is to explore and compare lifestyle habits among undergraduate medical students and other healthcare-related professions from different countries (Croatia, Lebanon, Italy, Poland, Spain, and Turkey). The goal is to obtain information on the presence of unhealthy habits in order to be able to intervene, offering the information needed for primordial disease prevention in this young and still healthy group of respondents, who are the health educators and role models of the future. The particular importance of this goal is to raise awareness of the problem of the ubiquitously present unhealthy lifestyles. Unfortunately, health-care students are not the exception regarding the prevalence of the unhealthy diet, sedentary behavior, sleep deprivation and high levels of psychological stress. Furthermore, the adoption of unhealthy lifestyle patterns in health-care workers, such as doctors and nurses, will have far-reaching negative consequences, in both their health and their patients' health. The results of this study will be used for identifying the needs and targets for intervention, enabling students to become a pillar of health education for their patients and the population in general.

NCT ID: NCT04242069 Recruiting - Clinical trials for Overweight and Obesity

Healthy for my Baby- RCT of a Lifestyle Intervention for Overweight Women in Preconception

Start date: June 18, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether an intervention combining motivational interviewing and follow-up with a mobile phone application will help overweight women and their partners adopt healthy lifestyle habits in the preconception period. This study will also evaluate the impact of the intervention on the weight, waist circumference, and body fat of women and their partners. Women and their partners will be followed through pregnancy to explore the effects of the intervention on the adequacy of gestational weight gain, rates of pregnancy complications, delivery mode, and infant birth weight.