Dataset Information

A Positive Emotion-Focused Intervention to Increase Physical Activity After Bariatric Surgery: Protocol for a Pilot Randomized Controlled Trial.

ABSTRACT:

Background

Physical activity levels after bariatric surgery are usually low, despite the significant protective health benefits of physical activity in this population. Positive psychological well-being is associated with improved adherence to health behaviors, but bariatric surgery patients often have negative associations with physical activity that prevent sustained engagement.

Objective

The Gaining Optimism After weight Loss Surgery (GOALS) pilot randomized controlled trial is aimed at testing a novel intervention to increase physical activity after bariatric surgery, which incorporates positive psychological skill-building with motivational interviewing and goal-setting.

Methods

The GOALS trial is a 2-arm, 24-week pilot randomized controlled trial that aims to enroll 58 adults who report less than 200 minutes per week of moderate to vigorous physical activity and a desire to become more active 6-12 months after bariatric surgery. GOALS is testing the feasibility, acceptability, and preliminary efficacy of a positive psychology-motivational interviewing telephone intervention targeting to increase physical activity and associated positive affect. Intervention components include positive psychology, goal-setting, self-monitoring via provided Fitbits, and motivational interviewing to overcome barriers and increase motivation. The intervention is compared to a physical activity education control that includes mailings with psychoeducation around physical activity and provision of a Fitbit. The primary outcomes of the pilot trial are feasibility and acceptability, measured as session completion rates and participant ratings of ease and helpfulness of each session. The main secondary outcome is change in accelerometer-measured moderate to vigorous physical activity post intervention and at 24-week follow-up. Additional outcomes include changes in attitudes related to physical activity, psychological well-being, and physical health measures.

Results

This multiphase project was funded in 2020 and institutional review board approval was obtained for the proposed trial in 2021. Recruitment for the randomized controlled trial began in July 2022. Upon completion of the pilot trial, we will examine the feasibility, acceptability, and preliminary efficacy of the intervention.

Conclusions

Although bariatric surgery is the most effective treatment available for severe obesity, weight regain occurs, often in the context of low psychological well-being. Many individuals would benefit from learning strategies to increase positive psychological well-being after bariatric surgery, which could help them maintain lifestyle changes. Positive psychology is a novel approach to improve adherence by increasing positive associations with health behaviors including physical activity. The GOALS pilot trial will determine whether this type of intervention is feasible and acceptable to this population and will provide a foundation for a future full-scale randomized controlled efficacy trial.

Trial registration

ClinicalTrials.gov NCT04868032; https://clinicaltrials.gov/ct2/show/NCT04868032.

International registered report identifier (irrid)

PRR1-10.2196/39856.

SUBMITTER: Feig EH

PROVIDER: S-EPMC9585441 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A Positive Emotion-Focused Intervention to Increase Physical Activity After Bariatric Surgery: Protocol for a Pilot Randomized Controlled Trial.

Feig Emily H EH Harnedy Lauren E LE Thorndike Anne N AN Psaros Christina C Healy Brian C BC Huffman Jeff C JC

JMIR research protocols 20221006 10

<h4>Background</h4>Physical activity levels after bariatric surgery are usually low, despite the significant protective health benefits of physical activity in this population. Positive psychological well-being is associated with improved adherence to health behaviors, but bariatric surgery patients often have negative associations with physical activity that prevent sustained engagement.<h4>Objective</h4>The Gaining Optimism After weight Loss Surgery (GOALS) pilot randomized controlled trial is ...[more]

PMID: 36201380

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Project description:BACKGROUND:Testicular cancer diagnosis and treatment, especially given its threat to sexuality and reproductive health, can be distressing in the formative period of young adulthood and the majority of young survivors experience impairing, distressing, and modifiable adverse outcomes that can persist long after medical treatment. These include psychological distress, impairment in pursuit of life goals, persistent physical side effects, elevated risk of secondary malignancies and chronic illness, and biobehavioral burden (e.g., enhanced inflammation, dysregulated diurnal stress hormones). However, few targeted interventions exist to assist young survivors in renegotiating life goals and regulating cancer-related emotions, and none focus on reducing the burden of morbidity via biobehavioral mechanisms. This paper describes the methodology of a randomized controlled biobehavioral trial designed to investigate the feasibility and preliminary impact of a novel intervention, Goal-focused Emotion-Regulation Therapy (GET), aimed at improving distress symptoms, emotion regulation, goal navigation skills, and stress-sensitive biomarkers in young adult testicular cancer patients. METHODS:Participants will be randomized to receive six sessions of GET or Individual Supportive Therapy (ISP) delivered over 8 weeks. In addition to indicators of intervention feasibility, we will measure primary (depressive and anxiety symptoms) and secondary (emotion regulation and goal navigation skills, career confusion) psychological outcomes prior to (T0), immediately after (T1), and 12 weeks after (T2) intervention. Additionally, identified biomarkers will be measured at baseline and at T2. DISCUSSION:GET may have the potential to improve self-regulation across biobehavioral domains, improve overall cancer adjustment, and address the need for targeted supportive care interventions for young adult cancer survivors. TRIAL REGISTRATION:Clinicaltrials.gov, NCT04150848. Registered on 28 October 2019.

Project description:BackgroundPeople with physical disabilities often experience premature multimorbidity and adverse health events. A tailored primary care approach for this vulnerable population that also accounts for social and functional risk factors could promote healthier aging and more equitable health care.ObjectiveThis project will evaluate the implementation of a health program designed for people with physical disabilities. The proposed evaluation result is to generate the first best-practice protocol focused specifically on developing primary care to help reduce preventable causes of morbidity and improve functioning among people with physical disabilities.MethodsWe will design and implement a pilot health program for people with physical disabilities at a primary care clinic within Michigan Medicine. The health program for people with physical disabilities will be an integrated intervention involving a tailored best practice alert designed to prompt family medicine providers to screen and monitor for common, preventable health conditions. The program will also collect social and functional status information to determine the patient's need for further care coordination and support. Adult participants from this clinic with identified physical disabilities will be targeted for potential enrollment. To create a quasi-experimental setting, a separate departmental clinic will serve as a control site for comparison purposes. A quantitative analysis to estimate the treatment effect of implementing this health program will be conducted using a difference-in-differences approach. Outcomes of interest will include the use of preventative services (eg, hemoglobin A1c for diabetes screening), social work assistance, and emergency and hospital services. These data will be extracted from electronic health records. Time-invariant covariates, particularly sociodemographic covariates, will be included in the models. A qualitative analysis of patient and health care provider interviews will also be completed to assess the effect of the health program. Patient Health Questionnaire-9 and Generalized Anxiety Disorder 7-item scores will be assessed to both screen for depression and anxiety as well as explore program impacts related to addressing health and functioning needs related to physical disabilities in a primary care setting. These will be summarized through descriptive analyses.ResultsThis study was funded in September 2018, data collection started in September 2021, and data collection is expected to be concluded in September 2023.ConclusionsThis study is a mixed methods evaluation of the effectiveness of an integrated health program designed for people with physical disabilities, based on a quasi-experimental comparison between an intervention and a control clinic site. The intervention will be considered successful if it leads to improvements in greater use of screening and monitoring for preventable health conditions, increased social worker referrals to assist with health and functioning needs, and improvements in emergency and hospital-based services. The findings will help inform best practices for people with physical disabilities in a primary care setting.International registered report identifier (irrid)DERR1-10.2196/50105.

Project description:BACKGROUND:Living with elevated symptoms of depression can have debilitating consequences for an individual's psychosocial and physical functioning, quality of life, and health care utilization. A growing body of evidence demonstrates that skills for increasing positive emotion can be helpful to individuals with depression. Although Web-based interventions to reduce negative emotion in individuals with depression are available, these interventions frequently suffer from poor retention and adherence and do not capitalize on the potential benefits of increasing positive emotion. OBJECTIVE:The aim of this study was to develop and test a Web-based positive emotion skills intervention tailored for individuals living with elevated depressive symptoms, as well as to develop and test enhancement strategies for increasing retention and adherence to that intervention. METHODS:This study protocol describes the development and testing for Mobile Affect Regulation Intervention with the Goal of Lowering Depression (MARIGOLD), a Web-based positive emotion skills intervention, adapted for individuals with elevated depressive symptomatology. The intervention development is taking place in three phases. In phase 1, we are tailoring an existing positive emotion skills intervention for individuals with elevated symptoms of depression and are pilot testing the tailored version of the intervention in a randomized controlled trial with two control conditions (N=60). In phase 2, we are developing and testing three enhancements aimed at boosting retention and adherence to the Web-based intervention (N=75): facilitator contact, an online discussion board, and virtual badges. In phase 3, we are conducting a multifactorial, nine-arm pilot trial (N=600) to systematically test these enhancement strategies, individually and in combination. The primary outcome is depressive symptom severity. Secondary outcomes include positive and negative emotion, psychological well-being, and coping resources. RESULTS:The project was funded in August 2014, and data collection was completed in May 2018. Data analysis is currently under way, and the first results are expected to be submitted for publication in 2018. CONCLUSIONS:Findings from this investigation will enable us to develop an optimal package of intervention content and enhancement strategies for individuals with elevated symptoms of depression. If this intervention proves to be effective, it will provide a cost-effective, anonymous, appealing, and flexible approach for reducing symptoms of depression and improving psychological adjustment through increasing positive emotion. TRIAL REGISTRATION:ClinicalTrials.gov NCT01964820 (Phase 1); https://clinicaltrials.gov/ct2/show/NCT01964820 (Archived by WebCite at http://www.webcitation.org/6zpmKBcyX). ClinicalTrials.gov NCT02861755 (Phase 2); https://clinicaltrials.gov/ct2/show/NCT02861755 (Archived by WebCite at http://www.webcitation.org/6zpmLmy8k). REGISTERED REPORT IDENTIFIER:RR1-10.2196/10494.

Dataset Information

A Positive Emotion-Focused Intervention to Increase Physical Activity After Bariatric Surgery: Protocol for a Pilot Randomized Controlled Trial.

Background

Objective

Methods

Results

Conclusions

Trial registration

International registered report identifier (irrid)

Publications

A Positive Emotion-Focused Intervention to Increase Physical Activity After Bariatric Surgery: Protocol for a Pilot Randomized Controlled Trial.

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