Feasibility and Impact of a Combined Supervised Exercise and Nutritional-Behavioral Intervention following Bariatric Surgery: A Pilot Study

Background.Lifestyle intervention programs after bariatric surgery have been suggested to maximise health outcomes. This pilot study aimed to investigate the feasibility and impact of an 8-week combined supervised exercise with nutritional-behavioral intervention following Roux-en-Y gastric bypass and sleeve gastrectomy.Methods.Eight female patients (44 ± 8 years old, BMI = 38.5 ± 7.2 kgm−2) completed the program. Before and after intervention, anthropometric measures, six-minute walk test (6MWT), physical activity level, eating behavior, and quality of life (QoL) were assessed. Percentage weight loss (%WL) outcomes were compared with a historical matched control group.Results.The program significantly improved functional capacity (mean increment in 6MWT was 127 ± 107 meters,p=0.043), increased strenuous intensity exercise (44 ± 49 min/week,p=0.043), increased consumption of fruits and vegetables (p=0.034), reduced consumption of ready meals (p=0.034), and improved “Change in Health” in QoL domain (p=0.039). The intervention group exhibited greater %WL in the 3–12-month postsurgery period compared to historical controls, 12.2 ± 7.5% versus 5.1 ± 5.4%, respectively (p=0.027).Conclusions.Lifestyle intervention program following bariatric surgery is feasible and resulted in several beneficial outcomes. A large randomised control trial is now warranted.

Download Full-text

Physical activity and Mediterranean diet as potential modulators of osteoprotegerin and soluble RANKL in gBRCA1/2 mutation carriers: results of the lifestyle intervention pilot study LIBRE-1

Breast Cancer Research and Treatment ◽

10.1007/s10549-021-06400-7 ◽

2021 ◽

Author(s):

Leonie Neirich ◽

Maryam Yahiaoui-Doktor ◽

Jacqueline Lammert ◽

Maryam Basrai ◽

Benjamin Seethaler ◽

...

Keyword(s):

Physical Activity ◽

Pilot Study ◽

Mediterranean Diet ◽

Lifestyle Intervention ◽

Intervention Program ◽

Intervention Group ◽

Serum Levels ◽

Control Group ◽

Baseline Serum ◽

Mutation Carriers

Abstract Purpose Emerging evidence suggests that the progesterone-mediated receptor activator of nuclear factor κB (RANK)/soluble RANK ligand (sRANKL)/osteoprotegerin (OPG) pathway plays an important role in mammary carcinogenesis and is hyperactivated in germline (g)BRCA1/2 mutation carriers. We analyzed the effects of a 3-month intensive lifestyle intervention within the LIBRE-1 study on the serum levels of OPG and sRANKL and hypothesized that the intervention program provides a beneficial impact on the biomarkers by increasing OPG and reducing sRANKL serum concentrations. Methods Serum levels of OPG and sRANKL of 49 gBRCA1/2 mutation carriers were quantified using enzyme-linked immunosorbent assays. We used previously collected blood samples from participants of the prospective LIBRE-1 study, who were randomized into an intervention group (IG), increasing physical activity and adherence to the Mediterranean diet (MedD) through supervised sessions from study entry to the first study visit after 3 months and a usual-care control group (CG). Differences in biomarker levels before and after the 3-month intervention were tested within and between study groups. Results The lifestyle intervention resulted in a significant increase in OPG for participants in both the IG (q = 0.022) and CG (q = 0.002). sRANKL decreased significantly in the IG (q = 0.0464) and seemed to decrease in the CG (q = 0.5584). An increase in the intake of Omega-3 polyunsaturated fatty acids was significantly associated with an increase in OPG (r = 0.579, q = 0.045). Baseline serum levels of sRANKL were a strong predictor for the change of sRANKL in the course of the intervention (ß-estimate = − 0.70; q = 0.0018). Baseline physical fitness (assessed as VO2peak) might predict the change of OPG in the course of the intervention program (ß-estimate = 0.133 pg/ml/ml/min/kg; p = 0.0319; q = 0.2871). Conclusion Findings from this pilot study seem to confirm our hypothesis by showing an increase in OPG and decrease in sRANKL over a 3-month lifestyle intervention and suggest that increased physical activity and adherence to the MedD are potent modulators of the biomarkers OPG and potentially sRANKL.

Download Full-text

Implementation of Foodcare a Hospital Nutritional Care Concept: A Pilot Study

10.21203/rs.3.rs-118281/v1 ◽

2020 ◽

Author(s):

Nanna Møller Lykkegaard Rasmussen ◽

Alexander Erichsen ◽

Allan Stubbe Christensen ◽

Kirstine Guld Frederiksen ◽

Signe Loftager Okkels ◽

...

Keyword(s):

Pilot Study ◽

Protein Intake ◽

Intervention Group ◽

Fixed Time ◽

Randomised Control Trial ◽

Control Group ◽

Nutritional Care ◽

Time Points ◽

On Demand ◽

Medical Inpatients

Abstract Background: Different attempts have been made to improve nutritional care and food intake in hospital inpatients. One way may be to improve the individual customisation of meals and meal time points. This pilot study compared the food concept FoodCare consisting of customised meals served on demand and standardised meals served at fixed time points concerning energy and protein intake in medical inpatients. Method: A pilot study including medical lung inpatients at a Danish regional hospital. The control group received a set menu with limited choices served at fixed times. The intervention group received a menu of customised dishes prepared by food professionals and served on demand. Results: Twelve patients were included in the control group and 26 patients in the intervention group. In the intervention group, the tendency showed an increased energy (8.8 ± 2.7 MJ (mean ± SD) compared with the control group of 7.3 ± 2.0 MJ, p=0.10) and protein intake (74 ± 26 grams compared with the control group of 60 ± 18 (mean ± SD) grams, p=0.08). Conclusion: This pilot study demonstrated that a self-selected menu served on demand may potentially increase energy and protein intake in medical inpatients. The concept should be further tested in a randomised control trial with a sufficient sample size.

Download Full-text

Impact of Lifestyle Intervention for Patients with Prostate Cancer

American Journal of Health Behavior ◽

10.5993/ajhb.44.1.10 ◽

2020 ◽

Vol 44 (1) ◽

pp. 90-99 ◽

Cited By ~ 1

Author(s):

Saengryeol Park ◽

Kwangnam Kim ◽

Hyun Kyu Ahn ◽

Jong Won Kim ◽

Gyurang Min ◽

...

Keyword(s):

Prostate Cancer ◽

Lifestyle Intervention ◽

Intervention Program ◽

Intervention Group ◽

Text Messages ◽

Self Report ◽

Control Group ◽

Accelerometer Data ◽

Promotion Of Physical Activity ◽

The Impact

Objectives: Androgen-deprivation therapy (ADT) for prostate cancer (PCa) is associated with reduced physical function and quality of life (QoL). We investigated the impact of a structured lifestyle intervention on the promotion of physical activity (PA) and reduction of sedentary behavior (SB), and its effect on QoL in men on ADT. Methods: Patients with advanced PCa on long-term ADT were randomized to the intervention (N = 11) or a control arm (N = 10) between February 2018 and May 2019. The intervention group received a structured lifestyle intervention including motivational text messages for 8 weeks (maintenance visit at week 12). At each visit, self-report measures and accelerometer data were used to assess PA and SB, and questionnaires were used to measure QoL, life satisfaction, anxiety, and depression. Results: Significantly greater improvements in QoL and depression compared to baseline were reported in the intervention group compared to the control group. In addition, the intervention group also showed a significantly greater increase in self-reported light, as well as moderate-to-vigorous PA, and reduction in self-reported SB. Conclusions: Given its inherent advantage in improving QoL and reducing depression, a lifestyle intervention program should be offered to patients on ADT.

Download Full-text

The effectiveness of raising Hong Kong parents’ awareness of antimicrobial resistance through an educational program with peer support on social media: A pilot study

10.21203/rs.3.rs-44737/v2 ◽

2021 ◽

Author(s):

Peggy P.L. Or ◽

Patricia T.Y. Ching

Keyword(s):

Social Media ◽

Pilot Study ◽

Antimicrobial Resistance ◽

Peer Support ◽

Large Scale ◽

Intervention Program ◽

Intervention Group ◽

Control Group ◽

P Value ◽

Significant Difference

Abstract Background To test whether parents’ awareness of antimicrobial resistance could be improved through the education programme with peer support on social media Methods A cluster randomized controlled trial with two-arms were implemented. The intervention program consisted of two weekly sessions and each session lasted for 90 minutes. A total of 48 parents had participated in the program. Parental knowledge, attitude, and their social network were measured before and after the program using the Parental Perception on Antibiotics (PAPA) scale and the General Self-Efficacy Scale (GSE) to assess differences between and within the intervention and control groups. Results All parents would have a sense that antibiotics could be effective at treating some infections and not others, as compared to 40% in the control group. All parents in the intervention group and 85% of the control group disagreed that they should reduce the dose of antibiotics when their children were recovering. The test was statistically significant (p = 0.039) with a p value < .05. There was a significant difference and a strong negative correlation between peer support in Facebook and the parents’ belief that antibiotics could be stopped when their children felt better, with Pearson coefficient of -0.78 and p = 0.001. In general, there was no significant difference between the two groups with respect to the GSE scale. Conclusions Based on the findings in this pilot study, a further study based on the education program with enhancement and peer support can be implemented in a large scale with a positive expectation of increasing parental awareness of antimicrobial resistance and potentially influencing patient prescribing expectations when seeking healthcare.

Download Full-text

The Effectiveness Of Raising Hong Kong Parents’ Awareness Of Antimicrobial Resistance Through An Educational Program With Peer Support On Social Media: A Pilot Study

10.21203/rs.3.rs-44737/v1 ◽

2020 ◽

Author(s):

Peggy P.L. Or ◽

Patricia T.Y. Ching

Keyword(s):

Social Media ◽

Pilot Study ◽

Antimicrobial Resistance ◽

Peer Support ◽

Education Program ◽

Large Scale ◽

Intervention Program ◽

Intervention Group ◽

Control Group ◽

Significant Difference

Abstract Objective: To test whether parents’ self-efficacy for appropriate antibiotic use could be improved through the education program with peer support on social media.Methods: A cluster randomized controlled trial with two-arms were implemented. The intervention program consisted of two weekly sessions and each session lasted for 90 minutes. A total of 48 parents had participated in the program. Parental knowledge, attitude, and their social network were measured before and after the program using the Parental Perception on Antibiotics (PAPA) scale and the GSE scale to assess differences between and within the intervention and control groups.Findings: All parents in the intervention group disagreed that antibiotics are effective against infections (virus, bacteria and fungi), as compared to a mere 40% in the control group. All parents in the intervention group and 85% of the control group disagreed that they should reduce the dose of antibiotics when their children were recovering. The test was statistically significant (p=0.039). There was a significant difference and a strong negative correlation between social media and the parents’ belief that antibiotics could be stopped when their children felt better, with Pearson coefficient of -0.78 and p=0.001. On the whole, there was no significant difference between the two groups with respect to the GSE scale Conclusion: Based on the findings in this pilot study, a further study based on the education program with enhancement and peer support can be implemented in a large scale with a positive expectation of reducing antimicrobial resistance.

Download Full-text

Parental Self-Efficacy to Promote Children’s Healthy Lifestyles: A Pilot and Feasibility Study

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18094794 ◽

2021 ◽

Vol 18 (9) ◽

pp. 4794

Author(s):

Cayetana Ruiz-Zaldibar ◽

Inmaculada Serrano-Monzó ◽

Olga Lopez-Dicastillo ◽

María Jesús Pumar-Méndez ◽

Andrea Iriarte ◽

...

Keyword(s):

Pilot Study ◽

Parenting Styles ◽

Self Efficacy ◽

Parenting Practices ◽

Healthy Lifestyle ◽

Intervention Group ◽

Positive Parenting ◽

Parenting Programs ◽

Control Group ◽

Healthy Lifestyles

Positive parenting programs are a key strategy to promote the development of parental competence. We designed a pilot study based on parental self-efficacy to promote healthy lifestyles in their children aged between 2 to 5 years old. In this pilot study, we aimed to assess the effects of a parenting program on parental self-efficacy and parenting styles. Twenty-five parents were allocated into intervention (N = 15) and control group (N = 10). Parents from the intervention group received four group sessions (120 mi per session) to develop a positive parenting, parenting styles and parenting skills regarding to children’s diet, exercise, and screen time, and two additional sessions about child development and family games. Parents from the control group received these two latter sessions. Parental self-efficacy, parenting styles, and meal-related parenting practices were measured before and after the intervention and at 3-month follow-up. Acceptability and feasibility of the program was also measured. Quantitative data were analyzed using the repeat measures ANOVA and ANCOVA tests and the effect size calculation. Content analysis was used to analyse open questions. Positive trends were found regarding parental self-efficacy and the use of authoritative parenting style. Parents also reported a great acceptability of the program getting high satisfaction. According to the feasibility barriers and facilitators aspects were identified. The positive trends founded in this study support the development of parenting programs to promote healthy lifestyle in children.

Download Full-text

The Effect of Reflexology on Lactation in Women Who Had Cesarean Section: A Randomized Controlled Pilot Study

Complementary Medicine Research ◽

10.1159/000513924 ◽

2021 ◽

pp. 1-8

Author(s):

Sevde Aksu ◽

Pelin Palas Karaca

Keyword(s):

Pilot Study ◽

Cesarean Section ◽

Intervention Group ◽

Control Group ◽

Breast Pain ◽

Randomized Controlled ◽

Significant Difference ◽

The Right ◽

Documentation Tool ◽

And Control

Aim: The research was conducted as a randomized controlled pilot study to evaluate the effects of reflexology on lactation in mothers who delivered by cesarean section (CS). Methods: A single-blind randomized controlled experimental study was conducted with a total of 60 postpartum women in the reflexology application (n = 30) and control groups (n = 30). After the CS, the mothers in the control group were given approximately 3-h routine nursing care after recovering from the effects of anesthesia; the introductory information form was applied, and the Breastfeeding Charting System and Documentation Tool (LATCH) and visual analog scale (VAS) for the signs of the onset of lactation were implemented on the first and second days. Reflexology was applied to the women in the intervention group after an average of 3 h following the mother’s condition had become stable and she had recovered from the effects of anesthesia. Reflexology was applied a total of 20 min – 10 min for the right foot, 10 min for the left foot – twice a day with 8-h intervals on the first and second days after CS. After the last reflexology application, the LATCH and VAS for the signs of the onset of lactation were applied. Results: Of the women, 70% breastfed their babies within 60 min after delivery; 46.7% of the mothers received breastfeeding training and 81.7% needed support for breastfeeding after the CS. The LATCH breastfeeding scores of the women in the intervention group on both days were significantly higher compared to those of the women in the control group (p < 0.001). On the first day after the CS, apart from breast pain, there was no significant difference between the two groups in terms of breast heat and breast tension (p > 0.05). On the second day after the CS, apart from breast tension, there was no significant difference between the groups in terms of breast heat and breast pain (p < 0.05). In the study, women in the intervention group were found to have higher scores in terms of all three symptoms compared to the control group (p < 0.05). Conclusions: In the study, it was determined that LATCH scores and signs of the onset of breastfeeding increased in the mothers who received reflexology after CS.

Download Full-text

83 A Medication Self-Management Intervention to Improve Medication Adherence For Older People with Multimorbidity: A Pilot Study

Age and Ageing ◽

10.1093/ageing/afab030.44 ◽

2021 ◽

Vol 50 (Supplement_1) ◽

pp. i12-i42

Author(s):

C Yang ◽

Z Hui ◽

S Zhu ◽

X Wang ◽

G Tang ◽

...

Keyword(s):

Medication Adherence ◽

Pilot Study ◽

Older People ◽

Intervention Group ◽

Self Management ◽

Control Group ◽

Medication Knowledge ◽

Management Intervention ◽

Patient Reported

Abstract Introduction Medication self-management support has been recognised as an essential element in primary health care to promote medication adherence and health outcomes for older people with chronic conditions. A patient-centred intervention empowering patients and supporting medication self-management activities could benefit older people. This pilot study tested a newly developed medication self-management intervention for improving medication adherence among older people with multimorbidity. Method This was a two-arm randomised controlled trial. Older people with multimorbidity were recruited from a community healthcare centre in Changsha, China. Participants were randomly allocated to either a control group receiving usual care (n = 14), or to an intervention group receiving three face-to-face medication self-management sessions and two follow-up phone calls over six weeks, targeting behavioural determinants of adherence from the Information-Motivation-Behavioural skills model (n = 14). Feasibility was assessed through recruitment and retention rates, outcome measures collection, and intervention implementation. Follow-up data were measured at six weeks after baseline using patient-reported outcomes including medication adherence, medication self-management capabilities, treatment experiences, and quality of life. Preliminary effectiveness of the intervention was explored using generalised estimating equations. Results Of the 72 approached participants, 28 (38.89%) were eligible for study participation. In the intervention group, 13 participants (92.86%) completed follow-up and 10 (71.42%) completed all intervention sessions. Ten participants (71.42%) in the control group completed follow-up. The intervention was found to be acceptable by participants and the intervention nurse. Comparing with the control group, participants in the intervention group showed significant improvements in medication adherence (β = 0.26, 95%CI 0.12, 0.40, P < 0.001), medication knowledge (β = 4.43, 95%CI 1.11, 7.75, P = 0.009), and perceived necessity of medications (β = −2.84, 95%CI -5.67, −0.01, P = 0.049) at follow-up. Conclusions The nurse-led medication self-management intervention is feasible and acceptable among older people with multimorbidity. Preliminary results showed that the intervention may improve patients’ medication knowledge and beliefs and thus lead to improved adherence.

Download Full-text

A Collaborative Deprescribing Intervention in a Subacute Medical Outpatient Clinic: A Pilot Randomized Controlled Trial

Metabolites ◽

10.3390/metabo11040204 ◽

2021 ◽

Vol 11 (4) ◽

pp. 204

Author(s):

Anissa Aharaz ◽

Jens Henning Rasmussen ◽

Helle Bach Ølgaard McNulty ◽

Arne Cyron ◽

Pia Keinicke Fabricius ◽

...

Keyword(s):

Pilot Study ◽

Controlled Trial ◽

Inappropriate Medication ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Patient Interviews ◽

Number Of Patients ◽

Multimorbid Patients ◽

And Control

Medication deprescribing is essential to prevent inappropriate medication use in multimorbid patients. However, experience of deprescribing in Danish Subacute Medical Outpatient Clinics (SMOCs) is limited. The objective of our pilot study was to evaluate the feasibility and sustainability of a collaborative deprescribing intervention by a pharmacist and a physician to multimorbid patients in a SMOC. A randomized controlled pilot study was conducted, with phone follow-up at 30 and 365+ days. A senior pharmacist performed a systematic deprescribing intervention using the Screening Tool of Older Persons’ potentially inappropriate Prescriptions (STOPP) criteria, the Danish deprescribing list, and patient interviews. A senior physician received the proposed recommendations and decided which should be implemented. The main outcome was the number of patients having ≥1 medication where deprescribing status was sustained 30 days after inclusion. Out of 76 eligible patients, 72 (95%) were included and 67 (93%) completed the study (57% male; mean age 73 years; mean number of 10 prescribed medications). Nineteen patients (56%) in the intervention group and four (12%) in the control group had ≥1 medication where deprescribing status was sustained 30 days after inclusion (p = 0.015). In total, 37 medications were deprescribed in the intervention group and five in the control group. At 365+ days after inclusion, 97% and 100% of the deprescribed medications were sustained in the intervention and control groups, respectively. The three most frequently deprescribed medication groups were analgesics, cardiovascular, and gastrointestinal medications. In conclusion, a collaborative deprescribing intervention for multimorbid patients was feasible and resulted in sustainable deprescribing of medication in a SMOC.

Download Full-text

Efficacy of ‘Foundations’, a Digital Mental Health App to Improve Mental Well-Being, during COVID-19: A Proof-of-Principle Randomised Controlled Trial (Preprint)

10.2196/preprints.30976 ◽

2021 ◽

Author(s):

Silvina Catuara-Solarz ◽

Bartlomiej Skorulski ◽

Inaki Estella ◽

Claudia Avella-Garcia ◽

Sarah Shepherd ◽

...

Keyword(s):

Mental Health ◽

Perceived Stress ◽

Intervention Group ◽

Well Being ◽

Self Report ◽

World Health ◽

Randomised Control Trial ◽

Control Group ◽

Mental Well Being ◽

Proof Of Principle

BACKGROUND Against a long-term trend of increasing demand, the COVID-19 pandemic has led to a global rise in common mental disorders. Now more than ever, there is an urgent need for scalable, evidence-based interventions to support mental well-being. OBJECTIVE The aim of this proof-of-principle study was to evaluate the efficacy of a mobile-based app in adults with self-reported symptoms of anxiety and stress in a randomised control trial that took place during the first wave of the COVID-19 pandemic in the UK. METHODS Adults with mild to severe anxiety and moderate to high levels of perceived stress were randomised to either the intervention or control arm. Participants in the intervention arm were given access to the app, Foundations, for the duration of the 4-week study. All participants were required to self-report a range of validated measures of mental well-being (10-item Connor-Davidson Resilience scale [CD-RISC-10]; 7-item Generalised Anxiety Disorder scale [GAD-7]; Office of National Statistics Four Subjective Well-being Questions [ONS-4]; World Health Organisation-5 Well-Being Index [WHO-5]) and sleep (Minimal Insomnia Scale [MISS]) at baseline and weeks 2 and 4; and, in addition, on perceived stress weekly (10-item Perceived Stress Score [PSS]). RESULTS 136 participants completed the study and were included in the final analysis. The intervention group (n=62) showed significant improvements compared to the control group (n=74) on measures of anxiety (GAD-7 score, delta from baseline to week 2 in the intervention group: -1.35 [SD 4.43]; control group: -0.23 [SD 3.24]; t134= 1.71 , P=.04), resilience (CD-RISC score, delta from baseline to week 2 in the intervention group: 1.79 [± SD 4.08]; control group: -0.31 [± SD 3.16]; t134 -3.37, P<.001), sleep (MISS score, delta from baseline to week 2 in the intervention group: -1.16 [± SD 2.67]; control group: -0.26 [± SD 2.29]; t134= 2.13, P=.01), and mental well-being (WHO-5 score, delta from baseline to week 2 in the intervention group: 1.53 [5.30]; control group: -0.23 [± SD 4.20]; t134= -2.16, P=.02) within 2 weeks of using Foundations, with further improvements emerging at week 4. Perceived stress was also reduced within the intervention group, although the results did not reach statistical significance relative to the control group (PSS score, delta from baseline to week 2 in the intervention group: -2.94 [± SD 6.84]; control group: -2.05 [± SD 5.34]; t134= 0.84, P=.20). CONCLUSIONS This study provides proof-of-principle that the digital mental health app, Foundations, can improve measures of mental well-being, anxiety, resilience, and sleep within 2 weeks of use, with greater effects after 4 weeks. It therefore offers potential as a scalable, cost-effective, and accessible solution to enhance mental well-being, even during times of crisis such as the COVID-19 pandemic.

Download Full-text