Targeting dietary restraint to reduce binge eating: a randomised controlled trial of a blended internet- and smartphone app-based intervention

Abstract Background Existing internet-based prevention and treatment programmes for binge eating are composed of multiple distinct modules that are designed to target a broad range of risk or maintaining factors. Such multi-modular programmes (1) may be unnecessarily long for those who do not require a full course of intervention and (2) make it difficult to distinguish those techniques that are effective from those that are redundant. Since dietary restraint is a well-replicated risk and maintaining factor for binge eating, we developed an internet- and app-based intervention composed solely of cognitive-behavioural techniques designed to modify dietary restraint as a mechanism to target binge eating. We tested the efficacy of this combined selective and indicated prevention programme in 403 participants, most of whom were highly symptomatic (90% reported binge eating once per week). Method Participants were randomly assigned to the internet intervention (n = 201) or an informational control group (n = 202). The primary outcome was objective binge-eating frequency. Secondary outcomes were indices of dietary restraint, shape, weight, and eating concerns, subjective binge eating, disinhibition, and psychological distress. Analyses were intention-to-treat. Results Intervention participants reported greater reductions in objective binge-eating episodes compared to the control group at post-test (small effect size). Significant effects were also observed on each of the secondary outcomes (small to large effect sizes). Improvements were sustained at 8 week follow-up. Conclusions Highly focused digital interventions that target one central risk/maintaining factor may be sufficient to induce meaningful change in core eating disorder symptoms.

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Efficacy of a transdiagnostic cognitive-behavioral intervention for eating disorder psychopathology delivered through a smartphone app: a randomized controlled trial

Psychological Medicine ◽

10.1017/s0033291720003426 ◽

2020 ◽

pp. 1-12 ◽

Cited By ~ 1

Author(s):

Jake Linardon ◽

Adrian Shatte ◽

John Rosato ◽

Matthew Fuller-Tyszkiewicz

Keyword(s):

Randomized Controlled Trial ◽

Eating Disorder ◽

Binge Eating ◽

Controlled Trial ◽

Cognitive Behavioral ◽

Smartphone App ◽

Control Group ◽

Randomized Controlled ◽

Post Test ◽

Secondary Outcomes

Abstract Background Although effective treatments exist for diagnostic and subthreshold-level eating disorders (EDs), a significant proportion of affected individuals do not receive help. Interventions translated for delivery through smartphone apps may be one solution towards reducing this treatment gap. However, evidence for the efficacy of smartphones apps for EDs is lacking. We developed a smartphone app based on the principles and techniques of transdiagnostic cognitive-behavioral therapy for EDs and evaluated it through a pre-registered randomized controlled trial. Methods Symptomatic individuals (those who reported the presence of binge eating) were randomly assigned to the app (n = 197) or waiting list (n = 195). Of the total sample, 42 and 31% exhibited diagnostic-level bulimia nervosa and binge-eating disorder symptoms, respectively. Assessments took place at baseline, 4 weeks, and 8 weeks post-randomization. Analyses were intention-to-treat. The primary outcome was global levels of ED psychopathology. Secondary outcomes were other ED symptoms, impairment, and distress. Results Intervention participants reported greater reductions in global ED psychopathology than the control group at post-test (d = −0.80). Significant effects were also observed for secondary outcomes (d's = −0.30 to −0.74), except compensatory behavior frequency. Symptom levels remained stable at follow-up. Participants were largely satisfied with the app, although the overall post-test attrition rate was 35%. Conclusion Findings highlight the potential for this app to serve as a cost-effective and easily accessible intervention for those who cannot receive standard treatment. The capacity for apps to be flexibly integrated within current models of mental health care delivery may prove vital for addressing the unmet needs of people with EDs.

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Effectiveness of Child to Parent Communication Using Information Package on Food Hygiene

International Journal of Innovative Research in Medical Science ◽

10.23958/ijirms/vol03-i07/02 ◽

2018 ◽

Vol 3 (07) ◽

Author(s):

Ms. Sonam Yangchen Bhutia ◽

Dr. Sushma Kumari Saini ◽

Dr. Manmeet Kaur ◽

Dr. Sandhya Ghai

Keyword(s):

School Children ◽

Home Visit ◽

Controlled Trial ◽

Family Members ◽

Sampling Technique ◽

Control Group ◽

Food Hygiene ◽

Parent Communication ◽

Post Test ◽

Randomised Controlled

School children can act as change agent not only for families but for community. The study aimed to assess effectiveness of information package on knowledge and practices of parents/family members of school children studying in Govt. Sr. Sec. School on food hygiene in Dhanas and Daddu Majra Colony, UT, Chandigarh. A non-randomised controlled trial was conducted on 201 school children studying in VIIth standard and their parents/family members. Purposive sampling technique was utilised to enrol 101 in case and 100 participants in control group. Interview schedule for knowledge assessment and observation checklist for assessing the practices of parents/ family members was used. Pre assessment of both the groups was done by a home visit. Experimental group school children were educated on food hygiene as per the protocol. Pre and post-test knowledge of school children on food hygiene was assessed and were asked to disseminate the information to their parents/family members. After 15 days, second time home visit was done to the parents/family members of both the groups for the post assessment of knowledge and practices. Significant improvement in knowledge and practices of parents/family members related to food hygiene was observed. Hence, school children can be an effective tool in health related knowledge dissemination which can further promote healthy practices.

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Effectiveness and cost-effectiveness of the PLAN-A intervention, a peer led physical activity program for adolescent girls: results of a cluster randomised controlled trial

International Journal of Behavioral Nutrition and Physical Activity ◽

10.1186/s12966-021-01133-8 ◽

2021 ◽

Vol 18 (1) ◽

Author(s):

Russell Jago ◽

Byron Tibbitts ◽

Kathryn Willis ◽

Emily Sanderson ◽

Rebecca Kandiyali ◽

...

Keyword(s):

Physical Activity ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Control Group ◽

Cluster Randomised ◽

Secondary Outcomes ◽

Randomised Controlled

Abstract Background Physical activity is associated with improved health. Girls are less active than boys. Pilot work showed that a peer-led physical activity intervention called PLAN-A was a promising method of increasing physical activity in secondary school age girls. This study examined the effectiveness and cost-effectiveness of the PLAN-A intervention. Methods We conducted a cluster randomised controlled trial with Year 9 (13–14 year old) girls recruited from 20 secondary schools. Schools were randomly assigned to the PLAN-A intervention or a non-intervention control group after baseline data collection. Girls nominated students to be peer leaders. The top 18 % of girls nominated by their peers in intervention schools received three days of training designed to prepare them to support physical activity. Data were collected at two time points, baseline (T0) and 5–6 months post-intervention (T1). Participants wore an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity (MVPA). Multivariable mixed effects linear regression was used to estimate differences in the primary outcome between the two arms on an Intention-to-Treat (ITT) basis. Resource use and quality of life were measured and a within trial economic evaluation from a public sector perspective was conducted. Results A total of 1558 girls were recruited to the study. At T0, girls in both arms engaged in an average of 51 min of MVPA per weekday. The adjusted mean difference in weekday MVPA at T1 was − 2.84 min per day (95 % CI = -5.94 to 0.25) indicating a slightly larger decline in weekday MVPA in the intervention group. Results were broadly consistent when repeated using a multiple imputation approach and for pre-specified secondary outcomes and sub-groups. The mean cost of the PLAN-A intervention was £2817 per school, equivalent to £31 per girl. Economic analyses indicated that PLAN-A did not lead to demonstrable cost-effectiveness in terms of cost per unit change in QALY. Conclusions This study has shown that the PLAN-A intervention did not result in higher levels of weekday MVPA or associated secondary outcomes among Year 9 girls. The PLAN-A intervention should not be disseminated as a public health strategy. Trial registration ISRCTN14539759–31 May, 2018.

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Does tension applied in kinesio taping affect pain or function in older women with knee osteoarthritis? A randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-041121 ◽

2020 ◽

Vol 10 (12) ◽

pp. e041121

Author(s):

Yago Tavares Pinheiro ◽

Germanna Medeiros Barbosa ◽

Hilmaynne Renaly Fonseca Fialho ◽

César Augusto Medeiros Silva ◽

Jaciara de Oliveira Anunciação ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Knee Osteoarthritis ◽

Older Women ◽

Controlled Trial ◽

Secondary Outcome ◽

Group Differences ◽

Control Group ◽

Kinesio Taping ◽

Secondary Outcomes ◽

Randomised Controlled

ObjectiveTo analyse the short-term effects of kinesio taping (KT) with tension (KTT) or without tension (KTNT) in older women with knee osteoarthritis (KOA), and compare them to controls who did not receive KT.DesignRandomised controlled trial.SettingUniversity physiotherapy school clinic.ParticipantsForty-five older women (fifteen participants per group) with 66.8 (±5.6) years and clinical diagnosis of KOA were assessed pre, post and 3 days after intervention.InterventionsParticipants were randomly allocated to KTT, who received two simultaneous applications of KT with tension on the knee and rectus femoris; KTNT, who received the same application as the KTT group, but without tension and a control group that attended a class on KOA.Primary and secondary outcome measuresPrimary outcome was pain intensity and secondary outcomes were knee-related health status, functional capacity, muscle strength and global rating of change.ResultsNo between-group differences were observed in pain after the first intervention (KTT vs KTNT: mean difference (MD), −1.8 points; 95% CI −4.2 to 0.5; KTT vs control: MD, −1.2 points; 95% CI −3.6 to 1.2; KTNT vs control: MD, 0.66 points; 95% CI −1.7 to 3.0) or 3 days later (KTT vs KTNT: MD, −1.3 points; 95% CI −3.7 to 1.0; KTT vs control: MD, 0.13 points; 95% CI −2.2 to 2.5; KTNT vs control: MD, 1.4 points; 95% CI −0.9 to 3.8). The lack of between-group differences was also found for secondary outcomes.ConclusionThe short-term use of KT with or without tension in older woman with KOA had no beneficial effects on pain and function. These findings call into question the clinical use of KT as a non-pharmacological therapy for this population.Trial registration numberNCT03624075.

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Metacognitive reflection and insight therapy (MERIT) for patients with schizophrenia

Psychological Medicine ◽

10.1017/s0033291718000855 ◽

2018 ◽

Vol 49 (2) ◽

pp. 303-313 ◽

Cited By ~ 25

Author(s):

S. de Jong ◽

R. J. M. van Donkersgoed ◽

M. E. Timmerman ◽

M. aan het Rot ◽

L. Wunderink ◽

...

Keyword(s):

Controlled Trial ◽

Drop Out ◽

Future Research ◽

Control Group ◽

Treatment As Usual ◽

Self Reflection ◽

Intention To Treat ◽

Metacognitive Reflection ◽

Secondary Outcomes

AbstractBackgroundImpaired metacognition is associated with difficulties in the daily functioning of people with psychosis. Metacognition can be divided into four domains: Self-Reflection, Understanding the Other's Mind, Decentration, and Mastery. This study investigated whether Metacognitive Reflection and Insight Therapy (MERIT) can be used to improve metacognition.MethodsThis study is a randomized controlled trial. Patients in the active condition (n = 35) received forty MERIT sessions, the control group (n = 35) received treatment as usual. Multilevel intention-to-treat and completers analyses were performed for metacognition and secondary outcomes (psychotic symptomatology, cognitive insight, Theory of Mind, empathy, depression, self-stigma, quality of life, social functioning, and work readiness).ResultsEighteen out of 35 participants finished treatment, half the drop-out stemmed from therapist attrition (N = 5) or before the first session (N = 4). Intention-to-treat analysis demonstrated that in both groups metacognition improved between pre- and post-measurements, with no significant differences between the groups. Patients who received MERIT continued to improve, while the control group returned to baseline, leading to significant differences at follow-up. Completers analysis (18/35) showed improvements on the Metacognition Assessment Scale (MAS-A) scales Self Reflectivity and metacognitive Mastery at follow-up. No effects were found on secondary outcomes.ConclusionsOn average, participants in the MERIT group were, based on MAS-A scores, at follow-up more likely to recognize their thoughts as changeable rather than as facts. MERIT might be useful for patients whose self-reflection is too limited to benefit from other therapies. Given how no changes were found in secondary measures, further research is needed. Limitations and suggestions for future research are discussed.

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Out-patient triple chronotherapy for the rapid treatment and maintenance of response in depression: feasibility and pilot randomised controlled trial

BJPsych Open ◽

10.1192/bjo.2021.1044 ◽

2021 ◽

Vol 7 (6) ◽

Author(s):

David Veale ◽

Marc Serfaty ◽

Clara Humpston ◽

Andriani Papageorgiou ◽

Sarah Markham ◽

...

Keyword(s):

Rating Scale ◽

Clinical Sample ◽

Controlled Trial ◽

Bright Light ◽

Light Therapy ◽

Control Group ◽

Intention To Treat ◽

Significant Difference ◽

Randomised Controlled ◽

Rapid Treatment

Background Triple chronotherapy (sleep deprivation for 36 h, followed by 4 days of advancing the time of sleep and daily morning bright-light therapy for 6 months) has demonstrated benefits for the rapid treatment of depressive symptoms in four small controlled trials of in-patients. Aims To test the feasibility of recruitment and delivery of triple chronotherapy for out-patients with depression (ISRCTN17706836; NCT03405493). Method In a single-blind trial, 82 participants were randomised to triple chronotherapy or a control intervention. The primary outcome was the number of participants recruited per month and adherence to the protocol. Secondary outcomes included the 6-item Hamilton Rating Scale for Depression (HRSD-6) at 1 week. Timings of observer ratings were baseline and 1, 2, 4, 8 and 26 weeks after randomisation. Results The triple chronotherapy group stayed awake for the planned 36 h and 89.9% adhered to the plan of phase advance of their sleep over the following 4 days. We achieved our recruitment target (60 participants completed the trial within 13 months). There were no reported adverse side-effects. We found a significant difference between the groups by intention-to-treat analysis for the HRSD-6 at weeks 1, 8 and 26. There was a large effect size of Cohen's d = 0.8 on HRSD-6 score at week 1, increasing to d = 1.30 at week 26. A response (≥50% reduction in symptoms) was achieved by 33.3% in the triple chronotherapy group and 16.2% in the control group. This stayed relatively steady until week 26 (35.9 v. 13.9%). Conclusions Triple chronotherapy produced a significant and rapid benefit after 1 week in out-patients with depression that was sustained at 26 weeks. Cost-effectiveness trials with a larger clinical sample are required.

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Testing the Efficacy of ‘Unlearning’, a Mindfulness and Compassion-Based Programme for Cultivating Nonviolence in Teenagers: A Randomised Controlled Trial

Frontiers in Psychology ◽

10.3389/fpsyg.2021.717736 ◽

2021 ◽

Vol 12 ◽

Author(s):

Irene Delgado-Suárez ◽

Yolanda López-del-Hoyo ◽

Javier García-Campayo ◽

Adrián Pérez-Aranda ◽

Marta Modrego-Alarcón ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Multiple Comparisons ◽

Post Treatment ◽

Control Group ◽

Self Compassion ◽

Baseline Levels ◽

Secondary Outcomes ◽

Randomised Controlled

Background: Most programmes developed to reduce aggressive attitudes among teenagers are based on cultivating nonviolence, a construct that has been related to compassion and, more indirectly, mindfulness. This study aims at testing the efficacy of ‘Unlearning’, a mindfulness and compassion-based programme, for reducing aggressive attitudes in adolescents.Method: A sample of 164 students from three high schools in Zaragoza (Spain) participated in the study. They were randomly assigned to (1) ‘Unlearning’, or (2) relaxation programme. Three assessment points were established: baseline, post-treatment and a 4-month follow-up. The outcome variables were the subscales of the ‘Attitudes Toward Social Aggression Scale’. Mindfulness and compassion were assessed as secondary outcomes.Results: ‘Unlearning’ did not produce changes in the primary outcomes, but significant effects were observed post-treatment in self-compassion; and in the follow-up, in self-compassion and mindfulness. The control group did not experience any change post-treatment, but a significant effect in mindfulness was observed in the follow-up. The intergroup analyses indicated that ‘Unlearning’ improved self-compassion, both post-treatment (t = −2.48, p = 0.014) and after 4-months (t = −2.03, p = 0.044), although these results were not statistically significant after correcting for multiple comparisons.Conclusion: ‘Unlearning’ did not produce significant reductions in aggressive attitudes compared to the control group. The low baseline levels may have hindered the efficacy of the interventions. ‘Unlearning’ showed potential to improve self-compassion, which is related to nonviolence, and this may have positive implications for the adolescents. Future interventions should include teachers and families to enhance the effectiveness of the programmes.

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Efficacy and safety of furosemide for prevention of intradialytic hypotension in haemodialysis patients: protocol for a multicentre randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-048015 ◽

2021 ◽

Vol 11 (7) ◽

pp. e048015

Author(s):

Wenwen Chen ◽

Fang Wang ◽

Yuliang Zhao ◽

Ling Zhang ◽

Zhiwen Chen ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Urine Volume ◽

Residual Renal Function ◽

Control Group ◽

Intradialytic Hypotension ◽

Efficacy And Safety ◽

Blank Control Group ◽

Intention To Treat ◽

Randomised Controlled

IntroductionIntradialytic hypotension (IDH) is a frequent and serious complication of maintaining haemodialysis (HD) patients and associated with subsequent cardiovascular events and higher mortality. Furosemide is commonly used in non-dialysis chronic kidney disease patients and can effectively manage the volume and blood pressure. However, these agents are often discontinued on initiation of dialysis. Two large observational studies have demonstrated that furosemide can lower the rate of IDH episodes. However, there is still no randomised controlled trial (RCT) to investigate the efficacy and safety of furosemide for prevention of IDH in HD patients. The purpose of this study was to assess the efficacy of furosemide in reducing IDH in HD patients with residual renal function.Methods and analysisA two-arm, parallel, multicente RCT will be conducted at 12 hospitals in China. An estimated sample of 560 HD patients will be recruited. Eligible patients will be randomly assigned to treatment group (patients receive oral furosemide 80 mg/day; after a 2-week treatment, if their urine volume is less than 400 mL/day, the dose of furosemide is adjusted to 160 mg/day) and blank control group via a central randomisation system using 1:1 ratio. The primary outcome is the occurrence of IDH. Outcome assessors and data analysts will be blinded and participants will be asked not to reveal their allocation to assessors. The outcome analyses will be performed both on the intention-to-treat, which includes all patients randomised, and per-protocol population, which includes eligible patients who adhere to the planned treatment and follow-ups.Ethics and disseminationThe trial protocol has been approved by the Biomedical Research Ethics Committee of West China Hospital of Sichuan University (2019.385)Results will be presented at national and international conferences and published in peer-reviewed journals.Trial registration numberChiCTR2000039724.

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Theory-based digital intervention to promote weight loss and weight loss maintenance (Choosing Health): protocol for a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-040183 ◽

2020 ◽

Vol 10 (11) ◽

pp. e040183

Author(s):

Dominika Kwasnicka ◽

Aleksandra Luszczynska ◽

Martin S Hagger ◽

Eleanor Quested ◽

Sherry L Pagoto ◽

...

Keyword(s):

Time Series ◽

Weight Loss ◽

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Weight Loss Maintenance ◽

Control Group ◽

Promote Weight Loss ◽

Secondary Outcomes ◽

Randomised Controlled

IntroductionDigital behavioural weight loss interventions have the potential to improve public health; however, these interventions are often not adequately tailored to the needs of the participants. This is the protocol for a trial that aims to determine the effectiveness and cost-effectiveness of the Choosing Health programme as a means to promote weight loss and weight loss maintenance among overweight/obese adults.Methods and analysisThe proposed study is a two-group randomised controlled trial with a nested interrupted time series (ITS) within-person design. Participants (n=285) will be randomly assigned to either the Choosing Health digital intervention or a control group. For intervention participants, ecological momentary assessment will be used to identify behavioural determinants for each individual in order to tailor evidence-based behaviour change techniques and intervention content.Control group participants will receive non-tailored weight loss advice via e-book and generic emails. The primary outcome is the mean difference in weight loss between groups at 6 months controlled for baseline. Secondary outcomes include blood pressure and percentage of body fat; self-reported measures of physical activity, sitting time, quality of life, cost and theory-derived correlates of weight loss. Secondary outcomes will be measured at baseline, 3, 6 and 12 months. The primary outcome for ITS will be daily weight loss plan adherence. Data will be analysed using regression and time series analyses.Ethics and disseminationEthics approval was granted by Faculty of Psychology, SWPS University of Social Sciences and Humanities, Wroclaw, Poland, approval number 03/P/12/2019. The project results will be disseminated through structured strategy implemented in collaboration with the Ministry of Health.Trial registration detailsThis trial was registered with www.clinicaltrials.gov; registration number NCT04291482.

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Short-term effect of a chronic pain self-management intervention delivered by an easily accessible primary healthcare service: a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2018-023017 ◽

2018 ◽

Vol 8 (12) ◽

pp. e023017 ◽

Cited By ~ 2

Author(s):

Torunn Hatlen Nøst ◽

Aslak Steinsbekk ◽

Ola Bratås ◽

Kjersti Grønning

Keyword(s):

Chronic Pain ◽

Healthcare Service ◽

Primary Outcome ◽

Controlled Trial ◽

Intervention Group ◽

Patient Activation ◽

Self Management ◽

Control Group ◽

Secondary Outcomes ◽

Randomised Controlled

ObjectivesTo investigate the effects on persons with chronic pain after 3 months of a group-based chronic pain self-management course compared with a drop-in, low-impact outdoor physical group activity on patient activation and a range of secondary outcomes.DesignAn open, pragmatic, parallel group randomised controlled trial. Analyses were performed using a two-level linear mixed model.SettingAn easily accessible healthcare service provided by Norwegian public primary healthcare.ParticipantsA total of 121 participants with self-reported chronic pain for 3 months or more were randomised with 60 participants placed in the intervention group and 61 placed in the control group (mean age 53 years, 88% women, 63% pain for 10 years or more).InterventionsThe intervention group was offered a group-based chronic pain self-management course with 2.5-hour weekly sessions for a period of 6 weeks. The sessions consisted of education, movement exercises and emphasised group discussions. The control group was offered a low-impact outdoor group physical activity in 1-hour weekly sessions that consisted of walking and simple strength exercises for a period of 6 weeks.Main outcomesThe primary outcome was patient activation assessed using the Patient Activation Measure. Secondary outcomes measured included assessments of pain, anxiety and depression, pain self-efficacy, sense of coherence, health-related quality of life, well-being and the 30 s chair to stand test.ResultsThere was no effect after 3 months of the group-based chronic pain self-management course compared with the control group for the primary outcome, patient activation (estimated mean difference: −0.5, 95% CI –4.8 to 3.7, p=0.802).ConclusionsThere was no support for the self-management course having a better effect after 3 months than a low-impact outdoor physical activity offered the control group.Trial registration numberNCT02531282; Results.

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