Dataset Information

Randomised controlled feasibility trial of an evidence-informed behavioural intervention for obese adults with additional risk factors.

ABSTRACT:

Background

Interventions for dietary and physical activity changes in obese adults may be less effective for participants with additional obesity-related risk factors and co-morbidities than for otherwise healthy individuals. This study aimed to test the feasibility and acceptability of the recruitment, allocation, measurement, retention and intervention procedures of a randomised controlled trial of an intervention to improve physical activity and dietary practices amongst obese adults with additional obesity related risk factors.

Method

Pilot single centre open-labelled outcome assessor-blinded randomised controlled trial of obese (Body Mass Index (BMI)?30 kg/m2) adults (age?18 y) with obesity related co-morbidities such as type 2 diabetes, impaired glucose tolerance or hypertension. Participants were randomly allocated to a manual-based group intervention or a leaflet control condition in accordance to a 2?1 allocation ratio. Primary outcome was acceptability and feasibility of trial procedures, secondary outcomes included measures of body composition, physical activity, food intake and psychological process measures.

Results

Out of 806 potentially eligible individuals identified through list searches in two primary care general medical practices N?=?81 participants (63% female; mean-age?=?56.56(11.44); mean-BMI?=?36.73(6.06)) with 2.35(1.47) co-morbidities were randomised. Scottish Index of Multiple Deprivation (SIMD) was the only significant predictor of providing consent to take part in the study (higher chances of consent for invitees with lower levels of deprivation). Participant flowcharts, qualitative and quantitative feedback suggested good acceptance and feasibility of intervention procedures but 34.6% of randomised participants were lost to follow-up due to overly high measurement burden and sub-optimal retention procedures. Participants in the intervention group showed positive trends for most psychological, behavioural and body composition outcomes.

Conclusions

The intervention procedures were found to be acceptable and feasible. Attrition rates were unacceptably high and areas for improvements of trial procedures were identified.

Trial registration

Controlled-Trials.com ISRCTN90101501.

SUBMITTER: Sniehotta FF

PROVIDER: S-EPMC3163575 | biostudies-literature | 2011

REPOSITORIES: biostudies-literature

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Publications

Randomised controlled feasibility trial of an evidence-informed behavioural intervention for obese adults with additional risk factors.

Sniehotta Falko F FF Dombrowski Stephan U SU Avenell Alison A Johnston Marie M McDonald Suzanne S Murchie Peter P Ramsay Craig R CR Robertson Kim K Araujo-Soares Vera V

PloS one 20110829 8

<h4>Background</h4>Interventions for dietary and physical activity changes in obese adults may be less effective for participants with additional obesity-related risk factors and co-morbidities than for otherwise healthy individuals. This study aimed to test the feasibility and acceptability of the recruitment, allocation, measurement, retention and intervention procedures of a randomised controlled trial of an intervention to improve physical activity and dietary practices amongst obese adults ...[more]

PMID: 21897841

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Project description:ObjectivesRandomised controlled trials are required to address causality in the reported associations between maternal influences and offspring adiposity. The aim of this study was to determine whether an antenatal lifestyle intervention, associated with improvements in maternal diet and reduced gestational weight gain (GWG) in obese pregnant women leads to a reduction in infant adiposity and sustained improvements in maternal lifestyle behaviours at 6 months postpartum.Subjects and methodsWe conducted a planned postnatal follow-up of a randomised controlled trial (UK Pregnancies Better Eating and Activity Trial (UPBEAT)) of a complex behavioural intervention targeting maternal diet (glycaemic load (GL) and saturated fat intake) and physical activity in 1555 obese pregnant women. The main outcome measure was infant adiposity, assessed by subscapular and triceps skinfold thicknesses. Maternal diet and physical activity, indices of the familial lifestyle environment, were assessed by questionnaire.ResultsA total of 698 (45.9%) infants (342 intervention and 356 standard antenatal care) were followed up at a mean age of 5.92 months. There was no difference in triceps skinfold thickness z-scores between the intervention vs standard care arms (difference -0.14 s.d., 95% confidence interval -0.38 to 0.10, P=0.246), but subscapular skinfold thickness z-score was 0.26 s.d. (-0.49 to -0.02; P=0.03) lower in the intervention arm. Maternal dietary GL (-35.34; -48.0 to -22.67; P<0.001) and saturated fat intake (-1.93% energy; -2.64 to -1.22; P<0.001) were reduced in the intervention arm at 6 months postpartum. Causal mediation analysis suggested that lower infant subscapular skinfold thickness was partially mediated by changes in antenatal maternal diet and GWG rather than postnatal diet.ConclusionsThis study provides evidence from follow-up of a randomised controlled trial that a maternal behavioural intervention in obese pregnant women has the potential to reduce infant adiposity and to produce a sustained improvement in maternal diet at 6 months postpartum.

Project description:BackgroundOsteoarthritis is a highly prevalent condition in older adults, that causes many sufferers to require a hip or knee replacement in order to improve their quality of life and reduce pain. Individuals waiting for hip or knee replacements are often highly sedentary; thus, it is pertinent to assess whether reducing their sedentariness prior to surgery may aid in improving post-operative outcomes.Methods/designThe study will be a randomised controlled feasibility trial design, with 2:1 randomisation into an intervention and usual care group respectively. A target of 45 patients aged 60?years or older waiting for elective hip and knee replacements will be recruited from Russells Hall Hospital, Dudley, UK, approximately 8-10?weeks before surgery. The intervention, informed by Self-Determination Theory (SDT), will be composed of multiple behaviour change techniques, namely, motivational interviewing, feedback on current objectively measured sedentary behaviour and activity, goal-setting, environmental modification, self-monitoring, and social support. Assessments will occur at baseline, 1?week pre-surgery, and 6?weeks post-surgery. The primary outcome will be the feasibility of intervention delivery and of the trial procedures, assessed quantitatively based on rates of recruitment, retention, measures-completion, and intervention fidelity assessment, and with mixed-methods assessment of acceptability, practicality, adaption, satisfaction, and safety. Exploratory outcomes will include physical function, cardiometabolic biomarkers, measurement of SDT constructs, and both objective and subjective measurement of physical activity and sedentariness. The study will last up to 18?weeks per participant. No formal between-group comparisons are planned, but the variance in within-group changes and differences between groups in outcome measures will be explored and reported with 95% confidence intervals.DiscussionThis is the first study assessing the feasibility of an intervention to reduce sedentary behaviour in older adults with mobility limitations, and the first to assess whether such a reduction could work in a prehabilitative context prior to surgery. The results of this study will help inform the design of a definitive randomised controlled trial.Trial registrationThis trial is registered on Clinicaltrials.gov. Registration number: NCT03740412. Date of registration: 13/11/2018.

Project description:BackgroundAt least 40% of people with psychosis have persistent distressing symptoms despite optimal medication treatment. Cognitive behaviour therapy for psychosis (CBTp) is the only NICE-recommended individual therapy for psychosis, with effects on symptoms, distress and quality of life. Yet <10% of service-users receive it and 94% of trusts struggle to provide it. Of those offered it, 22-43% refuse or do not attend. We have developed a new pre-CBTp informed choice intervention to address knowledge and attitudes that influence uptake and implementation and now want to test it in a feasibility trial.MethodsThe design is a two-arm, feasibility randomised controlled trial (RCT), with 1:1 randomisation, stratified by participant group and site. Participants are 40 psychosis patients and 40 clinicians, who are ambivalent towards uptake or implementation of CBTp. Sites are community and inpatient services in Sussex and London. The intervention is a pre-CBT digital psychoeducation intervention designed to address identified knowledge and attitudinal barriers to uptake and implementation of CBTp, incorporating behaviour change mechanisms, and supported by animated introductory, patient and clinician stories. The comparator is the NHS choices website for CBT. The primary aim is to assess clinical feasibility (recruitment, randomisation, acceptability, use, delivery, outcome measurement, retention). A secondary aim is a preliminary evaluation of efficacy. Outcomes will be assessed at baseline, post intervention, and one-month follow-up (blind to treatment arm). The primary efficacy outcome is likelihood of offering/taking up CBTp. Secondary outcomes include knowledge and attitudes towards CBTp, illness perceptions, empowerment, psychological wellbeing (patients only) and CBTp implementation (clinicians only). Use of the intervention and CBT behaviours during the follow-up period will be recorded and captured in a feedback questionnaire. Use, acceptability and experience of outcome assessment will be explored in qualitative interviews with participants (n?=?6 per group). The efficacy evaluation will report descriptive data, key model parameters and 95% highest probability density intervals in a Bayesian growth model.DiscussionThis is the first feasibility trial of a digital 'informed choice' decision aid for the implementation of CBTp. If the trial proves feasible and demonstrates preliminary evidence of efficacy, a large multi-site trial will be warranted.Trial registrationISRCTN registry, ISRCTN53107879 . Registered prospectively on 2 August 2017.

Project description:BackgroundLow quality social relationships in older adults are strongly associated with feelings of loneliness. Physical activity interventions could reduce loneliness and improve psychological well-being, among other health benefits. The aim of this study was to examine the feasibility of a Physical Activity Intervention for Loneliness (PAIL) in community-dwelling older adults at risk of loneliness.MethodsThe PAIL feasibility study was a 12-week randomized controlled feasibility trial (RCT) conducted in Birmingham, United Kingdom, from February 2018 to August 2018, and ran in two waves of data collection. Eligible participants were community-dwelling adults aged 60 years and older, sedentary (less than 20 min of moderate-to-vigorous PA (MVPA) a week), and at risk of loneliness. The intervention included once-weekly group walk and health education workshop up to 90 min per session in total, with a wait-listed (WL) control group. The primary feasibility outcomes were to estimate recruitment, retention rates and adherence to the intervention. Secondary outcome measures (not blinded assessment) were body mass index, blood pressure, physical activity and psychosocial variables. Process and outcome evaluations were conducted using focus groups interviews. The recruitment and retention progression criteria for the definitive large-scale RCT was set a-priori.ResultsForty-eight participants were recruited over 4 months with a recruitment rate of 25% (48/195); 52% (25/48) met the inclusion criteria and 100% (25/25) were randomised into the intervention (n = 12) and WL control groups (n = 13). Participants were 25 older adults (mean (SD) 68.5(8.05) years), 14 (56%) female, and 18 (72%) white. At 12 weeks, 10/12 (83.3%) intervention and 10/13 (76.9%) control participants completed the final assessments. The average attendance rate was 58.3% for the intervention group (range 33.0%-75.0%) and 42.3% (range 23.1%-69.2%) among controls. The a priori recruitment and retention criteria for progression were not met. No serious adverse events occurred. The focus group results identified three themes which showed overall positive experiences of participation in PAIL in terms of (1) study design and intervention; (2) walking sessions; and (3) health education workshops.ConclusionsThe findings suggest that community-dwelling older adults at risk of loneliness found the intervention and measures acceptable and could safely participate. However, a more extensive and robust strategy would be needed to support adequate recruitment of lonely older adults and adherence into a definitive RCT.Trial registrationClinicaltrials.gov, NCT03458793.

Project description:BackgroundTo tackle the problem of obesity and related diseases in Switzerland, cost-efficient, effective, and innovative primary health care interventions for weight management are required. In this context, Oviva has developed a scalable technology for registered dietitians to counsel overweight and obese patients via a mobile phone app.ObjectiveThe aim of this study was to evaluate the effectiveness and feasibility of weight loss counseling by dietitians using a mobile phone app for patients with overweight and obesity.MethodsIn this pre- and posttest pilot study, overweight and obese adults participated in a 1-year behavioral intervention to lose weight through remote counseling by dietitians in the German-speaking part of Switzerland. The study started in April 2016 and finished in May 2018. Participants received individual counseling through the app and the exchange with the dietitian focused on regular feedback on photo-based food log, motivation, and education. The contents were tailored to the individual lifestyle goal set. The predefined intensity of remote counseling decreased during the year. Group chat could be used. The outcomes examined were changes in weight (primary outcome), hemoglobin A1c, fasting glucose, fasting insulin, triglyceride, high-density lipoprotein cholesterol, blood pressure (BP), body mass index (BMI), waist circumference, body fat, and responses to a self-administered questionnaire with questions regarding participants' physical activity, dietary assessment, and health-related quality of life. Changes were tested at baseline, after 3 months, and after 12 months, as well as between the third and the 12th month.ResultsIn total, 36 women and 7 men, with a mean age of 40.6 years, participated and 36 participants completed the study. Median weight change after the first 12 weeks was -3.8 kg (range: -15 to 2.4 and P<.001), between week 12 and week 52 it was -1.1 kg (range: -9.7 to 7 and P=.08), and the median change during the entire period of intervention was -4.9 kg (range: -21.9 to 7.5 and P<.001). Furthermore, changes in BMI, waist circumference, body fat, and BP between baseline and 12 weeks and between baseline and 52 weeks were also significant. Significant changes in certain eating habits were also demonstrated (higher frequency of vegetable, fruit, and breakfast consumption and lower frequency of alcohol, sweet, and fat consumption).ConclusionsIn addition to the professional skills of a dietitian, a profession-specific app such as Oviva can provide effective support that meets the needs of dietitians and clients on the long path of behavioral change and sustainable weight reduction.Trial registrationClinicalTrials.gov NCT02694614; https://clinicaltrials.gov/ct2/show/NCT02694614 (Archived by WebCite at http://www.webcitation.org/76gYkGOIc).

Project description:BackgroundLong-term effects of behavioural weight loss interventions on diabetes complications are unknown. In a secondary analysis of the Look AHEAD (Action for Health in Diabetes) multicentre randomised clinical trial, we assessed whether an intensive lifestyle intervention (ILI) affects the development of nephropathy in people with type 2 diabetes.MethodsOverweight or obese people aged 45-76 years with type 2 diabetes were randomly assigned (1:1) to ILI or to a diabetes support and education (DSE) group by a central web-based data management system, stratified by clinical centre and blocked with random block sizes. The ILI was designed to achieve and maintain weight loss through reduced caloric consumption and increased physical activity. The interventions were terminated early because of absence of effect on the primary outcome of cardiovascular disease events in the main Look AHEAD trial. Albuminuria and estimated glomerular filtration rate were prespecified as two of many other outcomes and were assessed from baseline until the interventions ended. They were combined post hoc to define the main outcome for this report, very-high-risk chronic kidney disease (CKD), based on the 2013 Kidney Disease Improving Global Outcomes (KDIGO) classification. Outcomes assessors and laboratory staff were masked to treatment, but participants and interventionists were not masked. Time-to-event data were analysed by intention to treat by the Kaplan-Meier method and proportional hazards models. The Look AHEAD trial is registered with ClinicalTrials.gov, NCT00017953.FindingsOf the 5145 participants randomly assigned in the Look AHEAD trial (2570 to ILI and 2575 to DSE), analyses for very-high-risk CKD were done in 2423 (94%) of patients in the ILI group and 2408 (94%) of those in the DSE group. After a median of 8·0 years (IQR 7·9-9·9) of follow-up, the incidence of very-high-risk CKD was lower in the ILI group than in the DSE group, with incidence rates of 0·91 cases per 100 person-years in the DSE group and 0·63 per 100 person-years in the ILI group (difference 0·27 cases per 100 person-years, hazard ratio 0·69, 95% CI 0·55-0·87; p=0·0016). This effect was partly attributable to reductions in bodyweight, HbA1c, and systolic blood pressure. There were no safety concerns regarding kidney-related adverse events.InterpretationWeight loss should be considered as an adjunct to medical treatments to prevent or delay progression of CKD in overweight or obese people with type 2 diabetes.FundingNational Institute of Diabetes and Digestive and Kidney Diseases.

Dataset Information

Randomised controlled feasibility trial of an evidence-informed behavioural intervention for obese adults with additional risk factors.

Background

Method

Results

Conclusions

Trial registration

Publications

Randomised controlled feasibility trial of an evidence-informed behavioural intervention for obese adults with additional risk factors.

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