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Diet and exercise in uterine cancer survivors (DEUS pilot) - piloting a healthy eating and physical activity program: study protocol for a randomized controlled trial.

ABSTRACT: Endometrial cancer survivors comprise a high-risk group for obesity-related comorbidities. Healthy eating and physical activity can lead to better health and well-being, but this population may experience difficulties adopting healthy lifestyle practices. Personalised behaviour change programmes that are feasible, acceptable and cost-effective are needed. The aim of this trial is to pilot a manualised programme about healthy eating and physical activity.This is a phase II, individually randomized, parallel, controlled, two-site, pilot clinical trial. Adult endometrial cancer survivors (n = 64) who have been diagnosed with endometrial cancer within the previous 3 years and are not on active treatment will be invited to participate. Participants will be assigned in a 1:1 ratio through minimisation to either an 8-week, group-based, behaviour-change programme with weekly 90-min sessions about healthy eating and physical activity or usual care. The intervention will focus on self-monitoring, goal setting and self-rewards. Follow-up assessments will be conducted at 8 and 24 weeks from the baseline assessment. Primary feasibility outcomes will include rates of recruitment, adherence, and retention.The study results will inform the development of a definitive randomised controlled trial to test if the programme can improve the health and quality of life of this population. It will also provide guidance on costing the intervention and the health care resource use in this population.ClinicalTrials.gov identifier: NCT02433080, 20 April 2015.

SUBMITTER: Koutoukidis DA

PROVIDER: S-EPMC4785620 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature

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Diet and exercise in uterine cancer survivors (DEUS pilot) - piloting a healthy eating and physical activity program: study protocol for a randomized controlled trial.

Koutoukidis Dimitrios A DA Beeken Rebecca J RJ Manchanda Ranjit R Burnell Matthew M Knobf M Tish MT Lanceley Anne A

Trials 20160310 1

<h4>Background</h4>Endometrial cancer survivors comprise a high-risk group for obesity-related comorbidities. Healthy eating and physical activity can lead to better health and well-being, but this population may experience difficulties adopting healthy lifestyle practices. Personalised behaviour change programmes that are feasible, acceptable and cost-effective are needed. The aim of this trial is to pilot a manualised programme about healthy eating and physical activity.<h4>Methods/design</h4> ...[more]

PMID: 26965165

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Project description:OBJECTIVE:Healthy eating and physical activity may help endometrial cancer survivors (ECS) improve their quality of life. However, most ECS do not meet the relevant guidelines. This pilot trial aimed to test the study feasibility procedures for a definitive trial of a behavioural lifestyle programme. DESIGN AND SETTING:This 24-week parallel two-arm randomised pilot trial took place in two hospitals in London, UK (April 2015-June 2016). PARTICIPANTS:Sixty disease-free ECS within 3 years of diagnosis. INTERVENTIONS:Participants were randomised using minimisation to receive the intervention or care as usual. The 'Shape-Up following cancer treatment' programme used self-monitoring, goal-setting, self-incentives, problem-solving and group social support for 12?hours over 8 weeks to help survivors improve their eating and physical activity. OUTCOME MEASURES:The main outcome measures were recruitment, adherence, and retention rates. Further outcomes included barriers to participation and feedback on programme satisfaction. RESULTS:Of the 296 potentially eligible ECS, 20% (n=60) were randomly allocated to the active intervention (n=29) or control group (n=31). Three participants in each arm were deemed ineligible after randomisation and excluded from analysis. Twenty participants (77%; 95%?CI 61% to 93%) adhered to the intervention and provided generally favourable feedback. At 24 weeks, 25/26 (96%; 95%?CI 89% to 100%) intervention and 24/28 (86%; 95%?CI 73% to 99%) control participants completed their assessment. No intervention-related adverse events were reported. Among eligible survivors who declined study participation (n=83), inconvenience (78%; 95%?CI 69% to 87%) was the most common barrier. CONCLUSIONS:The trial was feasible to deliver based on the a priori feasibility criteria. Enhancing recruitment and adherence in a definitive trial will require designs that promote convenience and consider ECS-reported barriers. TRIAL REGISTRATION NUMBER:NCT02433080; Pre-results. TRIAL FUNDING:University College London, St. Bartholomew's Hospital Nurses League, and NIHR University College London Hospitals Biomedical Research Centre.

Project description:Regular physical activity (PA) is an important part of the treatment of several medical conditions, including overweight and obesity, in which there may be a weakened appetite control. Eating behaviour traits influence weight control and may be different in active and sedentary subjects. This paper reports the relationships between the time spent in sedentary behaviour and physical activity (PA) of different intensity, and eating behaviour traits in young, healthy adults. Additionally, it reports the results of a six-month-long, randomized, controlled trial to examine the effect of an exercise intervention on eating behaviour traits. A total of 139 young (22.06 ± 2.26 years) healthy adults (68.35% women) with a Body Mass Index (BMI) of 24.95 ± 4.57 kg/m2 were enrolled. Baseline assessments of habitual PA were made using wrist-worn triaxial accelerometers; eating behaviour traits were examined via the self-reported questionnaires: Binge Eating, Three-Factor Eating Questionnaire-R18 and Control of Eating Questionnaire. The subjects were then randomly assigned to one of three groups: control (usual lifestyle), moderate-intensity exercise (aerobic and resistance training 3¨C4 days/week at a heart rate equivalent to 60% of the heart rate reserve (HRres) for the aerobic component, and at 50% of the 1 repetition maximum (RM) for the resistance component), or vigorous-intensity exercise (the same training but at 80% HRres for half of the aerobic training, and 70% RM for the resistance training). At baseline, sedentary behaviour was inversely associated with binge eating (r = -0.181, p < 0.05) and with uncontrolled eating (r = -0.286, p = 0.001). Moderate PA (MPA) was inversely associated with craving control (r = -0.188, p < 0.05). Moderate-to-vigorous PA (MVPA) was directly associated with binge eating (r = 0.302, p < 0.001) and uncontrolled eating (r = 0.346, p < 0.001), and inversely associated with craving control (r = -0.170, p < 0.015). Overall, PA was directly associated with binge eating (r = 0.275, p = 0.001), uncontrolled eating (r = 0.321, p < 0.001) and emotional eating (r = 0.204, p < 0.05). Additionally, only emotional eating was modified by the intervention, increasing in the vigorous-intensity exercise group (p < 0.05). In summary, we observed that time spent in sedentary behaviour/PA of different intensity is associated with eating behaviour traits, especially binge eating in young adults. In contrast, the six-month exercise intervention did not lead to appreciable changes in eating behaviour traits.

Project description:Background: Childhood obesity is an important public health issue. Approximately 20% of 2-4 year olds are overweight or obese, meaning 1 in 5 Australian children start school above a healthy weight. In the state of New South Wales (NSW) the combined prevalence of childhood overweight and obesity is significantly higher among children from low socioeconomic status backgrounds and children from regional, rural and remote areas. This paper describes implementation of a healthy eating and active play program (Munch & Move) for center-based early childhood education and care (ECEC) services aimed at influencing healthy behaviors in young children in NSW, Australia. It shows changes over time including a focus on disadvantaged, Aboriginal and remote communities. It also discusses the challenges and future opportunities for the program. Methods: Routine data in relation to service delivery (reach) and implementation indicators are collected by Local Health District staff. Fifteen implementation indicators (known as practices) were introduced to monitor the implementation of Munch & Move (six related to promoting and encouraging healthy eating, four related to improving physical activity, two related to small screen recreation; and three related to quality of service delivery). Results: As of 30 June 2017, 88.4% of ECEC services have staff trained in Munch & Move. Of the 15 practices related to promoting and encouraging healthy eating, increasing physical activity and improving the quality of service delivery 13 practices saw significant improvements between 2012 and 2017. This was consistent for services with a high proportion of Aboriginal children and for services in disadvantaged and remote communities. There has been a statistically significant increase in the proportion (37.6-81.0%, p < 0.0001) and type of ECEC services (preschools 36.1-81.3%, p < 0.0001, long day care 38.6-81.0%, p < 0.0001, and occasional care 34.0-74.6%, p < 0.0001) that have implemented the program since 2012 as well as in services with a high proportion of Aboriginal children (33.6-85.2% p < 0.0001), services in disadvantaged communities (37.4-83.3% p < 0.001), and services in remote communities (27.8-59.4% p < 0.0139). Discussion: This paper demonstrates that Munch & Move has seen large improvements in the delivery of training, practice achievements and program adoption in ECEC services across NSW including services in disadvantaged and remote communities and that have a higher proportion of Aboriginal children.

Dataset Information

Diet and exercise in uterine cancer survivors (DEUS pilot) - piloting a healthy eating and physical activity program: study protocol for a randomized controlled trial.

Publications

Diet and exercise in uterine cancer survivors (DEUS pilot) - piloting a healthy eating and physical activity program: study protocol for a randomized controlled trial.

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