Evaluating the feasibility, effectiveness and acceptability of an active play intervention for disadvantaged preschool children : a pilot study

Australian children from disadvantaged families are at increased risk of delays in acquiring fundamental movement skills, with physical inactivity and increased risk of the potential consequences of obesity. The aims of this pilot study were to: 1) assess the fundamental movement skills of disadvantaged children; 2) evaluate the feasibility and effectiveness of adapting an existing parenting and child development program to incorporate additional weekly play activities (the intervention); and 3) examine the acceptability of the intervention. Children aged 1.5-5 years were assessed pre-intervention (n = 26) and postintervention (n = 16) over a period of 22 weeks using the gross motor component of the Peabody Developmental Motor Scales - 2nd Edition (PDMS-2) (Folio & Fewell, 2000). Parents completed a demographic and environmental survey and those implementing the intervention were interviewed to assess the feasibility and acceptability of the intervention. Pre-intervention the children from disadvantaged families had locomotion, object manipulation and Gross Motor Quotient (GMQ) scores significantly below the norm-referenced standards of the PDMS-2 (p < 0.05). The intervention was associated with improvements in the locomotion (8.35 to 9.5; p = 0.009), and object manipulation (8.6 to 9.6; p = 0.04) subtest scores and the GMQ scores (92.6 to 99.3; p < 0.01). The intervention was deemed feasible and acceptable by those implementing the program. Low levels of physical activity in disadvantaged communities may be related to delayed acquisition of fundamental movement skills in childhood. This pilot study raises the possibility of correcting this deficit in early childhood, and improving the potential for all children to lead an active life.

Developing a placebo-controlled trial in surgery : issues of design, acceptability and feasibility

Background: Surgical placebos are controversial. This in-depth study explored the design, acceptability, and feasibility issues relevant to designing a surgical placebo-controlled trial for the evaluation of the clinical and cost effectiveness of arthroscopic lavage for the management of people with osteoarthritis of the knee in the UK.
Methods: Two surgeon focus groups at a UK national meeting for orthopaedic surgeons and one regional surgeon focus group (41 surgeons); plenary discussion at a UK national meeting for orthopaedic anaesthetists (130 anaesthetists); three focus groups with anaesthetists (one national, two regional; 58 anaesthetists); two focus groups with members of the patient organisation Arthritis Care (7 participants); telephone interviews with people on consultant waiting lists from two UK regional centres (15 participants); interviews with Chairs of UK ethics committees (6 individuals); postal surveys of members of the British Association of Surgeons of the Knee (382 surgeons) and members of the British Society of Orthopaedic Anaesthetists (398 anaesthetists); two centre pilot (49 patients assessed).
Results: There was widespread acceptance that evaluation of arthroscopic lavage had to be conducted with a placebo control if scientific rigour was not to be compromised. The choice of placebo surgical procedure (three small incisions) proved easier than the method of anaesthesia (general anaesthesia). General anaesthesia, while an excellent mimic, was more intrusive and raised concerns among some stakeholders and caused extensive discussion with local decision-makers when seeking formal approval for the pilot. Patients were willing to participate in a pilot with a placebo arm; although some patients when allocated to surgery became apprehensive about the possibility of receiving placebo, and withdrew. Placebo surgery was undertaken successfully.
Conclusions: Our study illustrated the opposing and often strongly held opinions about surgical placebos, the ethical issues underpinning this controversy, and the challenges that exist even when ethics committee approval has been granted. It showed that a placebo-controlled trial could be conducted in principle, albeit with difficulty. It also highlighted that not only does a placebo-controlled trial in surgery have to be ethically and scientifically acceptable but that it also must be a feasible course of action. The place of placebo-controlled surgical trials more generally is likely to be limited and require specific circumstances to be met. Suggested criteria are presented.

Treatment acceptability and psychosocial outcomes of a randomised controlled trial of a cognitive behavioural lifestyle intervention for overweight and obese adolescents

This study explores the impact of a cognitive behavioural lifestyle program, the CHOOSE HEALTH Program, on psychosocial wellbeing in overweight and obese adolescents. The sample comprised 29 male and 34 female adolescents aged 11.5 to 18.9 years (M = 14.3, SD = 1.9) and classified as overweight (n = 15) or obese (n=48). Participantswere randomly allocated to treatment or wait-list control conditions; participants allocated the wait-list condition were offered treatment after 6 months. Adolescents and parents completed self-report measures of psychopathology, psychosocial and family functioning. Treatment did not have detrimental effects on the psychosocial factors assessed. It resulted in significant improvements in weight control behaviour, impulse regulation, social support from family and parent–adolescent problem communication (p<.05). Similar results were obtained with completer and intention-to-treat analyses. Treatment acceptability was high, with all respondents indicating that they made progress. Combined, results indicate that treatment did not have detrimental effects on psychopathology, psychosocial functioning, or family functioning. Treatment resulted in significant improvements in impulse regulation, social support from family and parent–adolescent communication. Thus, parents and professionals can be assured that a comprehensive, multifaceted, parent-supported, cognitive behavioural intervention for overweight and obese adolescents does not cause psychological harm.

Acceptability of a theory of planned behaviour email-based nutrition intervention

This study investigated feasibility and acceptability of a new email-delivered intervention promoting fruit and vegetable consumption in a university-based population of Australian young adults. The study explored whether there are differences in the reported feasibility and acceptability between demographic groups within the population of interest and at three levels of intervention intensity. The email-delivered intervention program consists of an implementation intention ‘planning task’ and between 3 and 15 short email messages over a 15-day study period. The intervention program was developed using the Theory of Planned Behaviour and was designed to modify perceived behavioural control. One hundred and ten participants (mean age = 19.21 years, 25.6% male) completed the feasibility and acceptability questionnaire at Day 15. This questionnaire contained items about all intervention components. High acceptability and feasibility scores were found for all intervention parts and at all levels of intervention intensity. There were few significant differences in the reported acceptability of items between key demographic sub-groups, and no differences in reported acceptability at different levels of intervention intensity. These results suggest that this email-delivered intervention is an acceptable and feasible tool for promoting fruit and vegetable consumption for participants in the target population.

Acceptability of a theory of planned behaviour email-based nutrition intervention

This study investigated feasibility and acceptability of a new email-delivered intervention promoting fruit and vegetable consumption in a university-based population of Australian young adults. The study explored whether there are differences in the reported feasibility and acceptability between demographic groups within the population of interest and at three levels of intervention intensity. The email-delivered intervention program consists of an implementation intention ‘planning task’ and between 3 and 15 short email messages over a 15-day study period. The intervention program was developed using the Theory of Planned Behaviour and was designed to modify perceived behavioural control. One hundred and ten participants (mean age = 19.21 years, 25.6% male) completed the feasibility and acceptability questionnaire at Day 15. This questionnaire contained items about all intervention components. High acceptability and feasibility scores were found for all intervention parts and at all levels of intervention intensity. There were few significant differences in the reported acceptability of items between key demographic sub-groups, and no differences in reported acceptability at different levels of intervention intensity. These results suggest that this email-delivered intervention is an acceptable and feasible tool for promoting fruit and vegetable consumption for participants in the target population.

Study protocol for "Moving bright, eating smart"- a phase 2 clinical trial on the acceptability and feasibility of a diet and physical activity intervention to prevent recurrence in colorectal cancer survivors

Background: Colorectal cancer is the second most common cancer and cancer-killer in Hong Kong with an alarming increasing incidence in recent years. The latest World Cancer Research Fund report concluded that foods low in fibre, and high in red and processed meat cause colorectal cancer whereas physical activity protects against
colon cancer. Yet, the influence of these lifestyle factors on cancer outcome is largely unknown even though cancer survivors are eager for lifestyle modifications. Observational studies suggested that low intake of a Western-pattern diet and high physical activity level reduced colorectal cancer mortality. The Theory of Planned
Behaviour and the Health Action Process Approach have guided the design of intervention models targeting a wide range of health-related behaviours.
Methods/design: We aim to demonstrate the feasibility of two behavioural interventions intended to improve colorectal cancer outcome and which are designed to increase physical activity level and reduce consumption of a Western-pattern diet. This three year study will be a multicentre, randomised controlled trial in a 2x2 factorial
design comparing the “Moving Bright, Eating Smart” (physical activity and diet) programme against usual care. Subjects will be recruited over a 12-month period, undertake intervention for 12 months and followed up for a further 12 months. Baseline, interim and three post-intervention assessments will be conducted. Two hundred and twenty-two colorectal cancer patients who completed curative treatment without evidence of recurrence will be recruited into the study. Primary outcome measure will be whether physical activity and dietary targets are met at the end of the 12-month intervention. Secondary outcome measures include the magnitude and
mechanism of behavioural change, the degree and determinants of compliance, and the additional health benefits and side effects of the intervention.
Discussion: The results of this study will establish the feasibility of targeting the two behaviours (diet and physical activity) and demonstrate the magnitude of behaviour change. The information will facilitate the design of a further larger phase III randomised controlled trial with colorectal cancer outcome as the study endpoint to determine whether this intervention model would reduce colorectal cancer recurrence and mortality.

Safety and acceptability of practice-nurse-managed care of depression in patients with diabetes or heart disease in the Australian TrueBlue study

Objectives:
To determine the safety and acceptability of the TrueBlue model of nurse-managed care in the primary healthcare setting.

Consumer acceptability and antioxidant potential of probiotic-yogurt with spices

The study focuses on developing novel probiotic yogurts containing spices with acceptable sensory properties, therapeutic levels of probiotics and with beneficial antioxidant capacity. Eight types of yogurts with added spice oleoresins (cardamom, cinnamon and nutmeg) and probiotics [Lactobacillus acidophilus strain 5(LA5), or Bifidobacterium animalisssp.Lactis (Bb12)] were produced. Two successive consumer sensory taste panels (n = 54) using a nine point hedonic scale were conducted to evaluate the acceptability of the yogurts. Viable counts of probiotics and antioxidant capacity of yogurt samples at 1, 7, 14 and 28 days of storage at 4 °C were monitored. The probiotic-yogurt products containing spices showed good sensory properties, with the best results obtained with cardamom oleoresin (with LA5 or Bb12). The presence of spice oleoresins (cardamom, nutmeg and cinnamon) did not affect the probiotic population (LA5or Bb12) in yogurt during 4 weeks of refrigerated storage. The antioxidant capacity (with LA5or Bb12) over the storage period was also maintained.

Effect of sorghum flour addition on in vitro starch digestibility, cooking quality and consumer acceptability of durum wheat pasta

Whole grain sorghum is a valuable source of resistant starch and polyphenolic antioxidants and its addition into staple food like pasta may reduce the starch digestibility. However, incorporating nondurum wheat materials into pasta provides a challenge in terms of maintaining cooking quality and consumer acceptability. Pasta was prepared from 100% durum wheat semolina (DWS) as control or by replacing DWS with either wholegrain red sorghum flour (RSF) or white sorghum flour (WSF) each at 20%, 30%, and 40% incorporation levels, following a laboratory-scale procedure. Pasta samples were evaluated for proximate composition, in vitro starch digestibility, cooking quality, and consumer acceptability. The addition of both RSF and WSF lowered the extent of in vitro starch digestion at all substitution levels compared to the control pasta. The rapidly digestible starch was lowered in all the sorghum-containing pastas compared to the control pasta. Neither RSF or WSF addition affected the pasta quality attributes (water absorption, swelling index, dry matter, adhesiveness, cohesiveness, and springiness), except color and hardness which were negatively affected. Consumer sensory results indicated that pasta samples containing 20% and 30% RSF or WSF had acceptable palatability based on meeting one or both of the preset acceptability criteria. It is concluded that the addition of wholegrain sorghum flour to pasta at 30% incorporation level is possible to reduce starch digestibility, while maintaining adequate cooking quality and consumer acceptability.

Feasibility, acceptability and potential effectiveness of a mobile health (mHealth) weight management programme for New Zealand adults

Background
Mobile health (mHealth) behaviour change programmes use mobile phones and the internet to deliver health information and behaviour change support to participants. Such programmes offer a potentially cost-effective way to reach many individuals who do not currently access weight loss services. We developed a mHealth weight management programme using proven face-to-face behaviour change techniques and incorporating target population input. Our aim was to evaluate the feasibility, acceptability and potential effectiveness of this programme for ethnically diverse adults with a view to informing a larger trial.

Results
Fifty three adults who had a BMI of ≥25 kg/m2 and wanted to lose weight (81% female, mean age 42 years, mean BMI 35.7 kg/m2, 26% Maori, 34% Pacific) received the eight-week mHealth weight loss programme. Anthropometric measures were taken at two face-to-face assessments at baseline and 12-weeks (i.e. four weeks after cessation of intervention).

Twelve-week follow-up measurements were available for 36/53 participants (68%). Non-completers were younger and more likely to be male and of Pacific ethnicity. Thirty five participants (66%) reported reading ‘all or most’ text messages sent and 96% responded to at least one text data collection question over the eight-week active intervention period. Eighty one per cent of participants logged in to the study website at least once during the eight-week study period. In the intention-to-treat analysis, mean weight change was -1.0 kg (SD 3.1) at 12 weeks (p = 0.024) and change in BMI was -0.34 kg/m2 (SD 1.1) (p = 0.026). In the completers only analysis (n = 36), mean weight change was -1.4 kg (SD 3.6) (p = 0.023) and change in BMI was -0.50 kg/m2 (SD 1.3) (p = 0.025).

Conclusions
A mHealth weight management programme is feasible to deliver to an ethnically diverse population. Changes in body weight and BMI at 12 weeks indicate that the programme could be effective in supporting people with weight loss. However, the high dropout rate indicates a need for further improvements to the programme.

Factors affecting acceptability of an email-based intervention to increase fruit and vegetable consumption

 Background: Fresh Facts is a 30-day email-delivered intervention designed to increase the fruit and vegetable consumption of Australian young adults. This study investigated the extent to which the program was acceptable to members of the target audience and examined the relationships between participant and intervention characteristics, attrition, effectiveness, and acceptability ratings. Methods: Young adults were randomised to two levels of message frequency: high-frequency (n = 102), low-frequency (n = 173). Individuals in the high-frequency group received daily emails while individuals in the low-frequency group received an email every 3 days. Results: Individuals in the high-frequency group were more likely to indicate that they received too many emails than individuals in the low-frequency group. No other differences in acceptability were observed. Baseline beliefs about fruit and vegetables were an important predictor of intervention acceptability. In turn, acceptability was associated with a number of indicators of intervention success, including change in fruit and vegetable consumption. Conclusions: The findings highlight the importance of considering the relationship between these intervention and participant factors and acceptability in intervention design and evaluation. Results support the ongoing use of email-based interventions to target fruit and vegetable consumption within young adults. However, the relationships between beliefs about fruit and vegetable consumption and acceptability suggest that this intervention may be differentially effective depending on individual's existing beliefs about fruit and vegetable consumption. As such, there is a pressing need to consider these factors in future research in order to minimize attrition and maximize intervention effectiveness when interventions are implemented outside of a research context.