Apps for IMproving FITness and increasing physical activity among young people: the AIMFIT pragmatic randomized controlled trial

BACKGROUND: Given the global prevalence of insufficient physical activity (PA), effective interventions that attenuate age-related decline in PA levels are needed. Mobile phone interventions that positively affect health (mHealth) show promise; however, their impact on PA levels and fitness in young people is unclear and little is known about what makes a good mHealth app. OBJECTIVE: The aim was to determine the effects of two commercially available smartphone apps (Zombies, Run and Get Running) on cardiorespiratory fitness and PA levels in insufficiently active healthy young people. A second aim was to identify the features of the app design that may contribute to improved fitness and PA levels. METHODS: Apps for IMproving FITness (AIMFIT) was a 3-arm, parallel, randomized controlled trial conducted in Auckland, New Zealand. Participants were recruited through advertisements in electronic mailing lists, local newspapers, flyers posted in community locations, and presentations at schools. Eligible young people aged 14-17 years were allocated at random to 1 of 3 conditions: (1) use of an immersive app (Zombies, Run), (2) use of a nonimmersive app (Get Running), or (3) usual behavior (control). Both smartphone apps consisted of a fully automated 8-week training program designed to improve fitness and ability to run 5 km; however, the immersive app featured a game-themed design and narrative. Intention-to-treat analysis was performed using data collected face-to-face at baseline and 8 weeks, and all regression models were adjusted for baseline outcome value and gender. The primary outcome was cardiorespiratory fitness, objectively assessed as time to complete the 1-mile run/walk test at 8 weeks. Secondary outcomes were PA levels (accelerometry and self-reported), enjoyment, psychological need satisfaction, self-efficacy, and acceptability and usability of the apps. RESULTS: A total of 51 participants were randomized to the immersive app intervention (n=17), nonimmersive app intervention (n=16), or the control group (n=18). The mean age of participants was 15.7 (SD 1.2) years; participants were mostly NZ Europeans (61%, 31/51) and 57% (29/51) were female. Overall retention rate was 96% (49/51). There was no significant intervention effect on the primary outcome using either of the apps. Compared to the control, time to complete the fitness test was -28.4 seconds shorter (95% CI -66.5 to 9.82, P=.20) for the immersive app group and -24.7 seconds (95% CI -63.5 to 14.2, P=.32) for the nonimmersive app group. No significant intervention effects were found for secondary outcomes. CONCLUSIONS: Although apps have the ability to increase reach at a low cost, our pragmatic approach using readily available commercial apps as a stand-alone instrument did not have a significant effect on fitness. However, interest in future use of PA apps is promising and highlights a potentially important role of these tools in a multifaceted approach to increase fitness, promote PA, and consequently reduce the adverse health outcomes associated with insufficient activity.

Feasibility, design and conduct of a pragmatic randomized controlled trial to reduce overweight and obesity in children: the electronic games to aid motivation to exercise (eGAME) study

BACKGROUND: Childhood obesity has reached epidemic proportions in developed countries. Sedentary screen-based activities such as video gaming are thought to displace active behaviors and are independently associated with obesity. Active video games, where players physically interact with images onscreen, may have utility as a novel intervention to increase physical activity and improve body composition in children. The aim of the Electronic Games to Aid Motivation to Exercise (eGAME) study is to determine the effects of an active video game intervention over 6 months on: body mass index (BMI), percent body fat, waist circumference, cardio-respiratory fitness, and physical activity levels in overweight children.

METHODS/DESIGN: Three hundred and thirty participants aged 10-14 years will be randomized to receive either an active video game upgrade package or to a control group (no intervention).

DISCUSSION: An overview of the eGAME study is presented, providing an example of a large, pragmatic randomized controlled trial in a community setting. Reflection is offered on key issues encountered during the course of the study. In particular, investigation into the feasibility of the proposed intervention, as well as robust testing of proposed study procedures is a critical step prior to implementation of a large-scale trial.

The ideal Ileal-Pouch design : a long-term randomized control trial of J- vs W-pouch construction

BACKGROUND: The IPAA has become established as the preferred technique for restoring intestinal continuity postproctocolectomy. The ideal pouch design has not been established. W-pouches may give better functional results owing to increased volume, whereas the J-pouch’s advantage is its straightforward construction. We report short- and long-term results of an randomized control trial designed to establish the ideal pouch.

DESIGN: Ninety-four patients were randomly assigned to J- and W-pouches (49:45) and assessed at 1 and 8.7 years postoperatively. Assessment was questionnaire based and designed to assess pouch function and patient quality of life.

RESULTS: Eighty-five percent of patients were followed up at 1 year, and 68% were followed up at 8.7 years. At 1 year, there was a significant difference in 24-hour bowel movement frequency J- vs W-pouches 7 vs 5(p < 0.001) and in daytime frequency J- vs W-pouches 6 vs 4 (p < 0.001), with no difference in nocturnal function. At 9-year follow-up, function had equilibrated between the 2 groups: 24-hour bowel movement frequency J- vs W-pouches 6.5 vs 6 (p = 0.36), daytime frequency 5.5 vs 5 (p = 0.233), and nocturnal function 1 vs 1 (p = 0.987). Mean operating time of J- and W-pouches was 195 and 215 minutes (p < 0.05). All other parameters, pad usage, urgency, incontinence, and quality of life, did not differ significantly between groups.

CONCLUSION: These data demonstrate that the theoretical functional advantage conferred on the W-pouch by its greater volume exists only in the short term and is of little consequence to patients’ long-term quality of life. This advantage is attenuated as the pouches mature, resulting in no disparity in pouch function. This, combined with the more consistent, efficient, and easily taught construction of the J-pouch, should conclusively establish it as the optimum ileal-pouch design.

Healthy together Victoria and childhood obesity-a methodology for measuring changes in childhood obesity in response to a community-based, whole of system cluster randomized control trial

BACKGROUND: Healthy Together Victoria (HTV) - a complex 'whole of system' intervention, including an embedded cluster randomized control trial, to reduce chronic disease by addressing risk factors (physical inactivity, poor diet quality, smoking and harmful alcohol use) among children and adults in selected communities in Victoria, Australia (Healthy Together Communities).

OBJECTIVES: To describe the methodology for: 1) assessing changes in the prevalence of measured childhood obesity and associated risks between primary and secondary school students in HTV communities, compared with comparison communities; and 2) assessing community-level system changes that influence childhood obesity in HTC and comparison communities.

METHODS: Twenty-four geographically bounded areas were randomized to either prevention or comparison (2012). A repeat cross-sectional study utilising opt-out consent will collect objectively measured height, weight, waist and self-reported behavioral data among primary [Grade 4 (aged 9-10y) and Grade 6 (aged 11-12y)] and secondary [Grade 8 (aged 13-14y) and Grade 10 (aged 15-16y)] school students (2014 to 2018). Relationships between measured childhood obesity and system causes, as defined in the Foresight obesity systems map, will be assessed using a range of routine and customised data.

CONCLUSION: This research methodology describes the beginnings of a state-wide childhood obesity monitoring system that can evolve to regularly inform progress on reducing obesity, and situate these changes in the context of broader community-level system change.

Design and conduct of a pragmatic randomized controlled trial to enhance smoking-cessation outcomes with exercise: The Fit2Quit study

Background: Most smokers want to stop smoking and many try to quit. However abstinence rates are low and most smokers do not manage to abstain for even a week. Relapse to smoking can be related to the occurrence of tobacco withdrawal symptoms (e.g., sleep disturbance, irritability, and craving) and weight gain. If regular exercise mitigates these effects it could have potential as an aid to smoking cessation. The aim of the Fit2Quit study is to determine the effects of a home and community-based exercise intervention on smoking abstinence at six months when used as an adjunct to usual care (telephone smoking-cessation counseling and nicotine replacement therapy; NRT). Methods/design: A prospective parallel two-arm randomized controlled trial. Participants (n = 1400, 700 per arm) will be randomized to a structured home and community-based exercise program plus usual care (behavioral counseling and NRT) or to usual-care alone. It is targeted that at least 25% of the sample will be of Mori ethnicity (New Zealand indigenous). Outcomes to be measured using intention-to-treat analysis include: seven-day point prevalence of smoking abstinence verified by salivary cotinine (primary outcome); 6 months continuous abstinence; body mass index (BMI); cardio-respiratory fitness; physical activity levels; and cost effectiveness. Discussion: The Fit2Quit study is an example of a large, pragmatic randomized controlled trial in a community setting. Specific components of the exercise intervention are outlined in detail. Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12609000637246.

Exercise to enhance smoking cessation: the getting physical on cigarette randomized control trial

BACKGROUND: Exercise has been proposed as a useful smoking cessation aid. PURPOSE: The purpose of the present study is to determine the effect of an exercise-aided smoking cessation intervention program, with built-in maintenance components, on post-intervention 14-, 26- and 56-week cessation rates. METHOD: Female cigarette smokers (n = 413) participating in a supervised exercise and nicotine replacement therapy (NRT) smoking cessation program were randomized to one of four conditions: exercise + smoking cessation maintenance, exercise maintenance + contact control, smoking cessation maintenance + contact control or contact control. The primary outcome was continuous smoking abstinence. RESULTS: Abstinence differences were found between the exercise and equal contact non-exercise maintenance groups at weeks 14 (57 vs 43 %), 26 (27 vs 21 %) and 56 (26 vs 23.5 %), respectively. Only the week 14 difference approached significance, p = 0.08. CONCLUSIONS: An exercise-aided NRT smoking cessation program with built-in maintenance components enhances post-intervention cessation rates at week 14 but not at weeks 26 and 56.

Effects of resistance exercise and fortified milk on skeletal muscle mass, muscle size, and functional performance in middle-aged and older men: an 18-mo randomized controlled trial

Limited data have suggested that the consumption of fluid milk after resistance training (RT) may promote skeletal muscle hypertrophy. The aim of this study was to assess whether a milk-based nutritional supplement could enhance the effects of RT on muscle mass, size, strength, and function in middle-aged and older men. This was an 18-mo factorial design (randomized control trial) in which 180 healthy men aged 50–79 yr were allocated to the following groups: 1) exercise + fortified milk, 2) exercise, 3) fortified milk, or 4) control. Exercise consisted of progressive RT with weight-bearing impact exercise. Men assigned to the fortified milk consumed 400 ml/day of low-fat milk, providing an additional 836 kJ, 1000 mg calcium, 800 IU vitamin D3, and 13.2 g protein per day. Total body lean mass (LM) and fat mass (FM) (dual-energy X-ray absorptiometry), midfemur muscle cross-sectional area (CSA) (quantitative computed tomography), muscle strength, and physical function were assessed. After 18 mo, there was no significant exercise by fortified milk interaction for total body LM, muscle CSA, or any functional measure. However, main effect analyses revealed that exercise significantly improved muscle strength (∼20–52%, P < 0.001), LM (0.6 kg, P < 0.05), FM (−1.1 kg, P < 0.001), muscle CSA (1.8%, P < 0.001), and gait speed (11%, P < 0.05) relative to no exercise. There were no effects of the fortified milk on muscle size, strength, or function. In conclusion, the daily consumption of low-fat fortified milk does not enhance the effects of RT on skeletal muscle size, strength, or function in healthy middle-aged and older men with adequate energy and nutrient intakes.

Web-based alcohol intervention for Māori university students: double-blind, multi-site randomized controlled trial

AIMS: Like many indigenous peoples, New Zealand Māori bear a heavy burden of alcohol-related harm relative to their non-indigenous compatriots, and disparities are greatest among young adults. We tested the effectiveness of web-based alcohol screening and brief intervention (e-SBI) for reducing hazardous drinking among Māori university students. DESIGN: Parallel, double-blind, multi-site, randomized controlled trial. SETTING: Seven of New Zealand's eight universities. PARTICIPANTS: In April 2010, we sent e-mail invitations to all 6697 17-24-year-old Māori students to complete a brief web questionnaire including the Alcohol Use Disorders Identification Test (AUDIT)-C, a screening tool for hazardous and harmful drinking. Those screening positive were computer randomized to: <10 minutes of web-based alcohol assessment and personalized feedback (intervention) or screening alone (control). MEASUREMENTS: We conducted a fully automated 5-month follow-up assessment with observers and participants blinded to study hypotheses, design and intervention delivery. Pre-determined primary outcomes were: (i) frequency of drinking, (ii) amount consumed per typical drinking occasion, (iii) overall volume of alcohol consumed and (iv) academic problems. FINDINGS: Of the participants, 1789 were hazardous or harmful drinkers (AUDIT-C ≥ 4) and were randomized: 850 to control, 939 to intervention. Follow-up assessments were completed by 682 controls (80%) and 733 intervention group members (78%). Relative to controls, participants receiving intervention drank less often [RR = 0.89; 95% confidence interval (CI): 0.82-0.97], less per drinking occasion (RR = 0.92; 95% CI: 0.84-1.00), less overall (RR = 0.78; 95% CI: 0.69-0.89) and had fewer academic problems (RR = 0.81; 95% CI: 0.69-0.95). CONCLUSIONS: Web-based screening and brief intervention reduced hazardous and harmful drinking among non-help-seeking Māori students in a large-scale pragmatic trial. The study has wider implications for behavioural intervention in the important but neglected area of indigenous health.

Smartphone apps to improve fitness and increase physical activity among young people: protocol of the Apps for IMproving FITness (AIMFIT) randomized controlled trial

BACKGROUND: Physical activity is a modifiable behavior related to many preventable non-communicable diseases. There is an age-related decline in physical activity levels in young people, which tracks into adulthood. Common interactive technologies such as smartphones, particularly employing immersive features, may enhance the appeal and delivery of interventions to increase levels of physical activity in young people. The primary aim of the Apps for IMproving FITness (AIMFIT) trial is to evaluate the effectiveness of two popular "off-the-shelf" smartphone apps for improving cardiorespiratory fitness in young people.

METHODS/DESIGN: A three-arm, parallel, randomized controlled trial will be conducted in Auckland, New Zealand. Fifty-one eligible young people aged 14-17 years will be randomized to one of three conditions: 1) use of an immersive smartphone app, 2) use of a non-immersive app, or 3) usual behavior (control). Both smartphone apps consist of an eight-week training program designed to improve fitness and ability to run 5 km, however, the immersive app features a game-themed design and adds a narrative. Data are collected at baseline and 8 weeks. The primary outcome is cardiorespiratory fitness, assessed as time to complete the one mile run/walk test at 8 weeks. Secondary outcomes are physical activity levels, self-efficacy, enjoyment, psychological need satisfaction, and acceptability and usability of the apps. Analysis using intention to treat principles will be performed using regression models.

DISCUSSION: Despite the proliferation of commercially available smartphone applications, there is a dearth of empirical evidence to support their effectiveness on the targeted health behavior. This pragmatic study will determine the effectiveness of two popular "off-the-shelf" apps as a stand-alone instrument for improving fitness and physical activity among young people. Adherence to app use will not be closely controlled; however, random allocation of participants, a heterogeneous group, and data analysis using intention to treat principles provide internal and external validity to the study. The primary outcome will be objectively assessed with a valid and reliable field-based test, as well as the secondary outcome of physical activity, via accelerometry. If effective, such applications could be used alongside existing interventions to promote fitness and physical activity in this population. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12613001030763. Registered 16 September 2013.

Screen-time weight-loss intervention targeting children at home (SWITCH): a randomized controlled trial study protocol

BACKGROUND: Approximately one third of New Zealand children and young people are overweight or obese. A similar proportion (33%) do not meet recommendations for physical activity, and 70% do not meet recommendations for screen time. Increased time being sedentary is positively associated with being overweight. There are few family-based interventions aimed at reducing sedentary behavior in children. The aim of this trial is to determine the effects of a 24 week home-based, family oriented intervention to reduce sedentary screen time on children's body composition, sedentary behavior, physical activity, and diet.

METHODS/DESIGN: The study design is a pragmatic two-arm parallel randomized controlled trial. Two hundred and seventy overweight children aged 9-12 years and primary caregivers are being recruited. Participants are randomized to intervention (family-based screen time intervention) or control (no change). At the end of the study, the control group is offered the intervention content. Data collection is undertaken at baseline and 24 weeks. The primary trial outcome is child body mass index (BMI) and standardized body mass index (zBMI). Secondary outcomes are change from baseline to 24 weeks in child percentage body fat; waist circumference; self-reported average daily time spent in physical and sedentary activities; dietary intake; and enjoyment of physical activity and sedentary behavior. Secondary outcomes for the primary caregiver include change in BMI and self-reported physical activity.

DISCUSSION: This study provides an excellent example of a theory-based, pragmatic, community-based trial targeting sedentary behavior in overweight children. The study has been specifically designed to allow for estimation of the consistency of effects on body composition for Māori (indigenous), Pacific and non-Māori/non-Pacific ethnic groups. If effective, this intervention is imminently scalable and could be integrated within existing weight management programs..

Additive effect of interferential therapyover pelvic floor exercise alone in the treatment of female urinary stress and urge incontinence: A randomized controlled trial

This pilot study attempted to examine the additional efficacy of interferential therapy in reducing the symptoms of urinary stress and urge incontinence. Twenty-four subjects were randomly allocated to the experimental group, which received interferential therapy plus pelvic floor exercises, or the control group, which received pelvic floor exercises only. Treatment was given three times a week for 4 weeks. Subjects were given urinary diaries to record urinary symptoms (including frequency of passing urine and number of times woken by desire to pass urine) for 5 days prior to and after treatment. Perineometer readings, pad weighing test and start/stop test were also performed in a physiotherapy clinic before and at completion of treatment regimes. Significant improvements were observed in all the outcome variables in the experimental group, but in only the perineometer readings in controls. When the changes from pre- to post-treatment were compared between the two groups, four of the dependent variables did not reach statistical significance. Power analysis indicated that the sample size for each group needed to be 70 for all results to be statistically significant. This study shows that interferential therapy plus pelvic floor exercise appears to be a more effective treatment modality than pelvic floor muscle strengthening exercise alone for incontinence, but a larger trial with longer followup is needed before definitive conclusions can be reached.

Reaching out to promote physical activity in Australia: a statewide randomized controlled trial of a stage-targeted intervention

Purpose. This study examined the broader use of a print-media intervention, which was previously shown to be effective at promoting physical activity to participants recruited from a regional Australian community, as a strategy suitable for a more diverse statewide population sample.
Methods. Participants were randomly selected adults who responded to a telephone interview conducted by the New South Wales Health Department and consented to Participate in a randomized controlled trial. Consenters were allocated to either intervention (n = 361) or control (n = 358) conditions. The intervention, a personalized letter plus stage-targeted booklets, was sent 1 week postbaseline. Data were collected via telephone interview at baseline and 2 and 8 months and were analyzed using repeated measures analysis of variance (ANOVA) and mean squared statistics.
Results. The groups were similar at baseline (mean age 43 +/- 3 years; 64 % women). Process evaluation showed high intervention recall (76 % at 2 months) and high follow-up response rates (> 85 % at 8 months) were achieved. Nonsignificant increases in physical activity were observed (Fl,719 = 2.18, p = .14).
Discussion. A single mailing of stage-targeted print materials was not effective in promoting increases in physical activity among participants selected from the statewide population. Future research could examine how the effectiveness of print media might be enhanced, possibly by using supplementary media, community-based prompts, or other incentives.