Attention Control Group Research Articles

Efficacy of laughter-inducing interventions in patients with somatic or mental health problems: A systematic review and meta-analysis of randomized-controlled trials

Background and purposeLaughter-inducing interventions hold promise as affordable and easy to implement treatments for a range of ailments. The aim of this study was to build on meta-analytic evidence for the efficacy of such interventions in treating somatic or mental health patients. MethodsStudies eligible for the meta-analysis were identified by a comprehensive literature search in MEDLINE, CENTRAL, Web of Science, and PsycINFO and by a manual search (date of last search 22/06/2021). All randomized controlled trials comparing spontaneous laughter or simulated laughter to treatment as usual, no treatment/waitlist, or attention control groups were included. There were no language or date restrictions. Separate random-effects meta-analyses were conducted for mental health, physiological, and physical health outcomes. Hedges’ g is reported as the standardized mean difference estimate. The study was registered on PROSPERO (#CRD42019139299). ResultsForty-five studies comprising 2,547 randomized participants were included. Laughter-inducing interventions showed significant positive effects on mental health (31 studies, 1,543 patients, g = 0.74, 95% CI [0.48; 1.00], I2 = 81%), physiological (14 studies, 761 patients, g = 0.61 [0.20; 1.03], I2 = 86%), and physical health outcomes (21 studies, 1,105 patients, g = 0.59 [0.30; 0.88], I2 = 80%). Only one study reported adverse events, which were mild in nature. ConclusionLaughter-inducing interventions can have beneficial effects on a variety of health-related outcomes including mental health, physical health, and physiological parameters. Future research should focus on examining differential intervention effects and mechanisms of action.

Attention control in a trial of an online psychoeducational intervention for caregivers.

In reports of randomized controlled trials, thorough description of the attention control condition has been recommended, yet is frequently lacking. The Tele-Savvy Caregiver program for informal caregivers of persons living with dementia was tested in a randomized controlled trial with an attention control condition. The purpose of this trial was to test Tele-Savvy's efficacy in reducing the negative effects of caregiving on caregivers, promoting quality of life for persons living with dementia, and improving caregiver mastery. We describe the design and implementation of and examine the outcomes associated with the attention control condition. Caregivers were randomized to the immediate Tele-Savvy (active condition), Healthy Living (attention control), or waitlist. The attention control content was focused on healthy lifestyle and was not intended to affect the outcomes that Tele-Savvy targeted. The attention control group was similar to Tele-Savvy in the intervention structure and duration: it consisted of seven weekly group videoconferences and 36 video lessons. Data on outcomes of caregivers and persons living with dementia were collected at baseline and 3 and 6 months postbaseline. Multilevel mixed effects models were used to determine changes in the outcomes. One hundred and eleven caregivers were randomized to the attention control condition (attrition 21.6%). Eighteen formative assessment interviews focusing on caregivers' experience in the attention control condition were conducted. The attention control condition completers had no statistically significant changes in the variables that Tele-Savvy targeted. These results may be used in the design and implementation of attention control conditions in behavioral intervention research.

Hyperbaric Oxygen to Assist Adults With Opioid Use Disorder in Reducing Methadone Dose.

Opioid withdrawal symptoms can interfere with substance use disorder treatment goals. This study investigated the acceptability, feasibility, and treatment effects of hyperbaric oxygen therapy (HBOT) as an adjunct to reduce withdrawal symptoms for adults initiating a medically supervised methadone dose reduction. Adults prescribed methadone for opioid use disorder were randomized into either a hyperbaric oxygen group (n = 17) or an attention control group (n = 14). The study site was an outpatient opioid treatment program in the northwestern United States. Participants were asked to attend five consecutive daily 90-minute HBOT sessions offered at 2.0 atmospheres absolute with 100% oxygen in a pressurized chamber. Treatment attendance and reported satisfaction were measures of acceptability and feasibility. Medication doses were tracked posttreatment at 1 week, 1 month, and 3 months. Withdrawal symptoms were assessed at baseline and daily during the 5-day intervention period. After randomization, 13 (76.5%) followed through with medical screening and HBOT sessions, and of those, nine (69.2%) completed all five 90-minute HBOT sessions. At 3 months, the treatment group maintained, on average, a 4.3-mg methadone dose reduction compared with an average reduction of 0.25 mg for control group participants. Opioid withdrawal symptoms were reduced after Day 1 of HBOT by twice as much, on average, compared with the control condition. Satisfaction surveys found participants were generally satisfied with ease and comfort of the treatment. The evidence that HBOT is an acceptable, feasible adjunct warrants future trials to determine more conclusively effects on withdrawal symptoms associated with methadone dose taper.

Promoting fruit and vegetable consumption during the COVID-19 pandemic - SportStudisMoveYou (SSMY): A randomized controlled trial.

The stay-at-home circumstances due to the global coronavirus pandemic have had some negative impacts on people's eating behavior. Therefore, this study attempted to improve fruit and vegetable (FV) consumption intention and behavior through an online video intervention based on the social cognitive theory. Participants were recruited with a promotion video posted on social media channels. After consenting and completing a pre-survey, participants were randomly assigned to either a) the intervention group addressing FV consumption or the b) attention control group addressing physical activity. After two weeks, the participants completed an online post-survey. The participants (N = 82) were 77% female and 50% students; 95% chose German for the survey language, and 84% were from Switzerland. The mean baseline FV consumption intention was 3.05 (standard deviation: 1.03), and FV consumption was 4.64 (standard deviation: 2.06) portions a day. The analysis showed no significant change in FV consumption intention (F = (1, 78) = 0.02, p = 0.88, ηp2 = 0.00) or behavior (F = (1, 78) = 0.019, p = 0.89, ηp2 = 0.03) due to the intervention. Plausible reasons why no significant effect was found were the brief intervention duration, the setting and insufficient tailoring. The lessons learned from this study are to plan better, tailor more to the needs of participants and carefully consider the goals before promoting an intervention.

Assessment of Optical Coherence Tomography Findings in Adults with Attention Deficit Hyperactivity Disorder: A Case-Control Study.

To assess retinal nerve fiber layer and ganglion cell-inner plexiform layer thickness using optical coherence tomography in attention deficit hyperactivity disorder adults on regular methylphenidate treatment, comparing them to healthy controls. A total of 33 attention deficit hyperactivity disorder adults and 31 healthy subjects, matched for age, gender, and education (control group), were included in this study. Retinal nerve fiber layer and ganglion cell-inner plexiform layer thickness of both eyes were measured using optical coherence tomography, and symptom severity was evaluated using Adult Attention Deficit Hyperactivity Disorder Self-Report Scale and Wender Utah Rating Scale. There was no significant difference in retinal nerve fiber layer thickness between the attention deficit hyperactivity disorder and control groups (P > .05). Thinner ganglion cell-inner plexiform layer total (P = .044), inferior (P = .012), and inferior nasal quadrant thickness (P = .049) were observed in attention deficit hyperactivity disorder patients as compared to the controls. Findings detected thinner ganglion cell-inner plexiform layer in some quadrants of attention deficit hyperactivity disorder adults, indicating an early disorder in retinal structure development. Whether retinal structures are sensitive attention deficit hyperactivity disorder biomarkers should be supported and investigated in future multimodal studies.

HomeStyles-2: Randomized controlled trial protocol for a web-based obesity prevention program for families with children in middle childhood

BackgroundParents are children's primary role models, are food and physical activity gatekeepers, and create the home structure/lifestyle environment. Thus, parents strongly influence children's weight-related behaviors and have the opportunity to cultivate a “culture of health” within the home. Yet, there is a dearth of evidence-based obesity prevention intervention programs, especially for families with children aged 6–11 years, commonly called middle childhood. MethodsThe aim of the HomeStyles-2 online learning mode RCT is to determine whether this novel, age-appropriate, family intervention enables and motivates parents to shape home environments and weight-related lifestyle practices (i.e.,diet, exercise, sleep) to be more supportive of optimal health and reduced obesity risk in middle childhood youth more than those in the control condition. The RCT will include the experimental group and an attention control group. The participants will be parents with school-age children who are systematically randomly assigned by computer to study condition. The HomeStyles intervention is predicated on the social cognitive theory and a social ecological framework. The RCT will collect sociodemographic characteristics of the participant, child, and partner/spouse; child and parent health status; parent weight-related cognitions; weight-related behaviors of the parent and child; and weight-related characteristics of the home environment. Deliverables Enrollment for this study will begin in 2022. DiscussionThis paper describes these aspects of the HomeStyles-2 intervention: rationale; sample eligibility criteria and recruitment; study design; experimental group intervention theoretical and philosophical underpinnings, structure, content, and development process; attention control intervention; survey instrument development and components; outcome measures; and planned analyses. Trial registrationClinicalTrials.gov, Protocol #NCT04802291, Registered March 14, 2021.

Guided self-determination intervention versus attention control for people with type 2 diabetes in outpatient clinics: a protocol for a randomised clinical trial

IntroductionIn the management of type 2 diabetes, autonomy-supporting interventions may be a prerequisite to achieving more long-term improvement. Preliminary evidence has shown that the guided self-determination (GSD) method might have...

Group-based telerehabilitation intervention using Wii Fit to improve walking in older adults with lower limb amputation (WiiNWalk): A randomized control trial

Objective Determine efficacy of the novel WiiNWalk intervention on walking-related outcomes in older adults with lower limb amputation. Design Multi-site, parallel, evaluator-masked randomized controlled trial. Setting Home-setting in three Canadian cities. Participants Community-dwelling lower limb prosthesis users over 50 years of age. Interventions The WiiNWalk group (n = 38) used modified Wii Fit activities for prosthetic rehabilitation. The attention control group (n = 33) used Big Brain Academy: Wii Degree, comprising of cognitive activities. Both groups completed a 4-week supervised phase with three 1-h sessions/week in groups of three overseen by a clinician via videoconferencing and a 4-week unstructured and unsupervised phase. Main Measures Primary outcome was walking capacity (2 min walk test); secondary outcomes were balance confidence (activities-specific balance confidence scale), dynamic balance (four-step square test), and lower limb functioning (short physical performance battery). Outcomes were compared across time points with repeated measures analysis of covariance, adjusting for baseline and age. Results Mean age was 65.0 (8.4) years, with 179.5 (223.5) months post-amputation and 80% transtibial amputation. No group difference in a 2 min walk test with an effect size: 1.53 95% CI [−3.17, 6.23] m. Activities balance confidence was greater in the WiiNWalk group by 5.53 [2.53, 8.52]%. No group difference in the four-step square test −0.16 [−1.25, 0.92] s, nor short physical performance battery 0.48 [−0.65, 1.61]. A post-hoc analysis showed the greatest difference in balance confidence immediately after an unsupervised phase. Conclusions The WiiNWalk intervention improved balance confidence, but not walking-related physical function in older adult lower limb prosthesis users. Future rehabilitation games should be specific to the amputation context. Clinical Trial Registration number, NCT 01942798.

Goals for Reaching Optimal Wellness (GROWell): A clinical trial protocol of a digital dietary intervention for pregnant and postpartum people with prenatal overweight or obesity

BackgroundExcess gestational weight gain (EGWG) is associated with multiple pregnancy complications and health risks for birthing people and their infants. Likewise, postpartum weight retention (PPWR), or not losing all pregnancy weight, has long-term health consequences. EGWG among people who enter pregnancy with overweight or obesity have worse obstetric outcomes and increased PPWR compared to women who gain within Institute of Medicine guidelines. MethodsThis study protocol describes the details of a blinded, randomized clinical trial of GROWell: Goals for Reaching Optimal Wellness, a mHealth tool designed to improve diet quality among people who enter pregnancy with overweight or obese BMIs to help them achieve appropriate GWG and safe postpartum pregnancy weight loss. Individuals with overweight and obesity will be randomly assigned to an attention control or intervention arm. The intervention group will receive personalized, goal-oriented text messages regarding dietary choices, while the attention control group will receive text messages about healthy pregnancy, labor, delivery, and early infancy. Both groups will complete online surveys at baseline, follow up, 3 and 6 months postpartum. Results and discussionCurrently, 162 subjects have been enrolled. Outcomes associated with GWG and pregnancy are expected in late 2023, while outcomes on postpartum weight retention GROWell adherence are expected in late 2024. The results of this trial will support the use of an evidence-based mHealth tool to be integrated into clinical practice to reduce EGWG and PPWR among pregnant people with overweight and obese BMIs, a resource that is currently lacking. Trial registrationClinicalTrials.gov identifier: NCT04449432. Registered on June 26, 2020.

Abstract 12807: Effects of Ischemic Pain Inducing Walking Exercise vs. Pain Free Walking Exercise on Walking Velocity and Functional Performance in Peripheral Artery Disease. Results From the Lite Randomized Clinical Trial

Introduction: The LITE randomized trial recently demonstrated that home-based pain free walking exercise did not improve 6-minute walk distance, compared to home-based ischemic pain inducing walking exercise, and compared to an attention control group, among people with lower extremity peripheral artery disease (PAD). This study examined effects of home-based pain free walking exercise and home-based ischemic pain inducing walking exercise on walking velocity, and the short physical performance battery (SPPB). Methods: 305 participants with PAD were randomized to home-based pain free walking exercise, home-based ischemic pain inducing walking exercise, or an attention control group in a multi-centered randomized trial, over 12 months. Participants in the pain free walking exercise group walked at a pace that did not cause ischemic leg symptoms. Participants in the ischemic pain inducing walking exercise group walked at a pace that caused ischemic leg symptoms. The attention control group received health education talks. Usual-paced 4-meter walking velocity (4MWV), fast-paced 4MWV, and SPPB (total score range: 0-12; 12=best) were measured at baseline and 12-month follow-up. Results: Of the 305 PAD participants randomized, 246 (mean age: 69 ± 9 years; 48% women; 60% black) with baseline or 12-month data on either usual-paced 4MWV, fast-paced 4MWV, or SPPB were included. The effects of the exercise interventions on each functional measure are shown in the table. Conclusion: These data suggest that ischemic pain inducing walking exercise improves walking speed and functional performance, while walking exercise at a comfortable pace may worsen walking velocity in PAD.

Abstract 11395: Randomized Feasibility Study of Problem-Solving Therapy Compared to Stroke Education for Depressive Symptoms and Quality of Life in Stroke Survivor-Care Partner Dyads

Introduction: Stroke survivors often face multiple physical and/or cognitive disabilities requiring ongoing assistance with activities of daily living. Family members often step in to provide this care. Both stroke survivors and care partners commonly report depressive symptoms impacting health and QOL. Poststroke depression is well-studied in survivors, but care partner depression is less understood. Symptoms shared by stroke survivors and their care partners present opportunities for dyad-focused interventions. Problem-Solving Therapy (PST) is a psychosocial intervention that has been effective for managing depression. We adapted this therapy in a novel way for use with stroke survivor-care partner dyads for reduction of depressive symptoms and improvement in QOL. Our primary aim was to address the feasibility and acceptability of PST with secondary aims measuring changes in PHQ-9 and EQ-5D pre/post intervention. Methods: A convenience sample of 14 adult stroke survivor-care partner dyads were randomized 1:1 to either 6 weekly sessions of PST or 6 matched weekly sessions of stroke-related health education as an attention control group. Participants completed PHQ-9 and EQ-5D at baseline, mid-point, and post-intervention. Survivor functional status and caregiver burden were also assessed at these points. Results: The PST intervention was well-received by dyads with 100% of post-intervention ratings indicating satisfaction or great satisfaction with the experience. Participants reported being challenged to think differently (55.6%), improved dyad communication (44.4%) and feeling a sense of accomplishment (33.3%). Analysis focused on feasibility measures, identifying recruitment challenges and design considerations for subsequent studies. No significant changes in outcome measures were noted in this small sample. Conclusion: A dyad approach to behavioral interventions may promote a sense of well-being by providing an opportunity to address challenges that are faced by both individuals. Feasibility and acceptability were established in this small sample; future studies should focus on a larger, diverse sample. Participant feedback suggests booster sessions may also be helpful in sustaining the impact of this novel approach.

Abstract 10681: Effect of Low vs. High Home-Based Walking Exercise on Physical Activity in Patients with Peripheral Artery Disease: The Lite Randomized Clinical Trial

Objective: In a randomized clinical trial of people with lower extremity peripheral artery disease (PAD), to test whether walking exercise conducted at a pace without ischemic leg symptoms improved physical activity more than walking exercise conducted at a pace that induced ischemic leg symptoms and more than an attention control group. Methods & Results: In the LITE multi-centered clinical trial, 305 participants with PAD (69±40 years, 181 (59%) black, 146 (48%) female) were randomized to: 1) walking exercise conducted at a comfortable pace without ischemic leg symptoms (low-intensity), 2) walking exercise conducted at a pace eliciting ischemic leg symptoms (high-intensity), or 3) an attention-control group for 12-months. Physical activity (i.e., activity counts per minute) was a pre-specified secondary outcome. Both exercise groups were asked to walk for exercise in an unsupervised setting for up to 5 times/week for up 50 minutes/session. Physical activity was measured for up to 10 days using an ActiGraph accelerometer at baseline, 6-month, and 12-month follow-up. Low intensity exercise increased physical activity significantly less than high intensity exercise at 6-month follow-up (-74 counts per minute, 95% CI: -123, -26, P=0.003; Table 1) and 12-month follow-up (-47 counts per minute, 95% CI: -79, -15, P=0.004; Table 1). High intensity exercise increased physical activity significantly more than control at 6-month follow-up (+104 counts per minute, 95% CI: 48, 162, P<0.001; Table 1) and 12-month follow-up (+55 cpm, 95% CI: 18, 93, P=0.004; Table 1). There was no difference between the low intensity group and control at 6-month or 12-month follow-up (Table 1). Conclusion: These results support home-based walking exercise conducted at a pace that induces ischemic leg symptoms, but not walking exercise conducted at a comfortable pace without ischemic leg symptoms, to improve physical activity in people with PAD.

Abstract 11390: Exercise Intensity, Minutes Walked for Exercise, and Improved Walk Performance in Peripheral Artery Disease: The Lite Randomized Clinical Trial

Introduction: Recent evidence showed that among people with peripheral artery disease (PAD), walking exercise conducted at a pace inducing ischemic leg symptoms improved six-minute walk distance (6MW), while walking exercise conducted at a pace without ischemic leg symptoms had no effect on 6MW. This report describes associations of walking exercise intensity and minutes walked for exercise among participants with PAD with the change in 6MW. Method & Results: In the LITE clinical trial, 305 participants with PAD (69±4 years, 181 (59%) Black, 146 (48%) female) were randomized to: 1) walking exercise conducted at a pace without ischemic leg symptoms (low-intensity: LI), 2) walking exercise conducted at a pace eliciting ischemic leg symptoms (high-intensity: HI), or 3) an attention-control group for 12-months. Participants in both exercise groups were asked to walk in or around the home for up to five days/week for up to 50 minutes/session. Measurements of walking intensity and exercise minutes per week were determined individually for each participant in each exercise group using an Accelerometer. Participants in each exercise group were categorized into quartiles according to exercise minutes per week and exercise intensity, respectively (4 th quartile indicated greatest minutes or intensity). Within the LI and HI groups, more minutes of exercise per week were associated with greater 6MW improvement [(LI: 4 th vs 1 st Q: +54 m, 95%CI:16, 92; P=0.018), (HI: 4 th vs 1 st Q: +54 m, 95% CI: 12, 96; P=0.010), Table 1]. Within the LI group, but not the HI group, greater exercise intensity was associated with greater 6MW improvement [(LI: 4 th vs 1 st Q: +80 m, 95% CI: 31, 128; P=0.002), Table 1]. Conclusion: While high intensity exercise improves 6MW in PAD, exercising for a greater duration offers greater benefit. Additionally, there is benefit in exercising at low intensity, focusing on increased duration of exercise, if patients are unable to exercise at high intensity.

Consumption of Dietary Guidelines for Americans Types and Amounts of Vegetables Increases Mean Subjective Happiness Scale Scores: A Randomized Controlled Trial

BackgroundThe health benefits of diets rich in fruits and vegetables (FV) are well established. Recent observational and intervention research suggests that FV consumption may also exert a positive effect on psychological well-being. ObjectiveThis study aimed to assess changes in mean Subjective Happiness Scale (SHS) scores in response to consuming 2010-2015 Dietary Guidelines for Americans (DGA) recommended types and amounts of vegetables. It was hypothesized that increased vegetable consumption would increase mean SHS scores. DesignThis study investigated a secondary outcome of a randomized, parallel, nonblinded controlled trial with a 1:1 allocation ratio to a provided vegetable intervention or attention control group. Participants/settingMen and women (n = 75) aged 18 to 65 years, body mass index ≥ 25, with low habitual vegetable consumption were recruited from Grand Forks, North Dakota, December 2016 to January 2018, for this community-based study. InterventionThe vegetable intervention consisted of an 8-week feeding phase during which participants were provided with vegetables in DGA-recommended types and amounts. The attention control group was not provided vegetables but completed the same testing schedule as the vegetable intervention group. Main outcome measureMean SHS scores were assessed before and after the intervention. Statistical analysesMean SHS scores were analyzed using a 2-way factorial mixed linear model analysis of variance. ResultsA significant interaction between treatment and visit (P = .015) revealed greater mean SHS scores at week 8 than at baseline in the vegetable intervention group (+0.23 ± 0.11) (mean difference ± SE of the difference) but no change in the attention control group (−0.15 ± 0.11). ConclusionsGreater mean SHS scores were observed after increasing vegetable consumption to meet DGA recommendations, suggesting that adhering to DGA vegetable guidance may help promote psychological well-being.

SToRytelling to Improve Disease outcomes in Gout (STRIDE-GO): a multicenter, randomized controlled trial in African American veterans with gout

BackgroundUrate-lowering therapy (ULT) adherence is low in gout, and few, if any, effective, low-cost, interventions are available. Our objective was to assess if a culturally appropriate gout-storytelling intervention is superior to an attention control for improving gout outcomes in African-Americans (AAs).MethodsIn a 1-year, multicenter, randomized controlled trial, AA veterans with gout were randomized to gout-storytelling intervention vs. a stress reduction video (attention control group; 1:1 ratio). The primary outcome was ULT adherence measured with MEMSCap™, an electronic monitoring system that objectively measured ULT medication adherence.ResultsThe 306 male AA veterans with gout who met the eligibility criteria were randomized to the gout-storytelling intervention (n = 152) or stress reduction video (n = 154); 261/306 (85%) completed the 1-year study. The mean age was 64 years, body mass index was 33 kg/m2, and gout disease duration was 3 years. ULT adherence was similar in the intervention vs. control groups: 3 months, 73% versus 70%; 6 months, 69% versus 69%; 9 months, 66% versus 67%; and 12 months, 61% versus 64% (p > 0.05 each). Secondary outcomes (gout flares, serum urate and gout-specific health-related quality of life [HRQOL]) in the intervention versus control groups were similar at all time points except intervention group outcomes were better for the following: (1) number of gout flares at 9 months were fewer, 0.7 versus 1.3 in the previous month (p = 0.03); (2) lower/better scores on two gout specific HRQOL subscales: gout medication side effects at 3 months, 32.8 vs. 39.6 (p = 0.02); and unmet gout treatment need at 3 months, 30.9 vs. 38.2 (p = 0.003), and 6 months, 29.5 vs. 34.5 (p = 0.03), respectively.ConclusionsA culturally appropriate gout-storytelling intervention was not superior to attention control for improving gout outcomes in AAs with gout.Trial registrationRegistered at ClinicalTrials.gov NCT02741700

Increasing Vegetable Intake Decreases Urinary Acidity and Bone Resorption Marker in Overweight and Obese Adults: An 8-Week Randomized Controlled Trial

BackgroundControlled intervention trials are needed to confirm a positive association from epidemiological studies between vegetable consumption and bone health. ObjectiveWe investigated whether providing vegetables at the Dietary Guidelines for Americans (DGA) recommended amount affects excretion of acid and calcium in urine and bone turnover markers in serum in adults with low vegetable intake. MethodsIn total, 102 adults (19 males and 83 females, age 18–65 y, BMI ≥25 kg/m2) consuming ≤1 serving of vegetables (128 g raw leafy or 64 g cooked vegetables) per d were recruited in a 2-arm, parallel, randomized, controlled, and community-based 8-wk feeding intervention trial. The 2 arms included a vegetable intervention (VI) during which participants received extra vegetables (∼270 g/d) and an attention control (CON) group that conducted only the testing visits. Measurements included nutrient intake, plasma carotenoids, and bone-related markers in serum and urine. Differences between CON and VI at week 8 were tested using the ANCOVA with baseline values as a covariate. ResultsCompared with CON, carotenoid intake (mean ± SD) was higher (6.4 ± 3.4 compared with 2.0 ± 1.2 mg/d) (P < 0.01) and dietary potential renal acid load was lower (20 ± 13 compared with 3.4 ± 14 mEq/d) (P < 0.01) in VI. Compared with CON at week 8, urine titratable acid and Mg were 24 and 26% lower, respectively, while urine pH was 3% greater (P < 0.05) and serum C-terminal telopeptide of type I collagen (CTX) was 19% lower in VI. There were no group differences in serum concentrations of propeptide of type 1 procollagen and tartrate-resistant acid phosphatase or urinary excretion of deoxypyridinoline and CTX. ConclusionsConsumption of vegetables at the DGA-recommended amount by adults with low vegetable intake potentially benefits bone health. This trial was registered at http://clinicaltrials.gov as NCT02585102.

Maintenance phase of a physical activity intervention in older kidney transplant recipients: A 12-month follow-up

Daily walking activities are associated with improving cardiovascular outcomes in older kidney transplant recipients. However, little is known regarding physical activity adherence outcomes in older kidney recipients. The purpose of this randomized controlled trial 12-month follow-up study was to evaluate the feasibility of the intervention (SystemCHANGE™ + activity tracker) during the maintenance period (7-12 months), compared to an attention-control group (activity tracker only) in older kidney recipients (age 60 and older). The sample included 60 participants (n = 30 IG; n = 30 ACG). Adherence rates for wearing the activity tracker daily were 96.5% in the IG and 80.8% in the ACG. The IG demonstrated within-group improvements for blood pressure at 12 months. Overall, there was a decrease in the average daily steps observed in both groups. These data suggest this intervention is feasible and additional boosters should be considered during the maintenance period to encourage physical activity.

Effects and tolerability of exercise therapy modality on cardiorespiratory fitness in lung cancer: a randomized controlled trial.

BackgroundPoor cardiorespiratory fitness (CRF) is a cardinal feature of post‐treatment primary lung cancer. The most effective exercise therapy regimen to improve CRF has not been determined.MethodsIn this parallel‐group factorial randomized controlled trial, lung cancer survivors with poor CRF (below age–sex sedentary values) were randomly allocated to receive 48 consecutive supervised sessions thrice weekly of (i) aerobic training (AT)—cycle ergometry at 55% to >95% of peak oxygen consumption (VO2peak); (ii) resistance training (RT)—lower and upper extremity exercises at 50–85% of maximal strength; (iii) combination training (CT)—AT plus RT; or (iv) stretching attention control (AC) for 16 weeks. The primary endpoint was change in CRF (VO2peak, mL O2·kg−1·min−1). Secondary endpoints were body composition, muscle strength, patient‐reported outcomes, tolerability (relative dose intensity of exercise), and safety. Analysis of covariance determined change in primary and secondary endpoints from baseline to post‐intervention (Week 17) with adjustment for baseline values of the endpoint and other relevant clinical covariates.ResultsNinety patients (65 ± 9 years; 66% female) were randomized (AT, n = 24; RT, n = 23; CT, n = 20; and AC, n = 23) of the planned n = 160. No serious adverse events were observed. For the overall cohort, the lost‐to‐follow‐up rate was 10%. Mean attendance was ≥75% in all groups. In intention‐to‐treat analysis, VO2peak increased 1.1 mL O2·kg−1·min−1 [95% confidence interval (CI): 0.0, 2.2, P = 0.04] and 1.4 mL O2·kg−1·min−1 (95% CI: 0.2, 2.5, P = 0.02) in AT and CT, respectively, compared with AC. There was no difference in VO2peak change between RT and AC (−0.1 mL O2·kg−1·min−1, 95% CI: −1.2, 1.0, P = 0.88). Favourable improvements in maximal strength and body composition were observed in RT and CT groups compared with AT and AC groups (Ps < 0.05). No between‐group changes were observed for any patient‐reported outcomes. Relative dose intensity of exercise was lower in RT and CT compared with AT (Ps < 0.05).ConclusionsIn the context of a smaller than planned sample size, AT and CT significantly improved VO2peak in lung cancer survivors; however, the tolerability‐to‐benefit ratio was superior for AT and hence may be the preferred modality to target impaired CRF in post‐treatment lung cancer survivors.

Effect of Individual Nutrition Therapy and Exercise Regime on Gait Speed, Physical Function, Strength and Balance, Body Composition, Energy and Protein, in Injured, Vulnerable Elderly: A Multisite Randomized Controlled Trial (INTERACTIVE).

It is imperative that the surgical treatment of hip fractures is followed up with rehabilitation to enhance recovery and quality of life. This randomized controlled trial aimed to determine if an individualised, combined exercise–nutrition intervention significantly improved health outcomes in older adults, after proximal femoral fracture. We commenced the community extended therapy while in hospital, within two weeks post-surgery. The primary outcome was gait speed and secondary outcomes included physical function, strength and balance, body composition, energy and protein intake. Eighty-six and 89 participants were randomized into six months individualised exercise and nutrition intervention and attention-control groups, respectively. There were no statistically significant differences in gait speed between the groups at six and 12 months. There were no major differences between groups with respect to the secondary outcomes, except estimated energy and protein intake. This may be explained by the sample size achieved. Participants in the intervention group had greater increment in energy (235 kcal; 95% CI, 95 to 375; p = 0.01) and protein intake (9.1 g; 95% CI, 1.5 to 16.8; p = 0.02), compared with those in the control group at six months but not significant at 12 months. This study has demonstrated that providing early, combined exercise and nutrition therapy can improve dietary energy and protein intake in older adults with hip fractures.

Disability-Inclusive Diabetes Self-management Telehealth Program: Protocol for a Pilot and Feasibility Study.

BackgroundIndividuals with disabilities and type 2 diabetes require self-management programs that are accessible, sustainable, inclusive, and adaptable. Health coaching has been shown to be an effective approach for improving behavioral changes in self-management. Health coaching combined with telehealth technology has the potential to improve the overall quality of and access to health services.ObjectiveThis protocol outlines the study design for implementing the Artificial Intelligence for Diabetes Management (AI4DM) intervention. The protocol will assess the feasibility, acceptability, and preliminary efficacy of the AI4DM telehealth platform for people with disabilities.MethodsThe AI4DM study is a 2-arm randomized controlled trial for evaluating the delivery of a 12-month intervention, which will involve telecoaching, diabetes educational content, and technology access, to 90 individuals with diabetes and physical disabilities. The hypothesis is that this pilot project is feasible and acceptable for adults with permanently impaired mobility and type 2 diabetes. We also hypothesize that adults in the AI4DM intervention groups will have significantly better glycemic control (glycated hemoglobin) and psychosocial and psychological measures than the attention control group at the 3-, 6-, and 12-month follow-ups.ResultsThe AI4DM study was approved by the university’s institutional review board, and recruitment and enrollment will begin in October 2021.ConclusionsThe AI4DM study will improve our understanding of the feasibility and efficacy of a web-based diabetes self-management program for people with disabilities. The AI4DM intervention has the potential to become a scalable and novel method for successfully managing type 2 diabetes in people with disabilities.Trial RegistrationClinicalTrials.gov NCT04927377; https://clinicaltrials.gov/ct2/show/NCT04927377International Registered Report Identifier (IRRID)PRR1-10.2196/31689