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Effectiveness of a Smartphone App to Promote Healthy Weight Gain, Diet, and Physical Activity During Pregnancy (HealthyMoms): Randomized Controlled Trial.
Sandborg, J, Söderström, E, Henriksson, P, Bendtsen, M, Henström, M, Leppänen, MH, Maddison, R, Migueles, JH, Blomberg, M, Löf, M
JMIR mHealth and uHealth. 2021;9(3):e26091
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Excessive gestational weight gain (GWG) is associated with increased risk of caesarean delivery, gestational diabetes, pre-eclampsia, and obesity in both mother and child. In the last decade, the use of digital technologies (eg, mobile Health [mHealth]) to deliver lifestyle interventions has increased. The aim of this study was to investigate the effectiveness of the HealthyMoms app on GWG (primary outcome), body fatness, dietary habits (Swedish Healthy Eating Index), moderate-to-vigorous physical activity, glycaemia, and insulin resistance (secondary outcomes) in gestational week 37 among Swedish women. This study is a 2-arm parallel design randomised controlled trial. A total of 305 pregnant women were enrolled and randomised into either the intervention group or the control group. Participants in the intervention group, in addition to standard maternity care, received the HealthyMoms app which is a 6-month program aimed at promoting recommended GWG. Results did not show any statistically significant effect of the app on GWG; however, there was some evidence that women who were overweight or obese before pregnancy gained less weight in the intervention group as compared with the control group. Authors conclude that this intervention, solely delivered through an app, has potential to be useful for promoting a healthy lifestyle during pregnancy in many women while using less resources from health care.
Abstract
BACKGROUND Excessive gestational weight gain (GWG) during pregnancy is a major public health concern associated with negative health outcomes for both mother and child. Scalable interventions are needed, and digital interventions have the potential to reach many women and promote healthy GWG. Most previous studies of digital interventions have been small pilot studies or have not included women from all BMI categories. We therefore examined the effectiveness of a smartphone app in a large sample (n=305) covering all BMI categories. OBJECTIVE To investigate the effectiveness of a 6-month intervention (the HealthyMoms app) on GWG, body fatness, dietary habits, moderate-to-vigorous physical activity (MVPA), glycemia, and insulin resistance in comparison to standard maternity care. METHODS A 2-arm parallel randomized controlled trial was conducted. Women in early pregnancy at maternity clinics in Östergötland, Sweden, were recruited. Eligible women who provided written informed consent completed baseline measures, before being randomized in a 1:1 ratio to either an intervention (n=152) or control group (n=153). The control group received standard maternity care while the intervention group received the HealthyMoms smartphone app for 6 months (which includes multiple features, eg, information; push notifications; self-monitoring; and feedback features for GWG, diet, and physical activity) in addition to standard care. Outcome measures were assessed at Linköping University Hospital at baseline (mean 13.9 [SD 0.7] gestational weeks) and follow-up (mean 36.4 [SD 0.4] gestational weeks). The primary outcome was GWG and secondary outcomes were body fatness (Bod Pod), dietary habits (Swedish Healthy Eating Index) using the web-based 3-day dietary record Riksmaten FLEX, MVPA using the ActiGraph wGT3x-BT accelerometer, glycemia, and insulin resistance. RESULTS Overall, we found no statistically significant effect on GWG (P=.62); however, the data indicate that the effect of the intervention differed by pre-pregnancy BMI, as women with overweight and obesity before pregnancy gained less weight in the intervention group as compared with the control group in the imputed analyses (-1.33 kg; 95% CI -2.92 to 0.26; P=.10) and completers-only analyses (-1.67 kg; 95% CI -3.26 to -0.09; P=.031]). Bayesian analyses showed that there was a 99% probability of any intervention effect on GWG among women with overweight and obesity, and an 81% probability that this effect was over 1 kg. The intervention group had higher scores for the Swedish Healthy Eating Index at follow-up than the control group (0.27; 95% CI 0.05-0.50; P=.017). We observed no statistically significant differences in body fatness, MVPA, glycemia, and insulin resistance between the intervention and control group at follow up (P≥.21). CONCLUSIONS Although we found no overall effect on GWG, our results demonstrate the potential of a smartphone app (HealthyMoms) to promote healthy dietary behaviors as well as to decrease weight gain during pregnancy in women with overweight and obesity. TRIAL REGISTRATION ClinicalTrials.gov NCT03298555; https://clinicaltrials.gov/ct2/show/NCT03298555. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/13011.
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Impact of a Web-Based Exercise and Nutritional Education Intervention in Patients Who Are Obese With Hypertension: Randomized Wait-List Controlled Trial.
Lisón, JF, Palomar, G, Mensorio, MS, Baños, RM, Cebolla-Martí, A, Botella, C, Benavent-Caballer, V, Rodilla, E
Journal of medical Internet research. 2020;22(4):e14196
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Cardiovascular disease is the leading cause of morbidity and mortality in developed countries. Internet-based interventions are a promising strategy for promoting healthy lifestyle behaviours. The aim of this study was to investigate the short- and long-term efficacy of a self-administered internet-based intervention aimed at promoting lifestyle changes in patients who are obese with hypertension. The study is a randomized wait-list controlled trial which recruited 105 adults with hypertension who were overweight or obese and randomly assigned to either a 3-month internet-based intervention group (n=55) or the wait-list control group (n=50). Results showed a significant decrease in the body mass index, body fat mass and blood glucose (blood sugar) levels at 3 months in the internet-based intervention group. In addition, there was a favourable trend towards a relation to blood pressure, which reached statistical significance at the 12-month follow-up. Authors conclude that simple strategies that can easily be incorporated into daily living in a scalable and cost-effective way can empower patients by educating them about health, thus, increasing their confidence and promoting self-management.
Abstract
BACKGROUND Internet-based interventions are a promising strategy for promoting healthy lifestyle behaviors. These have a tremendous potential for delivering electronic health interventions in scalable and cost-effective ways. There is strong evidence that the use of these programs can lead to weight loss and can lower patients' average blood pressure (BP) levels. So far, few studies have investigated the effects of internet-based programs on patients who are obese with hypertension (HTN). OBJECTIVE The aim of this study is to investigate the short- and long-term efficacy, in terms of body composition and BP parameters, of a self-administered internet-based intervention involving different modules and learning techniques aimed at promoting lifestyle changes (both physical activity and healthy eating) in patients who are obese with HTN. METHODS A randomized wait-list controlled trial design was used. We recruited 105 adults with HTN who were overweight or obese and randomly assigned them to either a 3-month internet-based intervention group (n=55) or the wait-list control group (n=50). We assessed BMI (primary outcome), body fat mass (BFM), systolic (S)BP and diastolic (D)BP, blood glucose and insulin levels, physical activity levels, and functional capacity for aerobic exercise at Time 0 (preintervention) and Time 1 (postintervention). All the patients in the wait-list control group subsequently received the intervention, and a secondary within-group analysis, which also included these participants, was conducted at Time 2 (12-month follow-up). RESULTS A 2-way mixed analysis of covariance showed a significant decrease in BMI, BFM, and blood glucose at 3 months in the internet-based intervention group; the effect size for the BMI and BFM parameters was moderate to large, and there was also a borderline significant trend for DBP and insulin. These results were either maintained or improved upon at Time 2 and showed significant changes for BMI (mean difference -0.4, 95% CI -0.1 to -0.6; P=.005), BFM (mean difference -2.4, 95% CI -1.1 to -3.6; P<.001), DBP (mean difference -1.8, 95% CI -0.2 to -3.3; P=.03), and blood glucose (mean difference -2, 95% CI 0 to -4; P=.04). CONCLUSIONS Implementation of our self-administered internet-based intervention, which involved different learning techniques aimed to promote lifestyle changes, resulted in positive short- and long-term health benefits in patients who are obese with HTN. TRIAL REGISTRATION ClinicalTrials.gov NCT03396302; https://clinicaltrials.gov/ct2/show/NCT03396302.
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Impact of changes in physical activity or BMI on risk of heart failure in women - the prospective population study of women in Gothenburg.
Halldin, AK, Lissner, L, Lernfelt, B, Björkelund, C
Scandinavian journal of primary health care. 2020;38(1):56-65
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Heart failure (HF) is a severe and progressive condition with poor prognosis. Obesity is a risk factor for HF. The aim of this study was to investigate the impact of change in physical activity or change in body mass index on the risk of later developing HF in women without a previous diagnosis of HF. This study is prospective longitudinal study which includes 1749 healthy women from the Prospective Population Study of Women in Gothenburg. Results indicate that gaining weight in early middle age is more harmful than gaining weight later in life, with regard to the risk of developing HF later in life. Furthermore, reduced risk of future HF in healthy women may be achieved by remaining physically active from young middle age and throughout life or by increasing the level of physical activity. Authors conclude that the role of physical activity in preventing the development of obesity must be taken into account.
Abstract
Objective: To longitudinally evaluate the impact of change in physical activity or change in body mass index (BMI) over time on the risk of developing heart failure (HF) in women without a previous diagnosis of HF.Design and setting: Longitudinal, observational, prospective study of women in Gothenburg, Sweden. Data on BMI and level of physical activity were collected from examinations 1968-1992 and hospital diagnoses and mortality data were ascertained from 1980 to 2012.Subjects: Data were obtained from 1749 women included in the Prospective Population Study of Women in Gothenburg.Main outcome measures: Hazard ratio (HR) for HF was calculated, using a Cox regression model.Results: Women with stable high physical activity during 1968-1980 and 1980-1992 reduced their risk of subsequent HF compared to the non-active women (for 1968-1980 HR 0.66, 95% Confidence Interval (CI) 0.44-0.99 and for 1980-1992 HR 0.47, 95% CI 0.29-0.74). Women with increasing levels of physical activity during 1980-1992 reduced their risk of HF compared to the non-active women (HR 0.40, 95% CI 0.22-0.72). Increase in BMI from overweight to obesity during 1968-1980 predicted increased risk of developing HF (HR 1.93, 95% CI 1.18-3.14).Conclusions: Reduced risk of future HF in healthy women may be achieved by remaining physically active from young middle age and throughout life or by increasing the level of physical activity. This is particularly important for sedentary women in middle age. The role of physical activity in preventing the development of obesity must be taken into account.Key pointsA sedentary lifestyle and obesity are risk factors for developing heart failure (HF) in women.The risk of developing HF may be reduced by increasing the level of activity in sedentary middle-aged women.For younger women, avoiding obesity is most important to reduce the risk of later HF.Primary care has a key role in guiding women towards the most effective lifestyle changes to prevent development of HF.
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Effects of A 12-Month Intensive Lifestyle Monitoring Program in Predominantly Overweight/Obese Arab Adults with Prediabetes.
Wani, K, Alfawaz, H, Alnaami, AM, Sabico, S, Khattak, MNK, Al-Attas, O, Alokail, MS, Alharbi, M, Chrousos, G, Kumar, S, et al
Nutrients. 2020;12(2)
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Key determinant factors associated with type 2 diabetes mellitus in the Arab world, aside from the genetic predisposition are obesity, rapid urbanization, and lack of physical activity. The aim of the study was to evaluate the effectiveness of a Diabetes Prevention Programme-based lifestyle modification program focused on overweight/obese Saudi adults with impaired fasting glucose. This study is a 12-month two-arm randomized controlled (1:1) lifestyle intervention. Participants were randomly assigned to receive either an intensive lifestyle modification program or general advice at the time of recruitment. Results showed that participants following the intensive lifestyle modification program had significant changes in body weight, body mass index and glycaemic indices post-intervention. Authors conclude that for Saudi adults with impaired fasting glucose, a self-monitoring-based lifestyle intervention may be a significant tool for weight loss and to reverse to normoglycemia [normal concentration of sugar in the blood].
Abstract
This 12-month, randomized, controlled lifestyle intervention study was aimed at assessing the effectiveness of a lifestyle intervention in terms of (1) the reduction of at least 5% of body weight compared to baseline and (2) the percentage of participants in which fasting blood glucose (FBG) normalizes (<5.6 mmol/L) post-intervention, in predominantly overweight/obese Saudi adults with impaired fasting glucose. A total of 300 Saudi adults with prediabetes at baseline (FBG 5.6-6.9 mmol/L) were enrolled to receive either general advice (GA) or a rigorous, self-monitored, lifestyle modification program (intervention group, IG) for 12 months, focused on food choices, physical activity, and weight loss. Anthropometric and biochemical estimations were analyzed at baseline, 6, and 12 months. At baseline, 136/150 in the GA group (90.7%) and 127/150 in the IG group (84.7%) were either overweight or obese. A total of 14% (n = 21) of the subjects in the IG arm discontinued, compared to 8% (n = 12) in the GA arm. Data from completers (92% (n = 138) and 86% (n= 129) participants in GA and IG arms, respectively) were considered for the final analysis. Post-intervention, 37.2% (n = 48) of participants in the IG group had ≥5% weight reduction, as compared to 12.3% (n = 17) in the GA group (p < 0.01). Similarly, the percentage of participants who normalized their FBG post-intervention was 46.5% (n = 60) in the IG group compared to 21.7% (n = 30) in the GA group (p < 0.01). A 12-month Diabetes Prevention Program (DPP)-styled intensive lifestyle program translated effectively in decreasing weight and improving fasting glucose compared to the GA group in predominantly overweight/obese Saudi adults with prediabetes, suggesting that in the case of guided intervention programs, people are willing to participate and possibly change a sedentary lifestyle.
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Additional Effects of Nutritional Antioxidant Supplementation on Peripheral Muscle during Pulmonary Rehabilitation in COPD Patients: A Randomized Controlled Trial.
Gouzi, F, Maury, J, Héraud, N, Molinari, N, Bertet, H, Ayoub, B, Blaquière, M, Bughin, F, De Rigal, P, Poulain, M, et al
Oxidative medicine and cellular longevity. 2019;2019:5496346
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Chronic obstructive pulmonary disease (COPD) is systematically associated with comorbidities. Muscle atrophy and weakness are therefore targets of exercise training interventions in pulmonary rehabilitation (PR). The aim of the study was to test the effects of oral antioxidant supplementation with vitamins and trace elements (i.e. vitamins C and E, zinc and selenium) versus placebo on muscle endurance (primary outcome) and muscle strength, oxidative stress, inflammation, and PR outcomes (secondary outcomes). The study is a randomized double-blind controlled trial during PR. COPD patients (aged between 40 and 78 years) were randomly assigned to the PR antioxidant group or to the PR placebo group. Results indicate that nutritional antioxidant supplementation (vitamins C and E, zinc, and selenium) failed to further improve the patients’ quadriceps endurance. However, results also demonstrate that additional improvements of three secondary outcomes and a trend toward increased muscle type I fiber proportion with supplementation versus placebo during PR. Authors conclude that efficient antioxidant supplementation results in greater improvement in muscle function when compared to placebo in combination with exercise training.
Abstract
BACKGROUND Skeletal muscle dysfunction in patients with chronic obstructive pulmonary disease (COPD) is not fully reversed by exercise training. Antioxidants are critical for muscle homeostasis and adaptation to training. However, COPD patients experience antioxidant deficits that worsen after training and might impact their muscle response to training. Nutritional antioxidant supplementation in combination with pulmonary rehabilitation (PR) would further improve muscle function, oxidative stress, and PR outcomes in COPD patients. METHODS Sixty-four COPD patients admitted to inpatient PR were randomized to receive 28 days of oral antioxidant supplementation targeting the previously observed deficits (PR antioxidant group; α-tocopherol: 30 mg/day, ascorbate: 180 mg/day, zinc gluconate: 15 mg/day, selenomethionine: 50 μg/day) or placebo (PR placebo group). PR consisted of 24 sessions of moderate-intensity exercise training. Changes in muscle endurance (primary outcome), oxidative stress, and PR outcomes were assessed. RESULTS Eighty-one percent of the patients (FEV1 = 58.9 ± 20.0%pred) showed at least one nutritional antioxidant deficit. Training improved muscle endurance in the PR placebo group (+37.4 ± 45.1%, p < 0.001), without additional increase in the PR antioxidant group (-6.6 ± 11.3%; p = 0.56). Nevertheless, supplementation increased the α-tocopherol/γ-tocopherol ratio and selenium (+58 ± 20%, p < 0.001, and +16 ± 5%, p < 0.01, respectively), muscle strength (+11 ± 3%, p < 0.001), and serum total proteins (+7 ± 2%, p < 0.001), and it tended to increase the type I fiber proportion (+32 ± 17%, p = 0.07). The prevalence of muscle weakness decreased in the PR antioxidant group only, from 30.0 to 10.7% (p < 0.05). CONCLUSIONS While the primary outcome was not significantly improved, COPD patients demonstrate significant improvements of secondary outcomes (muscle strength and other training-refractory outcomes), suggesting a potential "add-on" effect of the nutritional antioxidant supplementation (vitamins C and E, zinc, and selenium) during PR. This trial is registered with NCT01942889.
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Fat Soluble Vitamins in Institutionalized Elderly and the Effect of Exercise, Nutrition and Cognitive Training on Their Status-The Vienna Active Aging Study (VAAS): A Randomized Controlled Trial.
Franzke, B, Schober-Halper, B, Hofmann, M, Oesen, S, Tosevska, A, Strasser, EM, Marculescu, R, Wessner, B, Wagner, KH
Nutrients. 2019;11(6)
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Increasing life-expectancy and consequently the incidence of age-related diseases is one main challenge for health systems. Elderly people are often at risk for inadequate nutrient supply due to physiological, metabolic, and age-associated factors affecting nutrient and fluid intake. The main aim of this study was to evaluate the plasma status of ten fat soluble micronutrients in a cohort of institutionalized elderly. A secondary aim was to investigate the effect of six months of either strength training, strength training and a protein-vitamin supplement, or a cognitive intervention on their plasma status. The study is a secondary analysis of the ‘Vienna Active Ageing Study’. One hundred and seventeen institutionalized elderly women and men (aged 65–98 years) were recruited. The participants were randomly assigned into three intervention groups—cognitive training, resistance training (RT), RT + supplement, and stratified for gender in a randomised, controlled, observer-blind design. Results show a diverse plasma status of fat soluble micronutrients in old institutionalised elderly; appropriate for retinol, improvable for alpha-tocopherol, and not satisfying for beta-carotene. Furthermore, the effect of six months training intervention with or without protein-vitamin supplementation improved physical function, but it was very moderate on the status of fat soluble micronutrients. Authors conclude that their findings encourage a stronger focus on the supply of nutrient dense plant food in this age group in order to obtain sufficient micronutrient levels or, if not otherwise possible such as for vitamin D, to use specific supplements.
Abstract
BACKGROUND Institutionalized elderly are at higher risk for micronutrient deficiency. In particular, fat soluble micronutrients, which additionally have antioxidative function, are of interest. The purpose of this secondary investigation of the Vienna Active Ageing Study was to assess and evaluate the plasma status of retinol, alpha- and gamma-tocopherol, alpha- and beta-carotene, lutein, zeaxanthin, beta-cryptoxanthin, and lycopene, as well as vitamin D (25(OH)D) in a cohort of institutionalized elderly. We further determined the effect of six months strength training with or without supplementing (antioxidant) vitamins and protein on the plasma status of these ten micronutrients. METHODS Three groups (n = 117, age = 83.1 ± 6.1 years)-resistance training (RT), RT combined with protein and vitamin supplementation (RTS), or cognitive training (CT)-performed two guided training sessions per week for six months. Micronutrients were measured with High Performance Liquid Chromatography (HPLC) at baseline and after 6 months of intervention. Physical fitness was assessed by the 6-min-walking, the 30-s chair rise, isokinetic dynamometry, and the handgrip strength tests. RESULTS At baseline, the plasma status of retinol was satisfactory, for alpha-tocopherol, beta-carotene, and 25(OH)D, the percentage of individuals with an insufficient status was 33%, 73% and 61%/81% (when using 50 nmol/L or 75 nmol/L as threshold levels for 25(OH)D), respectively. Plasma analyses were supported by intake data. Six months of elastic band resistance training with or without protein-vitamin supplementation had no biological impact on the status of fat soluble micronutrients. Even for vitamin D, which was part of the nutritional supplement (additional 20 µg/d), the plasma status did not increase significantly, however it contributed to a lower percentage of elderly below the threshold levels of 50/75 nmol/L (49%/74%). CONCLUSIONS The findings of the study lead to the strong recommendation for regular physical activity and increased consumption of plant-based foods in institutionalized elderly. When supported by blood analysis, supplementing micronutrients in a moderate range should also be considered.
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Effects of aquatic exercise on mental health, functional autonomy and oxidative stress in depressed elderly individuals: A randomized clinical trial.
Silva, LAD, Tortelli, L, Motta, J, Menguer, L, Mariano, S, Tasca, G, Silveira, GB, Pinho, RA, Silveira, PCL
Clinics (Sao Paulo, Brazil). 2019;74:e322
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Decreased physical activity can contribute significantly to increased levels of depression. Whereas, regular physical activity positively alters the symptoms of depression thereby promoting mental health. The aim of this study was to investigate the effects of aquatic exercise on mental health, functional autonomy and oxidative stress parameters in depressed elderly individuals. The study is a longitudinal clinical study, conducted over a period of 12 weeks. Forty participants were recruited: 20 elderly individuals (men n = 9 men) with depression formed the depression group and another 20 (n = 13 men) individuals without depression formed the non-depression group. Both groups were subjected to the same aquatic physical training program. Results showed that a low-intensity aerobic training program in the aquatic environment can contribute to the treatment of depression by reducing anxiety and depression scores, improving functional autonomy and decreasing oxidative stress. Authors conclude that an intermittent aquatic physical exercise program improves the functional capacity of depressed elderly individuals.
Abstract
OBJECTIVES The aim of this study was to investigate the effects of aquatic exercise on mental health, functional autonomy and oxidative stress parameters in depressed elderly individuals. METHODS Initially, ninety-two elderly individuals were included in the study and were allocated into the depression group (n=16) and nondepression group (n=14). Both groups engaged in the aquatic exercise program for 12 weeks, including two weekly sessions (45 min/session) at a low intensity (between 50% and 60% of maximal heart rate or Borg scale scores of 13 to 14) throughout the intervention. All outcomes were evaluated at baseline and 12 weeks later. RESULTS The patients were 63.5±8.8 years old. The following scores were decreased after training in the depressed group: depression (53%), anxiety (48%), and Timed Up & Go (33%). The following scores increased: Berg Balance Scale (9%) and flexibility (44%). Regarding the blood-based parameters, there were decreases in protein carbonylation (46%) and nitric oxide (60%) and increases in glutathione (170%) and superoxide dismutase (160%) in the depression group (p<0.005). CONCLUSIONS The aquatic exercise program reduces depression and anxiety, improves functional autonomy and decreases oxidative stress in depressed elderly individuals.
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App-technology to improve lifestyle behaviors among working adults - the Health Integrator study, a randomized controlled trial.
Bonn, SE, Löf, M, Östenson, CG, Trolle Lagerros, Y
BMC public health. 2019;19(1):273
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Lifestyle is the single most important factor to improve health and decrease premature death. Digital solutions for implementing lifestyle change and tracking different types of health data are becoming popular preventative initiatives. The main aim of this study was to evaluate whether a digital platform (The Health Integrator) accessible via a smartphone-app offering lifestyle intervention, with and without additional health coach guidance, can be used to make lifestyle changes and improve health related quality of life in gainfully employed persons. The Health Integrator intervention study is a three-arm parallel randomized controlled trial. Participants were randomized to 1 of 3 groups: 1) intervention using Health Integrator and a monthly telephone session with the health coach during the 3 months of follow-up or 2) intervention using Health Integrator without extra health coach sessions or 3) control group which is not given any lifestyle advise during the intervention period. The study is still ongoing. However, mobile Health has been suggested as one way to take global action as it has the potential to make treatment and prevention widely accessible at a fraction of the current cost. In fact, Health Integrator was developed on the basis of previous research. Current literature shows that multi-component interventions including for example face-to-face counselling or provision of physical activity equipment in addition to an app, were more successful than a stand-alone app intervention.
Abstract
BACKGROUND Mobile health, mHealth is recognized as a strategy to improve lifestyle behaviors. Research targeting specific lifestyle behaviors has shown that interventions using smartphones can be effective. However, few studies have evaluated solutions with multicomponent interventions, tailoring the intervention to the specific needs of the participant using a combination of mHealth and conventional treatment. To accomplish this, we developed Health Integrator, an mHealth platform with services and offers in the areas of diet, physical activity, sleeping habits, stress, alcohol and tobacco use. In the system, the user selects an area of intervention together with a health coach and set weekly goals. This study protocol presents the design and methodology of the Health Integrator Study, a randomized controlled trial to promote improved lifestyle behaviors. METHODS A three-arm parallel randomized controlled trial (1:1:1) is conducted in the Stockholm County, Sweden. In total, 209 employees at a four different companies representing both white and blue collar workers, have been recruited. Participants are randomized to either a control group or to one of two intervention groups receiving a 3-month lifestyle behavior change program including either 1) use of Health Integrator and monthly health coaching sessions or 2) only Health Integrator. At baseline and follow-up after 3- and 6-months, all participants answer questionnaires assessing lifestyle behaviors and quality of life. At baseline and the 3-month follow-up (end of intervention period), weight, height, waist circumference and blood pressure are measured, and all participants wear an Actigraph accelerometer for 7 days to assess physical activity. Blood lipid profile and HbA1c are measured among all participants at baseline. If baseline measures fall outside the normal range, a second measurement is done after 3 months. DISCUSSION The Health Integrator Intervention Study will evaluate if a personalized intervention combining mHealth and conventional programs for lifestyle change, with or without additional health coach sessions, can improve lifestyle behaviors and quality of life. Based on the results from this trial, Health Integrator can easily be implemented within a broad public. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03579342 . Retrospectively registered, first submitted May 8, 2018.
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Proprietary Milk Protein Concentrate Reduces Joint Discomfort While Improving Exercise Performance in Non-Osteoarthritic Individuals.
Ziegenfuss, TN, Kerksick, CM, Kedia, AW, Sandrock, J, Raub, B, Lopez, HL
Nutrients. 2019;11(2)
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Osteoarthritis is the most common joint disorder of the different forms of arthritis. Key symptoms associated with osteoarthritis include the onset of pain, development of various disabilities such as increased difficulty with climbing stairs, walking and other activities of daily living. The aim of this study was to examine the impact of ingesting a concentrated milk protein derived from the milk produced by hyperimmunized cows on alleviating pain (discomfort) and function with and without an external physical stimulus in non-osteoarthritic participants. The study was a randomized, double-blind, placebo-controlled investigation using two parallel supplementation groups (milk protein concentrate group n = 24 and placebo group n = 34) that spanned eight weeks. Results indicate that treatment with proprietary milk protein concentrate resulted in greater improvements in several components within the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) assessment, walking performance, as well as self-reported levels of pain, discomfort, stiffness and stability. Authors conclude that daily doses of proprietary milk protein concentrate yielded improvements in several components and it was well tolerated with no significant changes in whole-blood or serum markers of clinical safety.
Abstract
Milk and dairy products are known to contain various bioactives with potential anti-inflammatory and immune modulating effects. Previous research has indicated that milk produced from hyperimmunized cows provided meaningful health benefits to individuals suffering from varying degrees of osteoarthritis and rheumatoid arthritis. PURPOSE To examine the impact of MicroLactin®, a proprietary milk protein concentrate, on joint discomfort and physical function, exercise performance, quality of life and various measures of affect. METHODS Non-osteoarthritic men (42.5 ± 8.9 years, 176.7 ± 6.7 cm, 89.9 ± 11.5 kg, 28.8 ± 3.5 kg/m², n = 30) and women (46.4 ± 9.6 years, 163.1 ± 8.2 cm, 72.2 ± 13.1 kg, 27.2 ± 5.3 kg/m², n = 28) with mild to moderate knee pain during physical activity were randomized in a double-blind, placebo-controlled fashion to consume daily either a placebo (PLA) or MicroLactin® (ML) for a period of 8 weeks. Participants completed a functional capacity test pre and post-supplementation and completed visual analog scales (VAS), a 6-min walking test, WOMAC and profile of mood states (POMS) to assess changes in joint health, discomfort, physical function, exercise performance and affect. Mixed factorial ANOVA was used for all statistical analysis and significance was set a priori at p ≤ 0.05. RESULTS Distance covered in the 6-min walking significantly improved 9% in ML versus 2% in PLA (mean difference: 110 ± 43 m, p = 0.012) in addition to 11 WOMAC components and 5 VAS reflective of ML improving joint health, discomfort and joint stability (all p < 0.05 vs. PLA). Additionally, ML also improved overall perceptions of neck and back health compared to PLA. Serum and whole blood indicators of clinical safety remained within normal ranges throughout the study. CONCLUSIONS In comparison to placebo, daily doses of MicroLactin® yielded improvements in several components of the WOMAC, multiple visual analog scales indicative of joint health and stability, discomfort and pain, as well as significant improvements in distance covered during a 6-min walking test. Supplementation was well tolerated with no significant changes in whole-blood or serum markers of clinical safety.
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Effects of a polysaccharide-based multi-ingredient supplement on salivary immunity in non-elite marathon runners.
Roca, E, Cantó, E, Nescolarde, L, Perea, L, Bayes-Genis, A, Sibila, O, Vidal, S
Journal of the International Society of Sports Nutrition. 2019;16(1):14
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Competing in very strenuous events such as marathons imposes severe metabolic stress and causes acute responses that may negatively alter the immune system. The aim of this study is to determine the impact of Advanced Ambrotose© complex powder (AA) on the levels of salivary secretory Immunoglobulin A (sIgA) [an antibody that plays a critical role in mucosal immunity], pro-inflammatory chemokines and anti-inflammatory proteins before and after running a marathon in non-elite marathoners. The study recruited 41 male participants which were randomly assigned to one of the two groups. Twenty participants (48%) received AA supplementation prior to the race (AA group), whilst the rest did not receive AA supplementation. Supplementation was received for 15 days prior to the marathon. Results indicate that there were no significant differences in age, weight, height, and training were found between runners who received AA supplementation and those who did not. However, findings show significant changes in salivary biomarkers of immune function in healthy, non-elite athletes before and after a strenuous exercise. Authors conclude that AA supplementation produces changes in salivary immunity that may have a positive effect on immunity before and after a marathon.
Abstract
BACKGROUND Extreme exercise may alter the innate immune system. Glycans are involved in several biological processes including immune system regulation. However, limited data regarding the impact of glycan supplementation on immunological parameters after strenuous exercise are available. We aimed to determine the impact of a standardized polysaccharide-based multi-ingredient supplement, Advanced Ambrotose© complex powder (AA) on salivary secretory Immunoglobulin A (sIgA) and pro- and anti-inflammatory protein levels before and after a marathon in non-elite runners. METHODS Forty-one male marathon runners who completed the 42.195 km of the 2016 Barcelona marathon were randomly assigned to two study groups. Of them, n = 20 (48%) received the AA supplement for 15 days prior the race (AA group) and n = 21 (52%) did not receive any AA supplement (non-AA group). Saliva and blood samples were collected the day before the marathon and two days after the end of the race. Salivary IgA, pro-inflammatory chemokines (Gro-alpha, Gro-beta, MCP-1) and anti-inflammatory proteins (Angiogenin, ACRP, Siglec 5) were determined using commercially ELISA kits in saliva supernatant. Biochemical parameters, including C-reactive protein, cardiac biomarkers, and blood hemogram were also evaluated. RESULTS Marathon runners who did not receive the AA supplement experienced a decrease of salivary sIgA and pro-inflammatory chemokines (Gro-alpha and Gro-beta) after the race, while runners with AA supplementation showed lower levels of anti-inflammatory chemokines (Angiogenin). Gro-alpha and Gro-beta salivary levels were lower before the race in the AA group and correlated with blood leukocytes and platelets. CONCLUSIONS Changes in salivary sIgA and inflammatory chemokines, especially Gro-alfa and Gro-beta, were observed in marathon runners supplemented with AA prior to the race. These findings suggested that AA may have a positive effect on immune response after a strenuous exercise.