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L-Arginine is a feasible supplement to heal chronic anal fissure via reducing internal anal sphincter pressure: a randomized clinical trial study.
Khalighi Sikaroudi, M, Sedaghat, M, Shidfar, F, Talebi, S, Hosseini-Baharanchi, FS, Masoodi, M, Farahani, SV
Amino acids. 2023;55(2):193-202
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An anal fissure is a condition resulting from a superficial open wound or tear in the anus mucosa with a sharp pain that can extend from the anal canal to the periphery. The aim of this study was to evaluate the effect of oral L-arginine as a safer method with better performance on clinical symptoms, quality of life, and internal anal sphincter pressure in patients with chronic anal fissure. This study is a randomised, double-blind, placebo-controlled trial with parallel design conducted in the 4-week intervention and the 8-week follow-up. The study recruited 76 adult men and women who were aged between 18 and 65 years of age and were diagnosed with chronic fissures. Participants were assigned to two groups: 3000 mg l-arginine, or a placebo filled with Maltodextrin. Results show that supplementation with l-arginine may relieve clinical symptoms, especially pain and bleeding, and improve the quality of life of patients with chronic anal fissure. In addition, analysis of anal internal sphincter pressures evaluated by manometry and balloon showed the significant reduction of sphincter pressure in these patients. Authors conclude that l-arginine supplementation may relieve clinical symptoms and improve the quality of life, anxiety, and depression in patients with chronic anal fissures.
Abstract
The hypertonicity of internal anal sphincter resting pressure is one of the main causes of chronic anal fissure. Therefore, the aim of this study was to assess the effect of oral administration of L-arginine on the improvement of the anal fissures by relaxing the internal anal sphincter. Seventy-six chronic anal fissure patients (aged 18-65 years) who were referred to Rasoul-e-Akram Hospital, Tehran, Iran from February 2019 to October 2020 participated in this randomized, double-blind, placebo-controlled trial. Participants were allocated into treatment (L-arginine) and placebo groups. They took a 1000 mg capsule three times a day for 1 month, and then we followed them at the end of the first and third months after the intervention. Clinical symptoms, anal sphincter resting pressure, and quality of life (QoL) were completed at baseline and the end of the study. The analysis of data showed a significant decrease in bleeding, fissure size, and pain for each group; however, in the L-arginine group was more than the control group at the end of the study (P values < 0.001). Following that, a significant increase in QoL was seen just in patients treated with L-arginine (P value = 0.006). In addition, the comparison of anal pressures at baseline and, between groups at the end of the study showed a significant reduction in sphincter pressure in patients treated with L-arginine (P value < 0.001, = 0.049; respectively). The oral administration of 3000 mg L-arginine can heal chronic anal fissures by reducing internal anal sphincter pressure with more negligible side effects. However, we recommend long-term study with more extended follow-up.Clinical trial registry: IRCT20190712044182N1 at Iranian clinical trials, date: 2019-08-27.
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Effect of vitamin D supplementation on depression in older Australian adults.
Rahman, ST, Waterhouse, M, Romero, BD, Baxter, C, English, DR, Almeida, OP, Berk, M, Ebeling, PR, Armstrong, BK, McLeod, DSA, et al
International journal of geriatric psychiatry. 2023;38(1):e5847
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Depression can considerably impair daily function. However, although medications and psychological therapy can be effective in treating depression, non‐compliance with and/or side effects of antidepressants are common. Thus, identifying alternative or adjunctive therapies to prevent or treat depression may help to overcome some limitations of current management strategies. The aim of this study was to examine whether supplementing older Australians with monthly doses of 60,000 IU of vitamin D3 for 5 years would reduce depressive symptoms or incidence of antidepressant use, as a surrogate for a formal diagnosis of depression. This study used data from the D‐Health Trial, a large population‐based randomised controlled trial. Authors randomly selected potential participants aged between 60 and 79 years from the Australian Commonwealth Electoral Roll. The participants who accepted the invitation were randomly allocated to either 60,000 IU of cholecalciferol (vitamin D3) or placebo in a 1:1 ratio. Results show that there wasn’t an overall benefit of monthly supplementation with 60,000 IU of vitamin D for up to 5 years on measures of depression. However, pre‐specified subgroup analyses suggested a potential beneficial effect of vitamin D supplementation in people taking antidepressants at baseline or with lower predicted baseline vitamin D3 concentration. However there was an unfavourable effect in participants with a body mass index <25 kg/m2 or those with higher predicted baseline vitamin D3 concentration. Authors conclude that routine supplementation with vitamin D in populations with a low prevalence of vitamin D deficiency is unlikely to be of benefit for depression and may cause harm in people with low body mass index or normal vitamin D status.
Abstract
OBJECTIVES To investigate whether vitamin D supplementation reduces depressive symptoms and incidence of antidepressant use. METHODS We used data from the D-Health Trial (N = 21,315), a randomized double-blind placebo-controlled trial of monthly vitamin D3 for the prevention of all-cause mortality. Participants were Australians aged 60-84 years. Participants completed the Patient Health Questionnaire (PHQ-9) at 1, 2 and 5 years after randomization to measure depressive symptoms; national prescribing records were used to capture antidepressant use. We used mixed models and survival models. RESULTS Analyses of PHQ-9 scores included 20,487 participants (mean age 69·3 years, 46% women); the mean difference (MD) in PHQ-9 score (vitamin D vs. placebo) was 0·02 (95% CI -0·06, 0·11). There was negligible difference in the prevalence of clinically relevant depression (PHQ-9 score ≥10) (odds ratio 0·99; 95% CI 0·90, 1·08). We included 16,670 participants in the analyses of incident antidepressant use (mean age 69·4 years, 43% women). Incidence of antidepressant use was similar between the groups (hazard ratio [HR] 1·04; 95% CI 0·96, 1·12). In subgroup analyses, vitamin D improved PHQ-9 scores in those taking antidepressants at baseline (MD -0·25; 95% CI -0·49, -0·01; p-interaction = 0·02). It decreased risk of antidepressant use in participants with predicted 25(OH)D concentration <50 nmol/L (HR 0·88; 95% CI 0·75, 1·02; p-interaction = 0·01) and increased risk in those with predicted 25(OH)D ≥ 50 nmol/L (HR 1·10; 95% CI 1·01, 1·20). CONCLUSION Monthly supplementation with high-dose vitamin D3 was not of benefit for measures of depression overall, but there was some evidence of benefit in subgroup analyses. CLINICAL TRIAL REGISTRATION The trial is registered on the Australian New Zealand Clinical Trials Registry: ACTRN12613000743763. https://www.anzctr.org.au/.
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Effectiveness of a minimally processed food-based nutritional counselling intervention on weight gain in overweight pregnant women: a randomized controlled trial.
Sartorelli, DS, Crivellenti, LC, Baroni, NF, de Andrade Miranda, DEG, da Silva Santos, I, Carvalho, MR, de Lima, MC, Carreira, NP, Chaves, AVL, Manochio-Pina, MG, et al
European journal of nutrition. 2023;62(1):443-454
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Excessive gestational weight gain exposes the woman and the child to a higher risk of harmful health outcomes in the short and long term. Dietary patterns based on the substitution of meals made with unprocessed or minimally processed foods for the consumption of ultra-processed items can be partly blamed for the exponential global growth in the incidence of obesity. The main aim of this study was to evaluate the effectiveness of a nutritional intervention based on encouraging the consumption of unprocessed and minimally processed foods rather than ultra-processed products. This study is a two-armed parallel randomised controlled trial conducted among overweight, pregnant women receiving prenatal care in seven primary health units. Participants (n=350) were randomly allocated into the intervention group (IG) or control group (CG). The women allocated into the IG, in addition to the usual prenatal care, were invited to participate in three individualised nutritional counselling sessions conducted by trained nutritionists. Results show that even though there were more women in the IG who had increased their daily intake of minimally processed foods and vegetables at lunch time when compared to the CG, this was not statistically significant. Additionally, there weren’t any differences between the groups in relation to physical activity. Authors conclude that their study was unprecedented in demonstrating that a nutritional counselling intervention based on the NOVA food classification system, together with the practice of physical activity, is effective in preventing excessive gestational weight gain in overweight pregnant women.
Abstract
PURPOSE This study aimed at evaluating the effectiveness of a nutritional counselling intervention based on encouraging the consumption of unprocessed and minimally processed foods, rather than ultra-processed products, and the practice of physical activities to prevent excessive gestational weight gain in overweight pregnant women. METHODS This was a two-armed, parallel, randomized controlled trial conducted in primary health units of a Brazilian municipality from 2018 to 2021. Overweight, adult pregnant women (n = 350) were randomly assigned to control (CG) or intervention groups (IG). The intervention consisted of three individualized nutritional counselling sessions based on encouraging the consumption of unprocessed and minimally processed foods rather than ultra-processed products, following the NOVA food classification system, and the practice of physical activities. The primary outcome was the proportion of women whose weekly gestational weight gain (GWG) exceeded the Institute of Medicine guidelines. Adjusted logistic regression models were employed. RESULTS Complete data on weight gain were available for 121 women of the IG and 139 of the CG. In modified intention-to-treat analysis, there was a lower chance of the IG women having excessive GWG [OR 0.56 (95% CI 0.32, 0.98), p = .04], when compared to the CG. No between-group differences were observed for the other maternal outcomes investigated. CONCLUSION The present study was unprecedented in demonstrating that nutritional counselling based on the NOVA food classification system, together with encouraging the practice of physical activity, is effective in preventing excessive weight gain in overweight pregnant women. TRIAL REGISTRATION Registered on July 30th 2018 at Brazilian Registry of Clinical Trials (RBR-2w9bhc).
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HOMEFOOD randomized trial-beneficial effects of 6-month nutrition therapy on body weight and physical function in older adults at risk for malnutrition after hospital discharge.
Blondal, BS, Geirsdottir, OG, Beck, AM, Halldorsson, TI, Jonsson, PV, Sveinsdottir, K, Ramel, A
European journal of clinical nutrition. 2023;77(1):45-54
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Malnutrition, which is commonly observed among older adults, is strongly associated with altered body composition, diminished physical and mental function as well as other adverse clinical outcomes. The aim of this study was to investigate the effects of intense nutritional therapy, including free access to energy- and protein-dense foods delivered to subjects recently discharged from hospital. This study is a 6-month, randomised controlled, assessor blinded intervention trial conducted in older adults. The participants (n=106) were randomly allocated to either the intervention or the control group. Results show that the nutrition intervention: - had strong beneficial effects on body weight (moderate weight gain in the intervention group compared to weight loss in the control group) and other anthropometric measures; - had favourable effects on physical function (however, there were no changes in muscular strength), and - led to improved nutritional status after being discharged from hospital (whereas the dietary intake decreased dramatically in the control group despite being informed at discharge of the importance of nutrition). Authors conclude that a 6-month nutrition therapy provided by a clinical nutritionist, following the principles of Nutrition Care Process in combination with freely delivered supplemental energy- and protein-dense foods, has beneficial effects on body weight, physical function, dietary intake, and nutritional status.
Abstract
BACKGROUND/OBJECTIVES Malnutrition is common among older adults. Dietary intervention studies in older adults aiming to improve anthropometrics measures and physical function have been inconsistent. We aimed to investigate the effects of nutrition therapy in combination with home delivered meals and oral nutritional supplements (ONS) in community-dwelling older adults discharged from hospital. METHODS A total of 106 participants (>65 years) were randomized into the intervention group (n = 53) and into the control group (n = 53). The intervention group received individual nutrition therapy (five in person visits and three phone calls) and freely delivered energy- and protein- rich foods, while the control group received standard care. Dietary intake, anthropometrics, and short physical performance battery (SPPB) were assessed at baseline and at endpoint. RESULTS Energy intake at baseline was similar in both groups (~1500 kcal at the hospital) but there was a significant increase in energy intake and body weight in the intervention group (+919 kcal/day and 1.7 kg, P < 0.001 in both cases) during the study period, compared to a significant decrease in both measures among controls (-815 kcal/day and -3.5 kg, P < 0.001 in both cases). SPPB score increased significantly in the intervention group while no changes were observed among controls. CONCLUSIONS Most Icelandic older adults experience substantial weight loss after hospital discharge when receiving current standard care. However, a 6-month multi-component nutrition therapy, provided by a clinical nutritionist in combination with freely delivered supplemental energy- and protein-dense foods has beneficial effects on body weight, physical function, and nutritional status. STUDY REGISTRATION This study was registered at ClinicalTrials.gov ( NCT03995303 ).
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Dose-response relationship between weight loss and improvements in obstructive sleep apnea severity after a diet/lifestyle interventions: secondary analyses of the "MIMOSA" randomized clinical trial.
Georgoulis, M, Yiannakouris, N, Kechribari, I, Lamprou, K, Perraki, E, Vagiakis, E, Kontogianni, MD
Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine. 2022;18(5):1251-1261
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Obstructive sleep apnoea (OSA) represents one of the most common and serious sleep-related breathing disorders. Excess body weight has emerged as the strongest modifiable predictor of the onset and severity of OSA. The aim of this study was to explore the dose-response relationship between the degree of weight loss and improvements in OSA severity. This study is a secondary analysis of the Mediterranean diet/lifestyle Intervention for the Management of Obstructive Sleep Apnea (MIMOSA) study, which was designed as a single-centre, single-blind, parallel, randomised, controlled clinical trial. Results show that respiratory events and oximetry indices improved only in patients who lost weight and improvements were proportional to the degree of weight loss. Authors conclude that their findings indicate a dose-response relationship between the degree of weight loss and improvement in OSA severity and symptoms. However, further research is needed to gather more data on the optimal degree of weight loss and appropriate weight-loss interventions for managing the wide spectrum of OSA severity to guide clinical practice.
Expert Review
Conflicts of interest:
None
Take Home Message:
Important from a public health perspective:
- This study has confirmed that even a small degree of weight loss can have a beneficial effect on respiratory events and oxygen desaturation in moderate-to-severe OSA, but clinicians should preferably aim at a ≥ 5% weight loss, and ideally a ≥ 10% weight loss, to achieve clinically meaningful reductions in OSA severity.
Evidence Category:
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A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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B: Systematic reviews including RCTs of limited number
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C: Non-randomized trials, observational studies, narrative reviews
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D: Case-reports, evidence-based clinical findings
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E: Opinion piece, other
Summary Review:
Introduction
OSA represents one of the most common and serious sleep-related breathing disorders, with a high worldwide prevalence of almost 1 billion people. OSA has numerous well-established cardiometabolic consequences.
The authors highlight that weight loss is essential for obstructive sleep apnea (OSA) management. However, the optimal degree of weight loss for improving OSA severity or eliminating sleep-disordered breathing has not been extensively studied. The aim of this study was to explore the dose-response relationship between the degree of weight loss and improvements in OSA severity.
Methods
This is a secondary analysis of the Mediterranean diet/lifestyle Intervention for the Management of Obstructive Sleep Apnea (MIMOSA) study. This study was designed as a single-center, single-blind, parallel, randomised, controlled clinical trial to evaluate the effectiveness of a weight-loss Mediterranean dietary/lifestyle intervention on managing OSA.
This 6-month long clinical trial included 180 adult, overweight/obese moderate-to-severe OSA patients (45 patients per study group plus a 29% dropout rate). All patients were prescribed the standard of care continuous positive airway pressure (CPAP) therapy and were randomised to 3 arms: standard care; Mediterranean diet; Mediterranean lifestyle
Based on percent change in weight at 6 months, participants were categorised into a weight-stable/gain (WS/GG) group or one of 3 weight-loss groups (WLG): < 5%WLG; 5%–10%WLG; ≥ 10%WLG. Polysomnographic data and OSA symptoms were also evaluated preintervention and postintervention.
Results
Results confirm a dose-response relationship between the degree of weight loss achieved through a dietary/lifestyle intervention and improvements in OSA severity.
- Respiratory events and oximetry indices improved only in patients who lost weight. Improvements were proportional to the degree of weight loss.
- Median percent change in apnea-hypopnea index (AHI) was −11.7%, − 37.9%, and − 49.3% in the < 5%WLG, 5%–10%WLG, and ≥ 10%WLG, respectively (P < .001).
- Compared to the WS/GG, the age-, sex-, baseline-, and CPAP use–adjusted relative risk (95% confidence interval) of severe OSA (AHI ≥ 30 events/h) was 0.45 (0.23–0.87) in the 5%–10%WLG and 0.32 (0.17–0.64) in the ≥ 10%WLG; the risk was also lower in the ≥ 10%WLG vs the < 5%WLG (0.42 [0.22–0.82]).
- Insomnia and daytime sleepiness also improved more in participants exhibiting ≥ 5% weight loss.
- The dose-response relationship between weight loss and improvement in OSA severity was evident regardless of self-reported CPAP use.
Conclusions
The authors conclude that even a < 5% weight loss was sufficient for improvements in respiratory events and oximetry indices, but the prevalence of severe OSA reduced only after a ≥ 5% weight loss, and patients achieving a ≥ 10% weight loss exhibited the greatest benefits compared to weight-stable/gain patients.
Clinical practice applications:
These findings might be useful for Nutritional Therapists and Clinical Practitioners:
- Clinicians should aim for a ≥ 5% weight loss, and ideally a ≥ 10% weight loss, to achieve clinically meaningful reductions in OSA severity.
- Improvements after weight loss were significant even though a healthy body weight was not achieved.
Considerations for future research:
- The study sample consisted of predominantly male, overweight, otherwise healthy patients with moderate-to-severe OSA. Therefore, findings cannot be generalised to the whole OSA population and further research is required with broader, diverse, study samples.
- 6 months is a short duration period, therefore longer trials are required.
- Self-reported CPAP use by participants is a limitation of this study. Further robust analysis methods should be considered for future trials.
- Participants were advised to abstain from CPAP therapy for 2 days prior to the follow-up PSG but this was not evaluated or confirmed in this study and should be in future research.
Abstract
STUDY OBJECTIVES Lifestyle-induced weight loss is a complementary therapeutic approach for obstructive sleep apnea (OSA). We aimed at identifying the dose-response relationship between weight loss and OSA severity improvement. METHODS This is a secondary analysis of a 6-month clinical trial in 180 adult, overweight/obese moderate-to-severe OSA patients. Participants were randomized to a standard care, a Mediterranean diet, or a Mediterranean lifestyle arm. All patients were prescribed with continuous positive airway pressure (CPAP), while intervention arms additionally participated in a weight-loss dietary/lifestyle intervention. Based on percent change in weight at 6 months, participants were categorized into a weight-stable/gain (WS/GG) group or 3 weight-loss groups (WLG): < 5%WLG, 5%-10%WLG, and ≥ 10%WLG. Polysomnographic data and OSA symptoms were evaluated preintervention and postintervention. RESULTS Respiratory events and oximetry indices improved only in patients who lost weight and improvements were proportional to the degree of weight loss. Median percent change in apnea-hypopnea index (AHI) was -11.7%, - 37.9%, and - 49.3% in the < 5%WLG, 5%-10%WLG, and ≥ 10%WLG, respectively (P < .001). Compared to the WS/GG, the age-, sex-, baseline-, and CPAP use-adjusted relative risk (95% confidence interval) of severe OSA (AHI ≥ 30 events/h) was 0.45 (0.23-0.87) in the 5%-10%WLG and 0.32 (0.17-0.64) in the ≥ 10%WLG; the risk was also lower in the ≥ 10%WLG vs the < 5%WLG (0.42 [0.22-0.82]). Insomnia and daytime sleepiness also improved more in participants exhibiting ≥ 5% weight loss. CONCLUSIONS Even a < 5% weight loss can reduce respiratory events, but a ≥ 5% and ideally ≥ 10% weight loss is necessary for reducing the prevalence of severe OSA. CLINICAL TRIAL REGISTRATION Registry: ClinicalTrials.gov; Name: Mediterranean Diet/Lifestyle Intervention in Obstructive Sleep Apnea; URL: https://clinicaltrials.gov/ct2/show/NCT02515357; Identifier: NCT02515357. CITATION Georgoulis M, Yiannakouris N, Kechribari I, et al. Dose-response relationship between weight loss and improvements in obstructive sleep apnea severity after a diet/lifestyle intervention: secondary analyses of the "MIMOSA" randomized clinical trial. J Clin Sleep Med. 2022;18(5):1251-1261.
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Effects of Probiotics on Anxiety, Stress, Mood and Fitness of Badminton Players.
Salleh, RM, Kuan, G, Aziz, MNA, Rahim, MRA, Rahayu, T, Sulaiman, S, Kusuma, DWY, Adikari, AMGCP, Razam, MSM, Radhakrishnan, AK, et al
Nutrients. 2021;13(6)
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Exercise has been shown to improve fitness, wellbeing, and health. However, strenuous exercise may be detrimental physiologically, as well as affecting psychological health. The aim of this study was to determine the effects of daily probiotic supplementation on anxiety, stress, mood and fitness levels among competitive badminton players. This study was a randomised, placebo-controlled study. Recruited participants (n=30) were randomly divided into the probiotic group and the control group. The participants were given treatments for six weeks without altering the training schedule of the athletes. Results showed that stress and anxiety in badminton players could be alleviated with the daily consumption of probiotics for six weeks. Additionally, probiotics supplementation increased aerobic capacity. Authors conclude that probiotic supplements could be beneficial for athletes to enhance their mental state and physical performance. Thus, probiotic supplementation that may influence the regulation of pathways (neuro-endocrine) and mechanism of action in response to physical and psychological stressors encountered by badminton players should further studied.
Abstract
BACKGROUND Reports of probiotic consumption on athletes' performance are debatable due to their equivocal results. There is a need for more evidence on the effects of probiotic intake on psychological state and fitness level. Thus, this study determined the effects of daily probiotic consumption on competitive anxiety, perceived stress and mood among university badminton players, besides their fitness like aerobic capacity, strength, speed, leg power and agility. METHODS Thirty university badminton players aged from 19 to 22 years old were randomly divided equally into two groups, where the probiotic group (PG; n = 15) received a drink that contained Lactobacillus casei Shirota (3 × 1010 CFU) and placebo group (CG; n = 15) a placebo drink for six weeks. Anxiety, stress and mood levels were determined using the CSAI-2R, PSS and BRUMS questionnaires, respectively. Fitness levels were measured using by subjecting the players to 20-m shuttle runs (aerobic capacity), handgrips (muscular strength), vertical jumps (leg power), 40-m dash (speed) and T-test (agility). The Student's t-test (p < 0.05) was used to determine the differences between PG and CG players. RESULTS After six weeks, the anxiety and stress levels of PG players significantly decreased by 16% (p < 0.001) and 20% (p < 0.001), respectively, but there were no significant changes detected in CG players. Supplementation of probiotics also improved aerobic capacity in PG players by 5.9% (p < 0.001) but did not influence the speed, strength, leg power and agility. CONCLUSIONS Probiotics supplementation showed improved aerobic capacity and relieve anxiety and stress. However, further studies need to be carried out to determine the mechanisms through which probiotic intake produces these effects.
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Effect of a Multidomain Lifestyle Intervention on Estimated Dementia Risk.
Solomon, A, Handels, R, Wimo, A, Antikainen, R, Laatikainen, T, Levälahti, E, Peltonen, M, Soininen, H, Strandberg, T, Tuomilehto, J, et al
Journal of Alzheimer's disease : JAD. 2021;82(4):1461-1466
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Early identification of individuals at-risk of dementia is essential for effective preventive strategies. The aim of this study was to investigate the effect of a multidomain lifestyle intervention on the risk of dementia. This study is a post-hoc analyses of intervention effects on change in the Cardiovascular Risk Factors, Aging and Dementia (CAIDE) Dementia Risk Score. The CAIDE score was used to select at-risk participants to the FINGER trial. FINGER is a multicentre study conducted in 6 centres in Finland. Results show a significant beneficial intervention effect, especially in women, on reducing estimated dementia risk measured by the CAIDE score. Authors conclude that CAIDE risk score can be used as a tool to communicate dementia risk, and to select persons that may benefit from lifestyle interventions.
Abstract
We investigated the effect of a multidomain lifestyle intervention on the risk of dementia estimated using the validated CAIDE risk score (post-hoc analysis). The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) is a 2-year randomized controlled trial among 1,260 at-risk older adults (60-77 years). Difference in the estimated mean change in CAIDE score at 2 years in the intervention compared to the control group was -0.16 (95 %CI -0.31 to 0.00) (p = 0.013), corresponding to a relative dementia risk reduction between 6.04-6.50%. This could be interpreted as a reflection of the prevention potential of the intervention.
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Personalised nutrition advice reduces intake of discretionary foods and beverages: findings from the Food4Me randomised controlled trial.
Livingstone, KM, Celis-Morales, C, Navas-Carretero, S, San-Cristobal, R, Forster, H, Woolhead, C, O'Donovan, CB, Moschonis, G, Manios, Y, Traczyk, I, et al
The international journal of behavioral nutrition and physical activity. 2021;18(1):70
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Food4Me is an internet-based personalised nutrition study that evaluates the effectiveness of personalized dietary advice in avoiding discretionary foods compared to conventional advice. In different countries, discretionary foods are classified differently. Therefore, this study included two measures of discretionary foods identified by the Food4Me Food Frequency Questionnaire, which covered 22 discretionary foods classified by Food Standards Scotland and 59 discretionary foods identified by Australian Dietary Guidelines. For six months, 1607 participants from seven European countries were randomly assigned to receive generalised dietary advice or one of three levels of personalised nutrition advice (based on diet [L1], phenotype [L2] and genotype [L3]). Personalised nutrition advice was found to be effective in reducing discretionary foods when categorisation included foods high in fat, added sugar and salt. There was a greater reduction in energy, sugar, salt, and saturated fat intakes in people who received personalised nutrition advice [L1-3] as compared to generalised dietary advice after six months. Results of this study can be used by healthcare professionals to support personalised nutrition strategies in the general population targeting discretionary foods to increase compliance with personalised nutrition strategies and achieve better health outcomes.
Abstract
BACKGROUND The effect of personalised nutrition advice on discretionary foods intake is unknown. To date, two national classifications for discretionary foods have been derived. This study examined changes in intake of discretionary foods and beverages following a personalised nutrition intervention using these two classifications. METHODS Participants were recruited into a 6-month RCT across seven European countries (Food4Me) and were randomised to receive generalised dietary advice (control) or one of three levels of personalised nutrition advice (based on diet [L1], phenotype [L2] and genotype [L3]). Dietary intake was derived from an FFQ. An analysis of covariance was used to determine intervention effects at month 6 between personalised nutrition (overall and by levels) and control on i) percentage energy from discretionary items and ii) percentage contribution of total fat, SFA, total sugars and salt to discretionary intake, defined by Food Standards Scotland (FSS) and Australian Dietary Guidelines (ADG) classifications. RESULTS Of the 1607 adults at baseline, n = 1270 (57% female) completed the intervention. Percentage sugars from FSS discretionary items was lower in personalised nutrition vs control (19.0 ± 0.37 vs 21.1 ± 0.65; P = 0.005). Percentage energy (31.2 ± 0.59 vs 32.7 ± 0.59; P = 0.031), percentage total fat (31.5 ± 0.37 vs 33.3 ± 0.65; P = 0.021), SFA (36.0 ± 0.43 vs 37.8 ± 0.75; P = 0.034) and sugars (31.7 ± 0.44 vs 34.7 ± 0.78; P < 0.001) from ADG discretionary items were lower in personalised nutrition vs control. There were greater reductions in ADG percentage energy and percentage total fat, SFA and salt for those randomised to L3 vs L2. CONCLUSIONS Compared with generalised dietary advice, personalised nutrition advice achieved greater reductions in discretionary foods intake when the classification included all foods high in fat, added sugars and salt. Future personalised nutrition approaches may be used to target intake of discretionary foods. TRIAL REGISTRATION Clinicaltrials.gov NCT01530139 . Registered 9 February 2012.
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Evaluating dose delivered of a behavioral intervention for childhood obesity prevention: a secondary analysis.
Heerman, WJ, Sommer, EC, Qi, A, Burgess, LE, Mitchell, SJ, Samuels, LR, Martin, NC, Barkin, SL
BMC public health. 2020;20(1):885
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Many trials designed to prevent or treat childhood obesity have shown only modest and unsustained effects on child weight. The aim of this study was to test the extent to which dose delivered behavioural intervention was associated with childhood weight outcomes. This study was a post-hoc analysis of the Growing Right Onto Wellness Trial (GROW). GROW was a randomized controlled trial of a parent-child intervention designed to prevent childhood obesity. The study included 610 participants who were randomized into one of the two groups, with 304 assigned to the intervention group and 306 to the control group. Results indicate that young underserved children can experience clinically meaningful improvement in body mass index (BMI) outcomes over 1 year with a multi-modal dose delivery that is less than 26 h. However, these changes in BMI were not significantly sustained at 2- or 3-year follow-up. Authors conclude that additional investigation into the best interventions of maintenance of weight loss remain an important step.
Abstract
BACKGROUND Current recommendations for intensive behavioral interventions for childhood obesity treatment do not account for variable participant attendance, optimal duration of the intervention, mode of delivery (phone vs. face-to-face), or address obesity prevention among young children. A secondary analysis of an active one-year behavioral intervention for childhood obesity prevention was conducted to test how "dose delivered" was associated with body mass index z-score (BMI-Z) across 3 years of follow-up. METHODS Parent-child pairs were eligible if they qualified for government assistance and spoke English or Spanish. Children were between three and 5 years old and were at risk for but not yet obese (BMI percentiles ≥50th and < 95th). The intended intervention dose was 18 h over 3-months via 12 face-to-face "intensive sessions" (90 min each) and 6.75 h over the next 9 months via 9 "maintenance phone calls" (45 min each). Ordinary least-squares multivariable regression was utilized to test for associations between dose delivered and child BMI-Z immediately after the 1-year intervention, and at 2-, and 3-year follow-up, including participants who were initially randomized to the control group as having "zero" dose. RESULTS Among 610 parent-child pairs (intervention n = 304, control n = 306), mean child age was 4.3 (SD = 0.9) years and 51.8% were female. Mean dose delivered was 10.9 (SD = 2.5) of 12 intensive sessions and 7.7 (SD = 2.4) of 9 maintenance calls. Multivariable linear regression models indicated statistically significant associations of intensive face-to-face contacts (B = -0.011; 95% CI [- 0.021, - 0.001]; p = 0.029) and maintenance calls (B = -0.015; 95% CI [- 0.026, - 0.004]; p = 0.006) with lower BMI-Z immediately following the 1-year intervention. Their interaction was also significant (p = 0.04), such that parent-child pairs who received higher numbers of both face-to-face intensive sessions (> 6) and maintenance calls (> 8) were predicted to have lower BMI-Z. Sustained impacts were not statistically significant at 2- or 3-year follow-up. CONCLUSIONS In a behavioral intervention for childhood obesity prevention, the combination of a modest dose of face-to-face sessions (> 6 h over 3 months) with sustained maintenance calls (> 8 calls over 9 months) was associated with improved BMI-Z at 1-year for underserved preschool aged children, but sustained impacts were not statistically significant at 2 or 3 year follow-up. CLINICAL TRIAL REGISTRATION The trial was registered on ClinicalTrials.gov (NCT01316653) on March 16, 2011, which was prior to participant enrollment.
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Effects of the Healthy Children, Healthy Families, Healthy Communities Program for Obesity Prevention among Vulnerable Children: A Cluster-Randomized Controlled Trial.
Choo, J, Yang, HM, Jae, SY, Kim, HJ, You, J, Lee, J
International journal of environmental research and public health. 2020;17(8)
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Plain language summary
Childhood obesity is especially pronounced in those from lower socioeconomical backgrounds. The Three-Healthy Programme is a multilevel initiative designed to target obesity in these children. This randomised control trial of 104 socioeconomically vulnerable children and 59 of their parents over 12 weeks aimed to determine the effects of the Three-Healthy Programme on healthy lifestyle behaviours and obesity in children in the public welfare system. The results showed that the Three-Healthy Programme, which targeted child behavioural strategies, parenting strategies and organisational strategies helped to increase a child’s knowledge of healthy lifestyle behaviours, vegetable intake and physical activity. However, there were no improvements in breakfast, fruit, milk, no-sugar beverage and fast-food consumption. This did not translate to improved obesity status. It was concluded that the Three-Healthy Programme may be effective at promoting healthy lifestyles in socioeconomically vulnerable children. The short study duration may be the reason why obesity did not improve, at least one year of intervention may be needed. This study could be used by healthcare professionals to understand the importance of targeting all influencers for weight loss in children from socioeconomically vulnerable backgrounds.
Abstract
Background: We aimed to examine whether the Healthy Children, Healthy Families, and Healthy Communities Program, consisting of multi-level strategies for obesity prevention tailoring the context of socioeconomically vulnerable children based on an ecological perspective, would be effective on improving their healthy lifestyle behaviors and obesity status. Methods: Participants were 104 children (and 59 parents) enrolled in public welfare systems in Seoul, South Korea. Based on a cluster-randomized controlled trial (no. ISRCTN11347525), eight centers were randomly assigned to intervention (four centers, 49 children, 27 parents) versus control groups (four centers, 55 children, 32 parents). Multi-level interventions of child-, parent-, and center-level strategies were conducted for 12 weeks. Children's healthy lifestyle behaviors and obesity status were assessed as daily recommended levels and body mass index ≥85th percentile, respectively. Parents' parenting behaviors were measured by the Family Nutrition and Physical Activity scale. Results: Compared to the control group, the intervention group showed significant improvements in total composite scores of healthy-lifestyle behaviors-including 60-min of moderate physical activity-but not in obesity status among children. Moreover, the intervention group showed significant improvements in parenting behaviors among parents. Conclusion: The multi-level strategies for obesity prevention based on an ecological perspective may be effective for promoting healthy lifestyles among socioeconomically vulnerable children.